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: Orange Book Blog: At the Intersection of Patent Law and FDA Law

OBB News Briefs

By Aaron Barkoff

• On June 25, the Congressional Budget Office released a cost estimate for the Biologics Price Competition and Innovation Act of 2007 (S. 1695), concluding that the biosimilars bill would save American consumers $25 billion on prescription drug costs over the next ten years.  For more: statements from BIO and PhRMA; FDA Legislative Watch; Pharmalot; The Hill's Congress Blog.
• Bayer and Barr announced on June 24 that they signed a deal licensing Barr to market authorized generic versions of Bayer's Yasmin and Yaz oral contraceptives.  Under the agreement, Bayer will continue to appeal the March 3rd district court decision on Yasmin and will receive higher royalties from Barr if it succeeds.  More: Reuters.
• On June 23, FDA Law Blog reported that Rep. William Delahunt (D-MA) introduced a bill specifically meant to allow The Medicines Company, a Massachusetts company, to obtain a patent term extension for its patent covering Angiomax (bivalirudin)--for $65 million.
• FDA Law Blog reported on June 19 that the House Commerce Committee posted the responses to its April 3rd letter soliciting feedback on how to establish a pathway for FDA approval of biosimilar products.
• On June 18, Pfizer and Ranbaxy announced a comprehensive settlement of patent litigation over generic Lipitor.  Under the agreement, Ranbaxy will have a license to sell generic versions of Lipitor (atorvastatin) and Caduet (atorvastatin/amlodipine) effective Nov. 30, 2011.  For more: NYT; Pharmalot; Reuters; WSJ; WSJ Health Blog.
• On June 17, the Federal Circuit affirmed the district court findings of inequitable conduct and exceptional case in Synthon IP v. Pfizer, in which Synthon unsuccessfully alleged that Pfizer infringed its patent on a process for making amlodipine, the active ingredient in Norvasc.
• The Lewis & Clark Law Review recently published a special issue devoted entirely to the patent law doctrine of obviousness.  One of the articles is of particular interest:  Pharma's Nonobvious Problem, by Prof. Rebecca S. Eisenberg.

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on July 07, 2008 (boomark / email).