Case Law

Amendments, Case Law, Competition, Generics, Kluwer Patent Cases, Litigation, Patents, Pharma, Pharmaceutical patent, Procedure, Revocation, United Kingdom, Validity

(Bristows)/

On 15 to 17 December 2021 a three-day trial took place to determine preliminary issues in a second action brought by Neurim against Mylan in relation to patents protecting the product Circadin (“Neurim v Mylan 2021”).  Meade J’s judgment (Neurim Pharmaceutical (1991) Limited and Anor v Generics (UK) Limited t/a Viatris and Anor [2022] EWHC…

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…

Case Law, Pharma, Russia, SPC

(Lidings)/

On 18 October 2021, the Russian IP Court rendered the decision in Geropharm vs. Novo Nordisk. While dismissing the claims, the IP Court has given the green light to a new legal mechanism of challenging a Patent Term Extension (‘PTE’) and Supplementary Protection Certificate (‘SPC’). It used to be problematic for generic companies to meet…

Case Law, Revocation, Spain, Sufficiency of disclosure

(Clifford Chance)/

Judgments from the Spanish Supreme Court on patent cases are a rare occurrence. In a recent decision, the Court rules on insufficiency of disclosure, a revocation ground which – once somewhat of a sideshow – is nowadays a staple of Spanish revocation proceedings. The Supreme Court provides some guidance on trial and error and undue…