BASICS: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” 35 U.S.C. § 271(e)(1). SeeShire (Fed. Cir. 09/24/15) (rev’g judgment of inducement; safe harbor protects supplier of active pharmaceutical ingredient used by ANDA filer to prepare its ANDA.) Safe haven applies to “development of information for regulatory approval of generic counterparts of patented products,” but not “routine” information reported to the FDA after marketing approval has been obtained. Classen-Biogen (Fed. Cir. 08/31/11); Momenta Pharm II (Fed. Cir. 11/10/15) (“routine quality control testing of each batch” “as part of the post approval, commercial production process” is not protected by safe harbor; despite suggesting otherwise at prel’y injunction stage: Momenta Pharm I (Fed. Cir. 08/03/12) (preliminary injunction vacated; safe harbor applies to testing, post ANDA approval, to create records maintained by manufacturer per FDA requirements for maintaining approval)); but seeClassen-Elan (Fed. Cir. 05/13/15) (safe harbor includes post-approval studies submitted in support of a label change); cf.Merck (U.S. 06/15/2005) (safe haven “extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA”); Amgen (Fed. Cir. 12/16/19) (aff’g jury verdict of infringement and that safe harbor did not apply; jury instructions correctly explained that “additional underlying purposes do not matter as long as … the manufacture of any given batch of drug substance was reasonably related to developing information for FDA submission.”) “Subsequent disclosure or use of information obtained from an exempt clinical study, even for purposes other than regulatory approval, does not repeal that exemption of the clinical study, provided that the subsequent disclosure or use is itself not an act of infringement of the asserted claims.” Classen-Elan (Fed. Cir. 05/13/15).
“Patented Invention” Limited To Inventions Within Scope Of Sec. 156: “Patented invention” means any “invention” covered in 35 U.S.C. § 156, even if patent was not eligible for extension of term under Sec. 156. Sec. 156: “(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended …. (f) For purposes of this section: (1) The term ‘product’ means: (A) A drug product. (B) Any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act. (2) The term ‘drug product’ means the active ingredient of-(A) a new drug, antibiotic drug, or human biological product … or …, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.” The “active ingredient” is the product actually present in the approved drug, not merely the “active moiety” responsible for the product’s pharmacological properties. Photocure (Fed. Cir. 05/10/10); seeOrtho-McNeil (Fed. Cir. 05/10/10) (“the enantiomer is a different drug product from the racemate ofloxacin”); cf.Biogen (Fed. Cir. 04/21/20) (aff’g non-infringement: de-esterified form of active ingredient not same product under § 156(f)).
Safe Haven Covers Imported Products Made By Patented Process: Despite Sec. 271(e)(1) referring to importation only of “a patented invention,” it is interpreted to immunize importation of the product of a process patented in U.S., where product is used for exempt purposes. Amgen (Fed. Cir. 04/30/09).
Safe Haven Does Not Extend To FDA-Unregulated Devices Used To Test FDA-Related Drugs: Sec. 271(e)(1) does not “immunize the manufacture, marketing, or sale of [a device that measures the physical parameters of aerosol sprays], which is used in the development of FDA regulatory submissions, but is not itself subject to the FDA premarket approval process.” Proveris (Fed. Cir. 08/05/08).
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