Opinion

BURLINGTON DRUG CO., INC. v. PFIZER INC.

Court: District Court, D. New Jersey
Filed: Jun 6, 2024
Cited by: 0 cases
Authority: More cited than 31.6%

“In order to establish antitrust injury here, the Appellants must show that the harm they say they experienced——increased drug prices for Wellbutrin XL (and its generic equivalents}—was caused by the settlement they are complaining about.” (internal citations omitted)

How later courts described this case

“In order to establish antitrust injury here, the Appellants must show that the harm they say they experienced——increased drug prices for Wellbutrin XL (and its generic equivalents}—was caused by the settlement they are complaining about.” (internal citations omitted)
“The mere existence of a scintilla of evidence in support of the plaintiffs position will be insufficient; there must be evidence on which the jury could reasonably find for the plaintiff.”

Written by the judges who cited it.

The opinion

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

IN RE LIPITOR ANTITRUST} MDL No. 2332

LITIGATION

Master Docket No,: 3:12-cv-2389

(PGS/JBD)

This Document Relates To:

All Actions MEMORANDUM

Pending before the Court are several motions—two Motions for Class

Certification and a Motion for Summary Judgment. Herein, the Court addresses the

Motion for Summary Judgment filed by Ranbaxy Inc., Ranbaxy Laboratories

Limited, Ranbaxy Pharmaceuticals, Inc, (hereinafter, “Ranbaxy” or “Defendant”).'

(ECF No. 1183). Plaintiffs are direct purchasers, end payors, and optout retailers of

brand and generic Lipitor, a cholesterol medication.

Defendant argues that Plaintiffs have failed to provide any evidence that FDA

would have approved Ranbaxy’s Lipitor ANDA any earlier-—-that is, on November

This Motion was originally filed by both Pfizer Inc., Pfizer Ireland

Pharmaceuticals, Warner-Lambert Company, and Warner-Lambert Company LLC

(collectively, “Pfizer’) and Ranbaxy. In August 2023, when oral argument was

tentatively scheduled, DPPs and EPPs announced their tentative settlement with

Pfizer. As such, Pfizer no longer participated in the motion practice surrounding

this motion. Herein, the Court refers only to the remaining Defendant Ranbaxy

although initial briefing was filed by both Pfizer and Ranbaxy.

29, 2011--had the November 30, 2011 launch date set forth in the disputed

Settlement Agreement been different. For their part, Plaintiffs argue that there is

extensive documentary evidence that Ranbaxy would have obtained FDA ANDA.

approval earlier than November 30, 2011 if the FDA had had a different launch date

to target. They argue that had Pfizer not paid Ranbaxy to delay entry and the generic

Lipitor launch date had been earlier than November 30, 2011, “it was more likely

than not” that FDA would have approved Ranbaxy’s [Lipitor] ANDA on an earlier

date. (ECF No. 1217 at 3). A number of exhibits and two expert opinions—that of

Plaintiffs’ Expert Kurt Karst (ECF No. 1184-3 at Ex. 3 (hereinafter, “Karst Rep.”))

and Defendant’s Expert, Daniel Troy (ECF No. 1184-3 at Ex. 8 (hereinafter, “Troy

Rep.”))—were submitted in support of this motion. Oral argument on the present

motion, the Motion for Class Certification by the Direct-Purchaser Plaintiffs (ECF

No. 1221), and the Motion for Class Certification by the End-Payor Purchaser

Plaintiffs ECF No. 1251) were heard on November 27 and 28, 2023. For the reasons

below, the Court agrees with Defendant that no genuine issue of material fact exists.

Summary judgment is therefore appropriate.

In ruling first on this Motion for Summary Judgment, the Court is acting in

the interests of judicial efficiency given the fundamental inability of the Plaintiffs to

show an integral element of their cause of action: causation, This is because, in

order to have standing to sue, Plaintiffs must show that the harm they say they

experienced—class-wide overcharges due to the delayed entry of a generic Lipitor—

was caused by the delay in the entry date of that generic Lipitor equivalent. Jn re

Wellbutrin XL Antitrust Litig. Indirect Purchaser Class, 868 F.3d 132, 164 (3d Cir.

2017) (“In order to establish antitrust injury here, the Appellants must show that the

harm they say they experienced——increased drug prices for Wellbutrin XL (and its

generic equivalents}—was caused by the settlement they are complaining about.”

(internal citations omitted)). Plaintiffs contend that if FDA approval of Ranbaxy’s

Lipitor ANDA had occurred any earlier—even by one day—that it is sufficient to

sustain their cause of action with respect to antitrust injury.

The elements of Plaintiffs’ antitrust claims are injury, causation, and damages.

See In re Hydrogen Peroxide Antitrust Litig., 552 F.3d 305, 311 Gd Cir. 2008), In

order to sustain a cause of action, Plaintiffs must prove that they suffered an injury

caused by Defendant’s conduct. Here, a particular aspect of causation—whether

FDA would have approved Ranbaxy’s Lipitor ANDA earlier than it actually did in

the real world had the disputed Settlement Agreement provided for a different,

earlier entry date, thereby directly affecting the injury suffered by the prospective

classes-—is at the forefront. Plaintiffs here are unable to show that Ranbaxy would

have obtained U.S. Food and Drug Administration (hereinafter, “FDA”) approval

for a generic Lipitor Abbreviated New Drug Application (hereinafter, “ANDA”)

before November 30, 2011 on November 29, 2011, Although Plaintiffs claim that

Pfizer, the manufacturer of brand-drug Lipitor, delayed competition per a disputed

Settlement Agreement with Ranbaxy (manufacturer of generic Lipitor) which

prevented the generic Lipitor equivalent to enter the market until November 30,

2011, the Court agrees with Defendant who contends that Plaintiffs have failed to

create a genuine issue of material fact that it was more likely than not that FDA

would have completed its review any sooner and approved Ranbaxy’s generic drug

manufacturer’s ANDA earlier than November 30, 2011—even by one day—on

November 29, 2011.

For the reasons below, summary judgment is GRANTED.

The following facts are largely adopted from Defendant’s Rule 56 Response

(ECF No. 1235-1). Plaintiffs disputed many of Defendant’s findings as

“immaterial,” sometimes arguing that a statement “implied” another conclusion that

was not a fact. Unless otherwise noted, the Court disagreed with Plaintiffs’

assessment and incorporated those findings as undisputed herein. Where the Court

thought that an argument as to whether a fact was undisputed was colorable, the

Court addressed such objections in a footnote.

I. Brand Lipitor for the Treatment of High Cholesterol and Reduction of

Heart Risk

A class of drugs known as “statins” lowers cholesterol by slowing down the

liver’s production of cholesterol and increasing the liver’s ability to remove

cholesterol that is already in the blood. (ECF No. 1235-1 □□ 41). Lipitor® is a statin

containing the active pharmaceutical ingredient atorvastatin calcium. (ECF No.

1235-1 at { 2).

Beginning in 1987, Pfizer secured several patents protecting Lipitor and the

active ingredient, atorvastatin calcium. (ECF No. 1235-1 at 93). On June 17, 1996,

Warner-Lambert—a wholly owned subsidiary of Pfizer, Inc-—submitted a New

Drug Application (hereinafter, “NDA”) seeking FDA approval to sell atorvastatin

calcium. (ECF No, 1235-1 at § 4), On December 17, 1996, FDA approved Warner-

Lambert’s NDA for atorvastatin calcium. (ECF No. 1235-1 at 95). Pfizer launched

its atorvastatin calcium, Lipitor, in 1997, (ECF No, 1235-1 at 6). Atorvastatin

calcium “can exist both in amorphous forms and in a significant number of different

crystalline forms;” but “crystalline forms of atorvastatin, are more chemically stable

than amorphous forms” and amorphous forms may exhibit “higher levels of

impurities” and “be more susceptible to degradation” than crystalline versions.

(ECF No, 1235-1 at 47). The active pharmaceutical ingredient in brand Lipitor is a

crystalline form of atorvastatin calcium. (ECF No. 1235-1 at ¥ 8).

II. EFDA’s Review and Approval of Generic Drugs

FDA is charged with reviewing and approving ANDAs that seek approval to

market generic versions of branded drugs. To ensure that a generic drug meets all

statutory requirements for approval, FDA reviews the application to ensure that it

has all the necessary components and then performs a bioequivalence review, a

chemistry/microbiology review, a labeling review, and a facility review (including

a facility inspection). (ECF No. 1235-1 at ¥ 9).

FDA generaily strives to review ANDAs efficiently to permit generic drugs

to launch as early as possible, but its first priority is to ensure the safety and

effectiveness of generic drugs. FDA will not “cut corners” to approve a product that

it has not determined is safe and effective. (ECF No, 1235-1 at 910; see also ECF

No. 1184-3 at T186:14-T187:3). Indeed, FDA does not always give ANDA

approval for generic products by the earliest possible entry date. (ECF No. 1235-1

at § 11). For example, FDA did not approve Ranbaxy’s first-to-file ANDA for

valsartan (generic Diovan®) until June 2014, despite that Ranbaxy was permitted to

launch valsartan in 2012. (d.). Similarly, Teva entered an agreement with Mylan

and Pfizer that would have permitted Teva to launch an epinephrine auto-injector

(generic EpiPen®) by June 22, 2015, but FDA did not approve Teva’s ANDA until

August 16, 2018. (id).

? Plaintiffs dispute these facts as “immaterial[,]” stating that the statements are “not

relevant to whether the FDA was likely to approve Ranbaxy’s ANDA earlier than

November 30, 2011 had Pfizer not paid Ranbaxy to delay its generic, the only issue

that Defendants sought leave of Court to address in this motion.” (/d.). In reply,

Ranbaxy states that the fact is undisputed and that Plaintiffs’ assertion is

argumentative and does not comport with the Local Rules of the District of New

Jersey. Because no genuine issue of material fact has been shown and because this

information is helpful to evaluating the timeline and the regulatory history upon

which FDA was working, the Court accepts the above included statements as fact.

HI. Ranbaxy Filed the First ANDA for Generic Lipitor and Triggered a

Patent Infringement Lawsuit

A. Ranbaxy’s Lipitor ANDA

Manufacturers who file an ANDA seeking FDA approval to market a generic

version of a brand product must include a “certification” in their ANDA based on

the status of patents that cover the brand product; if FDA’s “Orange Book” lists a

patent or patents that cover the brand product, an ANDA applicant’s patent

certification must state: (1) that the patent has expired (hereinafter, a “Paragraph I

Certification”); (2) that the applicant will not seek to launch a generic version of the

brand product until all Orange Book listed patents expire (hereinafter, a “Paragraph

Ill Certification”); or (3) that the relevant patents are “invalid, unenforceable, or will

not be infringed by the manufacture, use, or sale of the new drug for which the

application is submitted[]” (hereinafter, a “Paragraph IV Certification”). (ECF No.

1235-1 at § 12).

On August 19, 2002, Ranbaxy filed the first substantially complete ANDA

that contained a Paragraph IV Certification; this ANDA sought approval to market

a generic version of Lipitor (hereinafter, “Ranbaxy’s Lipitor ANDA”) and was,

therefore, eligible for a 180-day period of marketing exclusivity (a period of time

known as “first-filer exclusivity”), (ECF No. 1235-1 at § 13).

Ranbaxy’s Lipitor ANDA contained Paragraph IV Certifications alleging that

Pfizer’s U.S. Patent No. 4,681,893 (the “’893 patent”) and U.S. Patent No. 5,273,995

(hereinafter, the “’995 patent”) were either invalid or not infringed by Ranbaxy’s

generic atorvastatin calcium products. (ECF No. 1235-1 at 4 14).

Under the pre-2003 version of the Hatch-Waxman Act, FDA could not finally

approve any subsequently-filed ANDA for atorvastatin calcium tablets until: (1)

Ranbaxy’s first-filer exclusivity lapsed; (2} Ranbaxy relinquished or selectively

waived its first-filer exclusivity; (3) or FDA determined that Ranbaxy’s application

was not substantially complete when filed in 2002 and thus, Ranbaxy was not

eligible for first-filer exclusivity in the first place. (ECF No. 1235-1 at | 15).

While FDA approved a “more chemically stable” crystalline form of brand

Lipitor in 1996, Ranbaxy’s 2002 ANDA sought approval for an amorphous form of

atorvastatin calcium, which was “more susceptible to degradation.” (ECF No. 1235-

1 at 16). Ranbaxy’s 2002 ANDA indicated that its “Atorvastatin Calcium Tablets

10 mg, 20 mg, 40 mg and 80 mg [would] be manufactured at Ranbaxy Laboratories

Limited’s FDA registered and inspected Paonta Sahib, India facility” and the

“manufacturer of the Atorvastatin Calcium drug substance used to produce the

Plaintiffs dispute this finding in so much as it “implies that FDA had not determined

in 2002 that Ranbaxy’s generic Lipitor ANDA was substantially complete when

filed in 2002.” Ud.). Inreply, Defendant states that the fact is undisputed and that

Plaintiffs’ assertion is argumentative. The Court agrees that no such implication is

created by reciting the regulatory backdrop against which the parties were working.

Because no genuine issue of material fact has been shown and because this

information is helpful to evaluating the timeline and the regulatory history upon

which FDA was working, the Court relies on this statement as fact.

ANDA batches of drug product [was] Ranbaxy Laboratories Limited, Toansa,

India.” (ECF No. 1235-1 at ¥ 17).

Between 2003 and 2008, FDA identified several deficiencies with Ranbaxy’s

amorphous atorvastatin calcium, including issues with the bioequivalence of the

product to brand Lipitor, the stability and impurity of the generic product, and the

product’s labeling. CECF No. 1235-1 at § 18). Ranbaxy never received tentative or

final approval of its ANDA for the amorphous form of atorvastatin calcium. (ECF

No. 1235-1 at □□ 19).

B. Pfizer Initiated Patent Litigation Against Ranbaxy

According to FDA:

In order to challenge a patent in court, [a] generic applicant that

submitted a paragraph IV certification must notify the brand product

sponsor and any patent holder of the submission of the ANDA and

patent challenge. If the brand product sponsor or patent holder files an

infringement suit against the generic applicant within 45 days of the

ANDA. notification, FDA approval to market the generic drug is

generally postponed for 30 months unless the patent expires or is judged

to be invalid or not infringed before that time. This 30-month

postponement, commonly referred to as the “30-month stay,” gives the

brand product sponsor and patent holder a prescribed amount of time to

assert patent rights in court before a generic competitor is approved and

can market the drug.

(ECF No, 1235-1 at § 20 (quoting Ex. 23, U.S. Foop & DRUG ADMIN., Patent

Certifications and Suitability Petitions, https://perma.cc/JOPD-S92Q (last visited

May 20, 2024)).

Within forty-five days of receiving notice of Ranbaxy’s Paragraph IV

Certifications, Pfizer initiated a patent infringement lawsuit against Ranbaxy. Under

the Hatch-Waxman Act, this triggered an automatic thirty-month stay of FDA’s

approval of Ranbaxy’s Lipitor ANDA. (ECF No. 1235-1 at 921). In August 2006,

the Federal Circuit Court held that Pfizer’s ’893 patent was valid and would be

infringed by Ranbaxy’s generic product and found that one claim in Pfizer’s ’995

patent was invalid due to a scrivener’s error. (ECF No, 1235-1 at ¢ 22). In March

2008, Pfizer initiated a second patent infringement lawsuit against Ranbaxy, alleging

that Ranbaxy infringed Pfizer’s U.S. Patent No. 6,274,740 (hereinafter, the “’740

Patent”) and U.S. Patent No. 6,087,511 (hereinafter, the “’511 Patent”), which cover

the process of making Lipitor. (ECF No. 1235-1 at □ 23).

