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

OBB News Briefs

By Aaron Barkoff

• Teva announced Friday that it is acquiring Barr Pharmaceuticals for $7.5 billion plus $1.5 billion in debt.  For more:  AP; Reuters; WSJ.
• Zentiva, the Czech generic drug maker, announced Friday that it rejected a takeover bid from Sanofi-Aventis.  Sanofi already owns 25% of the company.
• Meanwhile, the WSJ Health Blog reports that the CEOs of GSK and Roche have no interest in getting into the generics business.
• FDA Law Blog recently reported on two interesting USPTO decisions denying Patent Term Extension requests under 35 U.S.C. § 156.  In both cases, AstraZeneca was the applicant:  July 8 (Symbicort); July 16 (Prilosec OTC).
• On July 11, Momenta Pharmaceuticals announced the filing of an ANDA with a paragraph IV certification for a generic version of Copaxone, Teva's $500 million multiple sclerosis drug.  According to Pharmalot, Teva's CEO is not concerned.
• The Baltimore Sun recently reported that the brand-name pharmaceutical industry has been successfully pushing legislation at the state level requiring pharmacists to inform doctors or get their permission before substituting a generic drug for a brand-name drug.
• The FDA announced on July 9 that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.  CDER will no longer issue "approvable" or "not approvable" letters.  For more:  Pharmalot; WSJ Health Blog.
• The WSJ Health Blog had an interesting post recently about a report from the HHS Inspector General, finding that FDA typically takes longer than the 180 days allowed under law to review a generic drug application.
• The Mircera case between Amgen and Roche is attracting a great deal of attention, particularly because of the "public interest" factor of the injunction analysis.  Patent Docs reported that BIO filed an amicus brief with the Federal Circuit.  Pharmalot has more on the case.
• Insmed recently announced that has developed a biosimilar version of Amgen's Neupogen, a $1 billion drug for the treatment of Neutropenia.  Pharmalot has more on the story.

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on July 20, 2008 (boomark / email).