Stopping Pharma’s Ripoffs and Drug Savings For All Act
This bill, aptly titled the Stopping Pharma’s Ripoffs and Drug Savings For All Act, would change how patent terms are treated for drugs and biologics to curb “double patenting” and potential evergreening. It creates a presumption that, after the earliest-expiring patent on a drug or biological product, the term of other related patents is disclaimed unless the patentee proves, by a preponderance of the evidence, that those patents claim patentably distinct inventions from the first patent. If distinct inventions are shown, no term is presumed disclaimed and existing patent term extensions (PTEs) continue to be respected, unless the patentee explicitly disclaims the term in writing. The bill also requires the USPTO to review its examination practices to prevent non-distinct patents on the same drug or biologic from issuing and to issue guidance to improve examination and curb improper patenting. A report with findings and recommendations would be due to Congress within one year of enactment. In short, the bill aims to limit the period of exclusive patent protection for drugs and biologics unless there is a clearly distinct invention, potentially reducing drug-cost-driving patent term extensions while preserving protections for truly new innovations. It also seeks to tighten USPTO examination practices to prevent improper patenting in the future.
Key Points
- 1Disclaimers of drug patent term: After the first patent on a drug or biological product, other related patents are presumed to have disclaimed their patent term, unless the patentee demonstrates they cover patentably distinct inventions from the first-expiring patent.
- 2Distinct inventions exception: If a patentee proves by a preponderance of the evidence that later patents cover patentably distinct inventions, no part of their term is presumed disclaimed, and patent term extensions remain in effect; however, the patentee must expressly disclaim the term in writing if they want to preserve it.
- 3Scope of application: The presumption applies in proceedings challenging patent validity under FDA drug provisions (section 505(c) of the Food, Drug, and Cosmetic Act) for drugs, under the Public Health Service Act for biological products (section 351(l)), or in federal district court proceedings involving patents linked to 271(e)(2) ( Hatch-Waxman-style) litigation.
- 4USPTO review mandate: The Director must conduct a comprehensive review of patent examination procedures to assess whether the Office is preventing the issuance of non-distinct patents related to the same drug or biologic and whether new practices or guidance are needed to improve examination and reduce improper extensions of exclusivity.
- 5Reporting requirement: Within one year after enactment, the Director must provide a report to the House Judiciary Committee detailing findings and recommendations from the review.