Opposition Brief — Royce Laboratories, Inc. v. Bristol-Myers Squibb Co.

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| Supreme Court, U.S.

FILED

os Mea iT

4 | DEC LLG

No. 95-737 —

IN THE

Supreme Court Of The Anited States

October Term, 1995

ROYCE LABORATORIES, INC.

Petitioner,

BRISTOL-MYERS SQUIBB COMPANY,

AND E.R. SQUIBB & SONS, INC.,

Respondents.

On Petition for a Writ of Certiorari to

the United States Court Of Appeals

for the Federal Circuit

BRIEF IN OPPOSITION

ROBERT L. BAECHTOLD ROBERT J. BROOKHISER

FITZPATRICK, CELLA, (Counsel Of Record)

HARPER & SCINTO HOWREY & SIMON

277 Park Avenue 1299 Pennsylvania Ave., N.W.

New York, NY 10172 Washington, D.C. 20004

(212) 758-2400 (202) 783-0800

Attorneys for Respondents

December 11, 1995

Additional Attorneys on Reverse

FS IS LS TT TR LL TTI TT aT TIT ITT TNE TRUEST BER INS BMI

DONALD J. BARRACK

BRISTOL-MYERS SQUIBB CO. and

E.R. SQUIBB & SONS, INC.

Route 206 and Provinceline Road

Princeton, NJ 08543

(609) 252-4328

JOHN D. KISER

JOHN M. ENGEL

FOX, BENNETT & TURNER

750 17th Street, N.W.

Washington, D.C. 20006

(202) 778-2300

Attorneys for Respondents

}

;

QUESTIONS PRESENTED

The Drug Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. No. 98-417) (“Hatch-

Waxman Act”) governs the filing and approval of

abbreviated new drug applications (“ANDAs”) to market

generic versions of previously approved new drugs and

provides that it is an act of infringement to file an ANDA

seeking approval by the Food and Drug Administration to

market a generic drug product prior to the expiration of any

patent which covers that drug. 35 U.S.C. § 271(e)(2). The

exclusive remedies for such acts of infringement are

provided in 35 U.S.C. § 271(e)(4), including an order that

the “effective date of any [FDA] approval of the drug...

[shall] be a date which is not earlier than the date of the

expiration of the patent that has been infringed." 35 U.S.C.

§ 271(e)(4)(A).

The Uruguay Round Agreements Act (“URAA”),

Pub. L. No. 103-465, 108 Stat. 4809 (codified in part at 35

U.S.C. § 154(c) (West Supp. 1995), enacted December 8,

1994, 21 U.S.C. § 154(c)(2), (3)), redefined the terms of

various patents and limited certain remedies available to

patentees. The transition provision of the URAA states:

(2) REMEDIES. The remedies of

sections 283, 284, and 285 of this title [35

U.S.C.A.] shall not apply to Acts which --

(A) were commenced or for which

substantial investment was made before the

date that is 6 months after the date of the

enactment of the Uruguay Round Agreements

Act [June 8, 1995]; and

(B) became infringing by reason of

paragraph (1) [the redefined expiration date].

(3) |. REMUNERATION. The acts referred

to in paragraph (2) may be continued only

upon the payment of an _ equitable

remuneration to the patentee that is

determined in an action brought under chapter

28 and chapter 29 (other than those provisions

excluded by paragraph (2) of this title [35

U.S.C.].

The questions presented by the Petition are:

1. Does the transition provision of the URAA,

which refers only to the remedies of 35 U.S.C. §§ 283, 284

and 285, abrogate the remedy provided by 35 U.S.C.

§ 271(e)(4)(A) for an act of infringement under 35 U.S.C.

§ 271(e)(2)?

y | Does the transition provision of the URAA

render certain acts committed during the transition period

non-infringing, or only limit certain remedies that are

available to the patentee for acts that are infringing?

iii

PARTIES TO THE PROCEEDING

The names of all parties in the court whose judgment

is sought to be reviewed appear in the caption of this Brief in

Opposition.

LIST OF PARTIES PURSUANT TO RULE 29.6

Bristol-Myers Squibb Company has no parent

corporation. E.R. Squibb & Sons, Inc. is a wholly-owned

subsidiary of Bristol-Myers Squibb. Set forth below is a list

of non-wholly owned subsidiaries of Bristol-Myers Squibb

Company.

Bristol-Myers Lion Ltd. (Japan)

Bristol-Myers S.A. (France)

Bristol-Myers Squibb G.m.b.h. (Germany)

Bristol-Myers Squibb Korea Limited (Korea)

Mead Johnson (Guangzhou) Ltd. (China)

P.T. Squibb Indonesia (Indonesia)

Squibb of Bangladesh Limited (Pakistan)

Synbiotics Limited (India)

Instituto Bio-Medico S.A. de C.V. (Mexico)

Laboratories UPSA SAS (France)

Myagen (France)

RCS Realty Corporation (Philippines)

Servicios Bio-Medicos de Compresion S.A. (Mexico)

Sino American Shanghai Squibb Pharma Ltd. (China)

SMI Bristol Limited (Japan)

Squibb Nigeria Limited (Nigeria)

UPSA Investissements (France)

2309 Realty Corporation (Philippines)

TABLE OF CONTENTS

QUESTIONS PRESET E ED) cccccessssecvcevesusinrenescsavensisicbinaltiones i

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A. The Statutory Framework. .......:cccccccsssossssssscsveescessesees 3

i, The Hatch-Waxman Act........cccssescsssseessees 3

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2. The District Court Proceedings ................... 10

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—<—_-

L THE DECISION BELOW IS CORRECT

AND DOES NOT CONFLICT WITH THE

DECISIONS OF THIS COURT OR ANY

FR Gi UN edi ccatibecevcusotcccvccccccesesevcoceece 14

A. There Is No Conflict with Any

Decision of This Court............ccccccccsceceeceees 14

B. The Decision Below Does Not

Conflict with Any Other Court of

FA CIID ereintdchecsssncecedcscevccevccsdscouee 15

S The Decision Below Correctly

Applies the Plain Language of the

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IL THE PETITION DOES NOT PRESENT

AN ISSUE OF GENERAL PUBLIC

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APPENDIX: FDA RESPONSE TO GLAXO’S

COTEEIN PIT i App.-1

TABLE OF AUTHORITIES

CASES

Bristol-Myers Squibb Company and E.R.

Squibb & Sons, Inc. v. Royce

Laboratories, Inc., 36 U.S.P.Q. 2d

ef | RE ee passim

Burlington Northern R.R. v. Oklahoma Tax

Commission, 481 U.S. 454 (1987)...........cccccccseeeeeees 22

Connecticut National Bank v. Germain,

Se Sis A EE Recin tencicutrerensebiidediddmicnvccunirssnenstees 22

DuPont Merck Pharmaceutical Co. v. Bristol-Myers

Squibb Co., 62 F.3d 1397

RE Se tecreniittiiasssemiernencestevinntainucbnictets 2,3,8,9,16

Eli Lilly Co. v. Medtronics, Inc.,

Pe A ei vtbietensiscnseintescensopsiadormanesiian 12,14,15

Laing v. United States, 423 U.S. 161 (1976).........cccceeeeeees 21

Layne & Bowler v. Western Well Works, Inc.,

Se eh i a ticiatseliniennciadintiscdnsnsncceinincnivctien 15

Morton v. Ruiz, 415 U.S. 199 (1974)... ecceececceseeeeeeeeeeees 16

STATUTES

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The Uruguay Round Agreements Act (URAA),

Pub. L. No. 103-465, 108 Stat. 4809

(codified in part at 35 U.S.C.A. § 154(c)

(West Supp. 1995), enacted Dec. 8, 1994)............. 5,6

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OTHER AUTHORITIES

BE Ch aes © POs He Pe ccctanitenistiieininisiniatintebeecenes 12

54 Fed. Reg. 28,872, 28,894 (July 10, 1989)... eee 12

57 Fed. Reg. 50,338, 50,353 (Oct. 3, 1994) oe ceecceeseeees 12

141 Cong. Rec. $6495 (daily ed. May 11, 1995)................ 21

141 Cong. Rec. $12388-12391 (August 11, 1995).............. 21

Chemical Marketing Reporter (January 2, 1995)..............+ 21

H. R. Doc. No. 316, 103d Cong., 2d Sess. 1003

CRW Ped kcctencatnsnavosshopsetinonisguaninsciiinienndtiabidinninditeiiaptiteins 22

(RL TEATRO LE LE LETTE ELT NNER A BTR TEN Tea

IN THE

Supreme Court Of The Anited States

October Term, 1995

ROYCE LABORATORIES, INC.

Petitioner,

BRISTOL-MYERS SQUIBB COMPANY,

AND E.R. SQUIBB & SONS, INC.,

Respondents.

On Petition for a Writ of Certiorari to

the United States Court Of Appeals

for the Federal Circuit

BRIEF IN OPPOSITION

Bristol-Myers Squibb Company and E.R. Squibb &

Sons, Inc. (collectively “Bristol”) file this brief in Opposition

to the Petition for a Writ of Certiorari filed by Petitioner,

Royce Laboratories, Inc. (“Royce”).

OPINIONS BELOW

The opinion of the Court of Appeals is reported at 36

U.S.P.Q. 2d 1641 (Fed. Cir. 1995) and is reproduced in the

Appendix to the petition, beginning at page A-1. The

opinion of the district court is reported at 36 U.S.P.Q. 2d

(BNA) 1637 (S.D.Fla. 1995) and is reproduced, along with

the district court order, in the Appendix to the petition,

beginning at page A-27.

JURISDICTION

The judgment of the Court of Appeals was entered on

November 1, 1995. The jurisdiction of this Court is invoked

under 28 U.S.C. 1254(1) (1988). The jurisdiction of the

district court rested on 28 U.S.C. § 1338(a) (1988).

