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…

After four years of experience with Spanish Act 24/2015, of 24 July, on Patents (the “new Patent Act”), which came into force on 1 April 2017, the time seems ripe now to update some aspects of the Act that could be further improved. In this vein, earlier this year the Spanish Patent and Trademark Office…

Austria will most likely become the member state which will trigger the start of the preparatory phase of the Unitary Patent project. Last Friday the National Council, one of the chambers of its parliament, unanimously approved draft legislation enabling Austria to ratify Protocol for Provisional Application (PPA) of the Unified Patent Court Agreement. Ratification of…

On September 30th, 2021, the Danish High Court (Eastern Division) rendered its decision in a long running patent infringement case. One important element of the case was the question of acquiescence, in particular, whether the patent pro-prietor is required to act on a possible patent infringement (and commence legal proceedings) when opposition proceedings are pending….

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 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…

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…

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…