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Paris 1st Instance Court - Pfizer Limited & others v/ Biogaran, Sanofi et others

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Paris First Instance Court


Pfizer Limited & others v/ Biogaran, Sanofi & others

BIOGARAN was represented by Marianne Gabriel, attorney at law. SANOFI was represented by Arnaud Casalonga, attorney at law, assisted by Floriane Codevelle, attorney at law. Gérard Dossmann, French and European Patent Attorney, assisted them.

This is the first case of skinny labeling in France.

Issues :

  • - Prohibition and immediate recall of products
  • - Closing of the generic market
  • - Huge financial consequences

In that case, Pfizer initially filed a patent on the pregabalin compound, which expired in 2013, and a patent for a second therapeutic application in 1997, for the use of pregabalin, already known to treat epilepsy and generalized anxiety disorder (GAD), for the preparation of a pharmaceutical composition for treating pain.

On this basis, Pfizer markets, under a centralized MA, its pregabalin original medicinal product under the name Lyrica, for three indications : epilepsy and TAG (for which the original patent expired), and neuropathic pain (covered by the second patent).

Generic laboratories have launched, as they were entitled, specific generic pregabalin drugs limited to the indications for the treatment of epilepsy and GAD.

However, given that French regulations encourage the substitution of original medicines with generic drugs and that the prescriptions for generic pregabalin exceeded the market share of prescriptions for indications in the treatment of epilepsy and TAG, Pfizer has :

  • - first brought a separate summary action against a sole pharmaceutical laboratory in 2015, without success since all its claims were rejected by interim order of October 26, 2015,
  • - then brought a global summary action against more than a dozen generic laboratories, requesting that they be condemned jointly with provisional measures of prohibition and information.

The question had already been raised (i) in Germany where interim injunction measures had been ordered when the indication in the treatment of pain was not excluded, (ii) in Spain and Italy where the health authorities had taken measures to inform the professionals that generics of Lyrica should not be prescribed and will not be reimbursed for the treatment of pain (iii) in Denmark where pharmacies had been provisionally banned from delivering the generic Lyrica in the indication for the treatment of pain and (iv) in England where the High Court of Justice ordered the NHS to issue directives to doctors to prescribe Lyrica in brand name for the treatment of pain, before declaring patent EP061 null for lack of description.

In France, the President of the Paris Court of First Instance was therefore seized in summary proceedings on the plausibility of counterfeiting, and in particular counterfeiting by means.

On this ground, it must be demonstrated, in accordance with the provisions of Article L.613-4 §1 of the CPI, that the third-party supplier knew or could not be unaware that the means were suitable and intended for the implementation of the invention.

However, that is not the case in the present case since the contested "means" are not "intended for the implementation of the invention". And when the products in question are currently in commerce, as is the case of pregabalin, it is also appropriate, in accordance with the provisions of Article L.613-4 §2 of the French Intellectual Property Code, to demonstrate that "the third party incites the person to whom it delivers to commit acts prohibited by Article L.613-3".

However, in this case, the generic laboratories had not made any incentive for doctors or pharmacists to prescribe / issue pregabalin for the indication of pain still protected, and instead had initiated information procedures to avoid prescribing / dispensing their specialty out of authorized indications of epilepsy and GAD.

By judgment of December 2, 2016, the President of the Paris Court of First Instance therefore rejected all Pfizer’s claims, considering that no act of infringement could possibly have been upheld, and condemned Pfizer to pay to each defendant the sum of € 100,000 under Article 700 of the Code of Civil Procedure.