By Robert A. Pollock, Linda A. Wadler, Robert D. Litowitz, Joyce Craig, Bart A. Gerstenblith, Christina Szakaly, Zhenyu Yang, and Mindy L. Ehrenfried | 61 Am. U. L. Rev. 785 (2012)

Finnegan, Henderson, Farabow, Garrett & Dunner LLP

Landmark.  Watershed.  Seminal.  These adjectives routinely populate legal writing—especially “year in review” compendiums such as this one.  Most readers gloss over them as mere hyperbole.  In 2011, however, “landmark,” “watershed,” and “seminal” only begin to describe the year’s legislative and judicial developments, which will transform and shape patent law for decades.

First came the Federal Circuit’s en banc ruling in Therasense, Inc. v. Becton, Dickinson & Co., in which the court clarified and tightened the standard for finding inequitable conduct, “redirect[ing] a doctrine that has been overused to the detriment of the public.”  The court revamped the elusive and often chaotic standards of inequitable conduct that had prevailed for years.  In  place  of  the “sliding scale” of intent and materiality, the Federal Circuit announced clearer, more demanding, independent standards for proving both prongs of inequitable conduct.  Patent holders, who until Therasense had grown accustomed to facing often tenuous, if not specious, charges of inequitable conduct in virtually every case, hailed the ruling.

Next, in Association for Molecular Pathology v. United States Patent & Trademark Office (Myriad), the Federal Circuit tackled the sensitive issue of whether DNA molecules are patent-eligible subject matter.  The Federal Circuit reversed a controversial district court ruling that had applied the “product of nature” exception to invalidate patent claims covering isolated genes used in diagnostic tests for breast cancer.  The court concluded that these isolated BRCA1 and BRCA2 genes were not the same as those found in the body.  This  decision preserved not just Myriad’s patent claims to the BRCA genes, but also left intact hundreds of other patents directed to isolated, purified DNA molecules.  The biotech industry, which has invested billions in developing diagnostic tests and therapies based on isolated DNA discoveries, breathed a qualified sigh of relief.  The  sigh  of  relief, however, may have only been temporary as the Supreme Court recently vacated and remanded Myriad in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc.

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