1. AIPLA IP Practice in Japan Committee Pre-Meeting Joerg-Uwe Szipl Griffin and Szipl, PC and Ranga Sourirajan McKool Smith, P.C. October 13, 2009 Are Reverse Payment Settlements on Reverse Gear? The opinions expressed herein are not to be attributed to Griffin and Szipl, PC’s or McKool Smith’s clients

2. Royalty Payments Patentee licenses patent to licensor; licensor pays royalty Licensor makes, uses, or sells product or method Reverse Payment Settlements Patentee pays to prevent challenge of patent Money, license grants, product development, delayed entry, supply/manufacturing/inventory/promotion agreements Pharmaceuticals ctHatch-Waxman Act Paragraph IV Certification – 180-day exclusivity Prescription drug makers enter into settlements with generics Introduction

3. Facts Abbott’s drug Hytrin to treat hypertension and enlarged prostrate; patents re terazosin hydrochloride compound Geneva Pharm. filed ANDA; Abbott sued Zenith filed ANDA, sued Abbott to delist ‘095 and ‘207 patents Geneva Pharm. agreed not to make generic; Abbott to pay $4.5M/mo. Abbott to pay $3M up front, $3M (3mo.), $6M/3mo.; Zenith not to make generic Procedure FTC sues; parties terminate agreements DCT: per se violation of § 1 of Sherman Act (“geographic market allocation between horizontal competitors”) Holding No per se liability; reversed DCT because it failed to consider patent’s exclusionary power in its antitrust analysis Valley Drug v. Geneva Pharms.

4. Facts Schering-Plough owns ‘743 patent re extended release formulation of potassium chloride (K-Dur 20); Upsher-Smith filed ANDA Prior to trial, Schering-Plough and Upsher-Smith settled Upsher-Smith to refrain from entry into market; Upsher-Smith licensed its cholesterol drug; Schering-Plough paid $60M for license and deal ESI Lederle settled with Schering-Plough ($30M) Procedure FTC sued Schering-Plough, Upsher-Smith and ESI Lederle ALJ ruled against FTC; FTC appealed; Commission found payments in violation of Sherman Act § 1 and FTC Act § 5; appeal to 11th Cir. DOJ – not the case to determine “the proper standards” for settlements Holding No AT liability where agreement does not extend restraining effect on competition beyond that inherent in the underlying patent Schering-Plough v. FTC

5. Facts AstraZeneca’s Nolvadex (tamoxifen), breast cancer treatment drug Zeneca sued Barr; DCT found Zeneca’s ‘516 patent invalid While on appeal, parties settled and agreed to vacate DCT’s decision; Zeneca to pay $21M for Barr’s delayed entry, Barr to market Class action suit challenging settlement between Zeneca and Barr Procedure DCT grants MTD FTC (amicus for en banc hr’g) – Hatch-Waxman encourages patent challenges; “prospect of consumer benefits from such challenges is enormous” DOJ (amicus for cert denial) – “correct approach is to apply the rule of reason, rather than a rule of per se legality (or illegality)” Holding Reverse settlement agreement is legal because allegations of excessive payment was insufficient to state an antitrust claim unless the allegations involved a fraudulently procured patent or was based on sham litigation Tamoxifen Litigation

6. Facts ‘444 patent issued; FDA grants approval to market Cipro Barr files ANDA, para. IV certification; Bayer sues Barr Barr counterclaims invalidity, noninfringement, and unenforceability Bayer settles with generics before trial ($348M); Bayer files reexam and PTO affirms patent validity Four generics file new ANDAs; Bayer sues generics Direct purchasers sue on antitrust (“AT”) grounds Procedure DCT denies P’s SJ on per se liability; P’s add Walker Process claim; P’s MSJ denied FTC – “market division agreements between competitors” violates AT SCOTUS denied cert. Holding Rule of reason should be applied because any anticompetitive effects of settlement agreements are within "exclusionary zone" of patent Cipro Litigation

7. Cipro cont. Arkansas Carpenters Health and Welfare Fund v. Bayer, 2 nd Cir. No. 05-2851 April, 2009, 2 nd Cir. Requests DOJ inputApril, 2009, 2 nd Cir. Requests DOJ input (1) Whether settlement of patent infringement lawsuits violates the federal antitrust laws when a potential generic drug manufacturer withdraws its challenge to the patent’s validity, which if successful would allow it to market a generic version of a drug, and the brand-name patent holder, in return, offers the generic manufacturer substantial payments.(1) Whether settlement of patent infringement lawsuits violates the federal antitrust laws when a potential generic drug manufacturer withdraws its challenge to the patent’s validity, which if successful would allow it to market a generic version of a drug, and the brand-name patent holder, in return, offers the generic manufacturer substantial payments. (2) whether the 2 nd Cir. has jurisdiction over the appeal(2) whether the 2 nd Cir. has jurisdiction over the appeal

8. Cipro cont. Arkansas Carpenters Health and Welfare Fund v. Bayer, 2 nd Cir. No. 05-2851 Brief filed July, 6, 2009 reverses Bush Administration Position:Brief filed July, 6, 2009 reverses Bush Administration Position: −Settlements involving reverse payments substantially in excess of anticipated litigation costs may upset the balance of Hatch-Waxman −Reverse payments are not essential to the settlement of patent disputes −Such payments are unknown outside of Hatch-Waxman context −The anticompetitive potential of reverse payments in the Hatch Waxman context is sufficiently clear for the alleged infringer’s agreement not to compete and to eschew any challenge to the patent is sufficiently clear that such agreements should be treated as presumptively unlawful under Section 1 of the Sherman Act

