In Brief: GATT patent extensions
Executive Summary
GATT patent extensions: U.S. Patent and Trademark Office should withdraw its final determination published in the Federal Register June 7 stating that Waxman/Hatch Sec. 156 extensions will not be added on top of the new 20-year patent terms enacted in the Uruguay Rounds Agreement Act, according to a June 12 letter to PTO Commissioner Bruce Lehman from Pharmaceutical Research & Manufacturers of America President Gerald Mossinghoff. PhRMA maintains that the PTO's argument for the several meanings of "original expiration date" is flawed because the "term appears only once in the entire patent statute" and simply refers to the date of expiration before a Waxman/Hatch extension is granted ("The Pink Sheet" June 12, p. 9)...
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth