IRS Guidance On New Excise Tax On Branded Pharmaceutical Companies: Filing Due January 21, 2011

By Peter S. Reichertz

In a prior article dated May 25, 2010, we advised of a new excise tax on branded pharmaceutical manufacturers. We indicated that the Patient Protection and Affordable Care Act ("PPACA") required the Internal Revenue Service ("IRS") to publish guidance "necessary to carry out the purpose" of the section in which the tax is included. The IRS has now issued that guidance ("the Guidance"). 

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Adjusting the Inequitable Conduct Doctrine: Federal Circuit Hears Oral Arguments En Banc in Therasense

By Gray M. Buccigross

On November 9, 2010, the Federal Circuit, sitting en banc, heard oral arguments in Therasense, Inc. v. Becton, Dickinson & Co., regarding the legal tests to be applied in determining whether a patent is unenforceable due to inequitable conduct. This has been a controversial issue over the last several years among practitioners, Federal Circuit judges, and industry groups, particularly Big Pharma. This article assumes some familiarity with the case and the issues. However, for background information on both, please click here.

 

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Therasense Opinions And The Doctrine Of Inequitable Conduct

By Gray M. Buccigross

I. BRIEF OVERVIEW OF THE DOCTRINE

Each person associated with the prosecution of a patent application has a duty of candor and good faith in dealing with the Patent and Trademark Office (“PTO”). Under the doctrine of inequitable conduct, a patent may be rendered unenforceable where that duty is breached, and the person intended to deceive or mislead the PTO.
 

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