Patents

Why Europe Needs the Biotech Act’s SPC Extension?

Uncategorized

SPC Manufacturing Waiver CJEU Referral on the Export Exemption: Case...

Intellectual property

Entitlement to an SPC under Article 3(d) of an uncombined...

Intellectual property

Une nouvelle taxe contre l’« evergreening » pharmaceutique : l’article...

Intellectual property

A New Tax to Combat Pharmaceutical “Evergreening”: Article L.138-10-1 of...

Industrial property Patents

The concept of “active ingredient”: Insights from the Halozyme referral...

Industrial property

Paris Court of Appeal Overturns the French Patent Office decision...

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...

Patents

Why Europe Needs the Biotech Act’s SPC Extension?

By Brigitte Carion Taravella, French and European patent attorney The EU Biotech Act, proposed by the European Commission in December 2025, introduces a targeted Supplementary Protection Certificate (SPC) extension mechanism for qualifying biotech medicines — 12 additional months of exclusivity, conditioned on demonstrable investment in European clinical development and manufacturing. The proposal sits within a broader five-pillar regulatory package designed to address structural competitiveness deficits in the EU life sciences sector. Competitive Position of the EU Life Sciences Sector The EU's share of global industry-sponsored clinical trials fell from 22% in 2013 to 12% in 2023, a contraction of nearly...
Uncategorized

SPC Manufacturing Waiver CJEU Referral on the Export Exemption: Case C-371/26

By European Federation of Pharmaceutical Industries and Association  Supplementary Protection Certificates and the Manufacturing Waiver Intellectual property (IP) rights, and their effective enforcement, are fundamental to ensure continued investment in pharmaceutical innovation and the development of innovative medicines. Supplementary protection certificates (SPCs) are a key component of this incentive structure by providing a limited period of additional patent term to innovative medicinal products in order to compensate for the time lost during the long development and regulatory approval processes required for innovative medicines. As such, SPCs are a critical form of IP protection for pharmaceutical investment in Europe, supporting continued...
Intellectual property

Entitlement to an SPC under Article 3(d) of an uncombined medicinal product (drospirenone): Laboratorios Leon Farma SA v Comptroller-General of...

By Daniel Byrne, Partner, VENNER SHIPLEY, London  Summary The historic CJEU decision in Medeva (C-322/10) states that a product “A” having an SPC precludes a later SPC for product “A + B” (except in some special cases). However, does the Medeva decision prevent a product “A” from being granted an SPC where that product has previously been authorised as part of a combination “A + B”? The court held that it does. It confirmed that the IPO had been right to refuse an SPC for drospirenone on that basis: an earlier marketing authorisation (“MA”) for drospirenone in combination with estrogen...
Intellectual property

Une nouvelle taxe contre l’« evergreening » pharmaceutique : l’article L.138-10-1 du Code de la sécurité sociale

Par Maître François Pochart et Maître Océane de La Verteville, cabinet August Debouzy Une nouvelle taxe s'est glissée dans la loi de financement de la sécurité sociale pour 2026 (Loi n° 2025-1403 du 30 décembre 2025 de financement de la sécurité sociale pour 2026), plus précisément dans son article 29 qui crée l’article L. 138-10-1 du Code de la sécurité sociale (L. 138-10-1 du Code de la sécurité sociale) reproduit ci-dessous. Ce nouvel article institue, à la charge des entreprises pharmaceutiques, une taxe de 3 % (portée à 5 % en cas de récidive) sur le chiffre d'affaires réalisé sur...
Intellectual property

A New Tax to Combat Pharmaceutical “Evergreening”: Article L.138-10-1 of the Social Security Code

By François Pochart, Partner, and Océane de La Verteville, Counsel, of the August Debouzy law firm A new tax was included in the French Social Security Financing Act for 2026 (Act No. 2025-1403 of December 30, 2025, on Social Security Funding for 2026), specifically in Article 29, which creates Article L. 138-10-1 of the French Social Security Code (Article L. 138-10-1 of the Social Security Code) as reproduced below. This new article imposes on pharmaceutical companies a 3% tax (increased to 5% in the event of a repeated offense) on the revenue generated from a pharmaceutical product when the commercial...
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...
Industrial property

Paris Court of Appeal Overturns the French Patent Office decision to refuse the grant of Two SPC Applications Filed by...

By Marie-Ange Pozzo di Borgo and Emilia Grenier, Associates at Gide Loyrette Nouel. In two rulings issued on 16 May 2025, the Paris Court of Appeal annulled decisions by the French Patent Office (INPI) refusing to grant supplementary protection certificates (SPCs) to Janssen Pharmaceutica NV. These are interesting decisions as they relate to combinations of active ingredients and are the first decisions implementing the recent Teva v. MSD CJEU decision in France. The SPC applications concerned the following combinations of active ingredients: First SPC: tenofovir alafenamide fumarate, emtricitabine, rilpivirine hydrochloride ; Second SPC: tenofovir alafenamide fumarate, rilpivirine hydrochloride. Seized with...
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...

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