C. Pfizer and Ranbaxy Resolved Pending Patent Infringement

Litigation

On June 17, 2008, Pfizer and Ranbaxy entered into a Settlement Agreement

to resolve litigation between the two companies regarding some of Pfizer’s Lipitor

patents. (ECF No. 1235-1 at § 24). The Settlement Agreement resolved, among

other things, (1) patent litigation regarding some of Pfizer’s patents for Lipitor,

including litigation abroad; (ii) patent litigation regarding some of Pfizer’s patents

for brand drug Accupril®; and Gii) patent litigation in Ecuador regarding some of

Pfizer’s patents for brand drug Viagra®. (ECF No. 1235-1 at 25).

Through the Settlement Agreement, Pfizer provided Ranbaxy a license that

permitted Ranbaxy to manufacture and launch a generic version of Lipitor

containing the crystalline form of atorvastatin calcium on or after November 30,

2011, approximately five years prior to the expiration of Pfizer’s latest-expiring

Lipitor patent. (ECF No, 1235-1 at § 26).4

In addition, the Settlement Agreement required Pfizer to transfer to Ranbaxy

information regarding its manufacturing technology to “enable [Ranbaxy] to make

the preferred crystalline” active pharmaceutical ingredient in Lipitor. (ECF No.

1235-1 at § 27).

IV. While Ranbaxy’s Lipitor ANDA Was Pending, the Company Faced

Severe Regulatory Consequences for Violations of Current Good

Manufacturing Practices

A. FDA Regulatory Programs to Ensure Compliance with Current Good

Manufacturing Practices

“FDA ensures the quality of drug products by carefully monitoring drug

manufacturers’ compliance with its Current Good Manufacturing Practice []

regulations” (hereinafter, “cGMP” or “CGMP”). “The approval process for new

and generic drug marketing applications includes a review of the manufacturer’s

Plaintiffs dispute this statement in so much that it “implies that Pfizer’s patents

would have prevented the launch of Ranbaxy’s generic Lipitor until the patents

expired.” Ud.). Plaintiffs’ argument is without merit; this is a statement laying out

the earliest possible entry date of generic Lipitor under the disputed Settlement

Agreement. The Court adopts this fact.

compliance with the CGMPs.” (ECF No. 1235-1 at 928). FDA routinely “conducts

inspections and assessments of regulated facilities to determine a firm’s compliance

with applicable laws and regulations.” (ECF No. 1235-1 at ¥ 29). If, during an

inspection, FDA investigators observe conditions at a manufacturing facility that

they deem to be objectionable, the investigators list their observations on an FDA

“Form 483.” (ECF No. 1235-1 at 7 30).

“When FDA finds that a manufacturer has significantly violated FDA

regulations, FDA notifies the manufacturer ... often in the form of a Warning

Letter.” (ECF No. 1235-1 at 4 31). As detailed by FDA in its “Fraud, Untrue

Statements of Material Facts, Bribery, and Illegal Gratuities” policy— commonly

referred to as the “Application Integrity Policy” (hereinafter, the “ATP”)—the AIP

describes FDA’s approach to “the review of applications that may be affected by

wrongful acts that raise significant questions regarding data reliability.” CECF No.

1235-1 at J 32).

As an aside, Paragraph 33 and Plaintiffs’ response present a procedural

concern that must be addressed. Plaintiffs dispute Paragraph 33 with a long

recitation of facts and argument that do not comport with Local Rule 56.1 of the

District Court of New Jersey. For its part, Ranbaxy claims that the statement in

Paragraph 33 is undisputed.

12 ,

For some unknown reason, Plaintiffs failed to submit a supplemental

statement of disputed material facts where their Paragraph 33 response could have

been more appropriately placed. Plaintiffs’ response does not conform with the rules

of this Court; it is rife with both legal arguments and conclusions of law. For

instance, in one of the sentences in their response, Plaintiffs write: “Had Ranbaxy

agreed to an earlier entry date with Pfizer, FDA would have targeted an earlier date

to complete review of Ranbaxy’s Lipitor.” (ECF No. 1235-1 at 33, response 0). This

sentence is the heart of this motion for summary judgment and is wholiy

inappropriate in a Rule 56.1 statement as it neither disputes the statement originally

set forth in Paragraph 33 nor does this statement raise a genuine issue of material

fact.

Like other Courts in this District, the Court “will not go through the responses

line by line to determine in each instance where Plaintiffs] ‘blur[] the line between

fact and opinion’” to determine where nonconformity with Rule 56.1 exists. Durkin

v. Wabash Nat., No. 10-cv-2013, 2013 WL 1314744, at *6 (D.N.J. Mar, 28, 2013)

(internal citations omitted), Instead, the Court adopts what it believes to be the key

point of Paragraph 33: there is a regulatory process known as the AIP which

enumerates FDA’s review procedure. In the AIP, FDA responds to concerns about

the reliability of data in the AIP applications. It is rarely invoked by FDA. (See

Troy Rep. at § 24; ECF No 1184-3 at Ex. 7 at Feb. 28, 2023 Karst Dep. at T57:2-4).

FDA’s validity assessment to determine whether an application is affected by

data-integrity issues “lead[s] to delays in [FDA’s] review of pending applications.”

(ECF No. 1235-1 at 7 34).°

B. Between 2006 and 2008 FDA Discovered and Warned Ranbaxy of

Several CGMP Violations at Ranbaxy’s Paonta Sahib Facility

On February 20, 21, 22, 23, 24, and 25, 2006, FDA inspected Ranbaxy’s

Paonta Sahib facility. (ECF No. 1235-1 at 935). On February 25, 2006, FDA

issued a Form 483 (hereinafter, the “February 25 Form 483”) to Ranbaxy listing

> Plaintiffs dispute this assertion in so much that it “implies” that the FDA validity

assessment led to delays in the ANDA review and that FDA “would not have begun

reviewing Ranbaxy’s Lipitor ANDA earlier absent the allegedly anticompetitive

conduct .....” To support this, Plaintiffs rely on their response to Paragraph 33.

Again, Plaintiffs’ response to Paragraph 33 is comprised of legal argumentation and

conclusions of law. Further, it is unclear which items of evidence cited in Plaintiffs’

Paragraph 33 response Plaintiffs believe support their purported dispute. See

Durkin, 2013 WL 1314744, at *6 (stressing that arguments regarding the “force”

and “legal relevancy” of a fact belong in a brief and should be disregarded in

response to a New Jersey Local Rule 56.1 statement of fact}; see also James v.

Vornlocker, 19-cv-13690, 2022 WL 3927203, at *2 n.3 (finding that plaintiff

“failfed] to create any disputed issue of material fact because her objections .. .

advance legal conclusions masquerading as fact”); Mays v. Toloza, No. 13-cv-6108,

2021 U.S. Dist. LEXIS 164143, at *2 n.2 (deeming facts undisputed where plaintiff

repeatedly cross-referenced its response to a previous paragraph covering “an array

of topics” and the court was “unable to discern what in the record cause|{d] Plaintiff

to dispute a specific fact”). Looking at the statement itself and the Plaintiffs’

response, there is a genuine dispute of material fact with relation to this fact. For

this reason, the Court accepts Defendant’s statements in Paragraph 34 as true.

eight “inspectional observations” related to “record retention, stability testing

deficiencies, [and] inadequate laboratory staffing.” (ECF No. 1235-1 at § 36).°

On March 20, April 20, and May 25, 2006, Ranbaxy submitted responses to

the inspectional observations set forth in the February 25 Form 483. (ECF No, 1235-

1 at | 37).’ FDA considered Ranbaxy’s “March 20, April 20, and May 25, 2006

responses to the FDA 483 Inspectional Observations issued at Paonta Sahib,” but

FDA “still [had] concerns regarding various observations.” (ECF No. 1235-1 □□

Thus, on June 15, 2006, FDA issued a Warning Letter to Ranbaxy, directed to

the company’s Vice President of Manufacturing, Ramesh Parekh, which indicated

that FDA’s “inspection of [Ranbaxy’s| pharmaceutical manufacturing facility in

Paonta Sahib, India, during the period of February 20-25, 2006 ... revealed

significant deviations from U.S. Current Good Manufacturing Practice (CGMP)

Regulations . . . in the manufacture of drug products.” (ECF No. 1235-1 at 739).

In its June 15, 2006 Warning Letter, FDA stated that “Ju]ntil FDA has

confirmed correction of the deficiencies observed during the most recent inspection

® Plaintiffs contend that this assertion is immaterial, and Defendant responds that

Plaintiffs have failed to indicate their disagreement with Defendant’s statement of

fact. The Court believes that this information belongs in the brief as it provides

context on the regulatory history and timeline under which FDA was working. As

such, the Court admits this statement as fact.

7 See supra note 6.

8 See supra note 6.

See supra note 6.

and compliance with CGMPs, [FDA] will recommend withholding approval of any

new applications listing [Ranbaxy’s] Paonta Sahib facility as the manufacturer of

finished pharmaceutical drug products.” (ECF No. 1235-1 at § 40).!°

The June 15, 2006 Warning Letter further indicated that Ranbaxy’s “failure

to correct the[] deficiencies may result in FDA denying entry of articles

manufactured by [Ranbaxy] into the United States.” (ECF No. 1235-1 at 41).!!

On August 29, 2006, Ranbaxy provided responses to FDA’s Warning Letter dated

June 15, 2006 and indicated that (1) Ranbaxy was “committed to addressing each

issue identified in the Warning Letter and during the FDAJ’s February 2006]

inspection;” (2) Ranbaxy was “undertaking a number of activities to improve [its]

quality programs and to enhance [its] operational performance at the Paonta Sahib

facility;” and (3) Ranbaxy had “retained Ron Tetzlaff and his colleagues at

PAREXEL Consulting (PAREXEL) to verify that [its] stability laboratory program

improvements [were] effective and systemic, and to verify the effectiveness of

[Ranbaxy’s] commitments made in response to the Warning Letter.’ (ECF No.

1235-1 at | 42).!2 On November 29, 2006, Ranbaxy met with FDA to “update FDA

10 See supra note 6.

See supra note 6.

2 See supra note 6,

on Ranbaxy’s progress in resolving the Warning Letter issues, and to hear from FDA

regarding any remaining concerns.” (ECF No. 1235-1 at 9 43).3 _

On January 26, 27, 28, and 29, 2007, FDA re-inspected Ranbaxy’s Paonta

Sahib drug product facility and inspected the API facility for the first time. (ECF

No, 1235-1 at 7 44)."

On February 1, 2007, FDA issued a second Form 483 (hereinafter, the

“February | Form 483”) detailing three inspectional observations made by FDA

representatives during its January 2007 inspection of Ranbaxy’s API facility and

related to Ranbaxy’s “lilnadequate review of production & analytical records, [its]

use of uncontrolled notebook in the warehouse, [and] batch records missing specific

information.” (ECF No. 1235-1 at 9 45). On February 28, 2007, Ranbaxy

submitted responses to the inspectional observations set forth in the February 1 Form

483. (ECF No. 1235-1 at 46).'°

Thereafter, Ranbaxy and FDA communicated on a number of occasions

regarding both FDA’s inspectional observations and Ranbaxy’s work to address

FDA’s concerns. This included communications: (1) on June 18, 2007 and

September 14, 2007 when Ranbaxy submitted retroactive stability verification data

See supra note 6,

'S See supra note 6.

'6 See supra note 6.

for various of its ANDAs; (2) on June 26, 2007, when Ranbaxy met with the Center

for Drug Evaluation and Research’s (hereinafter, “CDER”) Office of Compliance to

discuss Ranbaxy’s and third-party consultant PAREXEL’s retrospective stability

verification projects; (3) on July 27, 2007, when Ranbaxy submitted protocols and

final reports related to Ranbaxy’s and PAREXEL’s stability verification projects;

(4) on October 9, 2007, when FDA indicated it had completed its review of “the

Ranbaxy Stability Data Verification Project information” and provided a list of

“questions and concerns that need clarification;” and (5) on October 25, 2007, when

Ranbaxy provided responses to FDA’s October 9, 2007 questions. (ECF No. 1235-

1 at ¢47).7

On March 3, 4, 5, 6, and 7, 2008, FDA inspected Ranbaxy’s Batamandi

facility, which it deemed an “extension to the Paonta Sahib site.” (ECF No. 1235-1

at J 48).'8 On March 7, 2008, FDA issued a Form 483 (the “March 7 Form 483”) to

Ranbaxy listing seven inspectional observations regarding “discrepancies in batch

production records (production operations conducted by employees who were

apparently not present on the dates recorded), [and] inadequate [standard operating

procedures] and laboratory controls.” In April 2008, due to the various cGMP

violations FDA discovered during its inspections of Ranbaxy’s Paonta Sahib

18 See supra note 6.

facilities, Ranbaxy declared in federal court that it did not know and could not

estimate “when the FDA will tentatively approve [its Lipitor ANDA] or whether [its

ANDA|] will ever be approved by the FDA.” (ECF No. 1235-1 at 49).

On May 1, 2008, Ranbaxy submitted responses to the inspectional

observations set forth in the March 7 Form 483. (ECF No, 1235-1 at § 50). On

September 16, 2008, FDA issued two Warning Letters to Ranbaxy indicating that

inspections of Ranbaxy’s Batamandi and Dewas manufacturing facilities revealed

significant deviations from CGMP. (ECF No, 1235-1 at J 51).!

FDA also issued an Import Alert that remains in effect today for generic drugs

produced by Ranbaxy’s Dewas and Paonta Sahib plants. Pursuant to that Import

Alert: “U.S. officials may detain at the U.S. border, any active pharmaceutical

ingredients ... and both sterile and non-sterile finished drug products manufactured

at these Ranbaxy facilities and offered for import into the United States.” (ECF No.

1235-1 at 7 52).”

In its September 16 Warning Letter regarding Ranbaxy’s Batamandi site,

FDA noted that the Batamandi site was “under the same production and quality

management as the existing Paonta Sahib site,” the “Paonta Sahib site was involved

20 See supra note 6.

21 See supra note 6.

2 See supra note 6.

in various aspects of testing and production for the Batamandi site,” FDA

“consider[ed] the Batamandi (Unit IT) facility to be a part of the existing Paonta

Sahib facility,” and “fa]s such, the violations observed during the March 2008

inspection are indications of continuing CGMP deficiencies in the quality systems

at the Paonta Sahib facility including the failure of production and quality

management to prevent such deficiencies.” (ECF No. 1235-1 at ¥ 53).

FDA further indicated that “[u]ntil FDA has confirmed correction of the

deficiencies and compliance with CGMP, this office will continue to recommend

disapproval of any new applications listing the Paonta Sahib facility as the

manufacturing location for finished pharmaceutical drug products.” (ECF No. 1235-

1 at ¢54).24_ On November 13, 2008, Ranbaxy responded to FDA’s September 16

Warning Letter. (ECF No, 1235-1 at § 55).

