Over the past five years, the U.S. Supreme Court has morphed patent eligibility under 35 U.S.C. § 101 from a low-bar threshold test (e.g., anything under the sun that required the hand of man) to a substantive, complex standard that is ill-defined.
In the biotechnology area, the Supreme Court recently overturned two Federal Circuit holdings, surprising many in the IP community. Indeed, hundreds of claims in issued patents are thought to be invalid as a result of the new Supreme Court patent eligibility standards. For example, in Association for Molecular Pathology v. Myriad Genetics (2013), the Supreme Court held that claims to isolated genes (i.e., DNA isolated from a naturally occurring biological cell) are not patent eligible. This reversed the USPTO’s approximate thirty year policy of issuing such claims.
Further, in March 2014, the USPTO issued a memorandum setting forth examination guidelines for subject matter eligibility that many believe far overreach the Supreme Court holdings. These guidelines instruct examiners to reject claims drawn to any isolated natural product, not just isolated DNA.
The Supreme Court holdings and the USPTO Guidelines threaten to restrain innovation in natural products, including pharmaceuticals (~50% of all drugs are natural products or directly derived from natural products) and consumer products.
This presentation by Harry Guttman, Senior Counsel at Calfee, will discuss the Supreme Court holdings, the USPTO guidelines, and some possible strategies for protecting natural products in light of these recent developments.
For more information, and to register, please click here