COUNTERSTATEMENT OF THE CASE

The dispute between the parties concerns Royce’s

attempt to obtain approval by the Food and Drug

Administration (“FDA”) to market a generic version of a

patented prescription pharmaceutical product (captopril)

made by Bristol prior to the expiration date of Bristol’s

patent covering that product. Royce did so by amending its

abbreviated new drug application (“ANDA”) with the FDA

to contain a certification that Bristol’s patent was invalid or

unenforceable. Under the Hatch-Waxman Act, this is an act

of patent infringement.

There is no dispute that Bristol’s patent is valid and

that it covers Royce’s generic drug product. Royce’s only

“defense” to its admitted act of infringement is the claim that

the recently enacted Uruguay Round Agreements Act

(“URAA”) provides it with a “statutory license” to market

captopril prior to expiration of Bristol’s patent. A panel of

the Federal Circuit held that the URAA did not do so. A

different panel of the Federal Circuit had previously reached

the same conclusion in another case involving Bristol’s

captopril patent brought by two other generic drug

companies. See DuPont Merck Pharmaceutical Co. v.

Bristol-Myers Squibb Co., 62 F.3d 1397 (Fed Cir. 1995).

Neither of the plaintiffs in that case sought review by this

Court.

The decisions by these two different panels of the

Federal Circuit are consistent with an FDA policy decision

issued May 25, 1995. There has been no judicial challenge

to the FDA policy.

A. The Statutory Framework

The legal issue decided below concerns the

relationship between the provisions of the URAA and the

Hatch-Waxman Act.

i The Hatch-Waxman Act

The Hatch-Waxman Act introduced provisions to

both the Patent Code and the Food Drug and Cosmetic Act to

govern the filing, approval and effective date of approval of

ANDAs which seek approval by FDA to market generic

versions of previously approved new (“pioneer”) drugs.

Under the Hatch-Waxman Act, a pharmaceutical

manufacturer seeking approval to market a generic version

of a patented drug may submit to FDA an abbreviated new

drug application (ANDA).! 21 U.S.C. § 355(j) (1994). As

part of the ANDA process, when the patent has not expired,

the generic drug manufacturer must certify either the “date

on which [the] patent will expire” (a paragraph III

1 An ANDA permits a generic manufacturer to rely on the data

that research-based companies generated at great time and

expense to develop and secure original FDA approval of the drug.

certification) or that the patent is “invalid or will not be

infringed by the manufacture, use, or sale of the [generic]

drug for which the [ANDA] is submitted” (a paragraph IV

certification). 21 U.S.C. § 355(G)(2)(A){(vii)(IID, (TV).

If an ANDA contains a paragraph IV certification,

the ANDA applicant must give notice to the patentee and

must provide detailed bases for its belief that the patent is

invalid or not infringed. 21 U.S.C. § 355(j)(2)(B)(i). The

patentee then has 45 days to sue the ANDA applicant for

infringement. 21 U.S.C. § 355(j)(4)(B)(iii). If the patentee

files suit within that period, then FDA approval does not

occur until expiration of the patent, judicial resolution of the

infringement suit, or thirty months from the patentee’s

receipt of notice, whichever is earliest. /d.

The Hatch-Waxman Act also added provisions to the

Patent Code that relate specifically to the generic drug

approval process. Section 271(e)(2) states that it shall be an

act of infringement to submit an ANDA “if the purpose of

such submission is to obtain approval under [the FD&C Act]

to engage in the commercial manufacture, use, or sale of a

drug . . . claimed in a patent or the use of which is claimed in

a patent before the expiration of such patent.” 35 U.S.C.

§ 271(e)(2). Section 271(e)(4) lists the remedies available

for infringement under section 271(e)(2), and states that

these are the “only remedies” for such an act of

infringement. One of these remedies is an order that the

“effective date of any [FDA] approval of the drug ... be a

date which is not earlier than the date of the expiration of the

patent that has been infringed.” 35 U.S.C. § 271(e)(4)(A).

The remedy of section 271(e)(4)(A) is specifically identified

as one of the remedies which a court may order in an action

by the patentee in response to a paragraph IV certification.

See 21 U.S.C. § 355(j)(4)(B\iii).

2 Section 271(e)(1) establishes that it is not an act of infringement to

use a patented drug solely for purposes related to obtaining regulatory

approval of the product. 35 U.S.C. § 271(e(1).

2. The URAA

The URAA was enacted in December 1994 to

implement the Uruguay Round Agreements, a series of

multilateral trade agreements, which includes the General

Agreement on Tariffs and Trade (GATT) and the Agreement

on Trade-Related Aspects of Intellectual Property Rights

(TRIPs).

URAA’s provisions amend Title 35 of the U.S. Code

to redefine the period of patent protection for some patents.

Section 532(a)(1) of the URAA provides, inter alia, that, for

patents in force on June 8, 1995, or that result from an

application filed before that date, the patent term shall be the

greater of 17 years from the granting of the patent or 20

years from the date on which the application for the patent

was filed, or under certain circumstances 20 years from the

date of the earliest patent application filing.

The URAA contains a transitional provision

governing acts that will become infringing due to the

extension of patents in effect or already filed as of June 8,

1995. While both Royce and amici characterize this

provision as a “statutory license,” section 532(a)(1) of the

URAA merely limits the availability of certain specific

statutory patent infringement remedies for acts that were

commenced, or for which substantial investment was made,

before June 8, 1995, and which become infringing because

of the extension of the patent period.

Thus, section 532(a)(1) provides that the remedies set

out in sections 283, 284, and 285 of Title 35 (which provide

for injunctions, damages, and attorney and fees) will not

apply to infringing acts during this period. In lieu of those

3 Section 532 of the URAA provides:

(2) REMEDIES. The remedies of sections 283, 284, and

285 of this title [35 U.S.C.] shall not apply to Acts which --

remedies, the statute provides for payment of “equitable

remuneration.” The transition provision of URAA does not

refer to or limit the remedies set out in section 271(e)(4).4

The Hatch-Waxman Act provides that these are the “only

remedies” available for the act of infringement at issue in

this case, ie., infringement under section 271(e)(2). 35

U.S.C. § 271(e)(4).

3. FDA Policy Decision

The effect of URAA’s redefined patent terms on the

ANDA process was the subject of a notice and comment

proceeding conducted by the FDA in which representatives

of all segments of the pharmaceutical industry, including

(A) were commenced or for which substantial investment

was made before the date that is 6 months after the date of the

enactment of the Uruguay Round Agreements Act [June 8,

1995]; and

(B) became infringing by reason of paragraph (1) [the

redefined expiration date].

(3) REMUNERATION. The acts referred to in paragraph °

(2) may be continued only upon the payment of an equitable

remuneration to the patentee that is determined in an action

brought under chapter 28 and chapter 29 (other than those

provisions excluded by paragraph (2)) of this tile [35 U.S.C.A.].

URAA, Pub. L. No. 103-465, 108 Stat. 4809, 4984-85 (codified

at 35 U.S.C.A. § 154(c)West Supp. 1995)).

4 Congress was clearly aware of these provisions when enacted the

URAA since, as the FDA has recognized, they are amended by other

provisions of the URAA, albeit in ways not relevant here. See App.-14.

In this regard, the URAA provides that: “Nothing in this Act shall be

construed . . . to amend or modify any law of the United States, including

any law relating to--(I) the protection of human, animal or plant life or

health, ... unless specifically provided for in this Act.” Section

102(a)(2).

both generic and pioneer companies, submitted comments. In

a May 1995 letter, the FDA issued its decision on this issue,

concluding that the URAA provisions do not affect acts of

infringement under 35 U.S.C. § 271(e)(2) or the remedies for

that act of infringement under 35 U.S.C. § 271(e)(4). See

Appendix (“App.”).

Despite its expressed desire to do so, the FDA

“{could] not find a basis for adopting the interpretation of the

URAA that 35 U.S.C. 154, as amended, applies to

infringements through ANDA submissions, which are

governed by 35 U.S.C. 271(e).” App. 13-14. The FDA

recognized that “the URAA is not ‘silent or ambiguous’ on

the question of applying the transitional provision to the

generic drug approval process.” App. 13. Applying the

“plain language” of the transitional provision of the URAA,

FDA concluded that this provision simply “limits the

remedies available to a patentee in a suit brought against an

infringer whose actions became infringing due to the URAA

patent extension.” App. 14. In support of its conclusion, the

FDA observed that the URAA’s transition provision

specifically lists the three remedial provisions that are

unavailable, i.e., 35 U.S.C. 283, 284, and 285, but “does not

list among the unavailable remedies section 271(e)(4), which

provides for injunctions, damages, and attorney fees for

infringement actions arising from a manufacturer seeking

approval from FDA to market a generic version of a patented

drug product before the patent on the product expires.” App.

14. Responding to arguments by generic pharmaceutical

manufacturers that this was an inadvertent legislative

oversight, the FDA noted that this “is not an example of

Congress having overlooked a statutory provision it might

have changed had it been aware of its existence,” since the

URAA made other amendments to section 271(e)(4). App.

14,

Respondents are aware of no court challenge to the

FDA policy decision.

B. The Captopril Patent

Bristol owns United States Patent 4,105,776 (the

“captopril patent”), which discloses and claims the chemical

compound having the generic name “captopril.” Captopril

was developed, and marketed by Bristol under the trademark

Capoten®, for the treatment of hypertension, heart failure,

diabetic nephropathy, and left ventricular dysfunction

following myocardial infarction. The compound is the first

marketed compound in a class of drugs known as angiotensin

converting enzyme (“ACE”) inhibitors. When it issued on

August 8, 1978, the expiration date of the captopril patent

was August 8, 1995. Under the URAA, the expiration date

of United States Patent 4,105,776 is now February 13, 1996.

