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PUREPAC PHARMACEUTICAL CO., Plaintiff-Appellee, v., 2003 WL 25585736.
2003 WL 25585736 (C.A.D.C.) (Appellate Brief) United States Court of Appeals, District of Columbia Circuit.
PUREPAC PHARMACEUTICAL CO., Plaintiff-Appellee, Tommy G. THOMPSON, Secretary of Health and Human Services, and Mark B. McClellan, Commissioner of Food and Drugs, Defendants-Appellees, Torpharm, Inc. and Apotex, Inc., Intervenors-Appellants; Tommy G. Thompson, Secretary of Health and Human Services, and Mark B. McClellan, Commissioner of Food and Drugs, Defendants-Appellees, Purepac Pharmaceutical Co., Intervenor-Appellee.
Appeals from the United States District Court for the District of Columbia in Civil Nos. 02-1657 & 03-0254, Judge Ellen Segal Huvelle Final Brief of Purepac Pharmaceutical Co.
Of Counsel: Edgar H. Haug, Steven M. Amundson, Andrew M. Berdon, John G. Taylor, Wendy R. Fleischer.
Charles J. Raubicheck, Frommer Lawrence & Haug LLP, Attorneys for Purepac Pharmaceutical Co., 745 Fifth Avenue, New York, New York 10151, (212) 588-0800.
As required by Federal Rule of Appellate Procedure 26.1 and D.C. Circuit Rule 26.1, counsel for appellee Purepac Pharmaceutical Co. certifies the following: 1. The parent company of Purepac Pharmaceutical Co. is Alpharma Inc.
2. Other than Alpharma Inc., no company has a 10% or greater ownership interest in Purepac Pharmaceutical Co.
3. Purepac Pharmaceutical Co. develops and manufactures generic pharmaceutical products.
CERTIFICATE AS TO PARTIES, RULINGS, AND RELATED CASES .
PERTINENT STATUTES AND REGULATIONS .
STATEMENT OF THE CASE AND THE FACTS .
I. The District Court Correctly Required FDA to Accept Purepac's Section viii Statement for the ‘479 Patent .
A. TorPharm Obfuscates the Question .
B. TorPharm's Prior Conduct Undercuts Its Position .
C. FDA Unlawfully Refused to Accept Purepac's Section viii Statement .
1. Warner-Lambert's Patent Statements Establish that the ‘479 Patent Covers an Unapproved Use .
2. FDA's Use Codes Confirm that the ‘479 Patent Covers an Unapproved Use .
3. FDA's Patent-Listing Regulation Is Immaterial .
D. The District Court Did Not Substitute Its Judgment for FDA's by Rejecting FDA's Carve-Out Theory .
1. The Carve-Out Theory Was New .
2. The District Court Properly Rejected the Carve-Out Theory .
E. The District Court's Ruling Will Not Disrupt FDA's Patent-Listing Procedures .
II. The District Court Correctly Upheld FDA's Decision to Award Exclusivity to Purepac Based on the ‘482 Patent .
A. The Pertinent Statutes .
B. This Court Should Affirm Based on the Exclusivity Provision Alone .
C. FDA and the District Court Properly Declined to Nullify Exclusivity Based on Delayed Notice .
D. FDA Acted Reasonably Within Its Administrative Discretion .
E. FDA Did Not Disregard the Notice Requirement .
F. The District Court Correctly Determined that FDA Lawfully Interpreted “Submitted” to Mean “Received” .
G. TorPharm's Meritless Remaining Contentions .
III. The District Court Properly Upheld FDA's Decision That TorPharm Lacked Eligibility for Exclusivity .
A. FDA's Decision Is Based on the Mutually-Exclusive Rule for Paragraph IV Certifications and Section viii Statements .
B. The District Court Gave Proper Deference to FDA's Mutually-Exclusive Rule .
C. The Purepac Decision Independently Justified FDA's Exclusivity Determination Against TorPharm D. TorPharm's ‘479 Patent Litigation Didn't Affect the Purepac Decision .
E. FDA's Delisting Decision Didn't Affect Its Exclusivity Determination .
F. Pfizer's Submissions Independently Justified Delisting .
G. FDA's Mirtazapine Decision Is Immaterial .
H. This Court Should Not Reset the 180-Day Exclusivity Clock .
CasesChevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984) .
FPC v. Idaho Power Co., 344 U.S. 17 (1952) .
I.A.M. Nat'l Pension Fund v. Skolnick, 727 F.2d 1204 (D.C. Cir.
KPMG, LLP v. SEC, 289 F.3d 109 (D.C. Cir. 2002) .
Mylan Pharms., Inc. v. Thompson, 139 F. Supp. 2d 1 (D.D.C. 2001), rev'd on other grounds, 268 F.3d 1323 (Fed. Cir. 2001) .
Nat'l Pub. Radio, Inc. v. FCC, 254 F.3d 226 (D.C. Cir. 2001) .
Niagara Mohawk Power Corp. v. FPC, 379 F.2d 153 (D.C. Cir. 1967) .
Organon Inc. v. Teva Pharms., Inc., 244 F. Supp. 2d 370 (D.N.J.
2002), appeal dismissed per agreement, 56 Fed. Appx. 497 (Fed. Cir.
* Purepac Pharm. Co. v. Thompson, 238 F. Supp. 2d 191 (D.D.C.
Reuters Ltd. v. FCC, 781 F.2d 946 (D.C. Cir. 1979) .
Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) .
Smith v. Phillips, 455 U.S. 209 (1982) .
* TorPharm, Inc. v. Thompson, 260 F. Supp. 2d 69 (D.D.C. 2003) .
United States v. Mead Corp., 533 U.S. 218 (2001) .
Watson Pharms., Inc. v. Henney, 194 F. Supp. 2d 442 (D. Md. 2001) .
Other Authorities54 Fed. Reg. 28,872 (July 10, 1989) .
* 59 Fed. Reg. 50,338 (Oct. 3, 1994) .
