Industrial property,Patents

The concept of “active ingredient”: Insights from the Halozyme referral (C-456/24)

By Natali Goginashvili at Associate, HOYNG ROKH MONEGIER, Paris Background The applicant, Halozyme Inc, specializes in drug delivery technologies for emerging and established therapies. Its core technology ENHANZE® is based on recombinant human hyaluronidase ("rHuPH20"), which is a drug delivery enzyme that locally breaks down human hyaluronic acid, and when co-formulated with other drugs, facilitates their subcutaneous delivery after injection. Halozyme has partnered for ENHANZE® with multiple pharmaceutical companies, including Roche who markets a combination of trastuzumab and rHuPH20 branded as Herceptin®. Trastuzumab is a known active ingredient, which is a monoclonal antibody widely used in the treatment of breast...
Patents

German and Dutch courts have their say on the derogation to the protection conferred by an SPC for the purpose...

Béatrice HOLTZ French and European Patent Attorney LAVOIX   Background Supplementary Protection Certificates (SPCs) are intellectual property rights that serve as an extension to patent rights that protect medicinal (or phytopharmaceutical) products that have been authorised by regulatory authorities. Regulation (EC) No 469/2009 (hereafter the “Regulation”) governs the supplementary protection certificates for medicinal products. As provided in article 5(1) of the Regulation, the SPC confers the same rights as conferred by the basic patent. A derogation to this protection entitles EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if...
Industrial property,Patents

On the requirements of Article 3 (a) of EC Regulation n° 469/2009: INPI vs Dana-Farber

Marc Névant (French and European Patent Attorney) In a decision dated 31 January 2024 (appeal n° B 22-18.374), the French Supreme Court (Cour de Cassation) dismissed an appeal filed by the French Patent Office (INPI) against the decision of the Paris Court of Appeal (RG n° 21/08514 of 25 May 2022) annulling INPI’s decision to reject SPC application n° 17C1046. In their decision, the Cour de Cassation held the following: 1/ The Court of Appeal did not confine itself to ruling by way of assertion but noted that EP 424 referred to methods for the generation and identification of an antibody directed against a given...
Industrial property,Intellectual property,Legislation,Patents

European Parliament Adopts Proposals for Unitary SPC and SPC Reform: A New Era for the Protection of Medicinal Products

[Welcome Aboard] Blip! SPC: Uniting the SPC Community It has been a few years since the SPC community had its own place on the internet, dedicated entirely to its guilty pleasure. Well, rejoice SPC addicts! We have the pleasure of introducing Blip! SPC, which we hope will help satisfy that craving. Blip! SPC is part of the Blip! intellectual property blog offered by the International Centre for Intellectual Property Studies (CEIPI) at the University of Strasbourg. The blog is intended to be a forum open to all SPC specialists to share their thoughts on national and EU jurisprudence, legislation and,...