Cc. The DuPont-Merck Case

The instant case was preceded by another court

proceeding involving Bristol’s captopril patent. DuPont

Merck v. Bristol-Myers Squibb Co., 62 F.3d 1397 (Fed. Cir.

1995). Two generic drug manufacturers sued Bristol,

contending that the URAA transition provision gave them a

“license” or “authority” to market captopril prior to the

redefined term of the captopril patent if they paid “equitable

remuneration” to Bristol.

The district court dismissed plaintiffs’ declaratory

judgment action for lack of jurisdiction, holding that there

was no “actual case or controversy” because the two generic

manufacturers had not amended their ANDAs to include

paragraph IV certifications challenging the validity,

infringement or enforceability of Bristol’s captopril patent.

On appeal, the Federal Circuit found that there was

jurisdiction. Rather than remand, however, the court of

appeals proceeded to resolve “the merits of the dispute,”

holding that the generic companies have not stated a claim

“upon which relief may be granted” and “are not entitled to

So —————————————

relief as a matter of law.” 62 F.3d at 1402. Applying the

plain language of the URAA, the court of appeals held:

In sum, the URAA, by its terms,

exempts a qualified infringer from the

remedies of sections 283, 284, and

285 of Title 35. The URAA, however,

works no change on the definition of

infringement under section 271(e)(2)

and has no affect on the statutory

provisions relating to FDA approval of

ANDAs that are triggered by that act

of infringement. See 21 U.S.C.

§ 355(j).

Id. A petition for rehearing was denied on August 28, 1995.

Plaintiffs did not seek review by this Court.

D. The Dispute Between the Parties

1. Royce’s ANDA

Royce filed an ANDA seeking approval to market a

generic version of captopril. As originally filed, Royce’s

application contained a paragraph III certification stating that

the captopril patent expired on August 8, 1995. After the

enactment of URAA, that certification was no longer

accurate, and FDA could not lawfully approve Royce’s

ANDA. Consequently, Royce amended its ANDA by

eliminating the paragraph III patent certification and

substituting a paragraph IV certification.

As required by the Hatch-Waxman Act, Royce

notified Bristol of the paragraph IV certification. Royce did

not (and does not) contend that the captopril patent was

invalid or that the claims of the patent did not cover Royce’s

generic captopril product. The sole basis of Royce’s

“opinion” that the patent will not be infringed is its

contention that the transition provision of the URAA gives

Royce a “statutory license” to market captopril during the

period August 8, 1995 to February 13, 1996 because Royce

had made a “substantial investment” in anticipation of

marketing captopril and Royce will pay Bristol “equitable

remuneration.”

2. The District Court Proceedings

Bristol filed suit against Royce in the United States

District Court for the Southern District of Florida, alleging

that Royce had infringed Bristol’s captopril patent in

violation of 35 U.S.C. § 271(e)(2)(A) by submitting an

ANDA seeking FDA approval to market a generic version of

captopril before the expiration of Bristol’s patent. Bristol

alleged that Royce’s paragraph IV certification was

“insufficient and inadequate on its face, and inconsistent

with applicable law.”

Bristol sought judgment that (i) the captopril patent is

valid and has been infringed by Royce and (ii) the court enter

an order pursuant to 35 U.S.C.A. § 271(e)(4)(A) that the

effective date of any FDA approval of Royce’s ANDA under

21 U.S.C. § 355(j)(4)(B) be a date not earlier than the

February 13, 1996 expiration date of the captopril patent.

One week after the complaint was filed, Royce filed

an emergency motion “To Set Aside The Injunction

Delaying The Food And Drug Administration’s Approval Of

Defendant’s Abbreviated New Drug Application And To

Dismiss The Complaint.” In support of its motion, Royce

reiterated the contentions contained in its paragraph IV

notice to Bristol, and submitted a declaration of its president,

averring that Royce had spent over $1 million in connection

with the preparation and filing of its ANDA.

Bristol opposed Royce’s motion to dismiss on two

grounds. First, as a matter of law, the URAA does not

abrogate the remedies of section 271(e)(4) that result from a

section 271(e)(2) act of infringement. Second, even if the

URAA provides a “statutory license” of the sort claimed by

Royce, there was no way to ascertain whether Royce

satisfied the factual predicate of a “substantial investment”

on a motion to dismiss because it required discovery and an

evidentiary hearing.

On August 24, 1995 (without permitting any

discovery on the factual issues in dispute), the district court

issued an order granting Royce’s motion to dismiss and

dissolving the statutory stay on FDA approving Royce’s

ANDA.°> Although the district court found that Royce had

committed the act of infringement under 35 U.S.C.

§ 271(e)(2) alleged in the complaint (i.e., filing an ANDA

seeking FDA approval to market a generic drug product prior

to the expiration of the captopril patent), it held that this act

of infringement was not actionable because the “safe harbor”

provision of URAA made the ultimate commercial

manufacture and marketing of captopril non-infringing.§

Bristol appealed.

5 However, the District Court refused to order the FDA to make

approval of Royce’s ANDA immediately effective. A-39.

6 On the basis of the untested, conclusory assertion in an affidavit

submitted by Royce in support of its motion to dismiss, the district court

then found that Royce satisfied the URAA requirement of “substantial

investment” made prior to June 8, 1995. A-37. Although it recognized

that Bristol contested the factual and legal adequacy of Royce’s claimed

investment and sought discovery and an evidentiary hearing on this issue,

the district court (in a footnote) concluded that Royce had, in fact, made

a $1 million investment, and that, as a matter of law, this constituted a

“substantial investment” within the meaning of the URAA. /d The

district court ruled that Bristol therefore had no cause of action other than

a claim for “equitable remuneration.” Jd

3. The Decision Below

The Federal Circuit reversed the decision of the

district court.”

The court of appeals first examined the application of

the Hatch-Waxman Act requirements to Royce’s ANDA in

the absence of the URAA. Applying this Court’s decision in

Eli Lilly Co. v. Medtronics, Inc., 496 U.S. 661 (1990), the

court of appeals stated that, in an action for patent

infringement under section 271(e)(2)(A), the court must

“determine whether, if a particular drug were put on the

market, it would infringe the relevant patent.” A-12

(emphasis in original). The court recognized that if “the

patent is not invalid and the infringement would occur,” the

ANDA applicant’s paragraph IV certification is incorrect and

the patentee is entitled to an order that FDA approval of the

ANDA cannot be made effective prior to expiration of the

patent. Since Royce did not allege that the captopril patent is

invalid or that its claims did not cover Royce’s generic

captopril product, the court of appeals found that (in the

absence of the URAA), Royce would infringe Bristol’s

patent if it marketed captopril prior to the February 13, 1996

expiration date of the patent. A-13.

7 While Bristol’s Federal Circuit appeal was pending, Royce filed a

petition with the United States Court of Appeals for the Eleventh Circuit,

challenging the validity of an FDA regulation, 21 C.F.R.

§ 314.307(e)( 1995), which provides that FDA approval of an ANDA

which challenges the validity, enforceability of infringement of a patent

will be made effective on the date of an appellate decision that the patent

is invalid, unenforceable or not infringed. The reasons for this Rule were

set out at length in Federal Register notices proposing and adopting the

regulation. See 54 Fed. Reg. 28,872, 28,894-95 (July 10, 1989); 57 Fed.

Reg. 50,338, 50,353 (Oct. 3, 1994). Relying on the decision of the

district court in this case, Royce asked the Eleventh Circuit to order the

FDA to make its ANDA effective immediately -- relief that the district

court had refused to provide. Following the decision of the Federal

Circuit, Royce’s petition was dismissed as moot on December 2, 1995.

The court then proceeded to determine whether the

URAA altered this conclusion. Examining the language of

the URAA transition provision, 35 U.S.C. § 154(c), the court

found that the URAA does not make “infringing conduct

non-infringing during the Delta period.” A-15. After noting

that the plain language of the URAA merely limits remedies

for certain types of infringing conduct, i.e., the remedies of

35 U.S.C.A. §§ 283, 284 and 285, the court recognized that

“the URAA makes no mention of the provisions of the

Hatch-Waxman Act,” including the provisions for acts of

infringement under section 271(e)(2) and the remedies that

are available to the patentee under 35 U.S.C. section

271(e)(4) based on that act of infringement. As did the FDA

before it, the court pointed out that, if Congress had intended

to alter the Hatch-Waxman Act’s “finely crafted ANDA

approval process, in the manner urged by Royce, at the very

least it would have referred to 21 U.S.C. § 355(j) and 35

U.S.C. § 271 (e). ...” A-16-17.

Accordingly, the court held that the URAA “does not

convert Royce’s sale of generic captopril during the Delta

period into a non-infringing activity.” A-19. As a result,

Royce’s paragraph IV certification to the contrary was

incorrect, entitling Bristol to the remedy of

section 271(e)(4)(A).

The court did not reach the alternate ground for

reversal urged by Bristol based on the district court’s

improper resolution of factual issues on Royce’s motion to

After filing its Petition for Writ of Certiorari (and a

motion for expedited consideration) in this Court, Royce

filed a petition for rehearing with the Federal Circuit. On

December 8, 1995, the petition for rehearing was denied.

REASONS FOR DENYING CERTIORARI

The petition should be denied because the decision of

the Court of Appeals below is correct, does not conflict with

any decision of this Court or any other court of appeals and

does not present an important question for resolution by this

Court.