C. The United States Department of Justice Initiated an Investigation of

Ranbaxy’s CGMP Violations

In February 2007, the United States Department of Justice (hereinafter,

“DOYV’) executed search warrants at Ranbaxy’s United States facilities and began an

investigation concerning Ranbaxy’s possible violations of federal laws, including:

(1) potential violations of the Federal Food, Drug, and Cosmetic Act that the

3 See supra note 6.

*4 See supra note 6,

°5 See supra note 4,

Government “ha[d] reason to believe” resulted in the introduction of “adulterated

and misbranded products into interstate commerce;” (2) potential violations of the

False Claims Act; and (3) “a pattern of systemic fraudulent conduct, including

submissions by Ranbaxy to the FDA that contain false and fabricated information

about stability and bioequivalence, failure to timely report the distribution of drugs

that were out-of-specification (‘OOS’), and attempts to conceal violations of current

Good Manufacturing Practices (‘cGMP’) regulations from the FDA.” (ECF No.

1235-1 at | 56).76

The DOJ’s investigation ended only after (1) Ranbaxy signed a consent decree

that required Ranbaxy “to strengthen procedures and policies regarding data

integrity and to comply with good manufacturing practices,” and (2) Ranbaxy

pleaded guilty “to felony charges relating to the manufacture and distribution of

certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in

India” and “agreed to pay a criminal fine and forfeiture totaling $150 million and to

settle civil claims under the False Claims Act and related State laws for $350

million.” (ECF No. 1235-1 at 9 57).2’

D. FDA Invoked its AIP Against Ranbaxy’s Paonta Sahib Facility

*6 See supra note 6,

27 See supra note 6.

On February 25, 2009, FDA announced that it invoked its AIP against

Ranbaxy’s Paonta Sahib facility. (ECF No. 1235-1 at 9 58). In a memorandum

addressed to Ranbaxy’s CEO and Managing Director, Malvinder Mohan Singh,

FDA indicated that CDER:

“hal[d| determined that Ranbaxy Laboratories Limited (Ranbaxy)

submitted untrue statements of material fact in abbreviated and new

drug applications filed with the Agency. These findings concern the

submission of information, such as from stability test results in support

of pending and approved drug applications, from the Ranbaxy

Laboratories Limited site located at Paonta Sahib.”

(ECF No. 1235-1 at 959). According to FDA, FDA’s findings “indicate[d] a pattern

and practice of submitting untrue statements of material fact and other wrongful

conduct, which raise[d] significant questions regarding the reliability of the data and

information contained in applications (pending and approved) that [Ranbaxy] has

filed with the Agency and which contain data developed at the Ranbaxy

Laboratories, Paonta Sahib site.” CECF No. 1235-1 at | 60). As a result, and in

accordance with FDA policy, FDA needed to “assess the validity of the data and

information in all of Ranbaxy’s affected applications which contain data developed

at the Paonta Sahib site.” (ECF No. 1235-1 at 7 61).

FDA’s assessment of data and information validity took “priority over

substantive scientific data review until questions of data integrity [were] resolved,”

and therefore, FDA notified Ranbaxy that it did “not intend ordinarily to conduct or

to continue its normal substantive scientific review (including review of data and

labeling) of any such pending application or supplement, or of any new application

or supplemental applications filed after the date of this letter, that contain data

developed at the Paonta Sahib site, during a validity assessment of that application.”

(ECF No. 1235-1 at { 62).78

Ranbaxy’s atorvastatin calcium ANDA was among sixty-five applications

impacted by FDA’s invocation of the AIP. As a result of scientific review,

Ranbaxy’s Lipitor ANDA “was required to be delayed until FDA [was] satisfied that

the data or information in the application [was] reliable”’” (ECF No. 1235-1 at |

8 Plaintiffs argue that this statement is disputed because it “implies that the scientific

review of Ranbaxy’s Lipitor ANDA was actually delayed until FDA completed a

validity assessment was satisfied that the data or information in the ANDA was

reliable . . . [and that] this statement... implies FDA would not have begun

reviewing Ranbaxy’s Lipitor ANDA earlier absent the allegedly anticompetitive

conduct.” Plaintiffs generally assert that this rationale was addressed in their

Response to Paragraph 33. Defendant responds that the Plaintiffs failed to address

why the fact was disputed, instead asserting a legal argument. Here, the Court agrees

with Defendant’s rationale; Plaintiffs have failed to explain why the facts here are

in dispute, rather inserting legal argumentation in their Rule 56.1 response. Such a

response is both improper and unhelpful. As such, the Court admits these facts as

true.

In a similar way to their response to Paragraph 62, Plaintiffs claim that this is

disputed to the extent that the statement implies that the scientific review of

Ranbaxy’s Lipitor ANDA was actually delayed until the validity assessment was

completed and that this statement implies that FDA would not have begun reviewing

Ranbaxy’s Lipitor ANDA earlier absent the allegedly anticompetitive conduct.

Similarly, Plaintiffs incorporate by reference their response to Paragraph 33. For the

reasons previously stated in the analysis of Paragraph 62, the Court deems this

statement admitted. See supra note 28.

Y. Ranbaxy Attempted to Resolve the Significant Violations of CGMP that

Motivated Invocation of FDA’s Application Integrity Policy

A. Ranbaxy Submitted a Corrective Action Operating Plan to FDA for

Review

Once the AIP is invoked, an applicant is generally expected to develop a

“corrective action operating plan,” which is “the applicant’s written operating plan

that describes its commitment, procedures, actions, and controls to ensure data

integrity.” (ECF No, 1235-1 at 64)" Ranbaxy began planning its response to

FDA’s February 25, 2009 AIP letter immediately, beginning with an internal

meeting on February 26, 2009. (ECF No. 1235-1 at ¢ 65).2! On April 8, 2009,

Ranbaxy met with FDA representatives to discuss FDA’s February 25, 2009 letter

“implementing the Application Integrity Policy (AIP) relative to product

submissions containing data generated at Ranbaxy’s Paonta Sahib, India

manufacturing facility.” (ECF No. 1235-1 at | 66).°? During the April 8, 2009

meeting, Ranbaxy “provide[d] FDA with updated information on the actions taken

by Ranbaxy to address the issues mentioned in the AIP letter, and propose[d]

elements for a Corrective Action Operating Plan (CAOP) going forward.” (ECF No.

1235-1 at 4 67).*

30 See supra note 6.

3! See supra note 6,

32 See supra note 6.

33 See supra note 6,

According to minutes from the April 8, 2009 meeting, Joseph C. Famulare—

then Deputy Office Director of FDA’s Office of Compliance—stressed that FDA

wanted “assurance from Ranbaxy that all data are accurate.” Famulare noted that

“the errors reported by Ranbaxy were not few in number,” and he requested “a

complete and comprehensive plan” to resolve Ranbaxy’s cGMP violations,

including a third-party assessment of Ranbaxy’s raw data that could be sent directly

to FDA (rather than through Ranbaxy). (ECF No. 1235-1 at 4 68).*4

On May 18, 2009, Ranbaxy submitted a proposed Corrective Action

Operating Plan (“May 18 CAOP”) that Ranbaxy developed with third-party

Quintiles Consulting (hereinafter, “Quintiles”) and it “provide[d] for analysis of the

cause and scope of data integrity issues; audit of approved and pending applications;

and remediation of any errors detected,” (ECF No. 1235-1 at 69).° The May 18

CAOP’s purpose was to “(1) validate, through a series of audits, the reliability and

integrity of data contained in applications submitted to FDA; (2) ensure quality of

marketed products; and (3) prevent future instances of data errors and/or wrongful

acts, and noncompliance with regulatory requirements for approved and pending

applications—so as to help assure the credibility and accuracy of data contained

therein.” (ECF No. 1235-1 at 9 70).2° The May 18 CAOP proposed to determine

34 See supra note 6.

3° See supra note 6.

36 See supra note 6.

whether “the data contained in filed ANDA/NDA applications [was] authentic, and

traceable to source documents; or otherwise reliable through audits, reviews, and

assessments” by: (1) “|rleview[ing] past events which may have caused

compromised data to be included in applications made to FDA,” (2) “[a]udit[ing]

data contained in applications made to FDA; classifying] findings as minor, major

or critical; identify[ing the] root cause of findings; and provid[ing] corrective actions

to remediate past applications made to FDA-—and prevent recurrence,” (3)

[a]ssess[ing] cGMP/Quality System compliance as it relates to the manufacturing of

the product in the applications made to FDA, and develop[ing] corrective actions, as

warranted,” (ECF No. 1235-{ at § 71).2’ The May 18 CAOP further indicated that

third-party auditor Quintiles would audit applications implicated by the AIP “for

authenticity of data, traceability, and stability performance” including by reviewing

“bioequivalence, product formulations and manufacturing operations,” classifying

its findings as “Minor, Major, or Critical,” developing, implementing, and verifying

a corrective action plan, and reporting its findings directly to FDA. (ECF No, 1235-

1 at | 72)°® On July 1, 2009, Quintiles submitted a Product Validity Evaluation

Checklist addendum to the May 18 CAOP to FDA for its review. (ECF No. 1235-1

at § 73).°?

37 See supra note 6.

38 See supra note 6.

° See supra note 6.

B. FDA Provided Feedback Regarding Ranbaxy’s Corrective Action

Operating Plan

On July 31, 2009, FDA sent Ranbaxy a letter stating that it “concluded that

[the May 18 CAOP] will require significant improvements to meet the expectations

of the Application Integrity Policy” and noted that while the May 18 “CAOP

provides a high-level overview of the operations that will be conducted as part of the

plan,” FDA expected “to review the protocols that will provide specific instructions

and/or procedures to be followed by Quintiles;” FDA acknowledged in its letter that

it had not completed its review of Quintiles’ July 1, 2009 Product Validity

Evaluation Checklist. (ECF No. 1235-1 at 74).*°

On August 18, 2009, Ranbaxy met with FDA to discuss, among other things,

FDA’s feedback on the May 18 CAOP and the Product Evaluation Checklist. (ECF

No. 1235-1 at § 75).4! Deborah Autor, the Director of CDER’s Office of

Compliance, opened the August 18 meeting “with an FDA _ presentation

summarizing FDA’s perspective regarding Ranbaxy’s history of compliance, and

FDA’s residual concerns,” noting, for instance, that FDA’s current concerns

included, (1) Ranbaxy’s “[flailure to have an Appropriate Global Quality Culture,”

(2) Ranbaxy’s “[l]ack of overall understanding of GMPs,” (3) Ranbaxy’s “[rJepeated

violations of GMPs related to: (a) “lack of [standard operating procedures];” (b)

4° See supra note 6.

4! See supra note 6.

“Tslelecting convenient data to report;” (c) [ploor, inadequate or lack of

investigations,” (d) “[qjuestionable GMP practices regarding stability programs;”

(e) “[q]uestionable data handling and reporting practices;” and (£) “[e]mployees not

present at a site, appearing as performing an activity.” (ECF No. 1235-1 at § 76).

Ms. Autor’s presentation included an “FDA Message” indicating that “Ranbaxy

needled] to provide to FDA significant assurance of: 1) Sustainable CGMP

conformance has been instituted, and; 2) Robust evaluation and comprehensive

resolution of extant data integrity issues” adding that:

The agency has invested an extraordinary amount of resources

conducting reviews, inspections and evaluation of data submitted by

Ranbaxy, in an attempt to work with Ranbaxy in achieving compliance.

[Ranbaxy] has communicated its interest in being re-inspected by the

agency without the needed changes in global quality philosophy, data

integrity practices and CGMPs. We are not confident that all sites have

a clear understanding of FDA requirements, including CGMPs.

(ECF No. 1235-1 at 977)."7 During the same August 18, 2009 meeting, FDA gave

principle approval for Ranbaxy to commence initiation of the May 18 CAOP using

the Product Evaluation Checklist submitted on July 1, 2009. CECF No. 1235-1 at □

C. Ranbaxy and its Third-Party Auditor Began an ANDA Validity Review

Based on Ranbaxy’s Corrective Action Operating Plan

See supra note 6.

3 See supra note 6.

“4 See supra note 6.

On September 30, 2009, Ranbaxy sent a letter to CDER’s Deborah Autor

reporting “significant progress” that Ranbaxy had made “in several critical areas,”

noting that Quintiles had “revised, and submitted to [FDA] the ANDA audit

checklist consistent with [the] discussion on [August] 18th,” had “used [the]

checklist in completing a number of ANDA reviews,” and “anticipate[d] submitting

its first certifications to FDA soon.” (ECF No. 1235-1 at 79). On November

16, 2009, Quintiles completed a Ranbaxy Product Validity Evaluation Checklist

Summary for Ranbaxy’s Atorvastatin Calcium Tablets. (ECF No. 1235-1 at □ 80).*°

Quintiles summarized its findings and explained that its:

review of raw data in comparison to data contained in ANDA # 76-477,

Atorvastatin Calcitum, has been completed while many results were

verified as reported correctly in the ANDA, there were also deficiencies

identified. These included analyst and documentation errors,

documentation control issues and lack of an investigation regarding

accelerated dissolution out of specification (OOS) result... . The

Bioequivalence (BE) Study for Atorvastatin was evaluated in

accordance with the approved assessment checklist and found to be

deficient. Typical Fast/Fed clinical studies were conducted (in-vivo)

and correlated to the first campaign in-vitro Comparative Dissolution

testing. The most significant issue of this Side-by-Side

(Ranbaxy/Innovator) dissolution testing is that the original dissolution

data cannot be located. This is deemed to be a Critical finding and must

be addressed. There are two Major findings that must be addressed.

45 See supra note 6.

6 See supra note 6.

(ECF No. 1235-1 at § 81).4? Quintiles proposed several recommended corrective

actions, including that Ranbaxy repeat dissolution testing using new API and

possibly a new clinical study. (ECF No. 1235-1 at 82).

D. FDA Clarified that Ranbaxy’s Lipitor ANDA Validity Review Was

Premature and Requested a Comprehensive Internal Review

On December 8, 2009, FDA formally responded to the May 18 CAOP

indicating that FDA considered the current CAOP to be inadequate in several

respects. (ECE No. 1235-1 at 83)."8 FDA advised that Quintiles “should finish its

internal review of the underlying issues leading to FDA’s invocation of the AIP prior

to conducting validity assessments of the data contained in ANDAs subject to the

AIP.” (ECF No. 1235-1 at 7 84).”” Following receipt of FDA’s December 8, 2009

letter, Ranbaxy acknowledged that “the data upon which FDA makes critical public

health decisions must be reliable” and that “any corrective or preventative actions

[Ranbaxy] may take will be effective only if [it had] a clear understanding of the

scope of wrongdoings and the underlying root cause(s).” (ECF No. 1235-1 at | 85).°°

Thus, Ranbaxy agreed to have Quintiles conduct a detailed Internal Review

“designed to determine the connection between original source data and the

information ultimately submitted to the agency,” including by interviewing

7 See supra note 6.

‘8 See supra note 6.

? See supra note 6.

See supra note 6.

employees who were responsible for generating, reviewing, and approving data and

corroborating objective evidence such as attendance documentation, operation

records or eyewitness accounts to support any conclusions reached. (ECF No. 1235-

1 at J 86)! Pending the conclusion of Quintiles’ internal review, Quintiles

suspended its ongoing ANDA validity assessment and withdrew the ANDA validity

assessments previously submitted to FDA. (ECF No. 1235-1 at ¥ 87).°* Following

a January 21, 2010 meeting between Ranbaxy and FDA, Quintiles submitted an

internal review protocol to FDA for comment and FDA approved the proposed

protocol on February 25, 2010. (ECF No. 1235-1 at 7 88)?