68 Fed. Reg. 36,676 (June 18, 2003) .
Center for Drug Evaluation and Research, U.S. Dep't of Health & Human Services, Guidance for Industry: 180-Day Exclusivity WhenMultiple ANDAs Are Submitted on the Same Day (July 2003) .
H.R. Rep. No. 98-857, pt. I (1984), reprinted in 1984 U.S.C.C.A.N.
In accordance with D.C. Circuit Rule 28(a)(3), the table below identifies the abbreviations used in the briefs.
An abbreviated new drug application filed with FDA under21 U.S.C. §§355(j) et. seq. by a pharmaceutical companyseeking FDA approval to market a generic version of apreviously-approved drug in the United States The Administrative Procedure Act, 5 U.S.C. §702 et seq.
(2003) Administrative record prepared and filed in Purepac Pharm.
Co. v. Thompson, No. 02-1657 (D.D.C.) (Huvelle, J.) Administrative record prepared and filed in TorPharm, Inc.
v. Thompson, No. 03-0254 (D.D.C.) (Huvelle, J.) Declaration of Dr. David Coffin-Beach, executed onFebruary 11, 2003, submitted concurrently with TorPharm'sMemorandum of Points and Authorities in Support of itsMotion for Preliminary Injunction in TorPharm, Inc. v.
Thompson, No. 03-0254 (D.D.C.) (Huvelle, J.) 2012 Thomson Reuters. No claim to original U.S. Government Works.
The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§301et seq., as amended by the Drug Price Competition andPatent Term Restoration Act of 1984, 21 U.S.C. §355 (1999& Supp. 2002) and 35 U.S.C. §§271(d)-(h) (2001) The Drug Price Competition and Patent Term RestorationAct of 1984, 21 U.S.C. §355 (1999 & Supp. 2002) and 35U.S.C. §§271(d)-(h) (2001 & Supp. 2003)), which amendedthe Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301et. seq. (1999) Center for Drug Evaluation and Research, U.S. Dep't ofHealth and Human Services, Guidance for Industry: 180-Day Exclusivity When Multiple ANDAs Are Submitted on theSame Day (July 2003) A new drug application filed with FDA under 21 U.S.C.
§355(b) by a pharmaceutical company seeking FDAapproval to manufacture and sell an original new drug (i.e.,not a generic) in the United States FDA's publication Approved Drug Products withTherapeutic Equivalence Evaluations, available at http://www.fda.gov/cder/ob/default.htm A patent certification submitted under 21 U.S.C. §355(j)(2)(A)(vii)(IV) stating that a patent listed in the Orange Bookwill not be infringed by the generic applicant's product and/or that the patent is invalid December 16, 2002 Memorandum Opinion in PurepacPharm. Co. v. Thompson, 238 F. Supp. 2d 191 (D.D.C.
2002) (Huvelle, J.) Declaration of William A. Rakoczy, executed on February12, 2003, submitted concurrently with TorPharm'sMemorandum of Points and Authorities in Support of itsMotion for Preliminary Injunction in TorPharm, Inc. v.
Thompson, No. 03-0254 (D.D.C.) (Huvelle, J.) Supplemental Declaration of William A. Rakoczy, executedon March 12, 2003, submitted concurrently with TorPharm'sReply Brief in Support of its Motion for PreliminaryInjunction in TorPharm, Inc. v. Thompson, No. 03-0254(D.D.C.) (Huvelle, J.) A statement submitted under 21 U.S.C. §355(j)(2)(A)(viii)indicating that a method-of-use patent listed in the OrangeBook does not claim a use of the drug product for which theapplicant is seeking approval April 25, 2003 Memorandum Opinion in TorPharm, Inc. v.
Thompson, 260 F. Supp. 2d 69 (D.D.C. 2003) (Huvelle, J.) Purepac's Memorandum of Points and Authorities in Supportof Plaintiff's Motion for Preliminary Injunction or, in theAlternative, a Stay and Proposed Order, filed November 13,2002, in Purepac Pharm. Co. v. Thompson, No. 02-1657(D.D.C.) (Huvelle, J.) Declaration of William A. Rakoczy, executed on November25, 2002, submitted concurrently with the Memorandumof Intervenors-Defendants Apotex, Inc. and TorPharm,Inc. in Opposition to Purepac's Motion for a PreliminaryInjunction or, in the Alternative, a Stay in Purepac Pharm.
Co. v. Thompson, No. 02-1657 (D.D.C.) (Huvelle, J.) 2012 Thomson Reuters. No claim to original U.S. Government Works.
Federal Defendants' Memorandum in Opposition toPlaintiff's Motion for Preliminary Injunction, filed November26, 2002, in Purepac Pharm. Co. v. Thompson, No. 02-1657(D.D.C.) (Huvelle, J.) Mutual Pharmaceutical Company, Inc.'s Amicus Briefin Support of Motion by Purepac Pharmaceutical Co. forPreliminary Injunction, filed on November 26, 2002 inPurepac Pharm. Co. v. Thompson, No. 02-1657 (D.D.C.)(Huvelle, J.) Purepac's Reply Memorandum of Points and Authoritiesin Support of Plaintiff's Motion for Preliminary Injunctionor, In the alternative, a Stay, filed December 3, 2002, inPurepac Pharm. Co. v. Thompson, No. 02-1657 (D.D.C.)(Huvelle, J.) Federal Defendants' Memorandum in Opposition toPlaintiff's Motion for Preliminary Injunction, filed March 5,2003, in TorPharm, Inc. v. Thompson, No. 03-0254 (D.D.C.)(Huvelle, J.) Intervenor-Defendant Purepac's Memorandum of Pointsand Authorities in Opposition to Plaintiff's Motion forPreliminary Injunction, filed March 5, 2003, in TorPharm,Inc. v. Thompson, No. 03-0254 (D.D.C.) (Huvelle, J.) Rule Preamble to FDA's Final Rule concerning 21 C.F.R.