L THE DECISION BELOW IS CORRECT

AND DOES NOT CONFLICT WITH

THE DECISIONS OF THIS COURT OR

ANY COURT OF APPEALS

The court of appeals carefully considered and

rejected the arguments raised here by petitioner. There is no

conflict between the decision below and the decision of any

other court of appeals or this Court. To the contrary, this

was the second time that a panel of the Federal Circuit

reached the same conclusion in a case with respect to

Bristol’s captopril patent. The decision below was correct

and fully in accordance with applicable Supreme Court

precedent, the plain meaning of the statutes involved and the

policy of the FDA, viz. the federal agency with specific

statutory responsibility for administering the Hatch-Waxman

Act.

A. There Is No Conflict with Any

Decision of This Court

The Petition contends that the decision below

conflicts with the decision of this Court in Eli Lilly Co. v.

Medtronic, Inc., 496 U.S. 661 (1990). Pet. at 25. That is not

so.

In the first place, the Eli Lilly case did not address the

interrelaticnship between the URAA and the Hatch-Waxman

Act which was the subject of the decision below. Rather, Eli

Lilly dealt with the issue of whether certain of the patent

provisions of the Hatch-Waxman Act (35 U.S.C.

§ 271(e)(1)) applied to medical devices.

Moreover, the decision below is completely in accord

with this Court’s decision in Eli Lilly. The lower court

specifically cited Eli Lilly and applied the method for

evaluating the act of patent infringement under 35 U.S.C.

§ 271(e)(2) that is set out in the Court’s opinion in Eli Lilly.

Contrary to the suggestion of the Petition, the lower court did

not conclude that the mere filing of a paragraph IV

certification entitled Bristol to the relief it sought. Rather,

the lower court looked to see whether the ANDA applicant’s

paragraph IV certification was correct, ie., whether the

patent at issue is valid and, if so, whether sale of the generic

product at issue infringed that patent. This was the very

analysis that Royce asked the court to apply on the basis of

Eli Lilly. A-11.

Furthermore, the lower court properly recognized that

if, in enacting the URAA, Congress had meant to alter the

delicate balance of provisions in the Hatch-Waxman Act, as

described by this Court in Eli Lilly, it would have done so

explicitly and not by implication, as Royce suggests.

App. - 16-17. The lower court cited Eli Lilly for the

indisputable proposition that the provisions of the Hatch-

Waxman Act created “an important new mechanism

designed to guard against infringement of patents relating to

pioneer drugs” with enforcement provisions that “apply only

to drugs and not to other products.” 496 U.S. at 676-79.

App. - 16.

In short, there is no conflict whatsoever between the

decision below and this Court’s decision in Eli Lilly, and

certainly no irreconcilable “conflict” of the sort that might

support review by this Court. See, e.g, Layne & Bowler v.

Western Well Works, Inc., 261 U.S. 387, 393 (1923).

B. The Decision Below Does Not

Conflict with Any Other

Court of Appeals Decisions

Although Royce suggests that the issues raised in the

petition are novel, they have been previously considered in .

several different forums, with consistent results. As a result,

review by this court is not necessary to reconcile conflicting

appellate or administrative decisions.

The decision of the lower court is the second decision

by a panel of the Federal Circuit which has rejected the

contention that the URAA grants a “license” to generic drug

manufacturers to market captopril prior to the expiration of

Bristol’s admittedly valid patent. Thus, in DuPont Merck

(cited in the decision below), a different panel of the Federal

Circuit rejected the claims of two other generic drug

companies that the URAA gave them a right to market

captopril before expiration of the captopril patent, as

redefined by the URAA. Far from a conflict, there is

complete accord between the only two pertinent appellate

decisions on this issue.

Nor does the decision below conflict with any

administrative policy or interpretation of the Food and Drug

Administration -- the administrative agency with statutory

responsibility for implementing the ANDA process

established by the Hatch-Waxman Act. To the contrary, the

FDA specifically concluded that the URAA does not affect

the remedies available for acts of infringement under section

271(e)(2). That is also what the lower court found. There

has been no court challenge to FDA’s policy, and there is no

conflict between that policy and the decision below.

Compare Morton v. Ruiz, 415 U.S. 199, 201-02 (1974)

(decision below asserted to be “inconsistent with long-

established policy of the Secretary [of the Interior] and of the

Bureau”).

G The Decision Below

Correctly Applies the Plain

Language of the Statute

In an effort to secure review by this Court, both

Royce and amici ignore the actual language used by

Congress in enacting the URAA and misstate the decision of

the lower court.

First, contrary to the Petition’s repeated reference to

the “statutory license” of the URAA, the URAA does not

provide anyone, including an ANDA applicant, a “license”

to market any product. Nor does the URAA make any

conduct “non-infringing”. Rather, its plain language applies

only to acts which are infringing. Thus, section 154(c)(2)(B)

specifically states that it applies only to:

“Acts which --

(B) become infringing by reason of... .”

35 U.S.C. § 154(c)(2)(B)(emphasis added). When Congress

wishes to make acts non-infringing, it knows how to do so in

clear and unmistakable terms, as Congress did in the Hatch-

Waxman Act when it added section 271(e)(1), which stated:

“It shall not be an act of infringement ....” 35 U.S.C. §

271(e)(1).

Instead, as is clear from the plain language of the

statute, and as the FDA and two different panels of the

Federal Circuit have uniformly found, the transition

provision of the URAA simply limits certain remedies

available to certain patent holders in certain types of patent

infringement actions. The remedies that “shall not apply”

are specifically identified as the “remedies of Sections 283,

284 and 285” of the Patent Code. Clearly, 35 U.S.C.

§ 154(c) has no impact on an action to redress infringement

under 35 U.S.C. § 271(e)(2), the remedies for which are

provided by 35 U.S.C. § 271(e)(4). This includes the

remedy of section 271(e)(4)(A) which Royce seeks to avoid,

i.e., an order that the effective date of ANDA approval be “a

date which is not earlier than the date of the expiration of the

patent which has been infringed... .”

8 The URAA nowhere uses the term “license.” As the statutes which

Royce cited below make clear, Congress knows how to grant a “license”

in clear and unmistakable terms when it wishes to do so. See, e.g., 42

U.S.C. § 2183(b)(2) (1988) (“the Commission shall grant such patent

license . . .”); 42 U.S.C. § 7608 (1988) (“... issue an order requiring the

person who owns such patent to license it . . .”).

Second, Royce and amici distort the holding of the

lower court, contending that the decision “converts the

paragraph IV procedure into a trap which prevents otherwise

qualified parties from invoking a statutory license such as

that found in the URAA.” Pet. at 22. Petitioner suggests

that the lower court held that the mere filing of a Paragraph

IV certification is an act of infringement sufficient to justify

an order that the FDA cannot approve an ANDA prior to the

expiration of an applicable patent, whether or not the patent

was valid and whether or not it will actually be infringed.

That is simply not what the lower court held. To the

contrary, the Federal Circuit specifically found that once a

Paragraph IV certification is filed, the court must

determine whether, if a particular drug were

put on the market, it would infringe the

relevant patent. If the court determines that

the patent is not invalid and that

infringement would occur, and that therefore

the ANDA applicant’s paragraph IV

certification is incorrect, the patent owner is

entitled to an order that FDA approval of the

ANDA containing the paragraph IV

certification not be effective until the patent

expires.

A-12-13 (emphasis in original). Far from creating a Catch-

22 procedural trap, the lower court’s decision specifically

endorses the need for the very review Royce contends is

required.?

9 Here, there is no dispute that Bristol’s patent is valid and that it

covers Petitioner’s generic captopril product. Under the circumstances, it

is indisputable that Royce will infringe Bristol’s patent if it markets

captopril before expiration of the patent. Indeed, the very provision of

the URAA on which Royce relies for its alleged “license” confirms that

marketing by Royce would infringe Bristol’s patent because it

specifically relates only to acts that are (or become) “infringing.”

ieirir tery ee

4 DEA A PRATT OY LOT a

The lower court held (correctly) that the “safe

harbor” provision of the URAA simply eliminated the

remedies of sections 283, 284 and 285 in certain cases. It

did not take away the separate remedies of section 271(€)(4)

which are available to the patentee for an act of infringement

under section 271(e)(2) (admitted here) of seeking FDA

approval to market a generic product prior to the expiration

of a patent.!0 When Congress wishes to take away all

remedies, it says so in explicit terms. Compare 35 U.S.C.

§ 287(a) (“no damages shall be recovered”); 35 U.S.C.

§ 287(b)(2) (“no remedies for infringement ... shall be

available”); 35 U.S.C.A. § 271(g) (“no remedy may be

granted”). It did not do so here.

Contrary to the suggestion of Royce and amici, there

is nothing unusual or puzzling about the fact that Congress

did not alter the provisions of the Hatch-Waxman Act.

Doing so would have disturbed the delicate balance between

the interests of generic and pioneer pharmaceutical

companies that are reflected in the Hatch-Waxman Act

which created a new and self-contained section -- Section

271(e) -- of the Patent Code.!! The Hatch-Waxman Act

confers on generic drug companies an immunity from

infringement given to no other industry -- the freedom to use

a patented invention without liability or having to pay

compensation in order to develop ANDA applications. If

10 The remedies of sections 283, 284 and 285 have no application to

the generic drug approval process. “The remedies prescribed by

subparagraphs (a), (b) and (c) [of § 271(e)(4)] are the only remedies

which may be granted by a court for an act of infringement described in

paragraph (2)... .” 35 U.S.C. § 271(e)(4).

11 This section abolished traditional acts of infringement with respect

to ANDAs (section 271(e){1)), provided a new act of infringement

(section 271(e)(2)) for seeking FDA approval to market generic drug

products before the expiration of the applicable patents, and created a

new and exclusive set of remedies for that act of infringement (section

271(e)(4)), including the availability of a court order limiting the date of

FDA approval (section 271(e)(4)(A)).

