Through two decisions issued on July 18 and 19 2017, Barcelona Commercial Court Number 4 and Barcelona Commercial Court Number 1, respectively, lifted the preliminary injunctions that they had previously granted ex parte at the request of Mundipharma in relation to the imminent market launch of two oxycodone/naloxone generic medicinal products.
Mundipharma is the holder of European Patent 2425825 (EP’825), entitled “Pharmaceutical preparation containing oxycodone and naloxone”.
Claim 1 of EP’825 relates to an oral sustained release pharmaceutical formulation comprising 10 to 150 milligrams of oxycodone hydrochloride and one to 50 milligrams of naloxone hydrochloride in a weight ratio of 2:1.
Mundipharma exploits the alleged invention by commercialising its medicinal product Targin for pain relief.
In April and May 2017 Mundipharma requested and was granted ex parte preliminary injunctions against the defendants for alleged imminent infringement of EP’825.
The defendants opposed the preliminary injunctions, alleging the patent’s invalidity due to:
- added matter;
- insufficient disclosure;
- lack of novelty; and
- lack of inventive step.
Regarding the added matter objection, the defendants alleged that the specific combination of Claim 1’s features:
- was not individualised in the original patent application as filed; and
- did not derive directly and unambiguously from the same.
Further, they argued that Claim 1 of EP’825 omitted features that were essential according to the original patent application as filed (ie, invariable and independent release), which entailed an inadmissible generalisation. The defendants also argued that to extract the claimed combination of features from the examples of the application as filed would lead to an intermediate generalisation.
Mundipharma alleged that all Claim 1’s features had been disclosed in the original application as filed – in particular, in its examples, which revealed that the ultimately claimed combination of features was the preferred one. In this regard, Mundipharma stated that EP’825 focused solely on the clinical aspect of the alleged invention disclosed in the original application and not on its formulation aspects.
Both commercial courts upheld the defendants’ reasoning and revoked the preliminary injunctions. Each decision was deliberated by the three Barcelona patent judges.
The judges concluded that the original application included no pointer to the combination of features ultimately claimed in EP’825, whereas multiple selections would need to be made to arrive at such a combination of features.
The decisions do not elaborate on the additional invalidity grounds raised by the defendants on upholding the first grounds (ie, added matter).
This is the first time that a preliminary injunction has been revoked or refused in Spain based on indicia of invalidity of the asserted patent due to added matter.