Part 314 entitled “Applications for FDA Approval toMarket a New Drug: Patent Submission and ListingRequirements and Application of 30-Month Stays onApproval of Abbreviated New Drug Applications CertifyingThat a Patent Claiming a Drug Is Invalid or Will Not BeInfringed,” Docket No. 02N-0417, 68 Fed. Reg. 36,676(June 18 2003), available at http://www.fda.gov/OHRMS/DOCKETS/98fr/02N-0417-nfr00001.pdf (Display Date:June 12, 2003; Publication Date: June 18, 2003) A 180-day period of marketing exclusivity under 21 U.S.C.
§355(j)(5)(B)(iv) that may be awarded to the first genericapplicant to submit a paragraph IV certification to an OrangeBook-listed patent These appeals present three administrative-law issues under FDCA: 1. Where an ANDA does not seek approval for a use claimed in an Orange Book-listed use patent, Hatch-Waxman requires a section viii statement for the patent. Purepac's ANDA seeks approval for one use--epilepsy treatment. The patentee and Purepac agreed that the ‘479 patent claims neurodegenerative disease treatment--not epilepsy treatment--and FDA distinguished epilepsy from neurodegenerative diseases in use codes it created. Did the district court properly require FDA to accept Purepac's section 2. When an applicant amends its ANDA to include a paragraph IV certification, Hatch-Waxman requires that notice be sent simultaneously but says nothing about the consequences of delayed notice. Purepac amended its ANDA to include a paragraph IV certification for the ‘482 patent and later sent notice. Exercising its discretion, FDA refused to recognize Purepac's certification until it sent notice. But because Purepac fulfilled both requirements before TorPharm, FDA awarded eligibility for 180-day exclusivity to Purepac. Did the district court properly uphold FDA's exclusivity award for the ‘482 patent? 2012 Thomson Reuters. No claim to original U.S. Government Works.
The pertinent statutes and regulations appear in the addendum attached to this brief.
Purepac disagrees with TorPharm's statements, particularly its distorted account of the facts. Purepac relies instead on the district court's discussion of the factual, statutory, and procedural background. See Purepac Pharm. Co. v. Thompson, 238 F. Supp. 2d 191, 197-201 (D.D.C. 2002); TorPharm, Inc. v. Thompson, 260 F. Supp. 2d 69, 71-79 (D.D.C. 2003).
In Purepac, the district court properly determined that FDA must accept Purepac's section viii statement for the ‘479 patent because it claims an unapproved use for which no ANDA applicant can seek approval, as evidenced by: • Warner-Lambert's repeated representations that the patent claims an unapproved use; • FDA's creation of use codes based on Warner-Lambert's representations.
TorPharm asserts that the Purepac decision will radically alter FDA's patent-listing practices and policy of deferring to NDA holders' patent characterizations. But if that were true, FDA would have appealed the decision. That it didn't demonstrates the baselessness of TorPharm's assertion and doomsday prediction.
In TorPharm, the district court correctly ruled that Purepac is eligible for 180-day exclusivity on the ‘482 patent because Purepac both certified against it and sent notice before anyone else. The court rightly recognized that Hatch-Waxman specifies no penalty for delayed notice and gave suitable deference to FDA's delayed recognition of Purepac's certification.
In TorPharm, the district court correctly ruled that TorPharm is ineligible for 180-day exclusivity on the ‘479 patent because: • TorPharm's ineligibility logically flowed from FDA's mutually-exclusive rule, which TorPharm never challenged; • TorPharm could not block Purepac or any other applicant even if it retained its paragraph IV certification.
As for FDA's delisting decision, both the Purepac decision and Pfizer's submissions independently justified it.
The district court explained that the legality of FDA's refusal to accept Purepac's section viii statement for the ‘479 patent “rises and falls” on the agency's conclusion that the ‘479 patent claims gabapentin's use for treating epilepsy. Purepac at 204. The court determined that FDA's conclusion ran counter to the evidence before the agency, was therefore arbitrary and capricious in violation of the APA, and that FDA must accept Purepac's section viii statement. Id. at 207-11.
In an effort to deflect this Court's attention from FDA's unlawful action, TorPharm repeatedly--but misleadingly--urges that appeal no. 02-5410 involves a challenge to the ‘479 patent's listing in the Orange Book. (Tor.Br. 20-21, 26-30) In its preliminary- injunction motion, Purepac did not request delisting. (A0083-134,SA0004-07) Nor did the district court in Purepac direct FDA to delist the ‘479 patent, or even consider whether it should remain in the Orange Book. Purepac at 210-12. Rather, the court addressed the question whether FDA could properly require a paragraph IV certification instead of a section viii statement in the unique circumstances presented here. Id. at 204-11.
This Court should not lose sight of that question and countenance TorPharm's attempt to address a nonexistent delisting dispute in appeal no. 02-5410. Nor should this Court be misled by TorPharm's contentions concerning FDA's policy of refusing to police Orange Book listings. (Tor.Br. 20-21, 32) No party challenged that policy in the district court.
In infringement litigation involving the ‘479 patent, TorPharm represented to the Federal Circuit that a section viii statement For a method-of-use patent that, as in this case, does not claim a use for which the applicant is seeking approval, the ANDA applicant must submit a statement that the applicant is not seeking approval for such use. This is known as a “section (viii) (SA0014 (emphases added) (citation omitted)) TorPharm now reverses course and assails the district court for requiring FDA to accept Purepac's section viii statement. The district court saw through TorPharm's 180-degree change in position. Purepac at 206 n.23. This Court, in evaluating TorPharm's arguments, should give substantial weight to TorPharm's previous, contrary position, which it took before it saw an opportunity to profit from FDA's arbitrary and capricious action against Purepac.
