S. 43 — Skinny Labels, Big Savings Act

This section amends Section 271 of Title 35, United States Code, to establish safe harbors from direct, induced, or contributory infringement of method-of-use patents listed in FDA's Orange Book (human drugs), Abbreviated New Animal Drug Application files (animal drugs), or covering reference biological products. (1) For applications under FDCA §§505(j), 512(b)(2), or 505(b)(2) (21 U.S.C. §§355(j), 360b(b)(2), 355(b)(2)), it protects submitting the application with a patent certification excluding the patented use, promoting or commercially marketing the approved drug with its labeling, and describing it as generic or therapeutically equivalent to the listed drug—provided the materials do not reference the patented condition identified by the patent holder; (2) for biosimilar applications under PHS Act §351(k) (42 U.S.C. §262(k)), it protects submitting the application, describing the product as biosimilar or interchangeable with approved labeling (if not approved for the patented use), and promoting or commercially marketing it—provided the materials do not reference the patented condition. (Thus, generic, 505(b)(2), animal drug, and biosimilar manufacturers may use "skinny labels" excluding patented methods of use without infringement liability.) The section defines relevant terms (e.g., labeling per FDCA §201(m) (21 U.S.C. §321(m))) and applies retroactively to any conduct or pending proceedings.