In their latest Law360 column discussing noteworthy Federal Circuit cases, partners Jeremiah Helm and Sean Murray examine the recent decision in Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc., and how the court’s application of a “functionally related” test originally developed as part of the printed matter doctrine could affect future patent litigation.
In this case, Mylan and other parties brought a patentability challenge against Bayer’s patent directed to a method of reducing the risk of cardiac events by administering specified amounts of two drugs. At issue was whether Bayer’s “clinically proven effective” language in the patent sufficed to distinguish the patent from previously published clinical trial protocols. Following inter partes review, the Patent Trial and Appeal Board rejected Bayer’s argument, and the Federal Circuit affirmed, citing a “functionally related” analysis that had its origin in the printed matter doctrine.
In their assessment of the decision, Helm and Murray offer takeaways for both patent challengers and patent holders, particularly those in Abbreviated New Drug Application (ANDA) proceedings. They also consider whether the Federal Circuit might apply this analysis in other types of patent litigation, cautioning litigants to “be aware that the functional relationship analysis extends beyond its traditional scope.”
Read the full article here.
Subscribe for News and Updates
