Industrial property

What the envisaged modification of the Bolar exEmption with the...

Industrial property

CJEU decision in case C-181/24 (“Genmab”) – July 16, 2024

Industrial property

SPC Case law – France – Paris Court of Appeal...

Industrial property Uncategorized

Opinion of Advocate General Nicholas Emiliou delivered on June 6,...

Patents

German and Dutch courts have their say on the derogation...

Industrial property Patents

On the requirements of Article 3 (a) of EC Regulation...

Industrial property Intellectual property Legislation Patents

European Parliament Adopts Proposals for Unitary SPC and SPC Reform:...

Industrial property

What the envisaged modification of the Bolar exEmption with the EU-PHArma package could mean for IP RIGHTS HOLDERS?

By Florence Jacquand and Laurène Borey (Hoyng Rokh Monegier) 01. As the discussions on the proposal for a new Directive establishing a European Union code relating to medicinal products for human use and repealing Directive 2001/83/EC and Directive 2009/35/EC (so-called “EU pharma package”) are set to resume soon, this is the opportunity to bring focus on one envisaged amendment of the draft directive concerning the so-called Bolar exemption and draw attention to the practical consequences that the adoption of this amendment could entail for patent and supplementary protection certificate (SPC) proprietors against premature, infringing roll-outs of generics or biosimilars. The...
Industrial property

CJEU decision in case C-181/24 (“Genmab”) – July 16, 2024

Contribution by Dr. Kathrin Aftahy and Dr. Axel Berger, BARDEHLE PAGENBERG With reasoned order of July 16, 2024 in case C-181/24 (“Genmab”), the CJEU holds that an SPC cannot be granted based on a second marketing authorization even if the earlier first marketing authorization for said product was actively withdrawn before the filing of the SPC application. Art. 3 of Regulation (EC) No 469/2009 concerning supplementary protection certificates for medicinal products (“SPC Reg.”) contains the requirements for the grant of an SPC – and has been hotly debated ever since its coming into force. Art. 3(b) SPC Reg. requires that...
Industrial property

SPC Case law – France – Paris Court of Appeal – January 12, 2024

Articles 3a) and 3c) of Regulation No. 469/2009 In a decision of 12 January 2024, the Paris Court of Appeal (Docket No. 22/16673) dismissed an appeal filed by Mylan Ireland Ltd and its French subsidiary Viatris Santé (together « Mylan ») against the decision of the Paris First Instance Court (Docket No. 22/55128). More specifically, the Paris Court of Appeal confirmed the first instance decision in that SPC FR08C0033 held by Merck Sharp & Dohme LLC (« Merck ») covering the combination of sitagliptin and metformin is valid. More specifically, MSD is the owner of European patent No. 1 412 357  (« EP 357 »). MSD...
Industrial property,Uncategorized

Opinion of Advocate General Nicholas Emiliou delivered on June 6, 2024 (1) Joined Cases C-119/22 and C-149/22

In an opinion of 6 June 2024, the Advocate General Emiliou suggests a straightforward and literal construction of Article 3 (c) of the SPC Regulation 469/2009, while providing clarifications on Teva I (C-121-17) on the interpretation of paragraph (a) of the same Article. Background AG Emiliou opine in the context of the closely followed cases opposing Merck Sharp & Dome Corp. (hereinafter Merck) to: Teva BV and Teva Finland Oy (hereinafter Teva), challenging the validity of Merck’s SPC covering a combination of sitagliptin (hereinafter substance A, as the opinion puts it) and metformin (substance B) to treat type 2 diabetes, in front...
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,...

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