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

> District Court, D. New Jersey · June 6, 2024

URL: https://www.frixlaw.com/law-library/cases/10656128

## Case

- **Court:** District Court, D. New Jersey
- **Decided:** June 6, 2024
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10656128

## Opinion text

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.
I,
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).

19

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.
11

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).

13

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.
14

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.
i5

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,
16

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.
17

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.
18

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.
19

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,
20

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.
21

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
22

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.
23

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,
24

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.
25

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.
26

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.
27

“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.
28

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.
29

(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.
30

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,
See supra note 6,
See supra note 6,
See supra note 6,
°6 See supra note 6.
31

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.
32

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

33

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
34

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.
35

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.
36

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.
37

“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.
38

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

40

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.
Al

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.
A2

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

43

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.
44

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.
45

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.
46

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.
47

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.
48

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.
49

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.
50

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.
51

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.
52

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.
53

“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.
54

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.
55

“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

56

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

57

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

58

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

59

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

60

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

61

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

62

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.
63

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

64

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.

65

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.
66

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

67

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

68

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)
69

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
70

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

71

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

72

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

73

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

74

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
75

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.
76

(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,

[Text truncated at 120,000 characters. The full text is on the page linked above.]

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10656128. Public record. Not legal advice.