Sec. 271(e)(2) Infringement (e.g., ANDA)

  • BASICS: “(2) It shall be an act of infringement to submit – (A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent, or (B) an application under section 512 of such Act or under [21 U.S.C. § 151-58] for a drug or veterinary biological product which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques and which is 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 or veterinary biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.” See Eli Lilly (U.S. 06/18/1990) (explaining Hatch-Waxman Act statutory scheme creating this “highly artificial act of infringement”); Caraco Pharm. (U.S. 04/17/2012) (explaining NDA-ANDA statutory scheme, and authorizing generic’s counterclaim to challenge incorrect “use code” in NDA); FTC v. Actavis (U.S. 06/17/2013) (explaining statutory scheme, and holding that reverse settlement payments may violate antitrust laws under a rule-of-reason analysis); Takeda Pharm. (Fed. Cir. 05/06/15) (2-1) (aff’g denial of preliminary injunction based on inducement; explaining ANDA and “paper NDA” statutory schemes).
  • Applies Even When Patent Issues After ANDA Filed: Vanda Pharm. (Fed. Cir. 04/13/18) (2-1) (aff’g judgment of inducement infringement and grant of injunction; trial court had jurisdiction, and there could be an act of infringement under Sec. 271(e)(2), and injunction granted, despite patent issuing after ANDA filed and despite alleged infringer amending its ANDA to include para. IV certification for this patent (that patent invalid or not infringed) after complaint filed).
  • Use Listed In ANDA Is Subject Of Infringement Analysis: The term “the use” in Sec. 271(e)(2)(A) means “the use listed in the ANDA.” Warner-Lambert (Fed. Cir. 01/16/03); H. Lundbeck (Fed. Cir. 12/07/23) (aff’g no indirect infringement; “‘the use . . . claimed in a patent’ under section 271(e)(2)(A) must be the use for which an applicant is seeking marketing approval” whether or not the patent is for a use approved under the NDA); Bayer Schering (Fed. Cir. 04/16/12) (ANDA does not infringe where FDA approved use is not the narrow use to which the patent’s method claims are directed).
  • Need Not Show Actual Use Of Proposed Product Or Of Claimed Method Of Use: Court need determine only “‘whether, if a particular drug were put on the market, it would infringe the relevant patent.’” Vanda Pharm. (Fed. Cir. 04/13/18) (2-1) (aff’g inducement judgment where “proposed label ‘recommends’ that physicians perform the claimed steps,” whether or not the proposed ANDA product has “‘substantial noninfringing uses.’”).
  • Court Should Consider Product Likely To Be Sold: The sample analyzed must be “representative of what is likely to be approved and marketed.” Merck Sharp (Fed. Cir. 02/09/18) (aff’g judgment of no infringement). Filing ANDA “only constituted a technical act of infringement for jurisdictional purposes,” so court must consider amended ANDA and product likely to be sold. Ferring [Watson] (Fed. Cir. 08/22/14) (rev’g bench-trial judgment of infringement). Filing ANDA “only constituted a technical act of infringement for jurisdictional purposes,” so court must consider amended ANDA and product likely to be sold. Ferring [Watson] (Fed. Cir. 08/22/14) (rev’g bench-trial judgment of infringement).
  • Biosimilar Price Competition and Innovation Act (BPCIA): Amgen I (Fed. Cir. 07/21/15) (explaining Biosimilar Price Competition and Innovation Act (BPCIA) statutory scheme governing biosimilars and abbreviated biologics license applications.) and Amgen II (Fed. Cir. 07/05/16 (same), each vacated in part and reversed in part, Sandoz (U.S. 06/12/2017) (requirement that applicant provide its application and manufacturing information to manufacturer of the biologic is not enforceable by injunction under federal law but remands to Fed. Cir. to determine whether available under state law; applicant may give notice of intent to commercialize before obtaining a license from the FDA); on remand Amgen III (Fed. Cir. 12/14/17) (aff’g dismissal of state law claims; “the BPCIA preempts state law remedies for an applicant’s failure to comply with § 262(l)(2)(A),” under both field and conflict preemption); Genentech (Fed. Cir. 07/06/20) (holding that § 262(l)(8)(A) notice needs to be given only once for a specific biosimilar product, even if supplements were filed).
  • If ANDA Does Not Compel Infringement Or Non-Infringement, Look To Likely Product: If ANDA specifies an infringing product then there is infringement. Sunovion (Fed. Cir. 09/26/13); Par Pharm. (Fed. Cir. 08/18/22) (aff’g non-infringement because ANDA release and stability specification spoke clearly and directly to the question of infringement, specifying that pH would not exceed 3.6 throughout its shelf life where claims require pH in range of 3.7 to 3.9, so do not look further); Par Pharm. (Fed. Cir. 11/23/20) (non-precedential) (aff’g infringement by ANDA; Sunovion governs because “the ANDA is not silent as to whether Hospira’s product could contain sufficient concentrations of elemental impurities such that citric acid would complex with the transition metals in a high enough concentration to satisfy the [claim] limitation”). But if ANDA (or amended ANDA) does not compel or rule out infringement, then patentee has burden to prove that alleged infringer will likely market an infringing product pursuant to an approved ANDA. Ferring [Appotex] (Fed. Cir. 08/22/14); Ferring [Watson] (Fed. Cir. 08/22/14). See generally Tyco (Fed. Cir. 08/06/14) (patent owner may allege infringement under Sec. 271(e)(2)(A) if has evidence that the commercial ANDA product will infringe, even though the hypothetical product specified in the ANDA could not infringe.)
  • Requirements For Showing Inducement Infringement By An ANDA: Patent owner “is required to prove by a preponderance of the evidence (1) direct infringement, i.e., if defendant’s drug was ‘put on the market, it would infringe the relevant patent’; and (2) ‘that [defendant] possessed the specific intent to encourage another’s infringement.’ Specific intent may be shown if the defendant’s proposed label recommends, encourages, or promotes an infringing act.” Genentech (Sandoz) (Fed. Cir. 12/22/22) (2-1) (aff’g no inducement infringement because no showing that direct infringement would occur, despite proposed label recommending claimed methods, based on evidence of past conduct of physicians and what they would do); H. Lundbeck (Fed. Cir. 12/07/23) (where label describes uses recited in plaintiff’s expiring patents, aff’g label does not induce infringement of plaintiff’s newer patent for different use: “It is the label FDA required for the sale of the drug to treat MDD—a label that the patentee itself proposed for that purpose in connection with its NDA for treating MDD and that preexisted the issuance of the [newer] patent,” where “there is no new discovery requiring instructing how to safely take the drug, or identifying a class of patients who should not take the drug at all.”).
  • Generic Can Avoid Sec. 271(e)(2) Infringement By Excluding Patented Uses: “the Act allows generic manufacturers to limit the scope of regulatory approval they seek—and thereby forego Paragraph IV certification and a § 271(e)(2) infringement suit—by excluding patented indications from their ANDAs.” AstraZeneca (Fed. Cir. 02/09/12). But if the patent covers a step that will necessarily occur on the way to the generic’s indicated use, even if that step is not an FDA-approved use, there may be infringement. Braintree Labs. (non-precedential) (Fed. Cir. 05/05/17).

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