Moreover, while TorPharm faults Purepac for failing to “play by the rules,” TorPharm neglects to tell this Court that it improperly submitted both a section viii statement and a paragraph IV certification for the ‘479 patent. (A00350-52) These are mutually exclusive alternatives. Having submitted its own section viii statement for the ‘479 patent, TorPharm should not be heard to complain about Purepac's section viii statement or what happened after FDA rejected it.
Warner-Lambert holds NDAs for Neurontin(R) (gabapentin) and owns patents covering gabapentin. Under Hatch-Waxman, Warner-Lambert submitted patent statements to FDA. 21 U.S.C. §355(b)(1), §355(c)(2).
In its capsule NDA, Warner-Lambert represented to FDA that: • the ‘544 patent “covers a method for treating epilepsy using Neurontin(R)”; • the ‘479 patent “covers a method for treating neurodegenerative diseases with gabapentin.” In its tablet NDA, Warner-Lambert represented to FDA that: • the ‘544 patent “claims a method of treating certain forms of epilepsy. by. administration of” gabapentin; • the ‘479 patent “claims a method for treating neurodegenerative diseases with” gabapentin.
Similarly, in NDA submissions in November 1998 and April 2000, Warner-Lambert again informed FDA that the ‘544 patent concerns a “Method of Use (to treat epilepsy),” while the ‘479 patent concerns a “Method of Use (to treat neurodegenerative Thus, as the district court recognized, Warner-Lambert openly, repeatedly, and consistently told FDA that the ‘479 patent covers the treatment of neurodegenerative diseases, not epilepsy. Purepac at 205-06. After studying Warner-Lambert's patent statements, the district court determined that “[w]henever it was called upon to describe the coverage of the ‘479 patent,” • “explicitly stated that the patent at issue covers the use of gabapentin to treat neurodegenerative diseases”; • “never represented that the ‘479 patent covers the treatment of epilepsy”; • did not “identify the use claimed in the ‘479 patent as the approved use of gabapentin.” Purepac at 206, 209. Warner-Lambert's patent statements set forth above fully support those determinations.
Given FDA's “ministerial role” in accepting patentees' descriptions of patent coverage, FDA had to accept these unequivocal representations by Warner-Lambert. See Watson Pharms., Inc. v. Henney, 194 F. Supp. 2d 442, 445-46 (D. Md. 2001). As the district court rightly ruled, FDA arbitrarily and capriciously overlooked Warner-Lambert's clear statements. Purepac at 209-10.
TorPharm argues that FDA had to assume that the ‘479 patent also covers epilepsy treatment because certain parts of Warner- Lambert's patent statements suggest that the ‘479 patent covers “the” use of Neurontin(R) and that product was only approved for epilepsy treatment. (Tor.Br. 4, 24-26) Properly rejecting this argument, the district court correctly determined that “[t]here is no dispute that epilepsy is not a neurodegenerative disease. Treating such diseases with gabapentin is therefore unquestionably a different use of that drug than is treating epilepsy .” Purepac at 205 n.21. The fact that Warner-Lambert unequivocally told FDA that the ‘479 patent covers neurodegenerative diseases precludes coverage for epilepsy.
Furthermore, the declaration at the end of each patent statement appears in the summary form language of FDA's regulation governing the submission of patent information, 21 C.F.R. §314.53(c)(2). In focusing on the summary form language, TorPharm (as FDA arbitrarily did) intentionally overlooks the other, more-specific information in Warner-Lambert's patent statements, which said that the ‘479 patent claims “a” use of gabapentin (“treatment of neurodegenerative diseases”) and distinguished this use from the use covered by the ‘544 patent (“treatment of epilepsy”). Purepac at 209-10.
FDA's suggestion that the company made such a claim [that the ‘479 patent covers epilepsy treatment] by implication is largely refuted by the explicit assertion, in the same documents, that the ‘479 patent covers a different use altogether. In light of these assertions, reading the sentence “the ‘479 patent covers a use of Neurontin(R)” (or its counterpart in the 1998 declaration) as defendants would like--to mean that the patent covers the use of treating epilepsy--causes Warner-Lambert's submissions to become internally inconsistent, if not incomprehensible. To make matters worse, after unnecessarily creating this conflict through its artificial interpretation, the agency then chose to resolve it illogically, by favoring an unstated and ambiguous implication over a stated and definite declaration. This is unreasonable.
In sum, Warner-Lambert “consistently declared to the agency that the ‘479 patent ‘claims' the use of gabapentin to treat neurodegenerative diseases, not epilepsy.” Purepac at 205. To paraphrase the district court, Warner-Lambert's patent statements simply do not say what TorPharm wants them to say.
TorPharm attempts to diminish the significance of the more-specific information in Warner-Lambert's patent statements as “gratuitous,” “extraneous,” and without “regulatory significance.” (Tor.Br. 25, 26, 30, 31) But FDA attaches substantial significance to such information. For years, FDA has solicited information about use patents from NDA applicants/holders, so that the agency can create use codes and guide ANDA applicants regarding patent coverage. 59 Fed. Reg. 50,338, 50,346 no.
41 (Oct. 3, 1994). In an October 1986 letter, FDA noted that it “will publish the information on the indications covered by each use patent, as supplied by NDA applicants, in the Orange Book.” (A0166) As the district court appreciated, use codes “allow interested parties, including ANDA applicants, to determine the particular medical uses of brand-name drugs asserted by the various use patents listed in the Orange Book.” Purepac at 198.
Based on Warner-Lambert's patent statements, FDA created and published separate, distinct use codes for Warner-Lambert's • code U-106 “treatment of epilepsy” for the ‘544 patent; • code U-258 “treatment of neurodegenerative diseases” for the ‘479 patent.
In assigning different use codes for the ‘544 and ‘479 patents, FDA relied on Warner-Lambert's representations regarding their coverage and acknowledged that these patents cover different uses. FDA's assignment of a use code for the ‘479 patent different from the use code for the ‘544 patent told all ANDA applicants that the patents claim different uses.
