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Patent Settlement Bill Advances - And Firms Fight Back With Examples Of Early Generic Launches That Would Be Prohibited

Executive Summary

Four years ago, Teva inked a patent litigation settlement with Wyeth that enabled it to launch generic Effexor XR seven years before the patent on the drug expired

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PDUFA Reaches Approval Altitude; Can House Maintain Senate Speed?

After about a week of debate, the Senate overwhelmingly passes its FDA user fee package, with only track and trace to be finalized. House members are scheduled to begin floor debate after Memorial Day in the hopes of sending the bill to President Obama before July 4.

Senate Faces Amendment Gauntlet As User Fee Passage Nears

Seventeen amendments will be considered and final passage could come May 24. Along with a ban on generic drug settlements is a proposal to allow members of Congress to observe FDA-industry user fee negotiations.

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

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