BMS and Gide x Regimbeau repel Teva invalidity case against apixaban patent

On 8 June 2023, the Judicial Court of Paris handed down a decision in which it rejected Teva Santé’s request to invalidate EP 14 27 415, which belongs to innovator pharmaceutical company, Bristol-Myers Squibb (case ID: 21/112727). Teva Santé is the French subsidiary of Israeli group Teva B.v.

EP 415, described as “Compounds containing lactam and their derivatives as factor Xa inhibitors”, covers a blockbuster drug and SPC containing the compound anticoagulent apixaban. Medical professionals use the drug to treat and prevent blood clots.

According to the judgment, oral anticoagulant product Eliquis – in which apixaban is the active ingredient – was worth $9 billion in 2020. This value is expected to have risen, given the impact of the global COVID-19 pandemic. EP 415 expired on 17 September 2022, while a marketing authorisation covering the active ingredient was issued in 2011. From this, France’s National Institute of Industrial Property (INPI) granted a corresponding supplementary protection certificate (SPC), which expires on 20 May 2026.

Rejection on four grounds

Teva Santé is responsible for the distribution of a generic version of apixaban in France, with Teva B.v holding a marketing authorisation for its ‘Apixaban Teva’ product. In March 2021, Bristol-Myers Squibb asked Teva Santé and Teva B.v to confirm they would not commit infringing acts, based on its EP 415 and the SPC.

In October 2021, Teva then summoned Bristol Myers-Squibb to the Judicial Court of Paris, attempting to invalidate the patent and corresponding SPC. Teva also sought compensation, as well as payment of legal fees. However, presiding judge Nathalie Sabotier rejected Teva’s attempt to invalidate EP 415, which it had argued on four grounds: lack of plausibility, lack of inventive step, lack of novelty and insufficient disclosure. Proceedings are also ongoing in the Netherlands and Ireland.

Diverging from UK decision

However, the UK judges recently reached a different conclusion. In April 2023, the Court of Appeal confirmed the invalidation of EP 415. The decisions followed an appeal against High Court proceedings, which took place last year. Generic drug manufacturers Sandoz and Teva had brought proceedings against Bristol-Myers Squibb (case IDs: HP-2020-000042 and HP-2021-000003) to clear the way and launch a generic version of the lucrative anticoagulant.

In July 2022, the High Court also invalidated four further Bristol-Myers Squibb formulation patents, EP 32 46 021, EP 30 17 811, EP 32 51 660 and EP 32 57 500 (case IDs: HP-2020-000048; HP-2021-000009), after judge Richard Meade found them invalid for obviousness over the ‘Carreiro’ prior art. The party has appealed the decision to the Court of Appeal, but this is stayed pending the outcome of parallel EPO Technical Boards of Appeal proceedings.

The Xa factor

Initally, in both French and UK proceedings, Teva had claimed invalidity of EP 415. The party, alongside Sandoz in the UK, argued that the patent does not make plausible that apixaban has useful factor Xa inhibitory activity, or would be useful in therapeutic situations. This is also an argument in the Dutch proceedings.

Nor, say the parties, could medical professionals use the patented drug for any other purpose. Since apixaban’s success depends on the use of an Xa inhibitor, the court examined the issue of plausibility to determine invalidity. The UK proceedings were also the first time its judges have held a patent with a single claim to a pharmaceutical compound invalid for lack of plausibility, as well as the first UK decision to consider the concept of plausibility following the European Patent Office’s decision in G 2/21, which it handed down in March 2023.

Pan-European proceedings

In the Netherlands, Bristol-Myers Squibb is fighting against Sandoz, with the court ruling against Bristol-Myers Squibb in May 2023. In Ireland the company is up against Teva, with Pinsent Masons representing Teva in this jurisdiction, as well as in London. The London office of the mixed firm regularly acts for the generic drug company.

London-based IP boutique Bristows worked with Sandoz, which is a long-standing client for the firm. As such, both Sandoz and Teva had separate legal representation at trial, but split the advocacy between them. WilmerHale is coordinating the European litigation for Bristol-Myers Squibb while also representing the company in US proceedings. The team worked alongside Hogan Lovells in the UK.

First outing for Gide x Regimbeau

In May, French law firms Gide Loyrette Nouel and Regimbeau announced a patent litigation cooperation. The alliance, called Gide x Regimbeau – Patent Litigation, combines Gide’s legal experience with the technical expertise of Regimbeau’s patent attorneys.

Thus, the current proceedings against Teva are the first time Gide x Regimbeau have worked together on a patent case of national significance. For Bristol-Myers Squibb, Gide’s litigators handled court proceedings while Regimbeau’s patent attorneys lent expertise on the technical aspects.

However, the partnership is not completely unexpected. For years, Gide and Regimbeau have cooperated on a non-exclusive basis, beginning with the dispute between Johnson & Johnson and Boston Scientific over stents in the 1990s. In current proceedings, partners Emmanuel Larere and Raphaëlle Dequiré-Portier of Gide, and Regimbeau patent attorneys and partners Anne Boutaric and Emmanuelle Levy, led for Bristol-Myers Squibb.

Partner François Pochart of August Debouzy led for Teva. The relationship between Pochart and Teva is long-standing, with the patent lawyer acting for the generic drug company before he moved to the French IP boutique in 2011. He is also dual-qualified as a litigator and patent attorney. Teva is an important client for the firm, which currently represents the company in various proceedings against Daiichi Sankyo, Merck Sharp Dohme, Novartis and Bayer.

For Teva
August Debouzy (Paris): François Pochart (partner); associate: Pierre-Olivier Ally

For Bristol-Myers Squibb
Gide Loyrette Nouel (Paris): Emmanuel Larere, Raphaëlle Dequiré-Portier (partners); associate: Célia Révy
Regimbeau (Paris): Anne Boutaric, Emmanuelle Levy (partners); associate: Margaux Beretta (all patent attorneys)

Judicial Court of Paris, 3rd Chamber (section one)
Nathalie Sabotier (first deputy, vice president), Elodie Guennec (vice president), Malik Chapuis (judge), Caroline Reboul (clerk), Anne Boutron (intern)