This bill, titled the "Stopping Pharma's Ripoffs and Drug Savings For All Act," seeks to prevent pharmaceutical companies from improperly extending the market exclusivity of drugs and biological products. It introduces a new provision to title 35, United States Code, establishing a presumption that the term of later-issued patents for a drug or biological product will expire concurrently with the term of the first patent covering that product. This measure is specifically applicable in legal proceedings challenging patent validity related to drug approval pathways. However, this presumption can be overcome if the patentee demonstrates by a preponderance of the evidence that the later patents cover patentably distinct inventions from the first expiring patent. If distinctness is proven, all granted patent term extensions will be respected unless expressly disclaimed. The bill also mandates the Director of the United States Patent and Trademark Office (USPTO) to conduct a comprehensive review of its patent examination procedures. This review will assess whether current practices effectively prevent the issuance of patents that are not patentably distinct for the same drug or biological product, and whether new practices are needed to reduce the improper extension of exclusivity. The Director must report findings and recommendations to Congress within one year.
Stopping Pharma’s Ripoffs and Drug Savings For All Act
Introduced in House
Referred to the House Committee on the Judiciary.
Commerce
Stopping Pharma’s Ripoffs and Drug Savings For All Act
USA119th CongressHR-890| House
| Updated: 1/31/2025
This bill, titled the "Stopping Pharma's Ripoffs and Drug Savings For All Act," seeks to prevent pharmaceutical companies from improperly extending the market exclusivity of drugs and biological products. It introduces a new provision to title 35, United States Code, establishing a presumption that the term of later-issued patents for a drug or biological product will expire concurrently with the term of the first patent covering that product. This measure is specifically applicable in legal proceedings challenging patent validity related to drug approval pathways. However, this presumption can be overcome if the patentee demonstrates by a preponderance of the evidence that the later patents cover patentably distinct inventions from the first expiring patent. If distinctness is proven, all granted patent term extensions will be respected unless expressly disclaimed. The bill also mandates the Director of the United States Patent and Trademark Office (USPTO) to conduct a comprehensive review of its patent examination procedures. This review will assess whether current practices effectively prevent the issuance of patents that are not patentably distinct for the same drug or biological product, and whether new practices are needed to reduce the improper extension of exclusivity. The Director must report findings and recommendations to Congress within one year.