9. Cipro cont. Arkansas Carpenters Health and Welfare Fund v. Bayer, 2 nd Cir. No. 05-2851 −A settlement involving a payment to the alleged drug patent infringer in exchange for its agreement to withdraw its challenge to the patent and delay bringing its generic drug to market is presumptively unlawful and requires the defendant to offer justifications in order to avoid antitrust liability. −Defendants burden is to show that, despite the reverse payment, the agreed upon entry date and other terms of entry reasonably reflected their contemporaneous evaluations of the likelihood that a judgment in the patent litigation would have resulted in generic competition before patent expiration −DOJ did not take a position on the specific merits of this appeal −The present 2 nd Cir. Case is related to the Fed. Cir. In re Cipro case for which review was denied by the Supreme Court. −The DOJ brief does not mention the 2 nd Cir.’s earlier In re Tamoxifen case which upheld a similar reverse payment agreement −A 2 nd Cir. Holding in line with the DOJ’s new view would set up a circuit split that could prompt Supreme Court review.

10. Cipro cont. Arkansas Carpenters Health and Welfare Fund v. Bayer, 2 nd Cir. No. 05-2851 How would the analysis work under the DOJ Position?How would the analysis work under the DOJ Position? Because settlements may serve a legitimate purpose, they are appropriately analyzed under the rule of reasonBecause settlements may serve a legitimate purpose, they are appropriately analyzed under the rule of reason Under rule of reason challenger may make a prima facie caseUnder rule of reason challenger may make a prima facie case −The brand name patent holder made a payment to the generic, and −That payment was accompanied by the generic’s agreement to withdraw its patent challenge If the payment is in excess of litigation costs competitive effects will be looked atIf the payment is in excess of litigation costs competitive effects will be looked at If settlement does not allow market entry before patent expiration, defendants likely winIf settlement does not allow market entry before patent expiration, defendants likely win If market entry is before patent expiration, defendant may meet burden.If market entry is before patent expiration, defendant may meet burden.

11. Proposed Legislation Bills introduced in House and Senate to Ban reverse Payments (S. 369, H.R. 1706)Bills introduced in House and Senate to Ban reverse Payments (S. 369, H.R. 1706) −Both bills prohibit drug companies from receiving anything of value from brand-name drug companies for agreeing not to research, develop manufacture, or sell, for any period of time, a generic drug. −Bills are criticized by forcing patent litigation to go on to the bitter end and may actually reduce the number of generic drugs In response to criticism, Senate committee adopted a modified bill (Sept. 18, 2009)In response to criticism, Senate committee adopted a modified bill (Sept. 18, 2009) −FTC would make the decision to initiate a proceeding −Reverse royalty agreements would be presumed illegal −Drug companies would then have the opportunity to convince a judge that the agreement is pro-competitive

12. Proposed Legislation −Several factors would be considered: −The length of time remaining in the patent −The value to the consumers of competition from the ANDA product allowed by the agreement −Form and amount of consideration received by the ANDA filer by agreement −The revenue the ANDA filer would have received if they had won −The reduction of revenues of the the NDA filer if they had lost −Time period between the date of the agreement conveying value and the settlement of the patent infringement claim

13. Proposed Legislation House Bill would ban all settlements with certain exceptionsHouse Bill would ban all settlements with certain exceptions Agreements are allowed when the consideration received is no more thanAgreements are allowed when the consideration received is no more than −The right to market the drug that is to be manufactured under the patent infringement claim, before the expiration of the patent or other exclusivity, and −the waiver of damages based on prior marketing of the drug

14. Summary FTC has long taken the position that reverse payment agreements settling Paragraph 4 Hatch-Waxman cases are illegalFTC has long taken the position that reverse payment agreements settling Paragraph 4 Hatch-Waxman cases are illegal Courts have refused to adopt per se analysis and have generally upheld the agreements under a rule of reason analysis, Supreme Court has consistently denied reviewCourts have refused to adopt per se analysis and have generally upheld the agreements under a rule of reason analysis, Supreme Court has consistently denied review Present DOJ has aligned with the FTC in calling for “pay for delay” agreements to be presumptively illegal, shifting the burden on the drug companies to defend themPresent DOJ has aligned with the FTC in calling for “pay for delay” agreements to be presumptively illegal, shifting the burden on the drug companies to defend them Both the House and Senate have proposed bills that would regulate either ban such agreements or make them presumptively illegalBoth the House and Senate have proposed bills that would regulate either ban such agreements or make them presumptively illegal Related Issues:Related Issues: −Pathway for Generic Bioequivalents −Data Exclusivity −Authorized Generics

15. Cases In re Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323 (Fed. Cir. 2008), cert. denied, 129 S.Ct. 2828 (2008) In re Tamoxifen Citrate Antitrust Litigation, 466 F.3d 187 (2d Cir. 2006) Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005), cert. denied, 548 US 919 (2006) Valley Drug Co. v. Geneva Pharms., Inc., 344 F.3d 1294 (11th Cir. 2003) Legislation H.R. 1706, “Protecting Consumer Access to Generic Drugs Act of 2009,” 77 PTCJ 609. S. 369, 77 PTCJ 362, substitute bill at 78 PTCJ 592. List of Cases and Citations

16. Speaker Contact Information Joerg-Uwe Szipl Griffin and Szipl, PC 2300 Ninth St., South, Suite PH-1 Arlington, VA 22204 gands@szipl.com Ranga Sourirajan McKool Smith, P.C. 1700 K Street, N.W., Suite 740 Washington, DC 20006 rsourirajan@mckoolsmith.com