United States of America

Case Law, United States of America

, (Gibson, Dunn & Crutcher LLP)/

The U.S. Federal Rules of Civil Procedure allow parties to obtain discovery regarding any matter that is relevant to a party’s claim or defense. One important caveat to this general principle is that attorney-client communications and work product are privileged and protected from discovery. Generally speaking, when a party divulges privileged information to a third…

Case Law, United States of America

(Wolters Kluwer Legal & Regulatory US)/

Expanding on its 2016 Cuozzo decision, the U.S. Supreme Court holds that the “no appeal” provision of 35 U.S.C. § 314(d) precludes judicial review of the agency’s application of Section 315(b)’s time bar. In a 7-2 decision, the U.S. Supreme Court has held that Section 314(d) of the Patent Act precludes judicial review of the…

Case Law, United States of America, Validity

(Wolters Kluwer Legal & Regulatory US)/ /1 Comment

Because the patent failed to disclose the absence of a loading dose, the no-loading-dose limitation was without adequate written description support. A divided Federal Circuit panel has reconsidered and reversed a prior decision finding that a patent owned by Novatis for administering a drug to treat relapse multiple sclerosis was not invalid for lack of…

Case Law, Prior art, United States of America

(Wolters Kluwer Legal & Regulatory US)/

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 combine asserted prior art and would have had a reasonable expectation of success in do so. There was substantial evidence to support the Patent…

Case Law, Prior art, United States of America

(Wolters Kluwer Legal & Regulatory US)/

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. Concluding that the Patent Trial and Appeal Board incorrectly considered applicant admitted prior art (AAPA) in its review of a Qualcomm’s integrated circuit patent in a…

Case Law, Covid-19, Infringement, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

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. This trend has further increased speculation that remote working arrangements will become more widespread, even after the pandemic ends,…

Case Law, Pharma, United States of America

(Wolters Kluwer Legal & Regulatory US)/

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 decision that certain claims of a Biogen patent directed to the multiple sclerosis treatment drug Tecfidera were invalid for lack of written description support…

Case Law, FRAND, SEP, United Kingdom, United States of America

(City, University of London) and (University School of Law and Legal Studies, New Delhi)/

The UK and US governments have recently launched calls for views regarding their SEP and FRAND policies, in order to understand the opinions of all the stakeholders, such as patent owners, implementers, consumers, etc. In the US, the Department of Justice (DoJ), the National Institute of Standards and Technology (NIST), and the United States Patent…

Case Law, Pharma, Pharmaceutical patent, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

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 contain a written description of the invention and enable any person skilled in the art to make or use the invention. The court…

Case Law, Pharma, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/ /1 Comment

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 Drug Administration (“FDA”). If these representations contradict arguments made during prosecution of a patent at the United States Patent and Trademark Office (“USPTO”), they…