H.R. 6485 — Skinny Labels, Big Savings Act

This section establishes safe harbors from direct, induced, or contributory infringement liability under 35 U.S.C. §271 for method-of-use patents listed with the FDA for drugs (human and animal) and biologics. For generic drugs approved via ANDA (21 U.S.C. §355(j)), animal drug applications (21 U.S.C. §360b(b)(2)), or 505(b)(2) applications (21 U.S.C. §355(b)(2)), the safe harbor covers (1) submitting or seeking approval of such an application that includes a patent certification carve-out statement for the patented method of use; (2) promoting or commercially marketing the product using FDA-approved labeling; and (3) describing the product as generic to or therapeutically equivalent to the listed drug—provided the activities do not reference the carved-out patented condition of use as identified by the patent holder to the FDA. For biosimilars approved under 42 U.S.C. §262(k), the safe harbor covers (1) submitting or seeking approval of such an application; (2) describing the product as biosimilar to or interchangeable with the reference product using FDA-approved labeling, if not approved for the patented use; and (3) promoting or commercially marketing the product using such labeling—provided the activities do not reference the patented condition of use. The provision applies to all conduct and pending proceedings before, on, or after enactment and incorporates definitions for key terms (e.g., labeling under 21 U.S.C. §321(m)). (Thus, it expands "skinny label" safe harbors beyond manufacturing and initial FDA submission to include post-approval promotion and marketing of generics and biosimilars that exclude patented uses, potentially facilitating earlier market entry.)