Quintiles initiated its internal review on February 26, 2010. (ECF No. 1235-

1 at 7 89).°4 On April 30, 2010, Quintiles submitted an “Interim Report” to FDA

and on June 2, 2010, Quintiles submitted an addendum to its April 30, 2010 report.

(ECF No, 1235-1 at § 90).°°> As part of its internal review, Quintiles interviewed

over one hundred current and former Ranbaxy employees in the United States and

India and conducted “extensive historical reviews of hardcopy and electronic records

(BCF No. 1235-1 at 991).°° Ultimately, Quintiles concluded that “the major

See supra note 6,

°6 See supra note 6.

findings at Paonta Sahib formulation site are sufficient to conclude that the ANDA

submissions from this site are not supportable without remediation.” (ECF No.

1235-1 at 92).°? Quintiles indicated to FDA on May 28, 2010 and again on June

2, 2010 that it believed it “was at a point in the Internal Review where it may be

appropriate to schedule a meeting between FDA, Quintiles and Ranbaxy to discuss

where we are in the process, and agree on next steps.” (ECF No. 1235-1 at J 93).°8

On April 5, 2011, FDA met with Ranbaxy to “provide feedback on the Quintiles

AIP Internal Review (IR) Report and discuss the next steps forward towards

initiating the ANDA Validity Assessment.” (ECF No, 1235-1 at J 94).°?

VI. While the AIP Was In Place, Ranbaxy Took Several Steps to Put Generic

Atorvastatin on the Market As Soon As Possible

A. Ranbaxy Made Clear to FDA that Review of its Lipitor ANDA Was Top

Priority and Requested that FDA Resume Scientific Review of Its

ANDA on Multiple Occasions

On July 9, 2009, Ranbaxy provided a “priority list of the ANDAs referenced in

the AIP” which “reflect[ed] the order of importance of the products both in terms of

commercial importance and public health significance, ie., products that are of

critical importance by virtue of either being the 1st generic drug product that can be

available to consumers in the marketplace and/or providing a much needed

See supra note 6.

58 See supra note 6.

See supra note 6.

additional source to the healthcare system.” (ECF No. 1235-1 at 995). Ranbaxy’s

Atorvastatin Calcium Tablets were listed first on its July 9, 2009 priority ANDA list.

(ECF No. 1235-1 at 9 96). On August 18, 2009, Ranbaxy met with FDA to discuss,

among other things, the significance of timely availability of key generic drugs.

(ECF No, 1235-1 at § 97).

During its August 18, 2009 meeting with FDA, Ranbaxy provided an

explanation of the benefits of several “‘first-to-file” products currently pending at

Ranbaxy facilities, including Atorvastatin Calcium, “stress[ing] the importance of

assuring the earliest availability of these products to the public” and asking that FDA

“continufe] their substantive scientific review” of these products. In addition,

Ranbaxy told FDA that its planned launch date for generic Lipitor was November

30, 2011. (See ECF No, 1235-1 at 98).

In response, FDA asked Ranbaxy to provide an estimate of the total time for

review of the relevant applications, indicating that “Ranbaxy should take corrective

action based on the CAOP results,” and noting that FDA would consider granting

exceptions for first-to-file ANDAs “based on new information” that Ranbaxy

submitted, and “corrective actions” taken by Ranbaxy. (ECF No. 1235-1 at ¥ 99).

In a letter dated September 30, 2009, Ranbaxy responded to FDA’s August 18, 2009

request for an “estimate of the total time for review of all applications” involving

“important ‘first to file’ low cost generics” and indicated that “Quintiles now

estimates all reviews will be completed no sooner than April 2010.” □□□ No, 1235-

1 at ¥ 100). In light of Quintiles’ timeline, Ranbaxy requested that, “recognizing the

criticality of the timing of some of the ‘first to file’ applications,’ FDA “commence

review of those key ANDAs as Quintiles certifies them, rather than delaying review

until Quintiles has certified all affected applications.” (ECF No, 1235-1 at { 101).

In its letter, Ranbaxy included a table of “time critical products,” including

atorvastatin, and indicated that Ranbaxy would submit “alternate data generated

outside of the Paonta facility.” CECF No. 1235-1 at J 102).

On March 3, 2011, Ranbaxy’s counsel met with FDA. During this meeting,

Ranbaxy stressed that, in their view, “there [was] no support in the statute,

regulations, or the AIP itself for... withholding consideration of [Ranbaxy’s Lipitor

ANDA] where, [as in this case] there [was] no allegation or proof of fraud... .”

According to the minutes from that meeting, the meeting concluded by Ranbaxy

requesting “whether FDA would review the application” noting that an earlier

request to that effect had been made and not yet answered that FDA commence

review of Ranbaxy’s Lipitor ANDA. (ECF No. 1235-1 at § 103; ECF No. 1184-7

at 590),

6 Plaintiffs dispute this response on several grounds, including to the extent that the

statement “implies” FDA would not have begun reviewing Ranbaxy’ Lipitor ANDA

earlier absent the allegedly anticompetitive conduct—incorporating by reference

their response to Paragraph 33. The Court broadened the statement to provide a clear

B. Ranbaxy Submitted Major Amendments to its Lipitor ANDA

Following initial submission of an ANDA, applicants may submit

amendments to their applications, either in response to FDA deficiency notices or

with information not requested by FDA. ANDA amendments can be either minor

“typically require less extensive assessment by FDA”), major (7.e., “the content

of the information or data provided will require extensive assessment”), or

“telephone.” (ECF No. 1235-1 at 104). Major Amendments may include, for

example, “[m]anufacturing a new batch of drug product for any reason,

“Tplerforming a new [bioequivalence] study,” or “[d]eveloping new analytical

procedures and providing full validation data,” while Minor Amendments include,

“lmlinor deficiencies in the drug master file,” “[i]ncomplete dissolution data,” or

“Tllabeling deficiencies that have not been adequately addressed in response to an

information request.” (ECF No. 1235-1 at | 105).

On December 4, 2009, Ranbaxy submitted a Major Amendment to its Lipitor

ANDA (hereinafter, the “December 2009 Major Amendment”). (ECF No. 1235-1

at J 106).°' The December 2009 Major Amendment acknowledged that “Ranbaxy

picture of the factual events surrounding these statements. Accordingly, the Court

adopts the above language.

6! Plaintiffs dispute this response to the extent that the statement “implies that

Ranbaxy could not have submitted this amendment earlier in time.” This is a

statement of fact and makes no such implication. Accordingly, the Court adopts

the above language.

Laboratories Ltd., Paonta Sahib, India was proposed as a manufacturing site for

Atorvastatin Calcium Tablets, 10 mg, 20 mg, 40 mg and 80 mg [in] the original

ANDA” and proposed a series of changes to the original application, including (1) a

“Tclhange in the form of active pharmaceutical ingredient Atorvastatin Calcium from

Amorphous to Crystalline[;]” (2) a “[c]hange in the manufacturer of Atorvastatin

Calcium active pharmaceutical ingredient from M/s Ranbaxy Laboratories Ltd. to

M/s Pfizer[;]” (3) a “[rlevision in drug substance specifications and testing methods”

for the “Drug Substance[;]” (4) the “[a]ddition of a new manufacturing site Ohm

Laboratories Inc., Terminal Road, New Brunswick, New Jersey for the manufacture

of the Drug Product[;]” (5) the “[a]ddition of new analytical testing sites - Ohm

Laboratories Inc.[;]” (6) “Qualitative and Quantitative changes in the Drug Product

Formulation[;]” (7) a “[c]hange in the manufacturing process of the Drug Product];|”

(8) a “[rjevision in drug product specifications and testing methods” for the “Drug

Product[;]” and (9) a “[c]hange in container closure system.” (ECF No. 1235-1 at

107). Ranbaxy’s December 2009 Major Amendment was supported by new

bioequivalence studies. (ECF No. 1235-1 at { 108). Notably, Ranbaxy was able

to change the form of active pharmaceutical ingredient in its atorvastatin calcium

tablets from amorphous to crystalline by relying on the license Pfizer provided to

See supra note 61.

Ranbaxy in the Settlement Agreement, which enabled Ranbaxy to manufacture and

launch a crystalline form of atorvastatin calcium tablets and thereby avoid resolution

of the various ANDA deficiencies that had delayed tentative approval of Ranbaxy’s

Lipitor ANDA between August 19, 2002 and February 25, 2009. (ECF No. 1235-1

at 4 109).6' On November 12, 2010, Ranbaxy submitted another major amendment

to its Lipitor ANDA (the “November 2010 Major Amendment”). (ECF No. 1235-1

at J 110). The November 2010 Major Amendment proposed two further changes

to Ranbaxy’s Lipitor ANDA, including (1) an “[a]dditional source of API - Ranbaxy

Laboratories Limited’s DMF 24139 for Atorvastatin Calcium, USP (crystalline)”

manufactured by Ranbaxy’s Toansa, India facility and (2) “[m]Jinor changes in the

manufacturing process of the drug product manufactured using the proposed

Ranbaxy API.” (ECF No. 1235-1 at ¢ 111).

C. Ranbaxy Entered into an Agreement with Teva Pharmaceuticals USA to

Allow for Potential Launch of Generic Lipitor Prior to November 30,

2011

On December 7, 2010, Ranbaxy entered an agreement with Teva

Pharmaceuticals USA (hereinafter,

“Teva’) “to market finished generic atorvastatin calcium tablet products for

the prescription drug marketplace that are AB Rated” to brand Lipitor products (the

6 See supra note 6.

65 See supra note 61.

66 See supra note 61.

“Atorvastatin Agreement”), (ECF No. 1235-1 at § 112).°? Ranbaxy “believe[d] it

[was] eligible for First to File Exclusivity rights for the Product,” but in order to

make generic atorvastatin calcium tablets more quickly available to consumers in

the United States, Ranbaxy agreed—aunder certain conditions—to either “selectively

waive or relinquish its First to File Exclusivity rights,” and permit Teva to launch

generic atorvastatin calcium tablets pursuant to Teva’s own ANDA (hereinafter,

“Teva Lipitor ANDA”), (ECF No. 1235-1 at J 113).°% Under the terms of the

Atorvastatin Agreement, Teva agreed to use commercially reasonable efforts to

manufacture initial commercial launch quantities of its generic atorvastatin calcium

tablets by no later than June 28, 2011. (ECF No. 1235-1 at 4 114). In order to

launch its generic atorvastatin calcium tablets pursuant to the Atorvastatin

Agreement, Teva was required to provide Ranbaxy with written notice by November

30, 2011 that Teva had initial launch quantities of generic Atorvastatin Calcium

Tablets ready for commercial sale in the United States, that Teva had obtained

tentative approval for the Teva Lipitor ANDA or had received written confirmation

from FDA that the Teva Lipitor ANDA was eligible for final approval, and

requesting that Ranbaxy effectuate a selective waiver or relinquishment of its first-

67 See supra note 6,

68 See supra note 6,

6 See supra note 6.

to-file exclusivity rights. (ECF No. 1235-1 at | 115). On December 15, 2010,

Teva consented to the disclosure of the Atorvastatin Agreement to FDA. (ECF No.

1235-1 at J 116).’' On February 3, 2011, Ranbaxy’s counsel notified FDA that it

had “entered into an agreement with Teva which was intended to expedite the launch

generic atorvastatin” and summarized the critical aspects of the Atorvastatin

Agreement, stating that “the agreement envisions that Ranbaxy will continue to seek

approval of its own ANDA with the intent to commercialize the product,” and “the

agreement between Teva and Ranbaxy provides that Ranbaxy is required to either

relinquish its exclusivity or, if Ranbaxy’s [Lipitor] ANDA has been approved, to

selectively waive its exclusivity in favor of Teva, provided that Teva’s application

is in position to obtain final FDA approval, and Teva has manufactured sufficient

inventory for launch by June 30, 2011.” (ECF No. 1235-1 at 9 117).”2 Ranbaxy

stressed in its February 3 letter that “[a]s a result of the Teva/Ranbaxy arrangement,

Ranbaxy’s exclusivity would not be a bottle neck for approval of other pending

atorvastatin applications, and at least one generic version of atorvastatin should be

on the market in advance of the anticipated November 30, 2011 launch date.” (ECF

No. 1235-1 at ¥ 118).”

7! See supra note 6.

See supra note 6.

® See supra note 6.

. 39

VII. FDA Faced Significant Pressure from Generic Manufacturers of

Atorvastatin to Reassess Whether Ranbaxy’s Lipitor ANDA Was

Substantially Complete When Originally Filed in 2002

A. Apotex, Mylan, and Teva Argued that Ranbaxy’s 180-Day First-Filer

Exclusivity Should Be Extinguished Under the AIP and In Response FDA

Expedited Review of Various Lipitor ANDAs

Prior to the December 8, 2003 enactment of the Medicare Prescription Drug,

Improvement, and Modernization Act (hereinafter, “MMA”), 180-day exclusivity

was to be awarded to the first applicant to file a substantially complete ANDA with

a Paragraph IV Certification. (ECF No. 1235-1 at ¢ 119). The amendments passed

in the MMA established that a first-filer’s 180-day exclusivity period can be

forfeited under certain circumstances, thus, permitting the sponsors of later-filed

ANDAs to obtain final FDA approval. (ECF No. 1235-1 at ¢ 120). Because

Ranbaxy submitted its Lipitor ANDA in 2002, the MMA’s forfeiture provisions did

not apply to it and Ranbaxy’s first-filer exclusivity could be lost only if Ranbaxy

was “not actively pursuing approval of its [Lipitor ANDA]” or if FDA found that

Ranbaxy’s Lipitor ANDA “was not substantially complete when received in 2002,

and therefore did not qualify for the exclusivity under 21 C.F.R. § 314.107(c)(2).”

(ECF No, 1235-1 at 9121).

Recognizing that, but for Ranbaxy’s eligibility for 180-day exclusivity, their

subsequently-filed atorvastatin calctum ANDAs night be eligible for approval prior

to November 30, 2011, Apotex Inc, Mylan Inc., and Teva Pharmaceuticals USA

each wrote FDA arguing that “the agency should declare Ranbaxy ineligible for 180-

day exclusivity (in short, because of the AIP).” (ECF No. 1235-1 at 122). Mylan

Inc. additionally filed a lawsuit against FDA “arguing that since Ranbaxy’s ANDA

076477 originated from the Paonta Sahib site, it should be rejected, and that any

applicable 180-day exclusivity period is extinguished.” (ECF No. 1235-1 at § 123).”

Given the “unusual facts surrounding” Ranbaxy’s Lipitor ANDA, including the

invocation of FDA’s AIP while the ANDA was pending and the various challenges

FDA received to Ranbaxy’s eligibility for first-filer exclusivity, FDA decided to

reassess whether Ranbaxy’s Lipitor ANDA was substantially complete when filed.

(ECF No. 1235-1 at 124).”° Nevertheless, so that FDA would “be prepared to take

an action no matter what the outcome of the Ranbaxy 180-day eligibility decision,”

FDA granted expedited review status to the Teva Lipitor ANDA, Mylan’s ANDA

91-226, Apotex’s ANDA 90-548, and Sandoz Inc.’s ANDA 77-575 “based upon

™ See supra note 6.

® See supra note 6.

