USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
As explained in 1.2 Defendants/Other Parties to an Action and 1.6 Requirements to Bring Infringement Action , the Hatch-Waxman Act makes it an artificial act of infringement to submit an ANDA (or Section 505 (b)(2) NDA) seeking FDA approval of a drug or its use that is claimed in a patent. 35 USC 271 (e)(2). Thus, patent infringement suits can be brought after a Paragraph IV certification is submitted and before the drug is marketed. Indeed, there is a thirty-month stay of ANDA approval in Paragraph IV litigations so that the parties can resolve their patent infringement issues before launch. Because a marketed accused product typically does not exist at the time of suit, infringement is based on “whether the probable ANDA product would infringe once it is made, used or sold.” Par Pharm., Inc. v Eagle Pharms., Inc. , 44 F.4th 1379, 1383 (Fed. Cir. 2022). Damages are typically not at issue and thus most Hatch-Waxman cases are decided by a court instead of a jury. An ANDA applicant may also be liable for induced infringement under 35 USC 271 (b) if its ANDA prod ‑ uct, proposed label, and the other circumstances would induce infringement. Amarin Pharma, Inc. v Hikma Pharms. USA Inc. , 104 F.4th 1370, 1377 (Fed. Cir. 2024). An ANDA applicant may be liable for contributory infringement under 35 USC 271 (c) if it sells or offers to sell a material or apparatus for use in a patented combination or process where the ANDA product is a material part of the patented invention and has no substantial non-infringing uses. Eli Lilly & Co. v Actavis Elizabeth LLC , 435 F. App’x 917, 926 (Fed. Cir. 2011) (unpublished). 2.2 Regulatory Data and Market Exclusivity The FD&C Act sets forth various exclusivities for small-molecule products, the most common of which are set forth below. • NCE – five years; applies to small-molecule drugs with active moiety not previously approved by FDA; ANDAs and 505 (b)(2) applications can be filed with Paragraph IV certifications on the “NCE-1” date (21 USC 355 (c)(3)(E)(ii) and 355 (j)(5)(F)(ii)).
• ODE – seven years; orphan drug exclusivity for the same drug and the same condition (21 USC 360cc). • PED – six months; paediatric extension of exclusiv ‑ ity and listed patents (21 USC 355a). • Clinical – three years; exclusivity for new clinical investigations essential to approval (21 USC 355 (c) (3)(E)(iii) and 355 (j)(5)(F)(iii)). • 180-day ANDA – 180-day exclusivity for the first ANDA(s) with Paragraph IV certification (21 USC 355 (j)(5)(B)(iv)). 2.3 Acceptable Pre-Launch Preparations The Hatch-Waxman Act established a safe harbour provision providing that it “shall not be an act of infringement to make, use, offer to sell, or sell... a pat ‑ ented invention... solely for uses reasonably related to the development and submission of information under a federal law [that] regulates the manufacture, use, or sale of drugs.” 35 USC 271 (e)(1)). Such protec ‑ tion also extends to medical devices and biologics products. Eli Lilly & Co. v Medtronic, Inc. , 496 US 661, 663 (1990); Amgen Inc. v Hospira, Inc ., 944 F.3d 1327, 1337 (Fed. Cir. 2019). The safe harbour “extends to all uses of patented inventions that are reasonably related to the develop ‑ ment and submission of any information under the FDCA.” Merck KGaA v Integra Lifesciences I, Ltd. , 545 US 193, 202 (2005) (emphasis in original). The analy ‑ sis of whether an activity is “reasonably related” to seeking approval depends on the type of patent. For example, in the Amgen v Hospira case, the “accused activity is Hospira’s use of Amgen’s claimed methods of manufacture. The relevant inquiry, therefore, is not how Hospira used each batch it manufactured, but whether each act of manufacture was for uses rea ‑ sonably related to submitting information to the FDA.” Amgen Inc. , 944 F.3d at 1339. Thus, each infringing act (eg, the manufacture of each batch of drug) is analysed to see whether it was done solely for uses reasonably related to regulatory approval. 2.4 Publicly Available Drug and Patent Information The Orange Book provides a list of all approved pre ‑ scription drug products with therapeutic equivalence evaluations and patents identified by the reference
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