Petitioner expert testimony in inter partes review of a surgical tool patent was more credible than patent owner’s expert that a person of ordinary skill in the art would have been motivated to…
The Board incorrectly interpreted Section 311(b)’s “prior art consisting of patents or printed publications” to encompass applicant admitted prior art, but such art may be relevant as an admission.…
As we begin year three of the COVID-19 pandemic, the rise of the Omicron variant has caused many workers, who had returned to the office during summer and fall 2021, to revert to working from home.…
A person of ordinary skill in the art could not determine the effective dose of the active ingredient in Tecfidera from the original patent specification.
A West Virginia federal district court’s…
In recent years, the Court of Appeals for the Federal Circuit has invalidated or affirmed the invalidity of various biopharma patents under 35 U.S.C. § 112, which requires that a patent specification…
In the course of obtaining regulatory approval for a drug product in the United States, a pharmaceutical company will make numerous representations about its product in submissions to the Food and…
The Wako federal district court abused its discretion in fining that The Western District of Texas was a more convenient form that the Northern District of California.
The federal district court in…
Submission of an abbreviated Biologics License Application (“aBLA”), under the Biosimilar Price Competition and Innovation Act of 2009 (“BPCIA”), for a biosimilar version of an already-approved…
The Hatch-Waxman Act allows the FDA to permit a generic version of a branded product, which is partially patent protected, to come to market if the generic manufacturer “carves out” the patent-…
28 U.S.C § 1498 (a) (Governmental Use)
The United States (U.S.) does not have any provisions for a compulsory license. The closest provision that it does have to the licensing of medicines and…
