No. 10-844 In the Supreme Court of the United States __________ CARACO PHARMACEUTICAL LABORATORIES, LTD. AND SUN PHARMACEUTICAL INDUSTRIES, LTD., PETITIONERS v. NOVO NORDISK A/S AND NOVO NORDISK, INC., RESPONDENTS __________ ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT __________ BRIEF FOR APOTEX, INC. AS AMICUS CURIAE IN SUPPORT OF PETITIONERS __________ Shashank Upadhye, Esq. Vice President - Global Intellectual Property Apotex, Inc. 150 Signet Drive Toronto, ON Canada M9L 1T9 416-401-7701 (direct) 416-401-3808 (fax) email: [email protected] January, 2011 COUNSEL OF RECORD FOR AMICUS CURIAE QUESTION PRESENTED When the Food & Drug Administration (FDA) ap- proves a drug for multiple uses, the Hatch-Waxman Act allows generic drug makers to avoid contested pa- tent litigation by marketing generic versions of the drug solely for non-patented uses. The FDA lacks the authority and expertise needed to verify the patent information submitted by name-brand drug compa- nies, however, so it defers to their descriptions of the scope of their patents. Such companies can therefore block the approval of generic drugs by submitting overbroad patent descriptions to the FDA, effectively extending their patents to cover non-infringing uses. To combat this problem, the Act allows a “counter- claim seeking an order requiring the [patent] holder to correct or delete the patent information submitted by the holder * * * on the ground that the patent does not claim * * * an approved method of using the drug.” 21 U.S.C. § 355(j)(5)(C)(ii)(I). In a 2-1 decision that conflicts with this Court’s precedents and recent D.C. Circuit authority, the Federal Circuit held that the counterclaim provision effectively authorizes only “delet[ing]” improperly listed patents, but not “cor- rect[ing]” information that misrepresents the scope of the approved uses claimed by a patent. That ruling expressly invalidates longstanding FDA regulations defining “patent information,” which the FDA deems “essential” to administering the Act, without seeking the agency’s views. The question presented is: Whether this counterclaim provision applies where (1) there is “an approved method of using the drug” that “the patent does not claim,” and (2) the brand submits “patent information” to the FDA that miss- tates the patent’s scope, requiring “correct[ion].” ii TABLE OF CONTENTS Page QUESTION PRESENTED ........................................... i TABLE OF AUTHORITIES ....................................... iii INTRODUCTION ........................................................ 1 STATEMENT ............................................................... 2 SUMMARY OF ARGUMENT ..................................... 3 ARGUMENT ................................................................ 4 I. THE PANEL ERRED BY CONCLUDING THAT “REGULAR” PARAGRAPH IV LITIGATION IS AN EFFECTIVE TOOL TO VET OUT THE PATENT ISSUES .................................................................... 7 II. Left Uncorrected, the divided ruling below incorrectly placed blame on the FDA that is now hampered in its ability to administer the Act .................................................................. 11 III. Left Uncorrected, the Majority Opinion Facilitates Gaming of the Act to Delay Generic Drug Approvals. ..................................... 13 IV. Proper Use of Section viii Has Resulted in Successful Generic Drug Launches Saving Billions for Patients ............................................ 17 CONCLUSION .......................................................... 19 iii TABLE OF AUTHORITIES Page(s) CASES aaiPharma Inc. v. Thompson, 296 F.3d 227 (C.A.4, 2002) ....................................................................... 10 Apotex, Inc. v. Food & Drug Admin., 393 F.3d 210 (C.A.D.C.,2004) ......................................................... 5 Astrazeneca Pharmaceuticals LP v. Apotex Corp., 2010 WL 5376310 (D. Del., 2010) .......................... 18 Blonder-Tongue Labs v. Univ. of Illinois Found., 402 U.S. 313 (1971) ......................................................... 8 Bonito Boats v. Thundercraft Boats, 489 U.S. 141 (1989). ..................................................................... 15 Buckhannon Bd. and Care Home, Inc. v. West Virginia Dept. of Health & Human Resources, 532 U.S. 598 (2001) ....................................................... 10 FTC v. Bisaro, 2010 WL 4910266 (D.D.C., 2010) ....... 4 IMS Health Inc. v. Ayotte, 550 F.3d 42 (C.A.1, 2008). .................................................................................. 9 Marctec, LLC v. Johnson & Johnson, 2010 WL 680490 (S.D.Ill., 2010).............................................. 9 Price v. Kelley, 154 U.S. 669 (1881). ........................... 