Congress had wished to alter this statutory balance, it would

have said so explicitly, as both FDA and the lower court

recognized.

For the same reason, there is no basis for Royce’s

claim that the URAA contains a transitional provision whose

intended beneficiary must have been the generic drug

industry. Pet. at 9. If Congress had intended the transition

provision to apply to the generic drug approval process (a

contention flatly rejected by both the FDA and the court of

appeals), it is inconceivable that it would have failed to

include a specific reference to the very statutory provisions,

i.e., 35 U.S.C. § 271(e) and 21 U.S.C. § 355(j), it had created

expressly to govern that process.

IL THE PETITION DOES NOT

PRESENT AN ISSUE OF GENERAL

PUBLIC IMPORTANCE

Royce contends that the decision below will have

wide-ranging consequences for other products and other

parties, affecting the interests of “manufacturers of generic

prescription pharmaceuticals,” “the American public,” and

“federal, state and other third-party reimbursement

programs.” Pet. at 3.

While the decision below is not insignificant, both

Royce and amici exaggerate its importance. If the issue

decided below affects as many products and manufacturers

as Royce and amici assert, it would already be the subject of

a tidal wave of litigation. Significantly, however, neither

Royce nor amici point to any other litigation. In fact, except

for litigation involving Bristol’s patented captopril product,

there is no litigation (of which respondents are aware) that

addresses the issue decided below.!2 The absence of

12 Nor have any third parties (whether generic manufacturers, patented

pharmaceutical manufacturers or trade associations) previously

participated as amici, either in this case or in the DuPont Merck case.

comparable litigation concerning any other pharmaceutical

product strongly indicates that the issue is neither as

significant nor as pressing as the Petition suggests. Compare

Laing v. United States, 423 U.S. 161, 127 (1976) (70

pending cases in federal court depended on resolution of tax

conflict).

Both Royce and amici make the unsupported claim

that the decision below affects hundreds of drugs. The

current litigation position of Royce and amici is inconsistent

with the prior claim of amici that the URAA would have

only a minimal effect on the generic industry because “most

pharmaceutical patents in effect today took longer than three

years to issue. Therefore, switching to the new patent term

will provide them no extension of patent term.” Chemical

Marketing Reporter, Jan. 2, 1995, at 4 (quoting Lewis

Engman, President, GPIA). Moreover, the generic drug

industry has publicly recognized that the result they now

seek from this Court would require new legislation to amend

the URAA’s transition provision to close a “loophole.” See,

e.g., 141 Cong. Rec. $6495 (daily ed. May 11, 1995)

(remarks of Sen. Pryor) cited in Pet. at 9. 13 See also 141

Cong. Rec. $12388-12391 (August 11, 1995) (introducing

S.1191 to provide that the “remedies of section 271(e)(4) ...

shall not apply to acts” that become infringing as a result of

the URAA.)

Royce and amici also contend that this Court’s

review is necessary to correct the decision below which they

assert contravenes the clear intent of Congress. However,

the intent of Congress is determined first by reference to the

13 Similarly, the Corporate Counsel of one of the plaintiffs in the

DuPont Merck case -- and a principal member of amicus National

Association of Pharmaceutical Manufacturers -- stated in a presentation

to the Food and Drug Law Institute on February 6, 1995 that:

The GATT implementation language enacted by

Congress needs immediate revision prior to its

effective date of June 8, 1995.

language which Congress employed in the statute.

Connecticut Nat'l Bank v. Germain, 503 U.S. 249, 253-54

(1992). Moreover, neither Royce nor amici point to anything

in the legislative history of the URAA that would support

their claim that Congress intended to do anything other than

what the plain language of the statute indicates. Burlington

Northern R.R. v. Oklahoma Tax Comm'n, 481 U.S. 454, 461

(1987) (“[I]n the absence of a clearly expressed legislative

intention to the contrary, the language of the statute itself

must be ordinarily regarded as conclusive’”). In fact, the

legislative history supports the lower court’s construction of

the URAA. Thus, the President’s Statement of

Administrative Action explains the scope and effect of the

limitation of remedies provision of the URAA in exactly the

same way in which the FDA and the lower court have

construed it: “the patent owner will not be able to obtain an

injunction, recover a reasonable royalty, or obtain attorneys

fees as provided for in sections 283 to 285 of Title 35.” H.R.

Doc. No. 316, 103d Cong., 2d Sess. 1003 (1994) (emphasis

added).

In any event, review is not appropriate because the

judgment below was proper even if Royce’s interpretation of

the URAA’s transition provision is correct (which Bristol

denies and the Federal Circuit has twice rejected). The

statutory “safe harbor” applies only if Royce has made a

“substantial investment” in contemplation of acts which

“become infringing.” 35 U.S.C. § 154(c)(2). It remains to

be determined whether Royce satisfies this factual predicate

to the URAA “safe harbor.” While the district court below

concluded in a footnote that Royce met the statute’s

“substantial investment” criterion, that decision was clearly

erroneous since the district court improperly accepted the

factual assertions contained in an affidavit made in support

of a motion to dismiss Bristol’s complaint, without

permitting Bristol any opportunity to take any discovery on

this issue. Because the Federal Circuit found that there was

no legal basis to Petitioner’s claim, it did not reach the

validity of the district court’s decision on the issue of

“substantial investment.” As a result, a decision by this

Court on the issue presented by the Petition may be

unnecessary and irrelevant to the disposition of the case

below.

CONCLUSION

For all of the foregoing reasons, the Court should

deny the Petition.

Respectfully submitted,

ROBERT J. BROOKHISER

Counsel of Record

HOWREY & SIMON

1299 Pennsylvania Avenue, N.W.

Washington, D.C. 20004

(202) 783-0800

ROBERT L. BAECHTOLD

FITZPATRICK, CELLA, HARPER & SCINTO

277 Park Avenue

New York, NY 10172

(212) 758-2400

DONALD J. BARRACK

BRISTOL-MYERS SQUIBB CO. and

E.R. SQUIBB & SONS, INC.

Route 206 and Provinceline Road

Princeton, NJ 08543

(609) 252-4328

JOHN D. KISER

JOHN M. ENGEL

FOX, BENNETT & TURNER

750 17th Street, N.W.

Washington, D.C. 20006

(202) 778-2300

Attorneys for Respondents

Dated: December 11, 1995

APPENDIX

App.-1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Rockville MD 20857

May 25, 1995

Donald O. Beers

David E. Korn

Arnold & Porter

1200 New Hampshire Avenue, N.W.

Washington, D.C. 20036

Re: Docket No. 95P-0061/CP1

Dear Messrs. Beers and Korn:

This responds to the citizen petition you submitted on

behalf of Glaxo Inc. (Glaxo) dated March 7, 1995.! The

citizen petition requests that the Food and Drug

Administration (FDA) “follow the mandate of the [Uruguay

Round Agreements Act (Pub. L. 103-465)] URAA in

determining when approval of an Abbreviated New Drug

Application (‘ANDA’) or application of the type described

in Section 505(b)(2) of the Federal Food, Drug, and

| FDA has received a number of responses to Glaxo’s citizen petition

from generic and innovator drug manufacturers. Glaxo has submitted an

additional comment on the responses dated April 13, 1995. These

documents, as well as correspondence referred to in this response, are

included in Docket No. 95P-0061. The agency has considered these

submissions, as well as the oral and written submissions made in

connection with the February 16, 1995, hearing held by the Patent and

Trademark Office (PTO) at which these issues were addressed in its

response to Glaxo’s citizen petition.

App. -2

Cosmetic Act (‘FFDCA’), 21 U.S.C. § 355(b)(2), (*505(b)(2)

| application’), may be made effective.” Citizen Petition at 1.

| The citizen petition specifically requests that:

(1) FDA publish patent dates as revised by the

URAA in “Approved Drug Products With

Therapeutic Equivalence Evaluations” (the

Orange Book) prior to June 8, 1995;

(2) FDA announce that pending ANDA and

505(b)(2) applications containing paragraph

III certifications to the pre-URAA patent

expiration dates must be amended to

acknowledge the patent expiration dates as

extended by the URAA;

(3) FDA announce that any new ANDA’s or

505(b)(2) applications must refer to the patent

expiration dates extended by the URAA;

(4) | FDA not make approvals of any ANDA or

505(b)(2) application containing a paragraph

III certification effective prior to the patent

expiration date as revised by the URAA; and

(5) FDA require ANDA and 505(b)(2) applicants

that seek an effective date of approval prior to

the URAA-revised patent expiration date to

submit paragraph IV certifications for any

applicable patents.

Citizen Petition at 2-3.

For the reasons set out below, the agency grants your citizen

petition in part, and denies your citizen petition in part.

App. -3

L STATUTORY AND REGULATORY

BACKGROUND

The relief sought by the citizen petition filed on

behalf of Glaxo must be determined under the Federal Food,

Drug, and Cosmetic Act (the FD&C Act) and the URAA,

which establish the obligations of approved mew drug

application (NDA) holders, ANDA and 505(b)(2) applicants,

and the agency with respect to extended expiration dates for

patents covering listed drugs or their uses.?

A. The FD&C Act and FDA Regulations

The agency’s decision in this matter is governed by

provisions of the FD&C Act related to new drug and generic

drug approvals. These provisions were added to the FD&C

Act through the Drug Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. No. 98-417) (the Waxman-

Hatch Amendments). Title I of the Waxman-Hatch

Amendments was intended “to make available more low cost

generic drugs by establishing a generic drug approval

procedure for pioneer drugs first approved after 1962.” H.