Thus, the district court properly reasoned that “FDA gave the ‘544 patent a use code for ‘treatment of epilepsy’ ” but “did not use that code for the ‘479 patent” because “FDA believed--and understood Warner-Lambert to believe--that the ‘479 patent covered the treatment of neurodegenerative diseases.” Purepac at 210.
TorPharm calls FDA's carve-out theory a “long-standing interpretation.” (Tor.Br. 10, 26-30) But FDA first disclosed that theory on April 8, 2002, when it rejected Purepac's section viii statement. (A0278-82) On that date, FDA improperly rejected Purepac's section viii statement, saying, “A section viii statement is appropriate when - and only when - generic drug labeling is ‘carved out’ (omits an indication or protected labeling) to avoid infringement of a listed patent.” (A0281) FDA publicly disclosed that theory two days later at an industry meeting. (A0240, A0246-48,SA0001-03) No evidence indicates that FDA previously articulated that theory. For instance, FDA did not rely on that theory in its response to Purepac's March 1999 initial inquiry (A0294-302), nor include any earlier reference to that theory in the administrative record.
Quoting Hatch-Waxman's legislative history, TorPharm suggests that FDA's carve-out theory dates back to Hatch-Waxman's enactment in 1984. (Tor.Br. 10, 26-27) But the legislative history simply describes one--not the only-- situation where a section viii statement should be used. H.R. Rep. No. 98-857, pt. I, at 22, 33 (1984), reprinted in 1984 U.S.C.C.A.N. 2647, 2655, 2666.
The district court properly rejected FDA's carve-out theory because it contravened Hatch-Waxman's plain language. As the court recognized, “the language of section viii is quite clear: a statement of inapplicable use under section viii is required with respect to ‘a method of use patent which does not claim a use for which the applicant is seeking approval.’ ” Purepac at 204.
Moreover, FDA's carve-out theory conflicted with FDA's own implementing regulation. That regulation, 21 C.F.R. §314.94(a) (12)(iii)(A), requires a section viii statement where “the labeling for the drug product for which the applicant is seeking approval does not include any indications that are covered by the use patent.” The district court correctly concluded that the regulation “is equally clear” as the statute. Purepac at 204 n.18.
FDA's decision not to appeal the district court's ruling refutes TorPharm's assertion that the ruling will radically affect FDA's TorPharm contends that the district court's decision obligates FDA to construe claims and look behind patent declarations.
(Tor.Br. 25-29) But the court did just the opposite. It held that Warner-Lambert's patent statements themselves informed FDA what the ‘479 patent claims. FDA didn't have to do anything but defer to what Warner-Lambert declared, and FDA's failure Also, the district court noted the “unique factual circumstances” of this case. Purepac at 205. Unlike other cases involving use patents and section viii statements, e.g., Mylan Pharmaceuticals, Inc. v. Thompson, 139 F. Supp. 2d 1 (D.D.C. 2001), here the NDA holder and the ANDA applicant did not dispute the ‘479 patent's coverage. Purepac at 206.
TorPharm argues, as FDA did before the district court, that the Purepac decision allows an ANDA applicant to be the “final arbiter” of what a patent claims. (Tor.Br. 29-30) But because Warner-Lambert and Purepac agreed that the ‘479 patent claims gabapentin's unapproved use for treating neurodegenerative diseases, the district court appropriately rejected FDA's policy argument that negative consequences would follow if ANDA applicants could unilaterally disregard an NDA holder's patent construction. Purepac at 206. This Court should reject TorPharm's argument for similar reasons.
Nobody disputes that Purepac submitted a paragraph IV certification for the ‘482 patent on May 26, 2000 and sent notice of this certification to the NDA holder and patentee on June 13, 2000. TorPharm at 78. The sole question is whether FDA properly determined that Purepac was entitled to exclusivity because Purepac completed both acts before any other ANDA applicant.
TorPharm wrongly calls Hatch-Waxman's notice provision, 21 U.S.C. §355(j)(2)(B)(iii), the “controlling statute” for exclusivity purposes. (Tor.Br. 39, 42) Hatch-Waxman contains a separate provision governing exclusivity. 21 U.S.C. §355(j)(5)(B)(iv).
Hatch-Waxman's exclusivity provision does not condition exclusivity on notice to the NDA holder or patentee. Id. In clear and unambiguous language, that provision specifies a single condition for an ANDA applicant's eligibility for exclusivity on a listed patent--that it have a “previous application . containing” a paragraph IV certification for the patent. Id. It is undisputed that Purepac had a “previous application . containing” a paragraph IV certification vis-ã-vis TorPharm, since Purepac filed its paragraph IV certification for the ‘482 patent three weeks before TorPharm did (May 26 versus June 16, 2000).
Unlike the exclusivity provision, Hatch-Waxman's separate notice provision, 21 U.S.C. §355(j)(2)(B)(iii), requires a notice in addition to a certification. This section applies where an applicant certifies against a patent listed after ANDA filing (such as the ‘482 patent) and requires the applicant to send notice to the NDA holder and patentee “when” it certifies against such a patent. Id. Here, FDA incorporated the notice requirement into the exclusivity provision and conditioned exclusivity on submitting a certification and sending a notice. (A0872-73) FDA awarded exclusivity to Purepac because it certified and sent notice before any other applicant did both. (A0872-73) The district court affirmed FDA's ruling without reaching the question whether the exclusivity provision alone compelled this result. TorPharm at 82 n.14.
Purepac maintains (as it did previously) that the exclusivity provision's plain language--and its silence regarding any notice requirement--entitles Purepac to exclusivity based solely on its undisputed status as first to file a paragraph IV certification for the ‘482 patent. Although this Court should affirm Purepac's entitlement to exclusivity on the ‘482 patent based on FDA's reasonable construction of the exclusivity and notice provisions, it may also affirm based entirely on Purepac's satisfaction of the exclusivity provision without regard to the separate notice requirement. See Smith v. Phillips, 455 U.S. 209, 215 n.6 (1982) (stating that a party may defend a judgment on any ground permitted by the law and the record).
