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Patent Extension Arguments In Merck v. Hi-Tech Case Have Broad Implications

Executive Summary

Generic manufacturer Hi-Tech Pharmacal is pursuing a unusual challenge to Merck's patent for the anti-glaucoma drug dorzolamide

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The House Energy and Commerce Committee's inquiries into Sanofi-Aventis' Ketek could be a jumping-off point for a wide-ranging congressional look into the integrity of clinical trials and oversight of companies involved in those trials

Ketek Is Emerging As Lens For Wider Hill Scrutiny Of Clinical Trial Integrity

The House Energy and Commerce Committee's inquiries into Sanofi-Aventis' Ketek could be a jumping-off point for a wide-ranging congressional look into the integrity of clinical trials and oversight of companies involved in those trials

Merck wins Hi-Tech case

The Federal Circuit U.S. Court of Appeals on March 30 rejected Hi-Tech's novel argument that Merck's anti-glaucoma drug patent was not entitled to patent term extension because the patent had a terminal disclaimer. Such a disclaimer specifies that a drug is not "patentably distinct" from an earlier patent; Hi-Tech argued that the patent covering Trusopt (dorzolamide) and Cosopt (dorzolamide/timolol) would thus expire on the date of the previous patent (1"The Pink Sheet" Feb. 5, 2007, p. 8)...

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