Pharmaceutical patent proceedings

01-12-2010

Petri Eskola and Markus Lampinen

In Finland, patent litigation proceedings are handled in the first instance by the District Court of Helsinki.

Each month only a few cases are filed with the court, most of which to date have related to pharmaceutical patents. The primary reason for the high number of pharmaceutical cases is that patent protection of pharmaceuticals has been relatively weak since most of the best-selling products are protected by so-called ‘analogous process patents’.

This special type of patent only provides protection for certain manufacturing methods mentioned in patent claims, instead of the end product or invention.

This means that a generic manufacturer can, in principle, enter the market with a competing generic product using the same active product ingredient manufactured by a different and non-infringing process. For analogous process patents, a reversed burden of proof is applied, which means that during the infringement proceedings, the defendant has to present proof that the patented method has not been used.

Competition on the Finnish market has also become attractive for generic pharmaceutical products due to the mandatory substitution system and the recent implementation of the reference price system. The core essence of the system is that the pharmacies automatically substitute an original product for a cheaper generic one, while the customer usually gets reimbursement only according to the price of the cheapest product.

"A GENERIC MANUFACTURER CAN, IN PRINCIPLE, ENTER THE MARKET WITH A COMPETING GENERIC PRODUCT USING THE SAME ACTIVE PRODUCT INGREDIENT MANUFACTURED BY A DIFFERENT AND NON-INFRINGING PROCESS."

If a cheaper generic product enters the market, it will rapidly gain considerable market share, unless the original manufacturer lowers its prices as well. To prevent losing market share, the original manufacturers usually try to prevent the generic launch by applying for preliminary injunctions before the District Court of Helsinki. Such injunction proceedings constitute a crucial part of the parties’ process strategy.

Procedural features

In pharmaceutical patent matters, the doctrine of equivalence usually plays an important role. According to the doctrine, which is acknowledged in the European Patent Convention, literal infringement may not be the only grounds for a case. The argument may end up being over what was obvious to a person skilled in the art at a certain time.

As mentioned above, the doctrine of equivalence can contain an imaginary conception of a person skilled in the art and the general knowledge that existed in the field.

To support their arguments, the parties usually appoint expert witnesses to cover the technical questions. These expert witnesses may represent the highest academic skill in the field, and foreign experts are frequently appointed as well as local scientists.To assess these technical questions of pharmaceutical chemistry, the District Court uses two independent, court-appointed experts.

Their opinions on the technical questions have considerable importance, even though the experts are not officially members of the panel of judges. An interesting detail is that if the case proceeds to appeal stage, the appeal courts do not use court-appointed technical experts. 

Written evidence brought forward by the parties can be very chemistry-specific and fact-based. For instance, the original manufacturer could carry out laboratory tests to prove that the generic’s manufacturing process yields impurities that are characteristic of the patented process. Written opinions and declarations of independent experts in the field of chemistry are also used.

If the court finds that a patent infringement has been established, the defendant is obligated to pay a reasonable royalty for exploiting the patented invention and other damages sufficiently proven by the patent holder. The damages issue, which contains very complex argumentation as well, can be decided in separate proceedings after the infringement has been held to exist, should the parties agree to this two-stage procedure.

petri-eskola-jpg.JPG

markus-lampinen-jpg.JPG

Petri Eskola is a partner at Backström & Co Attorneys. He can be contacted at: petri.eskola@backstrom.fi

Markus Lampinen is an attorney at Backström & Co Attorneys. He can be contacted at: markus.lampinen@backstrom.fi

Pharmaceuticals, District Court of Helsinki

WIPR