TorPharm attempts to insert a nonexistent penalty into Hatch-Waxman, contending that “without simultaneous notice, a paragraph IV certification is ineffective for exclusivity purposes.” (Tor.Br. 39-41) TorPharm urges that a paragraph IV certification submitted without simultaneous notice should be deemed completely null, and that an applicant's “failure to simultaneously” certify and send notice renders it absolutely “ineligible for exclusivity.” (Tor.Br. 39-41, 45) No basis exists for the consequences urged by TorPharm. Congress established different requirements for exclusivity and notice.
Compare 21 U.S.C. §355(j)(5)(B)(iv) with §355(j)(2)(B)(iii). FDA promulgated different implementing regulations for each 2012 Thomson Reuters. No claim to original U.S. Government Works.
requirement. Compare 21 C.F.R. §314.107(c)(1) with §314.95(d). While the notice provision may require simultaneity, neither it nor any other Hatch-Waxman provision addresses how noncompliance impacts exclusivity. TorPharm at 79-80.
In this situation, FDA rightly recognized that Hatch-Waxman does not compel an applicant's total disqualification from eligibility for exclusivity where the applicant submits a paragraph IV amendment and subsequently sends notice. (A0871-73) Rather, FDA refused to treat “the original receipt date as the relevant date for exclusivity purposes,” but instead looked to “the date that Purepac actually sent the required notice, since this is the date upon which Purepac effectively met the statutory requirements by having both submitted a paragraph IV certification and sent notice of the submission.” TorPharm at 78.
The district court rightly supported FDA's approach by rejecting TorPharm's complete-nullity argument, noting that TorPharm “pointed to nothing” in the statute requiring FDA to disregard Purepac's certification. TorPharm at 81. The court correctly reasoned that Hatch-Waxman “is in fact silent on the issue of what follows from an applicant's failure to follow the mandate of simultaneity,” and that nothing in Hatch-Waxman “compels, or even suggests” absolute ineligibility. Id. at 80. And before this Court, TorPharm identifies no Hatch-Waxman provision to this effect.
Accurately observing that Hatch-Waxman does not address the precise question at issue--an appropriate penalty for delayed notice--the district court correctly concluded that “the agency had considerable flexibility” in deciding an appropriate consequence. TorPharm at 80. Quoting from Niagara Mohawk Power Corp. v. FPC, 379 F.2d 153, 159 (D.C. Cir. 1967), the court recognized that “the breadth of an agency's discretion is, if anything, at its zenith when the action assailed relates primarily . to the fashioning of policies, remedies and sanctions .” TorPharm at 80.
The district court soundly determined that FDA reasonably exercised its discretion in delaying the effective date of Purepac's paragraph IV certification. TorPharm at 80. The court correctly reasoned that FDA's ruling: • “constructively moves the certification's ‘submission’ date to the day on which the applicant mailed the notice”; • prevents an applicant from gaining an advantage by splitting certification and notice; • does not encourage noncompliance or “gaming” the system because FDA's ruling “punishes an applicant's failure to furnish simultaneous notice by refusing to make its solitary certification immediately effective upon receipt by the agency.” Id. at 80-81. Consequently, the district court properly rejected TorPharm's arguments that FDA's ruling “rewards” noncompliance and “ignores” or “waives” the simultaneous-certification-and-notice requirement. Id. at 80.
Indeed, FDA's ruling actually jeopardized Purepac's first-to-file status on the ‘482 patent. Had TorPharm--or anyone else-- submitted an amendment containing paragraph IV certification and sent notice before June 13, 2000, then FDA would have deemed Purepac ineligible for exclusivity. That TorPharm came close but missed does not alter the reasonableness of FDA's In light of statutory silence, FDA's decision to credit Purepac's paragraph IV certification as complete for exclusivity purposes upon satisfaction of both conditions was a reasonable interpretation of the statute entitled to Chevron deference.
TorPharm's contention that FDA's ruling reads the simultaneous-certification-and-notice requirement out of the statute and regulation lacks merit. FDA not only required both certification and notice, but also imposed a penalty by refusing to recognize Purepac's certification until it sent notice. (A0872) TorPharm at 80-81.
The cases TorPharm cites in this regard do not apply. (Tor.Br. 42-45) None of them involved an agency's decision to establish a penalty for noncompliance with a statutory requirement where the statute failed to directly address the question of 2012 Thomson Reuters. No claim to original U.S. Government Works.
Hatch-Waxman's exclusivity provision and FDA's implementing regulation condition exclusivity on having a previously “submitted” paragraph IV certification. 21 U.S.C. §355(j)(5)(B)(iv); 21 C.F.R. §314.107(c)(1). Hatch-Waxman's notice provision and FDA's implementing regulation specify that notice be given when an amended application is “submitted.” 21 U.S.C. §355(j)(2)(B)(iii); 21 C.F.R. §314.95(d). FDA permissibly interpreted “submitted” to mean “received” rather than The district court accurately observed that Hatch-Waxman does not define “submitted” or speak to the question of when a certification is effective for exclusivity purposes. TorPharm at 81-82. Nor do FDA's regulations define “submitted.” As this Court held in Serono Labs., Inc. v. Shalala, 158 F.3d 1313, 1321 (D.C. Cir. 1998), in these circumstances “courts are bound to uphold an agency interpretation as long as it is reasonable-regardless whether there may be other reasonable, or even more Here, FDA explained that a date-of-receipt rule has the benefit of “clarity and certainty” because it permits the agency to “rely on its own record of receipt in determining operative dates under the statute and regulations.” (A0617) FDA further explained that a date-of-mailing rule “could lead to potential confusion and ambiguity with respect to differences between the date on the submission itself, and the date it is post-marked or provided to a delivery service.” (A0617) FDA noted that it has consistently treated the receipt date as “the critical operative date with respect to NDA and ANDA submissions to the agency.” (A0617) And FDA cited specific regulations--21 C.F.R. §§314.100(a), 314.101 (a)(1)-- covering NDAs and ANDAs that expressly make the receipt date determinative. (A0617) Considering FDA's explanation for adopting a date-of-receipt rule rather than a date-of-mailing rule, the district court correctly decided that FDA proceeded permissibly in the face of “statutory and regulatory silence,” and that FDA had “administrative discretion to adopt this sort of reasonable ‘housekeeping’ rule.” TorPharm at 81-82.
