Pregabalin PI in France: a decision dealing with skinny label, second medical use claims and contributory infringement

A new pregabalin decision has been rendered on December 2, 2016 in France, in a PI litigation initiated by Warner-Lambert (hereafter: the patentee) and licensees Pfizer against 9 groups of generic companies (hereafter: the defendants). All defendants are on the market with marketing authorizations which comprise the two indications in the public domain (epilepsy and generalized anxiety disorders), but do not comprise the still-patented indication (a specific type of pain). Most defendants have communicated to the relevant health professionals that their product is not indicated for pain. We are thus dealing with the skinny label and appropriate communication.

The majority of the Lyrica pregabalin products are prescribed for the pain indication (83.8% of the sales in France, according to the patentee). Nevertheless, at the time the PI was filed, the generic sales were far above the market shares of the free indications. The patentee concluded that the defendants, all together, were contributory infringers: in view of the sales figures, a large part of the generic pregabalin products was necessarily and knowingly sold to treat pain.

The decision is interesting on many aspects, some giving directions on how French Courts interpret second medical use claims.
First, the decision confirms that Swiss type claims, as the ones of the opposed patent (use of pregabalin for the preparation of a pharmaceutical composition to treat pain) are to be considered as process claims, and not product claims. As a consequence, in a case like the present one, where the medicines are not manufactured in France, there can be no direct infringement since there is no downstream manufacturing after sale in France.

Second, contributory infringement was dismissed for two main reasons: not only the marketing authorizations were limited to the two indications in the public domain, but above all there has been a widely spread information to relevant health professionals about the specificities of the generic pregabalin launched.

On contributory infringement French law has a special requirement when the indirectly-infringing means are products routinely found on the market: the supplier of the products infringes only if he incites his clients to infringe. The Court ruled that medicines may fall under the definition of “products routinely found on the market”, even though it is subjected to strict regulations as regards its distribution.
The Court decided that the French regulatory framework as regards medicines (both prescription by physicians, and automatic substitution by pharmacists) cannot automatically lead to an infringement of second medical use claims when some of the indications of the compound are in the public domain.

Third, the request of the patentee was considered unlawful. The patentee requested to jointly forbid all defendants to sell more than 16.2% of the pregabalin market (representing the market share of the public domain indications in France), as well as to summon defendants to share with him information allowing to understand the origin and the distribution channels of the products (such as names of manufacturers and wholesalers, quantities produced and imported, or prices). The Court mentioned that ordering these requests would constitute an agreement (cartel) forbidden under the competition law as it would lead to the sharing of sensitive information between competitors and would also allocate between the generic companies volumes, clients, and market shares.

Other aspects of the decision are also of interest, even though not directly linked with the interpretation of second medical use claims. The decision for example underlines that collective infringement is an unknown concept in the French IP code. In particular, it is not sufficient to oppose a same patent to different economic actors to establish that they all contribute to the same damage.

This decision is the second PI decision on pregabalin, and both decisions were rendered by the same Judge. The first PI decision ruled that the generic company, which had also informed relevant health professionals that its product was not intended for pain, was not plausibly infringing via contributory infringement. The information to heath professionals, and therefore the lack of incitation to infringe, being a major decision factor in both decisions.

The first PI decision on pregabalin was not appealed. The deadline to appeal the second PI decision is still running.
On the merits, the patent was recognized valid in first instance, and an appeal is on-going. Another first instance 1st instance revocation proceedings was on-going at the time the second PI was filed.

An extract of the case in English can be read here.
A copy of the French decision can be accessed here.

Summary: François Pochart, Mathilde Rauline, and Loïc Lemercier from August-Debouzy (who represented Teva in this litigation)