The legal standard for enablement – the statutory requirement under 35 USC § 112 that a patent must enable those skilled in the art to “make and use” the claimed invention – remains unchanged after the US Supreme Court...more
As the industry for cannabis that is legal under state and/or federal law continues to expand, a flurry of court cases in recent years have addressed whether these businesses can utilize the federal courts to vindicate their...more
The Orange Book Transparency Act of 2020, signed into law on January 5, amends section 505(j) of the Federal Food, Drug and Cosmetic Act, codifying and clarifying some patent listing requirements of existing FDA regulations....more
Signed into law on December 27, 2020, the Biological Product Patent Transparency Act (42 U.S.C. § 262(k)(9)) requires biological reference product sponsors to provide to the US Food and Drug Administration within 30 days of...more
Last week, the Patent Trial and Appeal Board (PTAB) dismissed petitions for inter partes review (IPR) of a patent assigned to the University of Florida Research Foundation (UFRF) based on sovereign immunity, Covidien LP v....more
The Supreme Court issued a decision this week that is significant for all companies that operate in patent-intensive industries.
In Cuozzo Speed Technologies, LLC v. Lee, — S.Ct. — (2016), the Supreme Court considered...more
The success of your new venture depends on avoiding costly and time consuming patent litigation. Mature companies often engage patent counsel to provide “freedom to operate” opinions with respect to specific products or...more
In Limelight Networks, Inc. v. Akamai Techs., Inc. (U.S., No. 13-369), the Supreme Court held that a defendant cannot be liable for induced patent infringement under 35 U.S.C. § 271(b) in the absence of an underlying direct...more
June 2, 2014 – The Supreme Court issued its unanimous decision in Nautilus, Inc. v. Biosig Instruments, Inc., No. 13-369, 572 U.S. ___ (2014), lowering the standard for showing a patent claim is invalid for indefiniteness....more