Ono Pharmaceutical v INPI (CA Paris, RG 18/10540, 2021)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Paris Court of Appeal dismissed the appeal by Ono Pharmaceutical and its co-owner against the French Patent Office’s refusal of a second SPC for nivolumab (Opdivo), sought on a patent earlier than the one which had already supported a first certificate. It relied on two grounds. First, Article 3(c) precludes a further SPC for the same product in favour of Ono, which already holds one, co-ownership of the patent with another person being irrelevant. Second, although nivolumab falls within the functional definition in the claims, it was not specifically identifiable at the filing date and resulted from an independent inventive step within the meaning of Royalty Pharma (C-650/17). The judgment is relevant to holders of upstream research patents on antibodies defined by their function.

Facts and procedure

Ono and Mr H, co-owners of EP 1 537 878 filed on 2 July 2003 (entitled « Compositions immunostimulantes »), applied on 15 December 2015 for SPC No 15C0088 for nivolumab, based on the EU marketing authorisation of 19 June 2015 granted to Bristol-Myers Squibb Pharma EEIG for Opdivo. On 6 January 2017 Ono, together with ER Squibb & Sons, had already obtained SPC No 15C0087 for the same product on the basis of EP 2 161 336, filed on 2 May 2006, which expires on 24 June 2030. The Director General of INPI refused the application on 2 March 2018 under Article 3(c) and Article 3(a). The applicants appealed and, in the alternative, sought a preliminary reference.

The applicable law

A certificate requires that the product be protected by a basic patent in force and not already have been the subject of a certificate (Article 3(a) and (c) of Regulation 469/2009). Article 3(2) of Regulation 1610/96, which applies to medicinal products, allows several certificates for the same product only for holders of different patents, as confirmed in AHP Manufacturing (C-482/07). Under Article 3(a), the court applied Eli Lilly (C-493/12) and Royalty Pharma.

Question

May the co-owner of a patent obtain a second SPC for a product already certified in its favour on another patent held with a third party, and is an antibody defined functionally in an upstream patent protected by it within the meaning of Article 3(a)?

Decision

On Article 3(c), the court rejected reasoning based on the civil law rules on joint ownership: co-ownership of patents is governed by Articles L. 613-29 to L. 613-32 of the Intellectual Property Code, Article L. 613-30 excluding the general rules, and Ono, which may exploit each of the two patents alone, is their « holder » within Article 3(2). The first SPC therefore barred the second; INPI also stated that a certificate could have been granted to Mr H alone. On Article 3(a), it was no longer disputed that nivolumab fell within the functional definition and was implicitly but necessarily covered. However, a 2007 article filed by INPI showed that preparing monoclonal antibodies involves a complex and costly process of screening, cloning, selection and purification, not a routine operation. The three years Ono and its partner needed to file EP 336, which names seven inventors and defines the six CDR regions of nivolumab, were strong evidence of an independent inventive step. INPI had not required concrete identification of the product, and its practice on Markush formulae, which are structural, was not inconsistent. The CJEU case law being fully clear, a reference was refused and the appeal dismissed.

Key points for practice

• Under Article 3(c), a co-owner entitled to exploit the patent alone is its holder, whatever the make-up of the co-ownership.
• An antibody within a functional claim is not protected under Article 3(a) if obtaining it from the patent required an independent inventive step.
• The time taken to file, and the content of, a later patent specifically directed to the product serve as evidence of that independent step.
• Practical point: an applicant relying on an upstream patent must show, with technical evidence, that the product could be obtained by routine work at the filing date.

Relevance before the UPC

As the UPC may hear disputes over the validity of SPCs based on a European patent, this application of the Royalty Pharma « specifically identifiable » test may be debated before it.

Provisions applied

Regulation (EC) No 469/2009 (SPC)

Art. 3(a) and (c)

Regulation (EC) No 1610/96

Art. 3(2)

National law

French Intellectual Property Code, Articles L. 613-29 to L. 613-32; Code of Civil Procedure, Article 445

Case law cited

CJEU, 3 September 2009, AHP Manufacturing, C-482/07; CJEU, 24 November 2011, Medeva, C-322/10; CJEU, 12 December 2013, Eli Lilly, C-493/12; CJEU, 25 July 2018, Teva, C-121/17; CJEU, 30 April 2020, Royalty Pharma, C-650/17

Related decisions

• Royalty Pharma, CJEU, 30 April 2020, independent inventive step test applied.
• Eli Lilly v Human Genome Sciences, CJEU, 12 December 2013, functional definition covering the product specifically.
• Teva v Gilead, CJEU, 25 July 2018, cited on the balance of interests.
• Medeva, CJEU, 24 November 2011, cited in the INPI decision.

Prepared by Dhenne Avocats from the text of the decision (PIBD, INPI), consulted on 11 October 2026. Only the official text is authoritative.