Citing 21 C.F.R. § 10.20(e), TorPharm asserts that FDA “generally” considers things submitted on the day they are post-marked.
(Tor.Br. 48). But that regulation concerns public record submissions to FDA's dockets management branch, not submissions for NDAs or ANDAs. Given the specific regulations cited above, TorPharm misplaces its reliance on a general one.
TorPharm argues that FDA's date-of-receipt rule subjects applicants to the vagaries of the postal system and unfairly discriminates based on geographic distance from FDA. (Tor.Br. 48) TorPharm may have had a point in the days of the Pony Express, but its argument lacks merit in today's world where almost any applicant can use an overnight courier service.
TorPharm contends that FDA would have rewarded Purepac by considering it first to file even if FDA had received TorPharm's certification on the day Purepac sent notice. (Tor.Br. 47) That assertion rests on the speculative assumption that FDA would consider Purepac's earlier certification “first in the door” on the notice date. In a July 2003 Guidance for Industry, however, FDA advised that it will “treat all ANDAs containing a paragraph IV certification to a listed patent that are submitted on the same day as being submitted at the same time for purposes of 180-day exclusivity.” Multiple ANDA Guidance, at 5. In TorPharm's scenario, therefore, FDA would have considered both Purepac and TorPharm first to file.
TorPharm's reference to FDA's final rule regarding amendments to the agency's patent-listing and 180-day exclusivity regulations fares no better. This rule takes effect on August 18, 2003, and even if it applied, Purepac would still be eligible for exclusivity. Under the final rule, Purepac would not have had to provide any notice of its paragraph IV certification for the ‘482 patent, much less simultaneous notice. 68 Fed. Reg. 36,676, 36,688, 36,705-06 (June 18, 2003).
The final rule requires notice only for an applicant's first paragraph IV certification. Id. It does not require notice if an ANDA already containing a paragraph IV certification is later amended to include a certification for another patent. Id. In those circumstances, the certification alone--without notice--is effective for exclusivity purposes. Id. at 36,695. If the final rule applied here (which it doesn't), Purepac would not have needed to send notice for the ‘482 patent since Purepac had already sent notice when it certified against Warner-Lambert's ‘476 patent.
TorPharm's argument that FDA's ruling unfairly prejudices it by subjecting it “to a sudden, unforeseeable shift in the prevailing regulatory winds” rests on the erroneous premise that FDA had previously considered the consequences of delayed notice and had publicly announced a policy. Nothing in the record suggests that FDA had ever done so.
FDA properly ruled that TorPharm lacked eligibility for exclusivity based on TorPharm's paragraph IV certification for the ‘479 patent in light of the established principle that section viii statements and paragraph IV certifications are mutually exclusive.
In the preamble to its proposed ANDA regulations in 1989, FDA explained that section viii statements and paragraph IV certifications are mutually exclusive because they serve different functions, and that the use specified in an ANDA controls which one to submit. 54 Fed. Reg. 28,872, 28,886 (July 10, 1989). Thus, where an applicant does not seek approval for a use covered by a listed use patent, the applicant must submit a section viii statement. Id. In contrast, where an applicant does seek approval for a use covered by a listed use patent, the applicant must submit a paragraph IV certification. Id. In the preamble to its final ANDA regulations in 1994, FDA reiterated its mutually-exclusive rule, making clear that “an applicant does not have the option” of submitting a paragraph IV certification in lieu of or in addition to a section viii statement and that the two provisions “are not overlapping.” 59 Fed. Reg. at 50,347 no. 46.
Citing United States v. Mead Corp., 533 U.S. 218 (2001), the district court gave proper deference to FDA's mutually-exclusive rule and FDA's application of that rule. TorPharm at 84-85. Mead teaches that judicial deference to agency action varies with “the degree of the agency's care, its consistency, formality, and relative expertness, and to the persuasiveness of the agency's position.” 533 U.S. at 228. Here, the district court appropriately considered the consistency and persuasiveness of FDA's position that its mutually-exclusive rule controlled whether an ANDA applicant should submit a paragraph IV certification or a section viii statement for the ‘479 patent. TorPharm at 84-85.
TorPharm relies on Reuters Ltd. v. FCC, 781 F.2d 946 (D.C. Cir. 1979), for the proposition that an agency must stick to its rules. (Tor.Br. 43-44) There, this Court held that an agency cannot depart from its established rules to achieve what it considers a fair result. Id. at 950-51. But TorPharm wants this Court to direct FDA to do exactly what this Court in Reuters held an 2012 Thomson Reuters. No claim to original U.S. Government Works.
agency should not do. (A1007) TorPharm seeks an exception to FDA's mutually-exclusive rule so it can retain its paragraph IV certification for the ‘479 patent, even though it does not seek approval for the use claimed in that patent.
Both FDA and the district court rejected TorPharm's “equity” plea. (Tor.Br. 31-32) The court accurately observed that “FDA has long taken the position that paragraph IV certifications and section viii statements are mutually exclusive.” TorPharm at 83. The court correctly concluded that FDA had discretion to refuse “to make an equitable exception from this rule,” and noted that TorPharm “pointed to nothing in the statute or regulations to cast doubt on the rule itself.” Id. at 83-84. Before this Court, TorPharm likewise provides no justification for a departure from FDA's mutually-exclusive rule.
