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Quarterly Journal Issue 38, Volume 3

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Table of Contents

Lessons from the Federal Circuit: Defending Against Inequitable Conduct Claims locked.gif

The Federal Circuit's inequitable conduct decisions in 2008, 2009, and early 2010, while acknow ledging the need for candor and honesty in patent prosecution, have also emphasized the severity of inequitable conduct as a penalty and the potential for abuse in its assertion.  These decisions suggest a number of strategies to avoid a ruling of inequitable conduct.  The court's guidance ranges from what constitutes a legally sufficient pleading of inequitable conduct, to why a reasonable inference inconsistent with the intent to deceive or materiality may preclude finding inequitable conduct, to what constitutes mere attorney argument and why it does not support a claim of inequitable conduct, and to the importance of a good faith explanation for the challenged behavior.

Timothy G. Ackermann


The FDA Exemption and Research Tools: The Federal Circuit Gets It Wrong locked.gif

One of the most hotly contested patent law questions in the life sciences arena is the scope of the so-called "FDA exemption" of § 271(e)(1) of the Patent Act as applied to research tools.  The FDA exemption provides a safe harbor for experiments using "a patented invention . . . solely for uses reasonably related to the development and submission of information."  If a drug maker needs to use a patented research tool in an experiment directed at producing information for the FDA, can it do so without risking a suit for patent infringement?  The answer to that question has enormous consequences to both the biotech community and Big Pharma.

The Federal Circuit's opinion, in Proveris Scientific Corp. v. Innovasystems, Inc., limited the safe harbor's application to research tools.  Although the case did not involve the classic sort of biologic research tool of interest to the biotech community, its analysis leads almost inevitably to the conclusion that use of all manner of research tools falls outside the safe harbor.  But the Federal Circuit got it wrong by ignoring the  plain language of the FDA exemption, elevating its perception of what Congress was trying to achieve over the words Congress actually crafted.

E. Joshua Rosenkranz


"Likelihood of Confusion" is Confusing Enough: Why the Concept of Parody Has No Place in a Likelihood of Confusion Analysis locked.gif

This Article argues that courts should refrain from using the concept of parody in the likelihood of confusion analysis in trademark infringement actions.  The harmful results of the use of parody far outweigh its limited utility as an analytical tool.  Courts employ the concept in widely divergent ways.  Some permit greater risk of confusion because of a perceived need to protect underlying First Amendment values.  Other courts effectively make parody an affirmative defense, determining the likelihood of confusion solely by whether the particular use constitutes a successful parody.  Still others treat parody as yet another factor in likelihood of confusion test, producing uncertain results.  Beyond inconsistent standards among courts, determining that a challenged use is a parody does little to advance the case toward resolution because the jury still must decide whether the parody is likely to confuse the public.  Examining these and other shortcomings, this Article concludes that courts should avoid discussion of parody and focus solely on the longstanding likelihood of confusion analysis in trademark infringement actions.

Eric Sonju

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