7© Here, Plaintiffs dispute this statement of fact to the extent that the statement

“implies that FDA would not have re-examined the substantial completeness of

Ranbaxy’s Lipitor ANDA earlier in time had there been a need, ie., an earlier

Ranbaxy agreed upon entry date for FDA to target.” No such implication is created

by this statement of fact. Because this information is helpful to evaluating the

timeline and the regulatory history under which FDA was working, the Court relies

upon this statement as fact.

their stated ability to be approved on or about June 28, 2011.” (ECF No. 1235-1 at

q 125).”

B. FDA Re-Examined Ranbaxy’s Lipitor ANDA and Determined that It

Was Substantially Complete When Filed

On July 29, 2011, Martin Shimer—Branch Chief of the Office of Generic

Drug’s Regulatory Support Branch---issued a memorandum documenting FDA’s re-

examination of Ranbaxy’s eligibility for first-filer exclusivity. (ECF No. 1235-1 at

4 126).72 The memorandum explained that under 21 C.F.R. § 314.107(c)G)

“exclusivity can be lost if the eligible applicant is ‘not actively pursuing approval of

its abbreviated application;’” but any lull in the review of Ranbaxy’s Lipitor ANDA

was “a function of the AIP status of the ANDA, rather than a result of Ranbaxy’s

failure to pursue approval,” and therefore, “this regulation (which has never been

applied in practice) does not appear to be an appropriate basis on which to deny

Ranbaxy eligibility for exclusivity.” (ECF No. 1235-1 at 4 127).” FDA thus

focused its re-examination on the “second basis for finding Ranbaxy ineligible for

7 See supra note 6.

78 Here, the Plaintiffs dispute this statement of fact to the extent that it “implies FDA

could not and would not have issued approval to Ranbaxy’s ANDA earlier than

November 30, 2011 and/or re-examined the substantial completeness of Ranbaxy’s

Lipitor ANDA earlier in time had there been a need, i.e., an earlier Ranbaxy agreed

upon entry date for FDA to target.” (/d.). No such implication is created by this

statement. As such, because this information is helpful to evaluating the timeline

and the regulatory history under which FDA was working, the Court relies upon this

statement as fact.

See discussion at supra notes 6 and 78.

180-day exclusivity” and assessed whether Ranbaxy’s Lipitor ANDA was

substantially complete when it was submitted in 2002. (ECF No. 1235-1 at 4 128).®°

The Office of Generic Drugs “re-reviewed Ranbaxy’s original 2002 ANDA

submission to verify that it contained the items required for the ANDA to be

considered substantially complete,” including by: (1) “compar[ing] the information

recorded on the ANDA Checklist for Completeness and Acceptability as an

Application ... with the contents of the ANDAJ;]” (2) “confirm[ing] that Ranbaxy’s

original submission contained all required information described in the checklist,

including a signed and completed application form, a basis for submission

description of the reference listed drug (RLD), patent certification, comparison

between the proposed generic drug and RLD (ie., conditions of use, active

ingredient(s), route of administration, dosage form, strength), labeling,

bioavailability/bioequivalence information, components and composition

statements, raw materials controls, description of manufacturing facility, outside

firms including contract testing laboratories, manufacturing and processing

instructions, in-process controls, container information, controls for the finished

dosage form, stability information for finished dosage form, samples, environmental

impact analysis statement, and Generic Drug Enforcement Act information|;]” and

(3) “in light of the concerns about data reliability raised by the issues that formed

the basis for the AIP ., . look[ing] at documents contained in Ranbaxy’s original

submission in greater depth than is usual for a substantial completeness and filing

assessinent,” — e.g., “compar[ing] the lot numbers recorded on various documents to

ensure consistency throughout the submission,” and “review[ing] the dates recorded

on documents such as batch records, certificates of analysis, methods, method

validations, and stability data to ensure that the processes were performed in the

correct order.” (ECF No. 1235-1 at § 129).8! In addition, CDER’s Office of

Compliance “also reviewed sections of ANDA 076477 . . . as well as a number of

other documents” in order to “determine whether there was any evidence specific to

ANDA 076477 to indicate that this application was affected by the same systemic

concerns that were the basis for the AIP.” (ECF No. 1235-1 at 7 130). Following

the re-examination, FDA’s Office of Generic Drugs and Office of Compliance

concluded that, when filed, Ranbaxy’s Atorvastatin ANDA “was sufficiently

complete to permit a substantive review, and that there is no evidence of fraud to

support a conclusion that this determination is not justified.” Thus, FDA concluded

that Ranbaxy retained its first-filer status and was entitled to the 180-day exclusivity

period. (ECF No. 1235-1 at 7 131).8

FDA Granted Ranbaxy an Exception to the AIP and Permitted the Office

of Generic Drugs to Resume its Review of Ranbaxy’s Lipitor ANDA

82 See supra note 78.

83 See supra note 78.

On May 11, 2011, FDA’s Office of Compliance issued a memorandum

“address[ing| the question of whether OGD should proceed with the review of

Ranbaxy|‘s Lipitor] ANDA, as amended” (hereinafter, the “AIP Exception Memo”).

(ECF No. 1235-1 at 7 132).84 The AIP Exception Memo acknowledged submission

of the December 2009 Major Amendment and the November 2010 Major

Amendment, and indicated (1) that “[p]ursuant to the AIP, neither of these

amendments has been reviewed” and (2) the “amendments to the Ranbaxy

application necessitate, in essence, a new full review of the main elements of the

ANDA, including the CMC information, bioequivalence studies, and labeling.”

(ECF No. 1235-1 at § 133).8

In addition to its “new full review” of Ranbaxy’s Lipitor ANDA, FDA needed

“to ensure data reliability of the new Ranbaxy submissions from Ohm Laboratories”

and “determine that they are free of the concerns which gave rise to the AIP;” this

assessment would require FDA to answer at least the following questions: (1) “Have

data from Paonta Sahib or other facilities with significant cGMP or data reliability

concerns been included in the Ohm Laboratories submission?” (2) “Have data

‘migrated’ from earlier submissions into the amendments?” and (3) “Does the

application adequately address known areas of concern, including dissolution,

84 See supra note 78.

5 See supra note 78.

stability, other analytical data, and exhibit batch production records?” (ECF No.

1235-1 at J 134).%6

The Office of Compliance determined that review of Ranbaxy’s Lipitor

ANDA would be appropriate and recommended that review proceed because,

“among other things: (1) the initial findings of the third-party auditor conducting the

internal review at Paonta Sahib indicate that the practices at issue arose during a time

period after 2002; (2) this and other evidence currently available to FDA suggests

that the pattern of activity discussed in the AIP letter would not have affected the

originally filed 2002 ANDA (e.g., untrue statements identified by FDA occurred

subsequent to the original ANDA filing); (3) the ANDA, as amended, purportedly

does not contain data from the Paonta Sahib facility; (4) at this time, FDA is not

aware of evidence that the application for which Ranbaxy is seeking approval (/.e.,

as amended in 2009 and 2010) contains unreliable data or information; (5) review

may be necessary to avoid a situation in which the statutory 180-day exclusivity

blocks approval of any ANDA for atorvastatin; and (6) the overall circumstances are

such that the agency believes it will be able to determine whether the data and

information in the application as amended are reliable and whether the ANDA meets

the requirements for approval.” (ECF No. 1235-1 at 9 135).8”

8? See supra note 78.

FDA acknowledged in the AIP Exception Memo that “November 30, 2011, is

the earliest date Ranbaxy could market its atorvastatin calcium product under its

2008 settlement with Pfizer,” but stressed that “[i]f the data are found to be

unreliable, or the application otherwise does not meet the requirements for approval,

FDA would not approve the ANDA” and that “[t]o be approved, any ANDA for

atorvastatin must meet the requirements under section 505(j) of the FD&C Act and

applicable regulations.” (ECF No. 1235-1 at J 136).8* FDA proposed that, if

Ranbaxy was granted an AIP exception, an expedited review of Ranbaxy’s Lipitor

ANDA commence immediately, but noted that while it “anticipated that FDA’s

review of [Ranbaxy’s Lipitor ANDA could] be completed by” November 30, 2011,

“Fpjrompt review of the ANDA does not, of course, guarantee that the application

will be ready for final approval by November 30, 2011.” (ECF No. 1235-1 at □

137). FDA granted Ranbaxy an exception to the AIP on May 16, 2011. (ECF No.

1235-1 at § 138).°

IX. FDA Proceeded to Complete its Review of Ranbaxy’s Lipitor ANDA by

November 390, 2011

FDA completed its “new full review” of Ranbaxy’s Lipitor ANDA “both for

reliability and approvability” between May 16, 2011 and November 30, 201 1-——in

88 See supra note 78.

See supra note 78.

99 See supra note 78.

just over six months’ time. (ECF No. 1235-1 □□ 139).°! Between 2010 and 2011,

FDA’s median review time to review an ANDA from start to finish was 27,85

months and 29.52 months, respectively.”? (ECF No, 1235-1 at 140).

FDA’s decision to proceed with its review of Ranbaxy’s Lipitor ANDA “set

off flurry of activity at [the Office of Generic Drugs]—and at Ranbaxy.” (ECF No.

1235-1 at | 143).°> Following the May 16, 2011 ATP exception, FDA and Ranbaxy’s

activity related to the Ranbaxy Lipitor ANDA review included the following items:

i, June 2, 2011: Ranbaxy submitted a Gratuitous Labeling

Amendment.

li. June 3, 2017: Ranbaxy submitted a Patent Amendment.

ii, June 7, 2011: Ranbaxy submitted a Gratuitous Chemistry,

Manufacturing, and Controls Amendment.

iv. June 14, 2011: Ranbaxy re-submitted its June 3, 2011 Patent

Amendment to a corrected address.

Vv. June 14, 2011: FDA notified Ranbaxy of several minor quality

deficiencies and requested all available long-term stability data

from Ranbaxy.

vi. June 20, 2011: FDA notified Ranbaxy of bioequivalence

deficiencies and requested that Ranbaxy conduct additional

dissolution testing.

vii. July 18, 201]: Ranbaxy submitted a Bioequivalence Amendment

in response to FDA’s June 20 deficiency notice.

viii. July 27, 2017: Ranbaxy responded to FDA’s June 14 quality

deficiency letter.

ix. July 28, 20117. Ranbaxy submitted a Patent Amendment.

xX. July 29, 2011: FDA completed its Labeling review and

determined that Ranbaxy’s submissions were acceptable.

See supra note 78.

See supra note 6.

See supra note 78.

XL, August 16, 2011: FDA notified Ranbaxy of additional

bioequivalence deficiencies and requested that Ranbaxy repeat

dissolution testing,

xii. August 24, 2011: FDA and Ranbaxy met telephonically

regarding FDA’s August 16 bioequivalence deficiency notice.

xiii. August 26, 2011: Ranbaxy submitted a Bioequivalence

Amendment in response to FDA’s August 16 deficiency notice.

xiv. September I, 2011: Ranbaxy submitted a Gratuitous Amendment

in further response to FDA’s June 14 quality deficiency letter.

xv. September 22, 2011: FDA’s Division of Bioequivalence

submitted a request for a for-cause inspection of Ranbaxy’s Ohm

Laboratories dissolution testing site, citing a “history of

questionable dissolution data submitted for” Ranbaxy’s Lipitor

ANDA.

xvi. September 28-October 3, 2011: FDA’s Office of Manufacturing

and Product Quality conducted the requested inspection of

Ranbaxy’s Ohm Laboratories dissolution testing cite.

xvii, October 3, 2011: FDA requested that Ranbaxy submit a

Telephone Amendment to address minor chemistry deficiencies.

xvili. October 5, 2017: Ranbaxy submitted a Telephone Amendment

in response to FDA’s October 3 request.

xix. October 21, 2011: FDA completed its Quality (Chemistry)

Review and determined that Ranbaxy’s submissions were

acceptable.

xx. October 25, 2011: FDA’s Division of Bioequivalence received

the Office of Manufacturing and Product Quality’s Inspection

Report and found it acceptable.

xxi. October 25, 2011: FDA completed its Bioequivalence Review

and determined that Ranbaxy’s submissions were acceptable.

xxii. November 21-25, 2011: FDA conducted a pre-approval

inspection of Ranbaxy’s Toansa manufacturing facility.

xxili. November 25, 2011: FDA issued a Form 483 (hereinafter, the

“November 25 Form 483”) to Ranbaxy listing inspectional

observations made by FDA representatives during its November

21~25, 2011 inspection of Ranbaxy’s Toansa API facility.

xxiv. November 29, 2011: Ranbaxy responded to FDA’s November 25

Form 483.

xxv. November 30, 20/11: FDA entered an overall recommendation of

“Acceptable” in the Establishment Evaluation System for

Ranbaxy’s Toansa facility.

xxv. November 30, 20/1: FDA approved Ranbaxy’s Lipitor ANDA.

(ECF No, 1235-1 at ¥ 144).”

It was the Office of Generic Drug’s “prompt review of Ranbaxy’s [Lipitor

ANDA]” and “Ranbaxy’s prompt[] respon[ses] to OGD” deficiency

communications that “led to sign-off (i.e., acceptable status) of the application’s

labeling discipline review on July 29, 2011, the quality (chemistry) discipline review

on October 21, 2011, the bioequivalence discipline review on October 25, 2011, and

the facility discipline reviews on October 25, 2011... and on November 30, 2011.”

(ECF No. 1235-1 at § 145).

On October 26, 2011, Ranbaxy requested that FDA complete its review and

approve Ranbaxy’s Lipitor ANDA two weeks in advance of Ranbaxy’s November

30, 2011 licensed entry date. (ECF No. 1235-1 at 146).2© However, FDA was

4 Plaintiffs dispute this statement to the extent that it “implies” that Ranbaxy

received FDA’s request on September 29, 2011 rather than October 3. 2011 as

described in subpart xviii. (ECF No. 1235-1 at 9 144). Additionally, Plaintiffs

incorporate their response to Paragraph 33 by reference and dispute the statements

in paragraph 144 to the extent that it “implies FDA would not have begun work on

Ranbaxy’s Lipitor ANDA earlier had there been a need, Ze., an earlier Ranbaxy

agreed-upon entry date for FDA to target.” CUd.). This timeline creates no such

implication. The Court accepts this timeline into the factual record.

See supra note 94.

* Plaintiffs dispute this statement of fact to the extent that it “implies FDA was

targeting a date two weeks in advance of Ranbaxy’s November 30, 2011 licensed

entry date to complete review of Ranbaxy’s Lipitor ANDA.” No such implication

is created by this statement. As such, because this information is helpful to

evaluating the timeline, regulatory history, and back-and-forth between Ranbaxy

and FDA. The Court relies upon this statement as fact.

unable to accommodate Ranbaxy’s request for early approval. Instead,

correspondence demonstrates that FDA scheduled its inspection of Ranbaxy’s

Toansa facility on November 14, 2011 and conducted the inspection between

November 21 and 25, 2011. (ECF No. 1235-1 at 147).?’

