Where a substance or composition is already known to have been used in a ‘first medical use’, it may still be patentable for any second or further use, provided that said use is novel and inventive. This is an exception from the general principle that product claims can only be obtained for (absolutely) novel products. ‘Second Medical Use’ patents are an important component of the potential second-line patent protection.
A recent decision issued by the federal district court could impact medical use patents in Brazil. In an invalidity lawsuit filed by the Brazilian affiliate of Sun Pharma against Boehringer Ingelheim, Federal Judge Carvalho, sitting at the 9th Federal District Court in Rio de Janeiro, has granted a preliminary injunction ordering the Brazilian Patent and…
As per the EPC definition, a substance or composition that is already known to have been used in a “first medical use” may still be patentable for any second or further use, provided that said use is novel and inventive. Even though the first medical use was the subject of patent protection within the EPC…
In another chapter of the enforcement of Novartis’ patents concerning the second and further uses of everolimus for the treatment of several solid tumors (a first post can be viewed here), the Court of Milan has considered whether eliminating an indication claimed by a second medical use patent from the product label does or does…
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,…
Although second medical use protection has had limited importance in the treatment of COVID-19, it has put in the spotlight the overall need for quick reactions to new diseases, which is one of the many factors justifying such protection, according to Jochen Bühling, partner of the German law firm of Krieger Mes & Graf v….
On 4 December 2020, the English Patents Court handed down its decision in Neurim Pharmaceuticals (1991) Limited & Flynn Pharma Limited v Generics UK Limited (t/a Mylan) & Mylan UK Healthcare Limited, the main action proceedings regarding Neurim’s patent for Circadin™, EP 1 441 702 (“EP 702”). The judgment is available here. Many readers will…
The question whether SPCs should be available for new therapeutic applications of previously approved active ingredients has been a matter of debate ever since the SPC Regulation for Medicinal Products came into force in the European Union more than a quarter-century ago. While a literal reading of the SPC Regulation would clearly seem to exclude…
The English Patents Court has often been regarded as a relatively favourable jurisdiction for patentees seeking interim relief in the life sciences arena. This is for various reasons, including the fact that the English Court follows the approach adopted by the House of Lords in the American Cyanamid case, in which an assessment of the…
Today, Advocate General (AG) Mr. Giovanni Pitruzzella handed down his opinion in the referral C-673/18 (Santen). The case concerns an SPC based on a second medical use/formulation patent and stems from a referral to the CJEU made by the Paris Court of Appeal with decision of 9 October 2018 in Santen v. INPI (see here…