Rept. No. 857 (Part I), 98th Cong., 2d sess. at 14 (1984)

(House Report). Title II of the Waxman-Hatch Amendments

was intended to provide a new incentive for increased

expenditures for research and development of drug products

by “restoration of some of the time lost on patent life while

the product is awaiting pre-market approval.” (House Report

at 15.)3

2 This analysis applies as well to abbreviated new animal drug

applications (ANDA’s), by which manufacturers seek approval to market

generic versions of animal drugs under section 512 of the FD&C Act.

3 Until the Waxman-Hatch Amendments, manufacturers of generic

versions of pioneer drugs first approved after 1962 generally were

required to duplicate the time-consuming and expensive safety and

effectiveness studies already performed on the pioneer drugs. The

App. -4

1. New Drug Applications

Under the Waxman-Hatch Amendments,

pharmaceutical companies seeking to market pioneer drugs

must first obtain FDA approval through the filing of an NDA

(see section 505(a) and (b) of the FD&C Act). In addition to

data demonstrating the safety and effectiveness of the drug,

an NDA applicant is required to submit to FDA information

on any patent which claims the drug or a method of using

such drug for which a claim of patent infringement could

reasonably be asserted against an unauthorized party (see

section 505(b)(1) and (c)(2) of the FD&C Act). The patent

information must include the patent number and date of

expiration. Id. If patent information is available at the time

the NDA is submitted or becomes available during the

pendency of FDA’s review of the application, it must be

included with the NDA or filed in an amendment to the

application (see section 505(b)(1) of the FD&C Act).

The statute specifically anticipates that patents may

issue after approval of the NDA and provides for submission

of information to FDA on those patents (see section

505(c)(2) of the FD&C Act). The Waxman-Hatch

Amendments provide for the extension of patent term

expiration dates for listed patents under the patent term

restoration provisions (see 35 U.S.C. 156).

FDA is to publish the patent information submitted to

it by the NDA holder (see section 505(b)(1) and (c)(2) of the

FD&C Act). The agency publishes the required patent

information in its publication, the Orange Book. When

accepting patent information from the NDA sponsor under

Waxman-Hatch Amendments permit these generic drug manufacturers to

rely on FDA’s prior determinations of the safety and efficacy of the

pioneer drug (see House Report at 14 and 15).

App. -5

section 505(b)(1) and (c)(2) of the FD&C Act, FDA is acting

in a solely ministerial capacity. The agency relies on the

sponsor’s assessment of the applicability of the patent to the

drug and does not make an independent determination on

that issue (see the Federal Register of October 3, 1994, 59

FR 50338 at 50343, 50345, 50348, 50349, 50361). The

statutory scheme relies on private patent litigation to resolve

disputes concerning patent validity and applicability (see 59

FR 50338 at 50348).

Because current patent information is an important

part of the patent certification process, patent information

that becomes available after approval of the NDA because of

the issuance of a new patent or a Waxman-Hatch patent term

extension will be published by FDA (see 59 FR 50338 at

50343).

2. ANDA’s and 505(b)(2) Applications

A manufacturer that wishes to market a generic

version of a pioneer drug must submit to FDA an ANDA

(see section 505(a) and (j) of the FD&C Act). An applicant

that wishes to gain approval of an application for a new drug

when the investigations that show the safety and

effectiveness of the drug were not conducted by the applicant

and for which the applicant has not obtained a right of

reference or use must submit to FDA a 505(b)(2) application

(see section 505(a) and (b) of the FD&C Act). The statute

requires that an ANDA or 505(b)(2) application contain,

among other data and information, a certification with

respect to each patent that claims the drug for which the

ANDA applicant is seeking approval. This certification must

state one of the following:

(I) that the required patent information relating to

such patent has not been filed;

(II) _ that such patent has expired;

App. - 6

(III) that the patent will expire on a particular date;

(IV) that such patent is invalid or will not be

infringed by the drug for which approval is

being sought.

(See section 505(b)(2)(A) and (j)(2)(A)(vii) of the FD&C

Act.)

The two types of patent certifications particularly

relevant in this matter are those made under paragraph III (a

paragraph III certification) and paragraph IV (a paragraph IV

certification). A paragraph III certification indicates that the

applicant does not intend to market the drug until after the

expiration date of the applicable patent. An applicant whose

ANDA or 505(b)(2) application contains a paragraph IV

certification must give notice of the filing to the patent

owner and the NDA holder for the listed drug (see section

505(b)(3) and (j)(2)(B) of the FD&C Act). This notice must

include a detailed statement of the factual and legal basis for

the applicant’s opinion that the patent is not valid or will not

be infringed. Id.

FDA regulations require that an ANDA or 505(b)(2)

applicant amend its patent certification if “at any time before

the effective date of the approval of the application, the

applicant learns that the submitted certification is no longer

accurate” (see 21 CFR 314.94(a)(12)(viii)(C) published at 59

FR 50338 at 50366 and 21 CFR 314.50(i)(6)(iii)(A)

published at 59 FR 50338 at 50362).

a FDA Approval of ANDA’s and

505(b)(2) Applications

The timing of FDA’s approval of an ANDA or

505(b)(2) application is governed, in part, by the patent

certifications submitted by the applicant. FDA may approve

App. -7

an application that contains a paragraph III certification on

the date the patent to which the certification was made

expires (see section 505(c)(3)(B) and (j)(4)(B)(II) of the

FD&C Act). In the case of a paragraph IV certification,

FDA will approve the application, and the approval will

become effective immediately despite the unexpired patent,

unless an action for infringement of the patent is brought

against the applicant within 45 days of the date the patent

owner and the NDA holder receive notice of the paragraph

IV certification (see section 505(c)(3)(C) and (j(4)(B)(iii) of

the FD&C Act). If a patent action is brought within the

45-day period, FDA may make the approval of the ANDA or

505(b)(2) application effective no earlier (than) 30 months

from the date that the patent owner and NDA sponsor

received the notice, or such shorter or longer period as the

court may order. Id.

B. Uruguary Round Agreements Act

The citizen petition requests that FDA “follow the

mandate of the URAA” with respect to approvals of

ANDA’s and 505(b)(2) applications. Citizen Petition at 1.

The URAA was enacted in December 1994 to implement the

Uruguary Round Agreements, a series of multilateral

agreements, which includes the General Agreement on

Tariffs and Trade (GATT) and the Agreement on Trade-

Related Aspects of Intellectual Property Rights (TRIP’s).

URAA’s provisions amend Title 35 of the U.S. Code

to extend the period of patent protection for some patents.

Section 532(a)(1) of the URAA amends 35 U.S.C. 154 to

provide that patents issued after June 8, 1995 (the effective

date of the patent provisions of URAA), will have a term of

20 years from the date on which the application for the

patent was filed or, under certain circumstances, from the

date of the earliest patent application filing. Section

532(a)(1) of the URAA also provides that, for patents in

App. - 8

force on June 8, 1995, or that result from an application filed

before that date, the patent term shall be the greater of 17

years from the granting of the patent or 20 years from the

date on which the application for the patent was filed, or

under certain circumstances 20 years from the date of the

earliest patent application filing.

The URAA contains a transitional provision

governing acts that will become infringing due to the

extension of patents in effect or already filed as of June 8,

1995. Section 532(a)(1) of the URAA limits the availability

of certain statutory patent infringement remedies for acts that

were commenced, or for which substantial investment was

made, before June 8, 1995, and which become infringing

because of the extension of the patent period.

This provision establishes that the remedies set out in

sections 283, 284, and 285 of Title 35, which provide for

injunctions, damages, and attorney fees, will not apply to

infringing acts during this period. The URAA provides that

such infringing acts may be continued upon payment of

equitable remuneration to the patentee. The statute does not

define “substantial investment” or “equitable remuneration.”

The patent code also contains, at 35 U.S.C. 271(e)(4),

a provision that establishes the remedies available for

infringement of patents on drug products when a

manufacturer seeks approval to market a generic version of

the drug before the expiration of applicable patents. This

section, which provides for a court to order that the effective

date of an approval shall be no earlier than the patent

expiration date, and for injunctions, damages, and attorney

fees, was not among the remedial provisions explicitly made

unavailable under the URAA.

Section 271(e) of Title 35 was enacted as part of Title

II of the Waxman-Hatch Amendments and relates

App. -9

specifically to the approval process for generic drug

products.4 Section 271(e)(1) establishes that it is not an act

of infringement to use a patented drug for purposes related

to obtaining regulatory approval of the product.5 Section

271(e)(2) states that it shall be an act of infringement to

submit a 505(b)(2) application or ANDA “if the purpose of

such submission is to obtain approval under [the FD&C Act]

to engage in the commercial manufacture, use, or sale of a

drug . . . claimed in a patent or the use of which is claimed in

a patent before the expiration of such patent.” Section

271(e)(4) lists the remedies available for infringement

actions brought under section 271(e)(2), and states that these

will be the only remedies for a patent infringement action

brought under that provision.

IL. PETITIONER’S REQUEST

Petitioner requests that FDA take five specific actions

with respect to patents that have expiration dates that will be

extended by the URAA. Each of these requests is discussed

below.

4 The patent term extension provisions of the Waxman-Hatch

Amendments were also codified in the patent code. 35 U.S.C. 156.

5 This provision essentially overruled the court’s decision in Roche

Products, Inc, vy, Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir.

1984) cert, denied, 469 U.S. 856 (1984), that had determined that the use

of a patented product even for testing and preparing an application for

regulatory approval was an act of infringement.

6 The Supreme Court has observed that section 271(e)(2) creates these

“artificial” acts of infringement so that the underlying patent issue can be

resolved in a court proceeding pursuant to a paragraph IV certification.

