Pharmaceutical patent

Denmark, Enforcement, Generics, Infringement, Injunction, Litigation, Patents, Pharma, Pharmaceutical patent, Utility model

(Bugge Valentin)/ /4 Comments

In an appeal of a PI decision, the Danish Eastern High Court has ruled to uphold the dismissal of Novartis’ application for a preliminary injunction against Glenmark, Zentiva, and Viatris, based on the European patent application 2 959 894. In its decision, the Court firmly stated that a preliminary injunction can only be issued based…

Germany, Infringement, Patents, Pharma, Pharmaceutical patent

(Hoffmann Eitle)/

The so-called proportionality defense according to Sec. 139(1) clause 3 (hereinafter simply “proportionality defense”) is one of the newest provisions of the German Patent Act. It has only been introduced in August 2021 through the Patentrechtsmodernisierungsgesetz, a typical German word monster, of which an informative summary was posted here. The main driver of this proportionality…

(Cross-border) jurisdiction, Covid-19, France, Litigation, Patents, Pharmaceutical patent

(Dhenne Avocats)/ /7 Comments

The news was announced last week: Moderna is suing Pfizer for infringement of two of its patents related to Covid-19 vaccines. These highly targeted actions are likely to spread to many other countries: here is a brief overview of the case and its potential French perspective. In a press release dated August 26, 2022, Moderna…

Antibodies, Biologics, France, Pharma, Pharmaceutical patent, SPC

(Dhenne Avocats)/ /1 Comment

25 May 2022, the Paris Court of Appeal overturned the refusal of the French National Institute of Industrial Property (INPI) to grant an SPC on avelumab. This is a reversal of the “nivolumab” case law on the interpretation of Article 3(a) of Regulation (EC) No 469/2009 (hereafter the SPC Regulation).   In this case, Dana-Farber…

Australia, Case Law, Pharmaceutical patent

, , (Clayton Utz)/

In two separate judgments, the Full Court has provided much needed clarity on how to identify the pharmaceutical products that can support a valid patent term extension in Australia, as Natalie Shoolman, Kent Teague and Rose Jenkins explain in this article. Takeaways: Patent term extensions must be based on the “earliest first regulatory approval date”…

CJEU, Ireland, Patents, Pharmaceutical patent, SPC

(Bristows)/ /1 Comment

SPCs are often valuable and therefore important to their proprietors.  Indeed, such is the potential value of an additional period of exclusivity, that in the last decade or so, we have seen SPCs challenged where only a few weeks or even a few days of the SPC term remain.   It is therefore hardly surprising, especially…

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, 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…

EPO Decision, Generics, Injunction, Italy, Pharmaceutical patent, Plausibility, Second Medical Use

(Trevisan & Cuonzo)/

On 9 July 2021, the Court of Milan issued a preliminary injunction (PI) prohibiting a generic company from selling everolimus for use in combination with an aromatase inhibitor in the treatment of hormone receptor positive breast tumours.  The PI was issued on the basis of EP 3351246, which is one of the patents held by…

Litigation, Pharmaceutical patent, Plausibility, Second Medical Use, Sufficiency of disclosure, United Kingdom, Validity

, (Bristows)/ /1 Comment

In undoubtedly one of the most important decisions of the year so far, on 24 August 2021, the English Court of Appeal handed down its judgment in FibroGen v Akebia (FibroGen Inc v Akebia Therapeutics Inc [2021] EWCA Civ 1279), partially allowing FibroGen’s appeal, and so finding one of the ‘Family A’ patents, EP 823,…