Stopping Pharma’s Ripoffs and Drug Savings For All Act

This bill amends patent law to prevent double patenting for drugs and biological products, aiming to reduce improper patent term extensions that can delay lower-cost alternatives. It creates a presumption that patentees have disclaimed patent term for later patents after the first patent expires, unless they prove the patents cover distinct inventions. It also requires the U.S. Patent and Trademark Office to review its examination procedures and report to Congress.

Sec. 2, Prevention of double patenting: In patent validity challenges for drugs or biological products, the patentee is presumed to have disclaimed the term of each listed patent after the first patent expires. However, if the patentee shows by a preponderance of evidence that later patents cover patentably distinct inventions, no term is presumed disclaimed, and all patent term extensions are respected unless the patentee expressly disclaims term in writing.

Sec. 2(b), USPTO review: The Director of the U.S. Patent and Trademark Office must conduct a comprehensive review of patent examination procedures to determine if best practices are used to avoid issuing patents for the same drug or biological product that are not patentably distinct and lack an appropriate disclaimer. The Director must also consider developing new practices to improve examination and reduce improper patent issuance that extends exclusivity. Within one year of enactment, the Director must submit a report to the House Judiciary Committee with findings and recommendations.