Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more
The US Patent and Trademark Office (USPTO) has now made another rules change to counter the charge that it is a patent “death squad.” The upcoming change to the rules governing inter partes reviews (IPRs) and post-grant...more
The PTAB’s evolving evidentiary standards often perplex petitioners and patent owners. Historically, significant party effort has gone into attempting to establish that non-patent literature, such as articles, textbooks,...more
A petition to institute an inter partes review (IPR) can only be filed on the basis of prior art consisting of patents and printed publications. But what makes a reference a “printed publication”? On December 20, 2019, the...more
On December 20, 2019, the Precedential Opinion Panel (POP) of the Patent Trial and Appeal Board (PTAB) issued its decision in IPR2018-01039, addressing “What is required for a petitioner to establish that an asserted...more
In a recent precedential decision, Hulu, LLC v. Sound View Innovations, LLC, the Patent Trial and Appeal Board’s Precedential Opinion Panel (POP) clarified the standard for establishing a reference as a “printed publication”...more
In Hulu, LLC v. Sound View Innovations, LLC, Case IPR2018-01039, Paper 29 (P.T.A.B. Dec. 20, 2019) (precedential), the USPTO’s Precedential Opinion Panel (POP) addressed the following question: What is required for a...more
One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken...more