7 Purepac Pharm. Co. v. Thompson, 354 F.3d 877 (D.C. Cir. 2004) ................................................................ 15 iv Purepac Pharmaceutical Co. v. Thompson, 354 F.3d 877 (D.C. Cir. 2004) .................................................. 5 Schering-Plough Corp. v. F.T.C., 402 F.3d 1056 (C.A. 11 2005) .................................................................... 8 Watson Pharmaceuticals, Inc. v. Henney, 194 F.Supp.2d 442 (D.Md. 2001) .................................. 15 STATUTES AND REGULATIONS 21 C.F.R. § 314.53(c)(2)(ii)(P)(2) ................................ 14 21 U.S.C. § 355(c)(2) .................................................. 16 21 U.S.C. 355(j) ........................................................ 1, 4 21 U.S.C. 355(j)(2)(A)(viii) ........................................... 4 21USC§ 355(j) ............................................................ 10 35 U.S.C. §271(b) ......................................................... 8 601 F.3d at 1368 ........................................................ 16 OTHER AUTHORITIES Shashank Upadhye, Generic Pharmaceutical Patent and FDA Law (Thomson West, 2010 Ed.) .............................. 4, 10 v Morgan Stanley Research Europe, 01 Sept. 2010, Pharmaceuticals Report, entitled, “Potential Selective Upside for Industry post Prandin Ruling ................................................................................ 19 Terry G. Mahn, Patenting Drug Products: Anticipating Hatch-Waxman Issues During the Claims Drafting Process, 54 Food Drug Cosm. L.J. 245 (1999) ............................................................... 11 Testimony of Lester M. Crawford, Dep. Comm’r of Food & Drugs, House Committee on Energy & Commerce, Oct. 9, 2002 ......................................... 15 INTEREST OF AMICUS CURIAE Amicus curiae Apotex, Inc. is a global generic drug company that frequently files Abbreviated New Drug Applications (ANDAs) seeking U.S. FDA ap- proval to market its drugs and frequently uses “Sec- tion viii” statements to carve out information from FDA labels. Annually, in the U.S., Apotex is engaged in dozens of patent lawsuits under the Hatch Wax- man Act “HWA”, 21 U.S.C. 355(j) et seq. Apotex files this brief because, without correction, the underlying panel decision will gut the Act’s “section viii” approv- al process, which Congress designed as an alternative to Hatch-Waxman litigation.1 INTRODUCTION Apotex fully supports the Petitioners. The Federal Circuit panel majority’s reading of the Hatch- Waxman Act’s counterclaim provision is contrary to the Act’s text, structure, legislative history, and pur- pose. The panel decision is fundamentally flawed and will result in expensive, time-consuming, and complex patent litigation that can all be avoided by 1 Apotex received consent of the parties to file this amicus brief. Thus, no motion for leave to file is required. The parties’ letters of consent to the filing of this brief have been filed with the Clerk. Pursuant to this Court’s Rule 37.6, amicus curiae states that no counsel for a party wrote this brief in whole or in part, and no counsel or par- ty made a monetary contribution intended to fund the preparation or submission of this brief. No person or enti- ty, other than the amicus curiae, its members, or its coun- sel, has made a monetary contribution to this brief’s prep- aration or submission. 2 reinserting the plain statutory language that the panel judicially redacted. Judge Dyk’s dissent in the panel decision and Judges Gajarsa’s and Dyk’s dis- sent from the denial of the petition for panel rehear- ing or rehearing en banc both noted that gamesman- ship is in play, not actual controversy over the facts. See, 601 F.3d 1359, 1368 (panel decision); 615 F.3d 1374, 1377 (petition for rehearing en banc denied). As Judge Dyk noted, in “adopting Novo’s disin- genuous argument blam[ing] the FDA,” the majority overlooks “the manipulative nature of Novo’s ac- tions.” 601 F.3d at 1380. This manipulation— causing the FDA to reject approval of a drug that No- vo concedes would have been marketed for only non- infringing uses—is unconscionable. And now that the path for gaming the Act is clear, it will be followed by brand after brand, depriving sick patients of needed cost-effective drugs. The majority’s reasoning effec- tively: wrote out language in the statute; deprives the FDA of authority to require patent descriptions; and renders obsolete a long-established regulatory system that has benefitted generic drug applicants innumer- able times. STATEMENT The HWA provides the framework for filing generic drug applications (“ANDA’s”) and for quickly litigating potential patent disputes in expeditious manners. HWA follows a typical pattern: the ANDA is filed, the