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Gemzar "Double-Patenting" Case Has Broad Implications For Industry Pipeline

Executive Summary

Eli Lilly & Co. has the backing of the pharmaceutical and biotech industries in its effort to get an appeals court to reverse its ruling that the company’s Gemzar (gemcitabine) patent is invalid.

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Regulatory Updates, In Brief

If at first you don't succeed: The specter of legislation to end "pay-for-delay" patent settlements continues to haunt the pharmaceutical industry. Wisconsin Sen. Herb Kohl's S. 369, as reported by the Judiciary Committee in 2009, is in the financial services appropriation bill approved by the Senate Appropriations Committee July 29. The Kohl provision would bar generic companies from receiving anything of value and limiting drug development or sales in return for ending patent litigation unless the firms can prove by clear and convincing evidence that the deal will not harm competition. Sen. Arlen Specter, R-Pa., tried to strip S. 369 from the appropriations bill, but failed on a 15-15 vote. The measure is not in the financial services appropriations bill approved by a House subcommittee July 29, but it was in the war supplemental appropriations package approved by the full House (1"The Pink Sheet," July 19, 2010). The war supplemental sent to President Obama for his signature was the Senate version, which did not contain S. 369. Further action on the financial services bills has not yet been scheduled on either side of Capitol Hill

Sanofi Tries To Stop Lantus Biosimilar By Getting Supreme Court To Review PTAB, Again

Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based on Federal Circuit's ruling that PTAB judges were not constitutionally appointed.

Sanofi Improperly Listed Lantus Patent In FDA's Orange Book, Appeals Court Finds

First Circuit reverses dismissal of direct purchasers' suit alleging improper listing of patent on device drive mechanism delayed competition; district court to decide if this constitutes antitrust violation.

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