Because FDA mentioned the Federal Circuit's decision in Warner-Lambert v. Apotex (TorPharm's ‘479 patent litigation with Warner-Lambert) in explaining its exclusivity determination, TorPharm asserts that FDA violated 21 C.F.R. §314.94(a)(12) (viii)(B). (Tor.Br. 33-35) But FDA also expressly relied on the district court's Purepac decision. (A0870-71) Accordingly, the district court correctly concluded that FDA's reference to Warner-Lambert “does not require that the agency's decision be A reviewing court need not remand even though an agency based its action on questionable grounds, if the agency also based its action on proper grounds and will likely take the same action following remand. KPMG, LLP v. SEC, 289 F.3d 109, 125-26 In KPMG, SEC based a cease-and-desist order on securities-law violations stemming from an improper contingent-fee arrangement and an illegal loan. 289 F.3d at 114-15. This Court ruled that SEC's order could not rest on the contingent-fee arrangement because SEC did not provide fair notice that it considered that arrangement unethical. Id. at 117. Nevertheless, this Court declined to remand for futility reasons since SEC could justify its order on proper grounds, namely, the illegal loan.
Id. at 125-26. Reversal and remand are appropriate only “where there is a significant chance that but for the error, the agency might have reached a different result.” Id. at 125.
Here, FDA's explicit citation to the district court's Purepac decision afforded a proper basis for its exclusivity determination.
As FDA emphasized in its ruling, the district court's Purepac decision “was fatal to any claim TorPharm had to exclusivity.” (A0874) And as the district court observed, “[O]nce the agency decided that its long-standing rule would apply, a decision that TorPharm has not shown to be unreasonable, it followed inexorably from the terms of the Court's injunction that TorPharm would be required to withdraw its [paragraph IV] certification.” TorPharm at 86.
Because FDA had independently sufficient grounds for its action, the district court properly upheld FDA's exclusivity determination despite its reference to Warner-Lambert. See KPMG, 289 F.3d at 125-26.
TorPharm erroneously asserts that the district court in Purepac “necessarily” relied on the trial and appellate decisions in Warner-Lambert v. Apotex to assess the ‘479 patent's scope. The Federal Circuit's Warner-Lambert decision (January 16, 2003) came one month after the Purepac decision (December 16, 2002). As for the trial court's Warner-Lambert decision, the district court in Purepac relegated it to the factual-background section, and failed to even mention it in the legal-analysis section. And insofar as the district court included it as background, the court distinguished it as involving induced infringement, not the ‘479 patent's scope. Purepac at 200-01.
The district court reaffirmed this reality in TorPharm when it stated that “the facts relied upon by this court to support its [Purepac] holding did not relate to the infringement litigation between Warner-Lambert and TorPharm.” TorPharm at 84 n.16.
Instead, the court made clear that its “decision was based on information available to the FDA and the generic applicants” when 2012 Thomson Reuters. No claim to original U.S. Government Works.
A plain reading of both Purepac and TorPharm reveals that the Warner-Lambert v. Apotex litigation did not affect FDA's exclusivity determination for the ‘479 patent.
The district court recognized that FDA had two options once it deemed TorPharm's paragraph IV certification improper: • require TorPharm to replace its paragraph IV certification with a section viii statement; or • remove the ‘479 patent from the Orange Book.
TorPharm at 85. FDA chose the latter option.
The district court decided that FDA acted lawfully since “the prospect of exclusivity on the ‘479 patent had been vitiated by the determination that TorPharm could no longer use a paragraph IV certification, and the delisting regulation posed no impediment to striking the patent from the agency's records.” TorPharm at 85. The court correctly concluded that no functional difference existed between these options for exclusivity purposes because “either way TorPharm's claim to exclusivity based on the ‘479 Moreover, as FDA observed, even if it had not delisted the ‘479 patent and had allowed TorPharm to retain its paragraph IV certification, TorPharm still would not have been entitled to exclusivity. (A0871,n.1) A paragraph IV certification only entitles an ANDA applicant to exclusivity vis-ã-vis subsequent paragraph IV filers. (A0869) Due to its section viii statement for the ‘479 patent, Purepac was not a subsequent paragraph IV filer. Furthermore, the district court's decision necessarily allowed all other ANDA applicants to change their paragraph IV certifications to section viii statements. (A0871, n.1) Because there would have been no subsequent paragraph IV filers for the ‘479 patent, TorPharm's paragraph IV certification would have blocked no one and resulted in no exclusivity.
The district court rightly rejected TorPharm's contention that FDA's exclusivity determination for the ‘479 patent contradicts its exclusivity decision for a mirtazapine use patent. TorPharm at 85-86. The mirtazapine case differs markedly because the ANDA applicants involved all submitted paragraph IV certifications for a use patent covering an unapproved use. Organon Inc. v. Teva Pharms., Inc., 244 F. Supp. 2d 370, 376-78 (D.N.J. 2002). Hence, FDA neither confronted incompatible submissions from warring applicants, nor considered a section viii/paragraph IV conflict. And as the district court noted, no court decision constrained FDA to accept a section viii statement for the mirtazapine use patent. TorPharm at 85-86. Accordingly, the court correctly concluded that FDA's exclusivity decision for mirtazapine “does not stand for the proposition that the FDA will allow one generic applicant to use a section viii statement while allowing another applicant to use [a] paragraph IV certification to the same patent.” Id. at 86.
In addition, FDA published use codes for gabapentin but not for mirtazapine. Therefore, applicants seeking approval for gabapentin products--unlike applicants seeking approval for mirtazapine products--could rely on those published codes when deciding whether to submit a paragraph IV certification or a section viii statement.
For the above reasons, Purepac asks this Court to affirm the district court's decisions: • requiring FDA to accept Purepac's section viii statement for the ‘479 patent; • upholding FDA's award of 180-day exclusivity to Purepac based on its first-filed paragraph IV certification for the ‘482 patent; • upholding FDA's denial of exclusivity to TorPharm.
Authorities on which Purepac principally relies.

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