Stopping Pharma’s Ripoffs and Drug Savings For All Act

Summary

Creates a legal presumption that later-expiring patents covering the same drug or biological product as an earlier-expiring patent are treated as having disclaimed their extra patent term in certain statutory challenges, unless the patent owner proves the later patents claim patentably distinct inventions or expressly disclaims term in writing. Also directs the Director of the U.S. Patent and Trademark Office to review examination practices to reduce issuance of non-distinct patents on the same drug or biologic and report recommendations to Congress within one year.

• Creates a rebuttable presumption that later-expiring patents on the same drug/biologic have disclaimed their extra term in certain FDA-related patent challenges.
• Applies to statutory proceedings tied to drug and biologic approval pathways and district-court actions that affect market exclusivity timing.
• Patentees can overcome the presumption by proving patentable distinctness by a preponderance of the evidence.
• If the presumption stands, later patents will not extend exclusivity in the covered challenges; USPTO-granted term extensions are respected only if distinctness is proven or term is expressly disclaimed.
• Requires the USPTO Director to review patent examination practices and report recommendations to Congress within one year.
• Aims to limit strategic patent filings that extend exclusivity through multiple, non-distinct patents on the same product.
• Does not itself appropriate funds or create new spending programs; it changes legal presumptions and mandates a procedural review and report.
• Will influence litigation strategy for both patent owners and challengers in Hatch-Waxman and biologics-related disputes.