Eli Lilly and Co, v. Medtronic, Inc. 496 U.S. 661, 678 (1990). The

Court further observes that the remedies of section 271(e)(4) are also

artificial remedies. “Quite obviously, the purpose of subsections (¢)(2)

and (e)(4) is to enable the judicial adjudication upon which the ANDA

and paper NDA schemes depend.” Id,

App. - 10

A. FDA Should Publish Patent Expiration Dates

as Revised by the URAA in the Orange Book

Before June 8, 1995

The Waxman-Hatch Amendments require that FDA

publish the patent information submitted to it in accordance

with section 505(b)(1) and (c)(2) of the FD&C Act. The

agency publishes patent information submitted to FDA after

approval of the NDA when the patent information derives

from a patent term extension under 35 U.S.C. 156, or from

the issuance of a new patent (see 59 FR 50338 at 50343).

Publication of the URAA-extended patent expiration

dates in the Orange Book will assure that ANDA and

505(b)(2) applicants are aware of the patents and patent

expiration dates that NDA holders believe apply to the listed

drug product or use. This will permit the applicant or

another interested party either to provide a corresponding

certification in an ANDA or 505(b)(2) application, or to

challenge the accuracy of the patent information through the

procedures set out in 21 CFR 314.53(f) (published at 59 FR

50364) and 21 CFR 314.94(a)(12)(vii) (published at 59 FR

50365).

FDA denies petitioner’s request that the agency

publish the URAA-extended patent expiration dates before

June 8, 1995. As noted in the citizen petition at p. 10, the

new patent expiration dates will take effect on June 8, 1995

(see section 534 of the URAA). The agency will not accept

patent information that anticipates the granting of a new

patent, a situation analogous to this grant of patent term

extension (see the Federal Register of July 10, 1989 (54 FR

28872 at 28908)). This position is consistent with the

Waxman-Hatch Amendments’ requirement that information

on patents be submitted to the agency within 30 days of the

date of issue, notwithstanding that patent applicants may

receive advance notice that a patent will be issued (see

App.- 11

section 505(c)(2) of the FD&C Act). The agency has stated

that, with respect to new patents, the NDA holder may

informally notify the agency of the impending issuance of

the patent, but that no official action will be taken in

response to such notice (see 54 FR 28872 at 28908). This

procedure will apply as well with respect to URAA-extended

patent expiration dates. 7

The agency expects to receive information on the

URAA-extended patent expiration dates directly from the

NDA holder on or after June 8, 1995.8 The agency will

place this information on public display after June 8, 1995,

and will publish it in the monthly supplement to the Orange

Book after June 8, 1995 (see 21 CFR 314.53(e) published at

59 FR 50364).9

7 NDA holders that have already submitted information on URAA

extended patent terms should resubmit such information on or after June

8, 1995, but before July 8, 1995.

8 The agency considers the submission of information on URAA-

extended patent expiration dates to be analogous to the submission of

information on newly issued patents. Information on these URAA-

extended patent expiration dates should be submitted to FDA within 30

days of June 8, 1995. PTO stated in the Federal Register of March 27,

1995, that it intends to determine and publish the new expiration dates

for patents that (1) will be in force on June 8, 1995, (2) that are entitled to

a patent term of 20 years from the date of filing, and (3) that have

received patent term extension under the Waxman-Hatch Amendments

(see 60 FR 15748). PTO has indicated to FDA that it expects to publish

this information before June 8, 1995.

9 Updated information related to patents on human drug products

regulated by the Center for Drug Evaluation and Research will be placed

on public display in the Dockets Management Branch (HFA-305), Food

and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD

20857, under Docket No. 958-0117, after June 8, 1995. Updated

information related to patents on human drug products regulated by the

Center for Biologics Evaluation and Research will be placed on public

display in the Dockets Management Branch under Docket No. 95S-0135.

Updated informatién related to patents on animal drug products will be

placed on public display in the Dockets Management Branch under

App. - 12

B. FDA Should That A

FDA’s current regulations require that an ANDA or

505(b)(2) applicant amend its patent certification if “at any

time before the effective date of the approval of the

application, the applicant learns that the submitted

certification is no longer accurate” (see 21 CFR

314.94(a)(12)(viii)(C) published at 59 FR 50338 at 50366

and 21 CFR 314.50(i)(6)(iii)(A) published at 59 FR 50338 at

50362). After June 8, 1995, and upon timely submission by

the NDA holder of the URAA-extended patent expiration

dates, a pending ANDA or 505(b)(2) application that

contains a paragraph III certification to the pre-URAA patent

expiration date will be inaccurate under the current

regulations.

Because the Waxman-Hatch Amendments and

implementing regulations require that ANDA and 505(b)(2)

applicants certify as to timely patent information, and that

the timing of FDA’s approval be governed by these

certifications, the only way the agency could approve

ANDA’s and 505(b)(2) applications before the URAA-

extended patent expiration date is if the URAA permits FDA

to treat the period of extended patent protection granted by

the URAA differently than it treats other patent protection

asserted by NDA holders. In particular, the agency’s actions

depend upon whether the URAA permits FDA to make an

Docket No. 958-0126. Updated patent information on animal drug

products will be published in the monthly supplements to “FDA

Approved Animal Drug Products” (the Green Book) after June 8, 1995.

App. - 13

exception to the updated certification requirement for ANDA

and 505(b)(2) applications. If applicants are not required to

certify to the URAA-extended patent term, FDA may

approve the ANDA or 505(b)(2) application upon the

expiration of the pre-URAA patent term. Resolution of this

issue requires FDA to make a legal judgment concerning the

patent code, about which the agency has no special expertise,

to determine the applicability of the transitional provisions

set out within section 532(a)(1) of the URAA to the generic

drug approval process.

Arguably, FDA could treat the periods of URAA-

extended patent term differently than it treats other patent

protection asserted by NDA holders if the URAA’s

transitional “grandfather” provision within section 532(a)(1)

applied to infringements through ANDA submission and

approval. Section 532(a)(1) of the URAA amends 35 U.S.C.

154 to limit the remedies available for infringement,

permitting parties that have commenced acts, or made a

substantial investment toward acts, which will become

infringing under the extended patent period provided by the

URAA, to market their products during the URAA-extended

period upon payment of “equitable remuneration” to the

patentee. The agency cannot find a basis for adopting the

interpretation of the URAA that 35 U.S.C. 154, as amended,

applies to infringements through ANDA submissions, which

are governed by 35 U.S.C. 271(e).

The agency believes that interpretation of the

interrelationship between the transitional provisions of

section 532(a)(1) of the URAA and 35 U.S.C. 271(e)(4) is

governed by the plain language of the URAA. The Supreme

Court has established a two-step process for reviewing an

agency’s interpretation of a statute. Chevron, U.S.A., Inc. v.

Natural Resources Defense Council, Inc., 467 U.S. 837, 842

(1984). Under Chevron, the first question is whether

Congress has directly addressed the matter at issue. “If the

App. - 14

intent of Congress is clear, that is the end of the matter; for

the court, as well as the agency, must give effect to the

unambiguously expressed intent of Congress.” Id. at 842-43.

Only if the statute is silent or ambiguous does the court turn

to the second step of the Chevron analysis and determine

whether the agency’s interpretation of the statute is a

permissible one and therefore entitled to deference. Id. at

843-44. In the present matter, the plain meaning of the

URAA has determined the agency’s position. See United

States v. Ron Pair Enterprises, Inc, 489 U.S. 235, 241

(1989) (when language of statute is plain, it is to be enforced

according to its terms). The URAA is not “silent or

ambiguous” on the question of applying the transitional

provision to the generic drug approval process. Indeed, if

the statute did admit of more than one interpretation, FDA

would have found that approval of pending applications

upon the expiration of the pre-URAA patent term for patents

issued before June 8, 1995, is more consistent with the

underlying goals of the Waxman-Hatch Amendments.

The transitional provision of the URAA limits the

remedies available to a patentee in [a] suit brought against an

infringer whose actions became infringing due to the URAA

pateat extension. Section 532 of the URAA specifically lists

the three remedial provisions that are unavailable: 35 U.S.C.

283, 284, and 285. This provision does not list among the

unavailable remedies section 271(e)(4), which provides for

injunctions, damages, and attorney fees for infringement

actions arising from a manufacturer seeking approval from

FDA to market a generic version of a patented drug product

before the patent on the product expires. Moreover, this

apparently is not an example of Congress having overlooked

a statutory provision it might have changed had it been

aware of its existence; section 533 of the URAA amends 35

U.S.C. 271(e)(4) to apply the remedies specified to a broader

range of infringing actions (e.g., it extends coverage from

“sale” to “offer to sell”). In light of this reference in the

App. - 15

URAA to section 271, the agency does not believe that it can

assert that Congress was unaware of the existence of these

remedies for infringement of patents on drug products, and,

therefore, did not include them among the unavailable

remedies in section 532(a)(1) of the URAA.

In the present matter, therefore, the plain meaning of

the URAA is dispositive. While the results of this literal

interpretation of the words of the statute are puzzling, in that

Congress has--without explanation in the legislative

history--applied the transitional “grandfathering” provision

to every patented product except drugs, the agency believes

that this result follows from the language of the statute. !0

The limited legislative history for section 532 of the

URAA does not provide any affirmative support for the

argument asserted in responses to the citizen petition that it

was Congress’ intention to apply the transitional provision to

all acts of patent infringement. The language in the TRIP’s

Agreement permits, but does not require, the inclusion of a

transitional provision in the implementing legislation

adopted by a member country.!! The statements contained

10 ‘The statutory language is particularly perplexing in light of recent

congressional attention to health care costs, and the detrimental effect an

extension of patent term protection to innovator companies may have on

the availability to private and governmental consumers of lower-cost

generic alternatives. These are some of the same concerns that formed a

basis for passage of the 1984 Waxman-Hatch Amendments. Indeed, in a

March 29, 1995, letter to Commissioner Kessler, Representative Henry

Waxman, co-author of the Waxman-Hatch Amendments, notes that

“applying the transition provisions to allow the more timely entry of

generics onto the market is reflective of the spirit of the [Waxman-Hatch

Amendments].” In contrast, Senator Orrin Hatch, also a co-author of the

Waxman-Hatch Amendments, indicated in a January 19, 1995, letter to

Commissioner Kessler that it is his belief that if the agency were to

approve ANDA’s upon the expiration of the pre-URAA patent term, it

would jeopardize the “careful balance between the interests of the

generic and pioneer drug manufacturers.”

