Pharma

Pharma, an abbreviation commonly used for the pharmaceutical industry, discovers, develops, produces and markets drugs or pharmaceutical drugs for use as medication. Pharma depends heavily on patents to protect its inventions worldwide, as well as on Supplementary Protection Certificates (SPCs). Pharmaceutical companies are subject to laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. Pharma includes production of generic medicines. Pharma may also refer to (patent) litigation related to pharmaceutical products.

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, 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, 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, Japan, Pharma

, (Abe, Ikubo & Katayama)/

In Japanese patent litigation, calling expert witnesses is very rare and the parties usually try to prove common technical knowledge (CGK) by submitting documentary evidence, such as publications available as of the priority date and written expert declarations. Thus, parties need to be aware that descriptions in the publications are crucial and cannot be supplemented…

Case Law, EPC, Infringement, Pharma, United Kingdom

(Bristows)/

On 8 October 2021, His Honour Judge Hacon (sitting as a Judge of the High Court) handed down his decision in an action brought by Royalty Pharma Collection Trust (“Royalty Pharma”) for approximately €23 million in royalty payments from Boehringer Ingelheim GmbH (“Boehringer”) (Royalty Pharma Collection Trust v Boehringer Ingelheim GmbH [2021] EWHC 2692 (Pat))….

Case Law, Japan, Patents, Pharma

, (Abe, Ikubo & Katayama)/

In the pharma industry, constant battles have been taking place for many decades  between innovators and generics.  More recently, battles among innovators have also started to occur.  This post concerns a case which may have an impact on the development strategies of innovators, as well as licensing strategies of universities and public research institutions which…

Australia, Case Law, Pharma

, , (Clayton Utz)/

In a surprising decision, the Federal Court has modified the law of patent term extensions in Australia, by clarifying that it’s only the patentee’s goods that are relevant to the proposed extension – not those of a competitor, even if the competitor’s goods came first and also contain a “pharmaceutical substance per se” that is…

Competition, European Union, Pharma, Pharmaceutical patent

(University of Vienna, Austria)/ /1 Comment

We are happy to announce the new International Law Talk Podcast episode on EU competition law developments in the pharmaceutical sector. And this one is twice as good! Not only are we discussing both competition and IP issues, but I also interviewed two leading experts in the field: Michael Clancy and David Hull from Van…