Goedecke Aktiengesellschaft & Pfizer, S.A. v. Laboratorios Rubió, S.A., Supreme Court, Spain, 14 June 2010, Docket No. 1801/2006.
The Supreme Court, by means of a decision dated 14 June 2010, declared the existence of infringement of the patent ES 2063219, owned by Goedecke Aktiengesellschaft (Goedecke) and licensed in Spain to Pfizer, S.A. (Pfizer) in relation to the gabapentin generic drugs intended to be marketed in Spain by Laboratorios Rubió, thus confirming the previous judgment handed down by the Court of Appeals of Barcelona on 17 May 2006.
Goedecke and Pfizer had brought legal actions against Laboratorios Rubió with occasion of the request for and obtaining by this company of an authorization to market in Spain several gabapentin generic drugs. Indeed, the plaintiffs understood that the obtaining of such authorization infringed their rights derived from the aforementioned patent, protecting a method for the stabilization of pharmaceutical compositions comprising cyclic amino acids, one of them being gabapentin. Goedecke and Pfizer had therefore claimed for the patent infringement to be declared, the cease and desist of any exploitation activities over gabapentin compositions having being obtained by implementing the patented process, as well as a compensation for damages suffered.
Laboratorios Rubió opposed to the plaintiffs’ actions by affirming, amongst other arguments, the invalidity of the patent ES 2063219 since, in its opinion, the said patent would disguisedly be protecting pharmaceutical compositions of gabapentin, in breach of the interdiction to patent pharmaceutical products which was in force in Spain until 7 October 1992, by virtue of the reservation to the patentability criteria set forth in the European Patent Convention (EPC) entered by the Spanish Government pursuant to Article 167(2)(a) of the EPC itself. In line with well-settled case-law, the defendant argued that the process patented by Goedecke merely consisted in mixing the active compound with the appropriate excipients, lacking the plaintiff’s patent any description of any steps to be taken (“modus operandi”) to obtain the final composition starting from the active ingredient gabapentin. As a result, the patent would actually be conferring product protection to gabapentin compositions, which would motivate the invalidity of the patent.
The Supreme Court, contrary to the defendant’s arguments, considered that Goedecke’s patent was actually a valid process patent not conferring protection over the resulting composition but only over the method itself, thus not breaching the patentability principles in force in Spain when the patent application was filed.
The Supreme Court reminded in its decision that prior to May 1993 no pharmaceutical compositions of gabapentin could be marketed since a toxic substance (lactam) was generated during the obtaining and storage of the active compound, presenting compositions also an instability problem due to the formation of water in the formulation. Overcoming Goedecke’s patent these instability problems in gabapentin compositions, the Supreme Court, agreeing with the reasons previously put forward by the Court of Appeals, deemed proved that the patented processed implied indeed a chemical interaction between the active substance and the added excipients leading to stable compositions of gabapentin suitable for marketing. As long as the patented process allowed the stabilization of such compositions, not marketable up to then, it could not be deemed a simple mixture of ingredients, as defended by Laboratorios Rubió, not even considering that the excipients used in combination with gabapentin were neutral, in the sense of not altering the active compound.
Consequently, being Goedecke’s a valid process patent, and not having Laboratorios Rubió been able to demonstrate having used a different method to obtain the controversial gabapentin generics, the Supreme Court confirmed the Court of Appeals’ judgment declaring that the offering, use and launch into the market of the defendant’s gabapentin generics constituted acts of infringement of the patent ES 2063219, and ordering Laboratorios Rubió to desist on such activities until the expiration of the plaintiffs’ patent.
It must be highlighted, however, that other petitions lodged by the plaintiffs, such as the compensation for damages or the seizure and destruction of any items produced in infringement of the patent, had been previously dismissed by the Court of Appeals given that Laboratories Rubió had not carried out any infringing activities at the time when the complaint was filed, but it had only taken the necessary steps before the Spanish Medicines Agency to obtain a marketing authorization for the gabapentin generics, excluded from the consideration as infringing acts pursuant to the experimental use exception contained in Article 52(1)(b) of the Spanish Patents Act (Bolar provision).
Read the decision (in Spanish) here.
Summary: Luis Fernández-Novoa
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