1 The TRIP’s Agreement provides, at Article 70.4, that:

App. - 16

in the Statement of Administrative Action and in the Joint

Senate report are not specific as to the parties affected by the

transitional provision and are merely restatements of the

general technical aspects of the provision. !2

In respect of any acts in respect of specific objects

embodying protected subject matter which become

infringing under the terms of legislation in conformity with

this Agreement, and which were commenced, or in respect

of which a significant investment was made, before the date

of acceptance of the WTO Agreement by that Member, any

Member may provide for a limitation of the remedies

available to the right holder as to the continued

performance of such acts after the date of application of this

Agreement for that Member. In such cases, the Member

shall, however, at least provide for the payment of equitable

remuneration.

(Emphasis added.) Reprinted in H. Doc. No. 316, 103d Cong., 2d sess.

at 1651-1652 (1994) (House Document).

12 The Statement of Administrative Action that accompanied the

URAA states that:

Section 532(a) also adds sections 154(c)(2) and (3) [to the

patent code]. These sections address situations where a

third party begins use of a patented invention before the

date that is six months after the date of enactment of the

Uruguay Round Agreements Act and such use becomes

infringing because of a change in patent term due to

operation of section 154(c\(1). In such circumstances, the

patent owner wiil not be able to obtain an injunction,

recover a reasonable royalty, or obtain attorneys fees as

~ provided for in sections 283 to 285 of Title 35, but will be

able to recover equitable remuneration from a third party

who infringes the patent during the period in question.

House Document at 1003.

The Joint Report of the Committee on Finance, Agriculture, Nutrition,

and Forestry, and Governmental Affairs contains a nearly identical

statement:

Section 532(a) adds new sections 154(c)(2) and (3). These

sections address the situation where a third party begins

App. - 17

In a May 19, 1995, letter to Commissioner Kessler,

United States Trade Representative Kantor, chief negotiator

of the Uruguay Round Agreements, indicated that the

intention of the language of the provision was to treat all

companies equally. In other words, according to the United

States Trade Representative, generic pharmaceutical

companies that have made a substantial investment in

anticipation of the expiration of the pre-URAA patent should

be permitted to market their products as of that date, upon

payment of equitable remuneration. This letter indicates that

the language of the URAA does not reflect the legislative

intent. Nevertheless, the language of the statute is

controlling.

For the reasons set out above, the agency has

determined that the URAA provides no basis for FDA to

treat the period of patent extension furnished by the URAA

differently than it treats other patent protection asserted by

NDA holders. There is therefore no support for FDA to

change its regulation that requires an applicant with a

pending ANDA or 505(b)(2) application to amend its

certification to respond to patent information filed after the

application was submitted but before approval is effective.

ANDA and 505(b)(2) applications pending before the agency

on June 8, 1995, that contain certifications only with respect

to pre-URAA patent expiration dates must be amended to

S. Rept. No. 412, 103d Cong., 2d sess. at 228-229 (1994).

App. - 18

respond to URAA-extended patent expiration dates, if such

information is submitted in a timely manner by the NDA

holder. Applications that do not include certifications

amended to respond to the URAA-extended patent expiration

dates will not be approved.

c. FDA Should Announce That Any New

ANDAs or 505(b)(2) Applications Must

Refer to the Patent Expiration Dates Extended

by the URAA

The agency has determined that the URAA-extended

patent expiration dates submitted to FDA in a timely manner

by the NDA holder will be the applicable patent expiration

dates with respect to patent certifications under section

505(j(2)(A)(vii) and (b)(2)(A) of the FD&C Act. This

determination applies to new ANDA’s and 505(b)(2)

applications submitted to FDA after the effective date of the

URAA patent extension provisions, as well as to applications

pending before the agency on the effective date.

D. FDA Should Not Make Approvals of Any

ANCA or 505(b)(2) Application Containing a

Paragraph III Certification Effective Before

the Patent Expiration Date as Revised by the

URAA be

As discussed above, the timing of FDA approval of

an ANDA or 505(b)(2) application is governed in part by the

patent certifications submitted by the applicant. In the case

of a paragraph III certification, FDA will make approval of

the application effective no earlier than the expiration date of

the patent that is the subject of the paragraph III certification.

Further, FDA regulations require that an applicant with a

pending ANDA or 505(b)(2) application amend the

certification to respond to timely patent

information--including URAA patent extension

App. - 19

information--filed with the agency after the ANDA was

submitted. If an application contains a paragraph III

certification only with respect to the pre-URAA expiration

date for the patent, FDA will not approve the application

because the ANDA or 505(b)(2) application will not contain

a certification to patent information submitted by the NDA

holder in a timely fashion (see section 505(d)(6) and (j)(3)(J)

of the FD&C Act).

E. FDA Should Require ANDA and 505(b\(2

Applicants that Seek an Effective Date of

val Before the URAA-Revised Patent

iration Date to Submit P hiv

Certifications for Any Applicable Patents

The drug approval process established by the

Waxman-Hatch Amendments requires that an ANDA or

505(b)(2) application contain a certification stating the status

of patents submitted to FDA by the NDA holder. The only

certification that is appropriate if an applicant wishes to

challenge such a patent is a paragraph IV certification. The

paragraph IV certification is appropriate when the applicant

believes that the listed patent is “invalid or will not be

infringed by the manufacture, use, or sale of the new drug for

which the application is submitted” (see section

505(b)(2)(A iv) and (j)(2A)(vii\IV) of the FD&C Act). A

paragraph IV certification is also appropriate when an

applicant believes that the patent is unenforceable (see 21

CFR 314.94(a)(12)(iA)(4) published at 59 FR 50338 at

50365, 21 CFR 314.50(i)(1)(iA)(4) published at 59 FR

50338 at 50361, and 59 FR 50338 at 50339 (discussing

Merck vy. D Inc. 694 F. Supp. 1 (D. Del.

1988), aff'd, 873 F.2d 1418 (Fed. Cir. 1989))).

FDA cannot require an ANDA or 505(b)(2) applicant

to file a paragraph IV certification with respect to a patent. It

can, and will, however, refuse to approve an application that

App. - 20

contains a paragraph III certification to an incorrect patent

expiration date, including a certification to the pre-eURAA

expiration date of a patent for which a URAA-extended

patent expiration date has been submitted to the agency in a

timely fashion. If an applicant with an incorrect certification

wishes to obtain FDA approval of its ANDA or 505(b)(2)

application, it must amend its application to provide either a

paragraph III certification indicating that it will wait until the

URAA-extended patent has expired, or a paragraph IV

certification indicating that the patent is invalid,

unenforceable, or will not be infringed. As discussed above,

if a patent challenge is brought within 45 days by the patent

owner or NDA holder, FDA must stay its approval for at

least 30 months, unless a shorter or longer time is ordered by

a court.!3

Ii CONCLUSION

The 1984 Waxman-Hatch Amendments to the

Federal Food, Drug, and Cosmetic Act represent a careful

balance between the policies of fostering the availability of

generic drugs and of providing sufficient incentives for

research on breakthrough drugs. This landmark compromise

between the interests of the generic drug companies and the

pioneer companies was intended io grant a one-time patent

term extension in exchange for the prompt availability of

generic drug products. There is certainly a strong argument

to be made that such a compromise should not be upset

without hearings and careful deliberation as to the impact on

the twin interests served by the Waxman-Hatch

Amendments.

13, The agency is aware that for some applicants, the 30-month stay

required of FDA will consume whatever period of marketing the

applicant might have gained by obtaining approval upon the expiration of

the pre-URAA patent term.

App. - 21

Here there were neither hearings nor a single word of

debate on the floor of the House or Senate on the impact of

the URAA on the 1984 Waxman-Hatch Amendments. Nor

do the committee reports indicate that Congress understood

that the URAA would both grant a patent term extension for

certain pioneer products and block FDA from approving

generic versions of those drugs until the extended patent

terms have expired. Nonetheless, the language of the URAA

directs that result.

Accordingly, for the reasons stated above, FDA

grants your citizen petition in part and denies your citizen

petition in part. FDA has determined that the URAA-

extended patent term expiration dates will be the governing

patent expiration dates with respect to NDA submissions and

FDA publication of patent information on listed drugs and

their uses; however, FDA will not publish the URAA-

extended patent expiration dates until after they become

effective on June 8, 1995. ANDA’s and 505(b)(2)

applications pending before the agency on June 8, 1995,

must be amended to respond to the URAA-extended patent

expiration dates, if information on the new expiration dates

is submitted to the agency in a timely manner. ANDA’s and

505(b)(2) applications submitted after June 8, 1995, similarly

must provide patent certifications with respect to the URAA-

extended patent expiration dates. After June 8, 1995, FDA

will not approve any application that does not contain a

correct certification with respect to a URAA-extended patent

agency. Finally, FDA cannot require that an applicant

submit a paragraph IV certification as to a certain patent.

The agency expects that an ANDA or 505(b)(2) applicant

that wishes to market a generic version of a drug prior to the

expiration of a URAA-extended patent, for which

App. - 22

information was timely submitted to FDA, will file a

paragraph IV certification with respect to that patent.

Sincerely yours,

/s/William B. Schultz

Deputy Commissioner for Policy

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.