- 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 Teva Branded (Fed. Cir. 12/20/24) (explaining full statutory scheme surrounding ANDAs and patents, including Orange Book delisting counterclaim statute, 21 U.S.C. § 355(j)(5)(C)(ii)(I), and aff’g delisting of patents from Orange Book); 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: “To determine infringement under § 271(e)(2), courts must conduct an inquiry to determine whether the probable ANDA product would infringe once it is made, used, or sold. The ‘ANDA specification directly resolves the infringement question’ if ‘it defines a proposed generic product in a manner that either meets the limitations of an asserted patent claim or is outside the scope of such a claim.’ If the ANDA specification does not speak clearly and directly to the question of infringement, courts may look to other relevant evidence, such as data or samples the ANDA filer has submitted to the FDA, to assess whether a proposed product will infringe.” Galderma (Fed. Cir. 12/06/24) (aff’g non-infringement). 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).
- Counterclaim For Orange Book Delisting: As amended in 2021, NDA owner must list its patents (and only such patents) for “which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application.” 21 U.S.C. § 355(b)(1)(A)(viii). See Teva Branded (Fed. Cir. 12/20/24) (delisting patents from Orange Book because the patents did not “particularly point out and distinctly claim what was approved [in the NDA]—the ProAir® HFA with albuterol sulfate as the active ingredient,” without addressing whether claimed drug substance or drug product). An ANDA applicant sued for “artificial” patent infringement may counterclaim for “an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) on the ground that the patent does not claim either— (aa) the drug for which the application was approved; or (bb) an approved method of using the drug.” 21 U.S.C. § 355(j)(5)(C)(ii)(I). See Teva Branded (Fed. Cir. 12/20/24) (aff’g Rule 12(c) judgment delisting patents from Orange Book where NDA product is combination of “albuterol sulfate (the active ingredient) with a propellant, ethanol, and an inhaler device to administer the drug” but claims directed to improvements in metered-dose inhalers and do not require the presence of an active drug, let alone the NDA’s active drug). A patent “claims the drug,” in the listing and counterclaim/delisting provisions, when it “particularly points out and distinctly claims the drug as the invention,” not merely “if it reads on the approved drug.” Teva Branded (Fed. Cir. 12/20/24) (“The claims identify the invention. Infringement is a distinct concept with a different statutory basis. Inventors claim what they invent, but infringement occurs when others make, use, or sell the invention without authorization.”) “To qualify for listing [in the Orange Book], a patent must claim at least what made the product approvable as a drug in the first place—its active ingredient,” not merely claim any component (here the inhaler) of the drug product. Teva Branded (Fed. Cir. 12/20/24) (despite the FDA’s broad definition of “drug,” “it is the presence of this active ingredient that makes a product approvable as a drug” not as a medical device).