On November 25, 2011, FDA issued the November 25 Form 483 to Ranbaxy

listing inspectional observations made by FDA representatives during its November

21-25, 2011 inspection of Ranbaxy’s Toansa API facility. (ECF No. 1235-1 at

148).?8 On November 29, 2011, FDA “acknowledged the significance of tomorrow

[November 30, 2011], which [was] the widely anticipated launch date of generic

atorvastatin.” But it informed Ranbaxy that “it did not appear that resolution of the

Toansa inspection results could be reached by tomorrow because multiple parties

are involved, and [FDA] did not venture to guess when resolution would be

reached.” When Ranbaxy asked “whether, if they were to submit... an amendment

[removing the Toansa site] immediately, the ANDA could be approved tomorrow,”

°7 Plaintiffs dispute this statement. They state that “November 14, 2011 is the date

FDA notified Ranbaxy of the Toansa inspection, not necessarily the date FDA

scheduled the Toansa inspection.” After its review of the evidence provided, the

Court disagrees, and the Court adopts the above language. (See ECF No. 1184-10

at 919).

°8 Plaintiffs dispute this response to the extent that the statement “implies that FDA

would not have conducted the Toansa inspection earlier had there been a need, □□□□

an earlier Ranbaxy agreed-upon entry date for FDA to target.” This is a statement

of fact and makes no such implication. Accordingly, the Court adopts the above

language.

FDA responded that “it was possible, but [FDA] could not guarantee it,” even one

day before Ranbaxy’s licensed entry date. (ECF No. 1235-1 at 7 149).” Ranbaxy

submitted a response to the November 25 Form 483 on November 29, 2011. (ECF

No. 1235-1 at | 150). On November 30, 2011, FDA documented that it had

completed its validity assessment, and it concluded that its “review of Ranbaxy’s

[Lipitor] ANDA. . . and inspection of facilities referenced in the ANDA does not

reveal irregularities that would cause [FDA] to question the reliability of the

ANDA.” (ECF No. 1235-1 at 4 151).!°' In the end, FDA approved Ranbaxy’s

Lipitor ANDA on November 30, 2011. (ECF No. 1235-1 at 152).

X. FDA’s Expedited Review of Alternative Lipitor ANDAs Did Not Result

in the Earlier Launch of Generic Atorvastatin Calcium Tablets

FDA conducted its review of Apotex, Mylan, Teva, and Sandoz’s respective

ANDAs for atorvastatin calcium tablets, reasoning that if FDA were to determine

that Ranbaxy’s Lipitor ANDA was not “substantially complete” at the time of its

submission, it would be in “the public interest to have completed [the] scientific

reviews of any atorvastatin ANDA that otherwise could be approved and marketed

to the American public as early as June 28, 2011.” (ECF No. 1235-1 at ¥ 153).!”

” See supra note 98.

100 See supra note 98,

See supra note 98.

102 See supra note 6.

Nevertheless, no generic manufacturer was able to obtain tentative or final

approval by June 28, 2011, despite FDA’s review. (ECF No. 1235-1 at 154).!%

Indeed, Teva-—-which had the contractual right to launch its own generic atorvastatin

calcium product before November 30, 2011, irrespective of whether Ranbaxy was

entitled to first-filer exclusivity—could not obtain tentative FDA approval until

December 1, 2011. (ECF No. 1235-1 at 155).'* This approval process was mired

by problems which started on January 31, 2011, FDA sent Teva a letter captioned

“Warning Letter” (hereinafter, “The January 31, 2011 Warning Letter”) indicating

that FDA had “identified significant violations of Current Good Manufacturing

Practice (CGMP) regulations for Finished Pharmaceuticals” at Teva’s Jerusalem

manufacturing facility. (ECF No. 1235-1 at ¢ 156)! This January 31, 2011

Warning Letter indicated that “[u]ntil all corrections have been completed and FDA

has confirmed corrections of the violations and [Teva’s] compliance with CGMP,

FDA may withhold approval of any new applications or supplements listing [Teva]

as a drug product manufacturer.” (ECF No. 1235-1 at J 157).'!°° FDA re-inspected

Teva’s Jerusalem facility on June 19, 2011. (ECF No. 1235-1 at § 158).1°7

According to an email communication between Teva and Ranbaxy, Teva received a

103 See supra note 6.

104 See supra note 6.

105 See supra note 6.

106 See supra note 6.

107 See supra note 6.

“close-out letter from FDA” on September 9, 2011; as stated in this email, this close-

out letter formally notified the company that Teva had “addressed the issues raised

by the FDA in a warning letter received on January 31, 2011.” (ECF No, 1235-1

at 159),'°8 During and after the period in which FDA imposed the January 31,

2011 Warning Letter, Teva was in frequent contact with FDA to respond to

deficiencies in the Teva Lipitor ANDA. (ECF No. 1235-1 at 160)!" On

November 16, 2011, FDA requested a Telephone Amendment from Teva to resolve

certain minor deficiencies in the Teva Lipitor ANDA, including a request that Teva

revise the expiration dating of Teva’s atorvastatin calcium product to 18 months;

Teva indicated that it would comply with FDA’s request on November 17, 2011.

(ECF No, 1235-1 at ¥ 161).!!° On November 29, 2011, FDA indicated to Teva that

the Teva Lipitor ANDA approval package was being finalized, but FDA “could not

commit to tentative approval” by November 30, 2011. (ECF No. 1235-1 at 162).""

On November 29, 2011, Teva moved for a preliminary injunction and temporary

restraining order that would force Ranbaxy to selectively waive its first-filer

exclusivity pursuant to the Atorvastatin Agreement. (ECF No. 1235-1 at J 163),'?

108 See supra note 6.

109 See supra note 6.

110 See supra note 6.

See supra note 6,

12 See supra note 6.

In a brief filed in the United States District Court for the Southern District of

New York on November 30, 2011, Ranbaxy argued that Teva had failed to perform

its obligations under the Atorvastatin Agreement because (1) FDA had not

tentatively approved the Teva Lipitor ANDA, and (2) Teva did not have initial

commercial launch quantities ready for commercial sale, in part because Teva had

not re-labeled 10 million bottles of atorvastatin calcium in accordance with FDA’s

November 16, 2011 request in time for launch. (ECF No. 1235-1 at J 164).!¥

On November 30, 2011, the Teva and Ranbaxy lawsuit was settled. (ECF No.

1235-1 at 165).!4

IL.

A motion for summary judgment should be granted only if “there is no

genuine dispute as to any material fact and the movant is entitled to judgment as a

matter of law.” Fed.R.Civ.P. 56(a). “A factual dispute is ‘genuine’ if the ‘evidence

is such that a reasonable jury could return a verdict for the nonmoving party.’”

Razak y, Uber Techs., Inc., 951 F.3d 137, 144 (3d Cir. 2020) (quoting Anderson v.

Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)). “A factual dispute is ‘material’ if it

‘might affect the outcome of the suit under the governing law.’” Jd.

113 See supra note 6.

See supra note 6.

“The Court must view the facts and evidence presented on the motion in the

light most favorable to the nonmoving party.” Jd. (quoting Anderson, 477 U.S. at

255). Moreover, summary judgment “is inappropriate when the evidence is

susceptible of different interpretations or inferences by the trier of fact.” Hut v.

Cromartie, 526 U.S. 541, 553 (1999), Thus, the judge’s function “is not himself to

weigh the evidence and determine the truth of the matter, but to determine whether

there is a genuine issue for trial.” Anderson, 477 U.S. at 249. As such, “the court

must ask whether, on the summary judgment record, reasonable jurors could find

facts that demonstrated, by a preponderance of the evidence, that the nonmoving

party is entitled to a verdict.” Jn re Paoli R.R. Yard PCB Litigation, 916 F.2d 829,

860 (Gd Cir. 1990),

“When the moving party has the burden of proof at trial, that party must show

affirmatively the absence of a genuine issue of material fact: it... must show that,

on all the essential elements of its case on which it bears the burden of proof at trial,

no reasonable jury could find for the non-moving party.” Wasserman v. Bressman,

327 F.3d 229, 238 Gd Cir. 2003) (internal marks omitted), Where the moving party

bears the burden of proof, the evidence presented in support of summary judgment

must be “credible.” Jd. at 237. “Once a moving party with the burden of proof

makes such an affirmative showimg, it is entitled to summary judgment unless the

non-moving party comes forward with probative evidence that would demonstrate

the existence of a triable issue of fact.” Jd. at 238.

The nonmoving party “must do more than simply show that there is some

metaphysical doubt as to material facts.” Matsushita Elec, Indus. Co, v. Zenith Radio

Corp., 475 U.S. 574, 586 (1986). Summary judgment may be granted if the

nonmoving party’s “evidence is merely colorable or is not significantly probative.”

Anderson, 477 U.S, at 249-50,

TH.

a. Antitrust Causation

At their core, the elements of the Plaintiffs’ claims are (1) violation of the

antitrust laws; (2) individual injury resulting from that violation, and (3) measurable

damages. See In re Hydrogen Peroxide Antitrust Litig., 552 F.3d 305, 311 Gd Cir,

2008) (internal citations omitted). The second element is known as the “causation”

requirement. In re Flonase Antitrust Litig., 798 F. Supp. 2d 619, 626 (E.D. Pa, 2011)

(citing Callahan v. A.ELV., Inc., 182 F.3d 237, 250 Gd Cir.1999)). Accordingly, an

antitrust plaintiff must show that it suffered an antitrust injury that was sufficiently

linked to the complained-of conduct.

Antitrust injury “involves a causation requirement in order to define the class

of potential plaintiffs eligible to bring suit—those ‘injured... by anything forbidden

in the antitrust laws.’” Greater Rockford Energy & Tech. Corp. v. Shell Oil Co., 998

F.2d 391, 395 (7th Cir. 1993) (citations omitted). This causation requirement

“requires a plaintiff to show that the defendant's antitrust violation was a ‘material

cause’ of the plaintiff's injury.” Jn re Flonase Antitrust Litig., 798 F. Supp. 2d 619,

627 (E.D. Pa. 2011) (internal citations omitted). “On occasion . . . an independent

cause fully accounts for the plaintiffs alleged injury and breaks the causal

connection between the alleged antitrust violation and the plaintiff's injury.” Jn re

Wellbutrin SR/Zyban Antitrust Litig., 281 F.Supp.2d 751, 756 (E.D. Pa. 2003).

b. Causation as Applied

The causation question presented within this motion is whether FDA would

have approved Ranbaxy’s Lipitor ANDA even a day before it actually did on

November 30, 2011 (the earliest date that Ranbaxy was permitted to release its

generic Lipitor under the disputed Settlement Agreement). The resolution to this

question lies in the answer to two, parallel sub-questions: (1) whether FDA would

have granted an AIP exception before May 16, 2011 absent the disputed Settlement

Agreement and (2) whether Ranbaxy would have obtained final FDA approval

earlier than November 30, 2011 absent the disputed Settlement Agreement. For the

reasons below, there is no genuine issue of material fact as to these two sub-

questions. Summary judgment is therefore appropriate.

i. Evidence that FDA Would Have Granted an AIP Exception Before

May 16, 2011 Absent the Disputed Settlement Agreement

This first question relates to a regulatory mandate encountered by Ranbaxy in

its journey to ANDA approval: the AIP and the subsequent AIP exception. In the

first instance, the Court disagrees with Plaintiffs’ position that the evaluation of the

AIP process and its effect only goes to question of the impact of the length of any

delay in Ranbaxy Lipitor ANDA’s approval (See ECF No. 1217 at 38)-——the AIP and

Ranbaxy’s ability to obtain the AIP exception are central to deciding when and

whether the Ranbaxy Lipitor ANDA would be approved and how all plaintiffs in

this matter were affected. Thus, to decide whether Ranbaxy’s Lipitor ANDA could

have been reviewed and approved earlier by FDA, the Court must assess the AIP

process given that absent the AIP exception, any FDA review of Ranbaxy’s Lipitor

ANDA would have been impossible. For the reasons below, there is no evidence to

suggest that the AIP exception would have been granted any earlier. Arguments to

the contrary are pure speculation.

The AIP is a process invoked “[w]hen FDA finds that a manufacturer has

significantly violated FDA regulations ... .” (ECF No. 1235-1 at 4 31).

Manufacturers are often alerted in the form of a warning letter. Thereafter, a

manufacturer’s ANDA review is required to be delayed “until FDA is satisfied that

the data or information in the application is reliable.” (U/d.). Here, FDA invoked its

AIP against Ranbaxy on February 25, 2009. About two years later on May 16,

2011—after a series of back-and-forth between Ranbaxy and FDA—FDA granted

an exception to its AIP policy; this allowed a review of the Ranbaxy’s generic Lipitor

ANDA to proceed in spite of the ATP.

The Court first addresses the numerous communications between Ranbaxy

and FDA—-a significant factual history that cuts against Plaintiffs’ argument. Over

the period of two years between when the AIP was imposed and when the AIP

exception was granted, Ranbaxy and FDA communicated often; these

communications were largely efforts by Ranbaxy to secure an AIP exception in the

first place——an event that was by no means guaranteed. These correspondences are

summarized below:

e February 25, 2009: FDA invokes the AIP against Ranbaxy’s Paonta Sahib

site,

April 8, 2009: Ranbaxy meets with FDA to discuss the AIP.

e May 18, 2009: Ranbaxy submits the May 18 CAOP.

e July 9, 2009: Ranbaxy provides a “priority list of the ANDAs referenced in

AIP” which includes Ranbaxy’s generic Lipitor ANDA. Ranbaxy’s Lipitor

ANDA was listed first on that list.

e July 31, 2009: FDA rejects the May 18 CAOP.

August 18, 2009: Ranbaxy meets with FDA to discuss May 18 CAOP and

the Product Evaluation Checklist. FDA gives principle approval of May 18

CAOP incorporating changes added by Quintiles. During this meeting,

Ranbaxy informs FDA that it intends to launch generic Lipitor on November

30, 2011.

e September 30, 2009: Ranbaxy advises FDA that Quintiles reporting

“significant progress” that Ranbaxy had made “in several critical areas,”

noting that Quintiles had “revised, and submitted to [FDA] the ANDA audit

checklist consistent with [the] discussion on [August] 18th,” had “used [the]

checklist in completing a number of ANDA reviews,” and “anticipate[d]

submitting its first certifications to FDA soon.”

¢ December 4, 2009: Ranbaxy submits the December 2009 Major Amendment

to its Lipitor ANDA, changing: (1) the manufacturer of the atorvastatin

calcium in its formulation from its Paonta Sahib facility to a facility operated

by Pfizer; (2) adding Ohm Laboratories as a manufacturing site; and (3)

changing the form of its atorvastatin calctum from amorphous to crystalline.

December 8, 2009; FDA formally responds to May 18 CAOP.

e November 12, 2010: Ranbaxy submits the November 2010 Major

Amendment to its Lipitor ANDA to add another source for its atorvastatin

calcium through a Ranbaxy facility in Toansa, Punjab, India as well as

“fm]inor changes” in the drug product manufacturing process.

e March 2011: Ranbaxy’s counsel meets with FDA. They stress that, in their

view, “there [was] no support in the statute, regulations, or the AIP itself for .

.. withholding consideration of [Ranbaxy’s Lipitor ANDA] where, [as in this

case] there [was] no allegation or proof of fraud....” Additionally, Ranbaxy

requested that FDA commence review of Lipitor generic ANDA.

May 11, 2011: FDA issues the AIP Exception Memo, which considers

whether Ranbaxy should be given an AIP Exception to allow review of

ANDA to commence, The AIP Exception Memo concludes that FDA, having

“considered the complicated circumstances related to Ranbaxy’s atorvastatin

ANDA ... concluded that they support review of the ANDA.”

e May 16,2011: FDA grants Ranbaxy an AIP exception.

