Appeal court clarifies patent issues in Pfizer decision

On 9th May 2008 the Barcelona Court of Appeal issued a decision dealing with a number of key issues in the field of patents. Pfizer had sued Bayvit (now known as Stada) for infringement of its patents for amlodipine (ES 520,389 and EP 255,944), and Bayvit filed a counterclaim on the basis of nullity of the patents invoked.

The decision addressed the following issues.

Meaning and scope of Article 61.2 of the Patents Act
Article 61.2 of the Patents Act states that:

“if the subject matter of a patent is the process for the manufacture of new products or substances, there is a presumption – unless otherwise proved – that any product or substance having the same features has been obtained using the patented process.”

The court clarified that this presumption applies only where the patent protects a process for the preparation of a new product or substance. However, this does not mean that when the substance is not new the process of manufacture or preparation lacks novelty and cannot be patented.

The appeal court also declared that when a product prepared according to the patented process is new – and thus the presumption of Article 61.2 is applicable – the defendant must prove that the process followed is different from the patented process (eg, through the drug master file or manufacture sheets of the product).

Finally, the court stated that the fact that the defendant could prove that it had not used the patented process only excluded the applicability of Article 61 of the Patents Act, and it did not necessarily mean that there was no infringement, since there is a possibility that the process used by the defendant infringes the patent.

Analysis of the process for obtaining a chemical product
Traditionally, in order to determine whether there is infringement of a process claim for obtaining a pharmaceutical product, the Supreme Court has considered the starting product, the means of acting and the final product. However, in the case at hand the Barcelona Court of Appeal declared that such analysis is not binding case law.

The court stated that in order to determine whether a process claim for obtaining a chemical product (even if it contains one or more steps) has been infringed, every feature of the allegedly infringing industrial process must be compared with the text of the claim. If one part of the industrial process matches the step(s) defined in the claim, the claim has been infringed. It is irrelevant if the infringing industrial process implied other additional steps, operations or particular conditions.

Compensation for damages for patent infringement
The Supreme Court has frequently ruled that damages in cases of IP rights infringement are caused ex re ipsa (ie, they are a necessary consequence of the infringement).

However, the Barcelona Court of Appeal considered that this doctrine could not be automatically applied since there have been cases where patent infringement has occurred but no damage has been caused to the patentee. In the case at hand, Bayvit had infringed a pharmaceutical patent by offering a generic product. However, since Bayvit had not actually marketed the product, the court decided that there was no reason to grant Pfizer compensation for damages.

Determination of novelty and inventive step
The Barcelona Court of Appeal confirmed the opinion of other Spanish courts and the European Patent Office when evaluating the existence of novelty and inventive step in an invention: 

• When determining novelty, the court cannot combine elements obtained from different documents which constitute the prior art at the date of filing. On the contrary, each document must be analysed separately in order to check whether the claimed subject matter derived directly and unambiguously from such document, including any element which (for a person skilled in the art) was implicit in what was explicitly mentioned in such document. However, when carrying out this evaluation, it is incorrect to interpret a document by relying on information not included in that document. 
• When determining the inventive step, the person skilled in the art must not treat the prior art in an isolated manner (as it occurs when evaluating novelty). Prior art must be combined so that, by considering it as a whole, it can be determined whether there is sufficient information to conclude that a person skilled in the art would have reached the same conclusions without using the information disclosed by the inventor.