FDLI s IP Throughout the Drug Development Lifecycle

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1 FDLI s IP Throughout the Drug Development Lifecycle Post-Marketing IP Protection & Enforcement: View From the Generic Side Janine A. Carlan Arent Fox LLP Topics To Be Discussed Hatch-Waxman Process Orange Book ( OB ) Patent Strategies Paragraph IV ( PIV ) Notice Letter Authorized Generics Mining Data for Patentable Inventions 1

2 Hatch-Waxman Process Timeline: AFF Letter Received from FDA Within 20 Days: File PIV Notice Letter Within 45 Days: Suit by Brand Company - triggers 30-month stay of ANDA approval - calculated from date LAST recipient receives the PIV Notice Letter [21 CFR (f)] - District Court decision - Federal Circuit decision Hatch-Waxman Process (cont d) Goals: - Market entry day exclusivity [21 USC 355(j)(5)(B)(iv)] 2

3 OB Patent Strategies PI-PIV Certifications: Under 21 USC 355(j)(2)(A)(vii): (I) No patent information filed, (II) Patent expired, (III) Wait for patent to expire, or (IV) Patent is invalid or not infringed OB Patent Strategies (cont d) Section viii Statement: An abbreviated application for a new drug [ANDA] shall contain-... (viii) if with respect to the listed drug referred to in clause (i) information was filed under subsection (b) or (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use. [21 USC 355(j)(2)(A) (emphasis added)] 3

4 OB Patent Strategies (cont d) AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370 (Fed. Cir. 2012) No viable claim for infringement under 35 USC 271(e)(2) in view of the section viii statement : It shall be an act of infringement to submit--(a) an application... for a drug claimed in a patent or the use of which is claimed in a patent... if the purpose of such submission is to obtain approval under such 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 USC 271(e)(2)] OB Patent Strategies (cont d) Which patents to challenge? First generation patents Compound (API) patent First medical use Second generation patents Formulation patent (extended release, stabilizer, unique tablet configuration, etc.) Polymorph Second (newly-approved) medical use 4

5 OB Patent Strategies (cont d) Which patents to challenge? First generation patents Compound or first (only?) medical use patents: most difficult to challenge invalidity only, generic must infringe Second generation patents Formulation patent or polymorph non-infringement via design-around invalidity via obvious design choice Second (newly-approved) medical use section viii statement OB Patent Strategies (cont d) With increasing generic competition: Challenges come earlier in product life cycle Challenges frequently occur on NCE-1 date (after 4 th year of FDA approval) Possibility of forfeiture increases 5

6 OB Patent Strategies (cont d) NCE-1 challengers must consider forfeiture provision of FFDCA First ANDA applicant must market within 75 days of: (a) Appellate court decision in ANDA applicant s favor; (b) Settlement finding patent not infringed or invalid; or (c) Patent withdrawal OB Patent Strategies (cont d) Hypothetical: Which patents to challenge? 1 Compound patent (late 2019) 2 Formulation patents (2021 & 2023) NCE-1 date June 1, ½ year rule stay ANDA approval until early 2016 Trial court decision 2016? Fed. Cir. decision late 2017? Forced to challenge compound patent 6

7 OB Patent Strategies (cont d) Choose patent challenges in accordance with long-term business objectives Avoid potential forfeiture situations Seek legal advice on the timeline PIV Notice Letter Requirements for providing notice Statute: 21 USC 355(j)(2)(B) Regulations: 21 CFR & The Applicant shall include in the [ANDA] a statement that the applicant will give notice.... [35 USC 355(j)(2)(B)(i) and (iii)] 7

8 PIV Notice Letter (cont d) Minimum Requirements: (i) state that the ANDA contains bioavailability or bioequivalence data; and (ii) include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed. [21 USC 355 (j)(2)(b)(iv)] PIV Notice Letter (cont d) Content Controversies: What is sufficiently detailed? Fewer facts, detail and argument Narrows potential discovery Does not reveal litigation strategy May risk allegation of baseless certification More facts, detail, argument Broadens potential discovery Coextensiveness with litigation strategy closely scrutinized May increase likelihood of settlement 8

9 PIV Notice Letter (cont d) Yamanouchi Pharm. Co., Ltd. v. Danbury Pharmacal, Inc., 231 F.3d 1339 (Fed. Cir. 2000) No prima facie case of invalidity presented Attorney s fees awarded Takeda Chem. Indus., Ltd. v. Mylan Labs., Inc., 549 F.3d 1381 (Fed. Cir. 2008) No reasonable basis to claim patent invalid Notice letters did not match invalidity & unenforceability theories PIV Notice Letter (cont d) Offer of Confidential Access (OCA) ANDA applicant alleges non-infringement as a basis of a PIV certification MUST provide OCA to ANDA to preserve the right to file a Declaratory Judgment Action Not required to provide samples or other supporting documents 9

10 PIV Notice Letter (cont d) Recipients of notice: NDA Holder Listed on FDA website and in Orange Book and Patent Owner(s) Listed on USPTO assignment database Timing PIV Notice Letter (cont d) Newly-filed ANDA No later than 20 days after postmark date on FDA s AFF letter stating the ANDA has been filed [21 USC 355(j)(2)(B)(ii)(I)] Filed = FDA has made a threshold determination that the [ANDA] is sufficiently complete to permit a substantive review. [21 CFR (b)(1)] Existing ANDA At the time a supplement/amendment is submitted [21 USC 355(j)(2)(B)(ii)(II) & 21 CFR (d)] 10

11 PIV Notice Letter (cont d) Timing Controversies: How early? No earlier than postmark date on FDA s AFF letter SB Pharmco Puerto Rico Inc. v. Mutual Pharm. Co. Inc., 552 F.Supp.2d 500 (EDPA 2008) What is at the same time for existing ANDAs? Immediate notice reduces risk that another applicant will obtain exclusivity Purepac Pharm. Co. v. Thompson, 354 F.3d 877 (Fed. Cir. 2004) PIV Notice Letter (cont d) How to send Notice? U.S. Postal Service, registered or certified mail, return receipt requested Use tracking to obtain receipt information as proof of delivery Courier Advance permission required from FDA 11

12 Authorized Generics A brand company s product repackaged and marketed as a generic through a subsidiary or third party Timing: Typically at end of NDA holder s exclusivity Can compete directly against a generic during the 180-day exclusivity Examples: Provigil (modafinil), Geodon (ziprasidone) & Lipitor (atorvastatin) Authorized Generics (cont d) v. Hypothetical revenues in millions 6 months after generic entry in a $500 million product [Glass, Authorized Generics, Nature Reviews 4: (2005)] 12

13 Mining Data for Patentable Inventions Formulation patents Dosage form patents API & formulation method patents Thank You Janine A. Carlan Arent Fox LLP 1050 Connecticut Avenue, NW Washington, DC