In addition to showing the frequency and complexity of the interactions between the

parties, this factual timeline demonstrates three main points. First, it highlights the

major amendments that occurred on two occasions during this back~and-forth. In

2009 and 2010, Ranbaxy submitted major amendments to its ANDA. These major

amendments required that FDA—when and if the Ranbaxy Lipitor ANDA was

excepted from the AIP—restart its entire review of the Ranbaxy Lipitor ANDA. As

FDA stated in its AIP Exception Memo: “The amendments to the Ranbaxy

application necessitate, in essence, a new fill review of the main elements of the

ANDA, including the CMC information, bioequivalence studies, and labeling.”

(ECF No. 1235-1 at | 133 (emphasis added)). This included a detailed examination

of the data reliability of the new Ranbaxy submissions from Ohm Laboratories to

determine that those submissions were “free of the concerns which gave rise to the

AIP.” (ECF No. 1184-5 at 211). While FDA gave no timeline on how long such a

review would take, FDA stated that it “anticipate[d]” that it could complete the

ANDA review by that November 30, 2011; at the point of the AIP Exception

Memo’s issuance, that date was approximately seven months away. (Ud. at 213). It

is noteworthy that the AIP Exception Memo used the word “anticipated,” not

guaranteed or promised. The Court reads this language in the AIP Exception Memo

as an abstract discussion, looking to events that had not yet occurred.

Second, this back-and-forth across a period of two years highlights the fact

that, although FDA’s knowledge of the November 30, 2011 launch date never

changed, FDA took more than two years to grant an AIP exception to Ranbaxy in

the first place. There is no evidence that FDA would have reviewed this application

any faster should the earliest possible launch date under the disputed Settlement

Agreement even one day earlier on November 29, 2011. Similarly, while FDA

might have written in that same AIP Exception Memo that it “anticipated”

completion by such a date, there is no evidence to show that the review could have

or would have been completed any faster. There has been no testimony by FDA on

this point or any other party to suggest that FDA was dragging its feet. Plaintiffs

point only to FDA’s awareness of the November 30, 2011 and the fact that FDA

wrote that it “anticipate[d]” that its review could be completed by that date as

evidence supporting that the process would be. FDA’s awareness of the earliest

launch date and language to that effect is insufficient to raise a genuine issue of

material fact.!!5

Third, the Court notes that the AIP mechanism itself raises separate issues

with Plaintiffs’ argument. Specifically, the ATP’s unusual! nature and the fact that it

required a “restart” of application review upon its lifting render Plaintiffs’ arguments

that FDA would have approved Ranbaxy’s Lipitor ANDA earlier than November

30, 2011 on November 29, 2011 difficult to accept as anything beyond speculation.

The first point—the unusual nature of the AIP—-is agreed to by the experts in this

case. As stated by Daniel Troy, former FDA Chief Counsel from 2001 and 2004:

The AIP is an exceptional and rarely used program, intended for only

the most severe cases of non-compliance. In fact, only four firms out of

11 on the current AIP list (ast revised in December 2021) have been

added to the list by the Center for Drug Evaluation and Research

(“CDER”), the division of FDA responsible for generic drug

applications, and there are only 19 firms listed on FDA’s website that

have ever been subject to the ATP.

(Troy Rep. at ¥ 24). For his part, Plaintiffs’ expert Kurt Karst—in response to the

question at his deposition “do you agree that the invocation of the AIP is an unusual

step for the FDA”—responded: “Yes, I do agree with that.” CECF No 1184 at Feb.

28, 2023 Karst Dep. at T57:2-4). The highly unusual nature of the AIP creates a

See discussion at infra at 74.

problem for the Court in assessing Plaintiffs’ arguments about what FDA “would

have done” where Plaintiffs are unable to offer information other than speculation

on this point. The actual implications of the AIP create difficulties in forecasting

what FDA would have done since the Ranbaxy Lipitor ANDA approval process

“restarted” upon the lifting of the AIP given the major amendments that had been

submitted. Indeed, once an AIP exception was granted, FDA conducted a “new full

review” of the ANDA, defined as reviewing the main elements of the Ranbaxy

Lipitor ANDA from scratch. (Troy Rep. at § 27).

These points bring to bear a greater, main point: regulatory requirements in

this case obstruct Plaintiffs’ argument that FDA would have moved quicker had the

earliest entry date been November 29, 2011. Indeed, Plaintiffs largely fail to address

these significant regulatory requirements that Ranbaxy encountered. Plaintiffs

contend that the evidence shows that FDA made an exception to the AIP to review

“Ranbaxy’s Lipitor ANDA before ‘it was able to confirm the data and information

in Ranbaxy’s [Lipitor] ANDA as amended were reliable.’” CECF No. 1217 at 39)

(emphasis in the original). Further, Plaintiffs argue that FDA’s “completion of the

validity assessment after granting the AIP exception necessarily means that FDA

began its substantive review of Ranbaxy’s Lipitor ANDA before confirming the

reliability of data information in Ranbaxy’s ANDAJ,|” apparently arguing that had

the November 30, 2011 date been different by one day, FDA could have started this

same review earlier and granted the exception earlier. (See id. at 40). These

arguments fail to address the main problem facing the Court: what evidence is there

that FDA would have tried to and could have achieved an altered timeline had it had

a different entry-date to target? Arguments about when the review began do not

address this argument—they are speculative. In terms of evidence with respect to

FDA’s speed of review or incentives to review, the Court possesses only this factual

timeline and speculation as to how FDA’s awareness of November 30, 2011

motivated the approval process. Plaintiffs’ argument is uncompelling, and there is

little evidence to support it. What evidence there is, the Court finds to support a

reading of FDA’s diligence and concern with drug review—-a concern that would

not be altered based upon a drug entry date.

This conclusion is supported when looking at the problems encountered by

another generic manufacturer on its road for Lipitor ANDA approval: Teva. As

previously mentioned, Ranbaxy and Teva agreed that Teva could launch its generic

Lipitor prior to November 30, 2011 “if Teva received FDA tentative approval (or

FDA indicated the ANDA was otherwise approvable except for Ranbaxy’s

exclusivity), and manufactured certain quantities for sale.” (ECF No. 1184 at 34).

FDA was aware that Teva was permitted earlier market entry.

Notwithstanding its awareness of earlier possible entry for one of the “largest

blockbuster drug ever,”!'® FDA did not approve Teva’s generic ANDA prior to

November 30, 2011. Instead, FDA issued a warning letter to Teva regarding its

Jerusalem facility on January 31,2011. FDA re-inspected Teva’s Jerusalem facility

on June 19, 2011, and according to an email communication between Teva and

Ranbaxy, Teva received a “close-out letter from FDA” on September 9, 2011.

According to the email communication, the close-out letter formally notified the

company that Teva had “addressed the issues raised by FDA in a warning letter

received on January 31,2011.” On November 16, 2011, FDA requested a Telephone

Amendment from Teva to resolve certain minor deficiencies in the Teva Lipitor

ANDA, including a request that Teva revise the expiration dating of Teva’s

atorvastatin calcium product to 18 months; Teva indicated that it would comply with

FDA’s request on November 17, 2011. On November 29, 2011, FDA indicated to

Teva that the Teva Lipitor ANDA approval package was being finalized, but FDA

“could not commit to tentative approval” by November 30, 2011. Teva did not

receive the approval prior to November 30, 2011. This timeline demonstrates to the

Court that FDA’s awareness of the availability of an earlier entry date when handling

the same “blockbuster” drug made no difference in FDA’s approval timeline where

there were regulatory mandates in place. Further, it again highlights FDA’s

116 RCF No. 1184-5 at 340.

commitment to ensuring the safety of drugs on the market for consumers, In

addressing Teva’s Lipitor ANDA, Plaintiffs largely gloss over these facts, merely

stating in a footnote:

Because there is evidence that FDA would have approved Ranbaxy’s

[Lipitor] ANDA as amended earlier had Pfizer not paid Ranbaxy to

delay, the Court need not reach the question of whether Teva’s generic

would have also been approved earlier or if there were other ways that

FDA could have approved Ranbaxy’s ANDA.

(ECF No. 1217 at 6n.1), While the Court need not address the speed at which the

Teva Lipitor ANDA was approved in formulating its decision, the Court believes

that the Teva Lipitor ANDA approval timeline sheds light onto regulatory mandates

encountered by manufacturers and how FDA does not alter its regulatory review

processes merely because there is an earlier entry date allowed for these

manufacturers.

The Court’s decision is also supported by Third Circuit precedent. In Jn re

Wellbutrin, the Third Circuit examined inter alia the district court’s granting

summary judgment to defendant, GlaskoSmithKline (“GSK”). Jn re Wellbutrin XL

Antitrust Litig. Indirect Purchaser Class, 868 F.3d 132, 143 Gd Cir. 2017). The

Court briefly recites the underlying facts of In re Wellbutrin, which are similar to

those of the case presently before the Court. In 1985, GSK obtained FDA approval

for bupropion hydrochloride, a drug which became branded as “Wellbutrin.” Jd. at

145, Over the years, several companies tried to develop an extended-release

formulation of bupropion hydrochloride (‘Wellbutrin XL”), with at least two

companies—Biovail and Andrx Pharmaceuticals, LLC—creating these formulations

and obtaining patents covering extended-release formulations of the drug. 7d. Since

GSK never developed an extended-release formulation of bupropion hydrochloride

(and it wished to access an extended-release formulation), GSK obtained an

exclusive license to some of Biovail’s patents. /d. In August 2002, GSK filed an

NDA for the new formulation, which was approved the following year. Jd.

Between September 2004 and May 2005, four generic manufacturers—

Anchen, Abrika, Impax, and Watson—filed ANDAs seeking approval to market

generic versions of Wellbutrin XL. Each of the four filed a paragraph IV

certification. fd. Anchen was the first to file its ANDA, and, as a result, was entitled

to the 180-day exclusivity period. Jd.

Biovail filed patent infringement suits against all four generic companies. Id.

On December 21, 2005, Andrx filed suit against GSK, alleging that Wellbutrin XL,

in 150 mg dosages, violated Andrx’s ‘708 patent. /d. at 146. Andrx also filed suit

against Anchen for infringing the same patent with a generic version of Wellbutrin

XL. Jd. In both cases, Andrx sought damages and an injunction against the sale of

infringing products. Jd. In February 2007, all the parties involved in the Wellbutrin-

related patent litigation (except for Abrika) entered into a settlement. /d. Pursuant

to the terms of the agreements, Anchen waited until May 2008 to launch its 150 mg

generic version of Wellbutrin XL, and GSKK waited 180 days to launch authorized

generic versions of both 150 mg and 300 mg Wellbutrin XL. /d. at 145-46; 160.

In examining a series of disputed settlement agreements, the Third Circuit

evaluated whether the District Court had correctly granted summary judgment on

the question of whether the increased drug prices were caused by the disputed

settlement agreements. The Third Circuit determined that In re Wellbutrin plaintiffs

had no antitrust standing which is proven by a plaintiff showing that the “‘injury □□□□

of the type that antitrust laws were intended to prevent and that flows from that which

makes [the] defendants’ acts unlawful.’” Jd. (citing Ethypharm S.A. France vy.

Abbott Labs., 707 F.3d 223, 233 (3d Cir, 2013)). The Third Circuit reasoned that to

establish antitrust injury, /n re Wellbutrin plaintiffs needed to show that the harm

they experienced—the increased drug prices for Wellbutrin XL and its generic

equivalents—was caused by the disputed settlement. /d at 164-65. The /n re

Wellbutrin plaintiffs sought to meet their burden by “pointing to evidence showing

that, in the absence of the agreements, [a generic] would have launched . . . no later

than the middle of 2007.” The Third Circuit noted:

At first glance, that argument seems appealing. Indeed, the District

Court found that there was at least a question of fact as to whether

Anchen would have launched the drug in June 2007. The problem with

the argument however, is that it does not take into account [a] blocking

patent, the ‘708 patent. It is not enough for the Appellants to show that

Anchen wanted to launch its drug; they must also show that the launch

would have been legal. After all, if the launch were stopped because it

was illegal, then the Appellants injury (if it could still be called that)

would be caused not by the settlement but by the patent laws prohibiting

the launch. After ail, if the launch were stopped because it was illegal,

then the Appellants’ injury (if it could still be called that) would be

caused not by the settlement but by the patent laws prohibiting the

launch .... Thata regulatory or legislative bar can break the chain of

causation in an antitrust case is beyond fair dispute.

Id. The Third Circuit noted that the In re Wellbutrin plaintiffs attempted to

circumvent this legality hurdle with two arguments: a license-based argument and

litigation-based argument.

The Third Circuit concluded that the record supported neither argument. With

respect to arguments that Anchen would have been able to receive a license to

distribute a generic (the license-based argument), the Third Circuit stated that

plaintiffs needed to:

produce evidence from which a reasonable jury could conclude that it

[was] more likely than not that Anchen would have obtained a license.

Evidence showing that Anchen may have been able to obtain a license

does not meet that standard. A plaintiff cannot satisfy the summary

judgment burden based on speculation alone.

Id. at 167. Additionally, the Third Circuit disagreed with In re Wellbutrin plaintiffs’

argument that because Anchen was negotiating a license agreement with Andrx in

the days preceding the disputed settlement agreements and had agreed on all but one

of the terms, that a reasonable jury could infer that the two companies would have

reached an agreement. The Third Circuit rejected this argument, stating:

[T]his argument is completely speculative. It is certainly possible that

Anchen and Andrx would have reached an agreement, but it is also

certainly possible that negotiations would have stalled and failed. Many

a contract has foundered on a single deal-breaker point. Without more

specific or concrete evidence, the jury in this case would be left within

anything on which it could rely to reach a conclusion one way or

another.

Td.

In terms of the litigation-based argument, or the scenario premised upon the

idea that Anchen would have prevailed in the underlying patent litigation between

Anchen and Andrx, the Court examined plaintiffs’ arguments that the size of the

reverse payment was a surrogate for the patent’s weakness and approximations by

defendant’s expert regarding the chances of prevailing on different issues in that □

litigation. The Third Circuit pointed out that neither Jn re Wellbutrin plaintiffs nor

GSK identified any other evidence in the record that spoke to the possibility of the

resolution of the Anchen-Andrx litigation. As such, “no reasonable jury could

conclude that Anchen would have been more likely than not to prevail.” Jd. at 168.

The Third Circuit concluded that summary judgment was appropriate.

Like in Jn re: Wellbutrin, Plaintiffs here must show that an earlier launch of

the Ranbaxy’s generic Lipitor would have been legal. There is nothing in the record

aside from speculation that the regulatory requirements presented by FDA’s AIP

would have permitted an entry date for Ranbaxy’s generic Lipitor on November 29,

2011 or that FDA would have altered its regulatory processes to expedite the AIP

process had the earliest launch date been November 29, 2011. Like in In re

Wellbutrin, “a regulatory or legislative bar [has] brok|[en] the chain of causation in

[this] antitrust case.. ..” Jd. at 164-65. Similar to In re Wellbutrin, here, there was

a regulatory requirement that actually precluded earlier entry of Ranbaxy’s Lipitor

ANDA—a barrier that was independent of the disputed agreement. These regulatory

requirements interrupted the causal link between the alleged injury and any damages

complained-of injury by Plaintiffs, and the Court does not see how any factfinder

could find otherwise.

