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Hatch-Waxman Basics

Hatch-Waxman Basics

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Hatch-Waxman Basics

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  1. Hatch-Waxman Reforms Under The “Medicare Prescription Drug, Improvement, And Modernization Act 2003”Brian V. Slater, Esq.Fitzpatrick, Cella, Harper & ScintoLaw Seminars International, Raleigh, NC May 3, 2004

  2. Hatch-Waxman Basics • Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman”) • NDA holder must inform FDA of patents covering drug or method of using drug (not process patents), including those issuing after NDA approval (FDA publishes this in the “Orange Book”) • Generic applicant (either ANDA or 505(b)(2)) seeking to market prior to patent expiration, must • certify listed patent is invalid, not infringed or unenforceable (so-called “Paragraph IV”) • notify NDA holder and patent owner and provide detailed statement of factual and legal basis 2

  3. Hatch-Waxman Basics • NDA holder/patent owner has 45 days from receipt of Para IV notice to sue for patent infringement • If timely suit is brought, automatic 30-month stay of FDA approval of generic application unless “court” decision of invalidity, non-infringement or unenforceability • For certain ANDAs after 3/2000 FDA interpreted “court” as “district court” [65 Fed. Reg. 16922] • Non-concurrent, multiple 30-month stays for each Para IV sued on 3

  4. Hatch-Waxman Basics • Filing generic application with a Para IV is an act of infringement. [35 U.S.C. § 271(e)(2)] • No declaratory judgment action re patent by generic allowed until 45-day window has passed • First ANDA Para IV filer obtains 180-day exclusivity against other generic competitors (triggered by earlier of commercial marketing or “court” decision of non-infringement or invalidity) • For certain ANDAs after 3/2000 FDA interpreted “court” as “district court” [65 Fed. Reg. 16922] 4

  5. Medicare Prescription Drug, Improvement, And Modernization Act 2003 • Background: • Criticisms of Hatch-Waxman scheme in FTC 2002 “Generic Drug Entry” Study • FDA 2003 regulations adopted some FTC recommendations [68 FR 36676] • Medicare Act signed into law December 8, 2003 • Title XI – “Access To Affordable Pharmaceuticals” modifies aspects of Hatch-Waxman, codifies some F.D.A. practices, reverses some and modifies others 5

  6. Effect Of Litigation On Final Approval • Opportunity for one 30-month stay per generic application limited to patent information submitted by NDA holder prior to generic’s original application • For later-listed patents, generic applicant still has to notify patent owner of Para IV and patent owner can still sue, but no additional 30-month stay • Applies only to patent information submitted by NDA holder on or after 8/18/03 (otherwise old law applies, i.e., non-concurrent 30-month stays for each Para IV sued on) 6

  7. Notice By Generic Applicant For Para IV certifications on or after 8/18/03, generic must give notice to NDA holder/patent owner: • Within 20 days of postmark on FDA letter confirming filing of generic application [new]; or • At same time generic submits amendment or supplement (regardless of whether applicant has previously given notice of another Para IV) [reverses FDA 2003 regulation] 7

  8. Section 283 only provides injunction to prevent remedy future infringement so would not cover drug products resulting from tool use if tool use over Effect Of Litigation On Final Approval Generic approval prior to expiry of 30-month stay if: • The district court decides patent is invalid or not infringed; or • In appeal from district court infringement judgment, appeals court decides patent is invalid or not infringed; or • Settlement order or consent decree signed by district or appellate court that patent is invalid or not infringed 8

  9. Generic Causes of Action • Changes to existing declaratory judgment provisions • New Orange Book “delisting” counterclaim • Both provisions apply to “any proceedings” pending on or after December 8, 2003 • No damages in either case 9

  10. Declaratory Judgment Actions • Generic may bring declaratory judgment action of non-infringement or invalidity if no suit brought during 45 day period [change] • “The courts of the United States shall, to the extent consistent with the Constitution, have subject matter jurisdiction” over such actions. [35 U.S.C. § 271(e)(5)] [new] • Action must be brought in judicial district where defendant has principal or a regular and established place of business [same] 10

  11. Declaratory Judgment Actions • For declaratory judgment actions based on a non-infringement Para IV, the Para IV notice must have been accompanied by offer of confidential access to the generic’s application for the sole purpose of evaluating possible infringement [new]: • Irrelevant information can be redacted by generic • Can be offered under protective order like restrictions • Request for access to generic application under such an offer is considered an enforceable contract • What about DMFs? 11

  12. Declaratory Judgment Actions Q. If generic applicant is not sued, why would it file a declaratory judgment action? • First generic filer probably would not. • In past, subsequent generic filer sued to burn off first ANDA filer’s 180-day exclusivity. See Teva Pharms., USA, Inc. v. United States FDA, 182 F.3d 1003 (D.C. Cir. 1999)(dismissal of d.j. action was “court decision” triggering 180-days exclusivity). • Court decision is still a trigger of 180-days under certain circumstances and is a forfeiture event but now “decision” means a decision from which no appeal has/can be taken. (see below) 12

