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…

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”…

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…

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…

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…

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…

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,…

On 1 June 2021, the Amended Patent Law took effect and introduced patent term extension (“PTE“) and patent linkage (“PL“), which are closely related to the pharmaceutical industry. The legislative amendment reflects China’s determination to promote the research and development of innovative drugs in the pharmaceutical industry. The China National Intellectual Property Administration (“CNIPA“), the…

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…

As any aficionado of American legal history will be well aware, Judge Holmes, the third most cited American legal scholar of the 20th century, was nicknamed “the Great Dissenter.” This was a tribute to the 55 dissenting opinions that he wrote during his 29 years serving at the U.S. Supreme Court. Interestingly, over the years…