H.R. 890 — Stopping Pharma’s Ripoffs and Drug Savings For All Act

This section amends 35 U.S.C. 253 to establish a presumption, in proceedings challenging listed patent validity under FDA drug approval provisions (21 U.S.C. 355(c)), biosimilar provisions (42 U.S.C. 262(l)), or related district court actions (35 U.S.C. 271(e)(2)), that a patentee has disclaimed the term of such patents for a drug or biological product after the first patent expires—unless the patentee demonstrates by a preponderance of the evidence that later patents cover patentably distinct inventions, in which case all patent term extensions remain in effect absent an express written disclaimer. This section also directs the United States Patent and Trademark Office Director to review agency examination procedures for issuing non-distinct patents on the same drug or biological product, identify best practices to avoid such issuances, and submit a report with findings and recommendations to the House Committee on the Judiciary within one year of enactment.