  13. Declaratory Judgment Actions Q.Can a generic that is not sued on Para IV demonstrate an “actual controversy” under 28 U.S.C. §2201(a)? • Actual controversy requires, inter alia, an explicit threat or other action by patentee giving rise to a “reasonable apprehension” of suit? [Gen-Probe v. Vysis, 02-1617 (Fed. Cir. 3/5/04] • Isn’t non-suit the antithesis of a threat of suit? • Orange Book listing and refusal to grant covenant not to sue do not give rise to “reasonable apprehension” of suit [See Teva Pharms. USA, Inc. v. Pfizer Inc., 2003 WL 22888848 (D. Mass. 12/8/03); Dr. Reddy’s Labs. v. Pfizer Inc., 2003 WL 21638254 (D.N.J. 7/28/03)] 13

  14. Declaratory Judgment Actions • If there is an actual controversy, is a court requiredto exercise declaratory judgment jurisdiction? • Declaratory judgment statute gives court discretion whether to exercise its jurisdiction. [28 U.S.C. § 2201(a) (“in a case of actual controversy . . .any court . . . may declare the rights and other legal relations of any interested party . . .“)] • One commentator has argued the “the federal courts should take declaratory judgment jurisdiction where they have discretion to do so” • Act does not mandate that district court exercise discretion in favor of entertaining declaratory judgment action. 14

  15. Orange Book “Delisting” Counterclaim • Previously, generic had no private cause of action against NDA holder to delist patents from Orange Book [See Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323, 1332 (Fed. Cir. 2001); see also Apotex v. Thompson, 349 F.3d 1335 (Fed. Cir. 2003)] • Now, generic may bring a counterclaim in a an infringement action for order requiring NDA holder to correct or delete patent information because it does not claim either the approved drug or an approved method of using the drug • Does not authorize independent Orange Book delisting action (e.g., declaratory judgment) 15

  16. 180-Day Exclusivity Eligibility • A “first applicant” who submits a “substantially complete” ANDA with a Para IV for a drug on the first day that any applicant makes a Para IV obtains 180-day exclusivity (i.e., unless forfeited) • Exclusivity now tied to drug, not patents – avoids situation where multiple generics file Para IVs on different patents [D.C. Dist. (Roberts J.) 1/2/04 decision overturned FDA position that generics should share exclusivity re PAXIL] • Can be more than one “first applicant” – avoids having to determine who filed first on a particular day; results in shared exclusivity • Applies only to ANDAs filed for a drug as to which no Para IV was made before December 8, 2003 16

  17. 180-Day Exclusivity Trigger • For ANDAs where no Para IV prior to 12/8/03, only trigger is first commercial marketing of generic drug or brand drug by any first applicant • Court decision is no longer a trigger but is now a forfeiture event (see below) • Includes marketing of brand drug under a settlement agreement with innovator • For ANDAs where was Para IV prior to 12/8/03 (where trigger has not already occurred), trigger is commercial marketing or decision from which no appeal has been/can be been taken [return to FDA Practice before 3/2000 Guidance] 17

  18. 180-Day Exclusivity Forfeiture First applicant’s 180-day exclusivity forfeited by: • Failure to market under certain circs. (see next slide) • Withdrawal of ANDA (either voluntarily or by FDA) • Amendment or withdrawal of qualifying Para IV as to all patents • Failure to obtain tentative approval within 30 months • Agreement with another ANDA applicant, NDA holder or patent owner adjudicated to violate antitrust laws • Expiration of all the patents that are the subject of qualifying Para IV 18

  19. 180-Day Exclusivity Forfeiture • Failure to market: A firstapplicant forfeits exclusivity by failing to market by the later of: • 75 days after FDA approval is made effective or 30 months after ANDA filing, whichever is earlier; or • 75 days after one of the following has occurred with respect to each patent in first applicant’s Para IV (in an infringement or declaratory judgment action involving first applicant or another applicant with tentative approval) • The court enters a final decision from which no appeal has been/can be taken that the patent is invalid or not infringed • The court signs a settlement order or consent decree that enters a final judgment that patent is invalid or not infringed • NDA holder withdraws the patent information 19

  20. 180-Day Exclusivity Forfeiture • Only forfeiture by all first applicants means subsequent applicants are not subject to 180-day exclusivity • If all first applicants forfeit 180-day exclusivity, subsequent applicant does not inherit 180-day exclusivity • 180-day forfeiture provisions apply to ANDAs filed for a drug as to which no Para IV was made before December 8, 2003, except that • Exclusivity is forfeited where first applicant enters agreement violating antitrust laws (regardless of when first Para IV was made) 20

  21. FTC Review Of Agreements • The following agreements must be filed with the Assistant Attorney General and the FTC: • Agreements between ANDA Para IV filer and brand name co. regarding (i) manufacture, marketing or sale of brand name drug or generic drug or (ii) the 180-day exclusivity period • Agreements between two ANDA Para IV filers regarding the 180-day exclusivity period • Doesn’t apply to 505(b)(2) generic applicant • Agreements must be filed by each party prior to first commercial marketing of drug and no later than 10 business days after execution • Applies to agreements entered into on or after 1/8/04 21

  22. Thank You