Here, the AIP Exception Memo setting forth the decision to grant the AIP

exception discusses how FDA “anticipated” its review of the Ranbaxy Lipitor

ANDA could be completed by the November 30, 2011 date, not that this review

would be completed by that date. Further, FDA disclaimed this prospective timeline

by saying: “Prompt review of the ANDA does not, of course, guarantee that the

application will be ready for final approval by November 30, 2011. To be approved,

any ANDA for atorvastatin must meet the requirements under section 505(j) of the

FD&C Act and applicable regulations.” This language is insufficient to create a

genuine issue of material fact as to an earlier launch date. Instead, the language

shows that while FDA may have been targeting a date, FDA approval was limited

by its AIP and was uncertain on the approval timeline. Particularly where Ranbaxy

submitted major amendments to its ANDA—which included a change to the actual

form of the atorvastatin calctum and a change to the facilities where the product

would be produced—that required a new full review of the Ranbaxy Lipitor ANDA

upon a resumption of the review process, it is difficult to see how a reasonable jury

could have found the FDA AIP’s exception timeline to be different on the

information before the Court.

As speculative arguments often go, Plaintiffs’ argumentation also works

against them. In an alternate world, it is just as likely that the AIP process could

have taken longer to complete, or FDA could have refused to grant the AIP

exception—thereby resulting in further interruptions in Ranbaxy’s Lipitor ANDA

review and delaying review even longer than it did in the actual world. The Court

struggles to see how it can accept that FDA’s mere awareness of a date evidenced--~

evidenced by FDA documents and language that FDA “targeted” a date—creates a

genuine issue of material fact as to the ability of FDA approval to occur even a day

earlier. There is no genuine issue of material fact before the Court as to whether the

AIP exception could have been granted earlier. Absent the granting of this AIP

exception, review of Ranbaxy’s Lipitor ANDA could not have occurred.

. The Court proceeds to the next sub-question.

ii. Evidence that Ranbaxy Would Have Obtained Final FDA ANDA

Approval Earlier _had_ the November 30, 2011 Launch Date been

Different

Even assuming that there was a genuine issue of material fact surrounding

FDA’s ability to grant an earlier ATP exception, there is no evidence that Ranbaxy

would have received approval of its ANDA earlier than it did had the launch date of

Ranbaxy’s generic Lipitor been November 29, 2011 instead of November 30, 2011.

The principal issue with evaluating the question of an earlier ANDA approval is that

it requires the Court to guess what FDA would have done had the launch date for

generic Lipitor been different. Guesswork does not create a genuine issue of

material fact, and no reasonable jury could find for Plaintiffs. See Anderson v.

Liberty Lobby, Inc., 477 U.S. 242, 252 (1986) (“The mere existence of a scintilla of

evidence in support of the plaintiffs position will be insufficient; there must be

evidence on which the jury could reasonably find for the plaintiff.”). Summary

judgment is therefore appropriate.

Plaintiffs rely almost exclusively upon FDA’s awareness of the November 30,

2011 date to demonstrate that FDA would have approved Ranbaxy’s Lipitor ANDA

earlier. Plaintiffs use this awareness in an attempt to demonstrate that it motivated

FDA’s approval process and decision-making timeline. It is undisputed that FDA

knew of the November 30, 2011 date as the earliest date that Ranbaxy could have

launched its generic Lipitor under the Settlement Agreement. Indeed, there is

extensive documentation on this point. The question before the Court is better

phrased as follows: how did FDA’s awareness of the November 30, 2011 launch

date affect FDA’s review and what evidence exists that there could have been earlier

FDA approval of Ranbaxy’s Lipitor ANDA if the disputed Settlement Agreement

had provided for a different date of entry?

The Court finds two documents helpful in evaluating these questions: the AIP

Exception Memo and a note regarding a phone call with Ranbaxy and FDA on

October 26, 2011 (hereinafter, the “October 2011 Cumulative Monthly Report”). In

the AIP Exception Memo from the Director of the Office of Compliance to the

Director for the Center for Drug Evaluation and Research regarding “Proposal to

Review Ranbaxy’s Atrovastatin ANDA,” FDA states:

November 30, 2011, the earliest date Ranbaxy can market its

atorvastatin product under its 2008 settlement with Pfizer, is about 7

months away. We anticipate that FDA’s review of this ANDA can be

completed by that date. If this application is granted an exception from

the AIP’s restriction on review. OGD proposes that expedited review

of this ANDA both for reliability and approvability commence

immediately. Prompt review of the ANDA does not, of course,

guarantee that the application will be ready for final approval by

November 30, 2011. To be approved, any ANDA for atorvastatin must

meet the requirements under section 505(j) of the FD&C Act and

applicable regulations.

(ECF No. 1184-5 at 213). Further discussion between FDA and Ranbaxy that

November 30, 2011 was the earliest possible launch date is detailed in the October

2011 Cumulative Monthly Report. This appears to be an internal call note drafted

by Sameer Manan of Ranbaxy. In it, Manan details a phone call between Manan

and Bob West of FDA on October 26, 2011. The note reads:

FDA Telephone Contact- Sameer Manan with Bob West. Sameer

called Bob to check on the status of the ANDA and inform him that we

received the EIR from the NJDO, wherein they have given an approval

recommendation for the product. Bob said he has the approved

clearance from compliance and they are looking at the end of the month

for approval. Sameer questioned him ‘end of October, or November’

and he said, “no, November 30th, isn’t that the day you are targeting

too?” I explained that we have a settlement agreement which permits

us to launch on Nov 30th, but nothing is in the way of preventing the

Agency from approving us before that date. He agreed, but said they

were working and targeting the Nov 30th date. He said it isn’t written

in stone, but at this point they were targeting Nov 30th. He asked if

there was a benefit to getting the approval sooner and I explained that

yes. If we received approval at least 2 weeks ahead of that date, it would

enable us to talk to our customers and get the product where it had to

be to ensure a smooth launch on the 30th, He said he couldn't promise

anything, but again that they are working towards the Nov 30th date. I

thanked him and told him I will check back in 2 weeks.

(ECF No. at 1184-10 at 210).

Both of these documents are instructive on several points, Both excerpts

demonstrate FDA’s knowledge of the November 30, 2011 date as the earliest

possible launch date--a fact that is beyond dispute. However, the documents

demonstrate other important facts. The AIP Exception Memo, for example,

reiterates the fact that approval of the Ranbaxy Lipitor ANDA was conditioned upon

an AIP exception being granted. Indeed, the AIP Exception Memo’s sense of

urgency surrounding the Ranbaxy Lipitor ANDA launch date is tempered by this

fact. Specifically, the AIP Exception Memo reads:

November 30, 2011, the earliest date Ranbaxy can market its

atorvastatin product under its 2008 settlement with Pfizer, is about 7

months away. We anticipate that FDA’s review of this ANDA can be

completed by that date. [f this application is granted an exception from

the AIP’s restriction on review.

(ECF No. 1184-5 at 213 (emphasis added)). Thus, Ranbaxy’s Lipitor ANDA

approval was always conditional upon an AIP exception or complete removal of the

AIP. In every alternate world, it always would be conditional upon these facts—

even if Ranbaxy’s Lipitor ANDA launch date were earlier. Ranbaxy’s Lipitor

ANDA approval was wholly predicated upon the AIP exception being granted or the

AIP being removed. As such, Ranbaxy’s Lipitor ANDA approval was based upon

an event completely separate of the date put forward by the disputed Settlement

Agreement. As previously discussed, there has been no substantive showing that the

November 30, 2011 date had any bearing upon the AIP period and the exception

Ranbaxy was eventually granted.

Next (and perhaps most importantly), both of these documents highlight the

fact that the November 30, 2011 date was merely a target for FDA. Even had that

“target” been earlier, there is no evidence to suggest that FDA’s review process

would have been faster. The AIP Exception Memo itself disclaims: “Prompt review

of the ANDA does not, of course, guarantee that the application will be ready for

final approval by November 30, 2011.” Similarly, the October 2011 Cumulative

Monthly Report entry notes that: “[Bob West] said he couldn’t promise anything,

but again that they are working towards the Nov 30th date. I thanked him and told

him I will check back in 2 weeks.” Pointing to these statements as evidence that—

had the launch date under the disputed Settlement Agreement been November 29,

2011—FDA would have worked faster and approved the date more quickly is

insufficient. Accordingly, the Court does not find that arguing that the earliest

launch date being a target and showing the Court evidence that FDA was targeting

such a date leads to the conclusion that FDA would have reviewed the Ranbaxy

Lipitor ANDA any faster.

The argument’s speculative nature is highlighted by Plaintiffs’ argumentation

at oral argument, Plaintiffs argued that the occurrence of FDA approval in itself on

the earliest possible entry date under the disputed Settlement Agreement is evidence

that FDA would have targeted and achieved an earlier date had the earliest launch

date been November 29, 2011 because it would be wildly coincidental if this

approval had occurred on this date for any other reason. (Nov. 27, 2023 Tr. at

T36:4-10). Plaintiffs stated that it is “very reasonable ... very easy to conclude that

if FDA was aware of an earlier agreed upon entry date, they would have done what

they did in the real world, martial their resources to target an earlier date, and either

meet the specific earlier date or the earliest date right after that date.” Ud. at T36:4—

10). In a colorful analogy, Plaintiffs stated that Defendant would have the Court

believe that the Ranbaxy Lipitor ANDA was approved on November 30, 2011 ina

“sheer cosmic coincidence . . . That it was just somehow a quirk of the universe that

such a thing could happen.” (/d. at T36:13--18). This argumentation further

highlights to the Court the speculative nature of Plaintiffs’ argumentation; unable to

point to any information aside from documents showing that FDA was “targeting”

November 30, 2011, Plaintiffs rely on the actual approval date as proof of that FDA

could have moved faster. Such arguments are appeals to “metaphysical doubt/s] as

to material facts.” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574,

586 (1986). As previously noted, the date of approval in itself is not proof that FDA

would have approved the Ranbaxy’s Lipitor ANDA any faster.

Language from FDA itself is particularly helpful in evaluating this point. In

the AIP Exception Memo, FDA explained:

It is acknowledged that the circumstances here do not fit squarely

under OGD’s MaPP 52.40.3, which among other things describes

circumstances under which an ANDA will be given expedited review.

However, the circumstances here (e.g., the existence and complexity

of the questions related to Ranbaxy AIP and ANDA reliability and the

highly uncertain date upon which ANDAs may be eligible for final

approval, the review issues posed by the applications, and the size of

the market demand for this drug product) are of such an unusual nature

that they could not have been anticipated. Review of these

applications on an expedited basis, is, however, consistent with OGD’s

long-term goal of reviewing pending ANDAs in such a manner that,

by the time patent and exclusivity barriers to approval have expired,

appropriate reviews will have been completed. With first generic

ANDAs that have been found scientifically approvable, OGD has a

long history of approving these as promptly as permitted under

statutory provisions pertaining to patents, patent litigation, and

exclusivity. Prompt review of ANDAs does not, of course, guarantee

that any application will be ready for final approval as of a specific

date.

(ECF No. 1184-9 at 190 n.1). FDA acknowledges in its memorandum the unusual

circumstances surrounding the Ranbaxy Lipitor ANDA. FDA recognizes that the

“circumstances here (e.g., the existence and complexity of the questions related to

Ranbaxy AIP and ANDA reliability and the highly uncertain date upon which

ANDAs may be eligible for final approval, the review issues posed by the

applications, and the size of the market demand for this drug product) are of such an

unusual nature that they could not have been anticipated.” (Ud. (emphasis added)).

FDA further explains: “With first generic ANDAs that have been found

scientifically approvable, OGD has a long history of approving these as promptly as

permitted under statutory provisions pertaining to patents, patent litigation, and

exclusivity. Prompt review of ANDAs does not, of course, guarantee that any

application will be ready for final approval as of a specific date.” (d.). The Court

notes that first, FDA acknowledged that the elements of the Ranbaxy Lipitor ANDA

process were so unusual “they could not have been anticipated.” Additionally, FDA

stated that, while OGD has a “long history of approving” ANDAs “as promptly as

permitted under statutory provisions... . [p]rompt review of ANDAs, does not, of

course, guarantee that any application will be ready for final approval as of a specific

date.” Again, FDA was targeting a date. A target date does not equal a guarantee

or even raise the likelihood that, more likely than not, FDA would have approved

Ranbaxy’s Lipitor ANDA any faster for a reasonable jury. Even if that target date

had been earlier, the Plaintiffs have failed to show that FDA would have reviewed

the ANDA application on a different timeline given the incredibly unusual

circumstances of this case. The Court is unmoved by the argument that the approval

on November 30, 2011 is proof itself; particularly considering the facts from FDA

putting forth the unusual nature of the Ranbaxy Lipitor ANDA, the likelihood of the

purported “cosmic coincidence” appears high. The Court fundamentally disagrees

with Plaintiffs that a target date is sufficient to raise a genuine issue of material fact

as to whether FDA would have moved faster on the Ranbaxy Lipitor ANDA.

This conclusion is additionally supported when evaluating FDA ANDA

review of other “blockbuster” drugs. Specifically, other ANDAs for other

blockbuster drugs were not approved by FDA by the earliest launch dates. These

dates support the Court’s conclusion that even if FDA “targets” a date, this does not

necessarily mean that FDA is able to, can deliver by that date, or whether “targeting”

has any effect at all on FDA review. Indeed, if FDA approval is not ready by a

certain date——despite an earlier launch date’s availability—-FDA does not approve

it. Take the EpiPen, a medication used to treat anaphylaxis, for example. In April

2012, Teva entered into a settlement agreement with Mylan and a Pfizer subsidiary □ □

“that would allow Teva to launch a generic version of the blockbuster drug,

epinephrine auto-injector (““EpiPen”) by June 22, 2015 or earlier under certain

circumstances, However, even with this date, Teva’s generic version of the EpiPen

was not approved until August 16, 2018. CECF No. 1235-1 at 7 11; Troy Rep. at □

145). Another example is the generic version of Diovan, a blood pressure

medication. In 2007, Ranbaxy and Novartis reached a settlement in which Ranbaxy

“agreed that it would not market generic Diovan until the expiration of the U.S.

patent in 2012 or until the patent claims were declared invalid, whichever came first,

and no later than September 2012.” (Troy Rep. at ¢ 142). FDA did not approve

Ranbaxy’s ANDA for generic Diovan until June 2014.

These examples hammer home the fact that FDA is not glued to meeting

earliest possible entry dates and will not achieve an earlier entry-date merely to

achieve a target date put forth by pharmaceutical manufacturers. Overall, this

evidence (or the lack thereof) shows that there is no genuine issue of material fact,

and summary judgment is appropriate in this case.

IV.

For the reasons set forth above, there is no genuine issue of material fact as to

whether FDA would have approved Ranbaxy’s Lipitor ANDA earlier than

November 30, 2011 on November 29, 2011. Indeed, the evidence presented to the

Court is that FDA may have been able to do so.

Plaintiffs’ evidence showing that FDA “may have been able” to approve

Ranbaxy’s Lipttor ANDA on November 29, 2011 does not meet the summary

judgment standard. See In re Wellbutrin XL Antitrust Litig. Indirect Purchaser

Class, 868 F.3d 132, 167 (Gd Cir. 2017). Accordingly, no genuine dispute of

material fact as to this question exists.

Summary Judgment is granted.

f’ ah WB. af Gfx, “f

PETER G. SHERIDAN, U.S.D J.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.