Enforcement of modified European patents

One of the most successful products commercialised by pharmaceutical company F. Hoffmann La Roche is the osteoporosis medicine marketed under the trademark Bonviva. Two European patents covered this product. The first one (covering the active substance: ibandronic acid) expired in June 2011 while the second patent (covering a certain dosage and administration method) has an expiration date of May 2023.

Eight generics companies filed oppositions against the granting of the second patent. During the opposition proceedings the owner of the patent decided not to defend the version of the patent initially granted by the European Patent Office (EPO) and filed a new set of claims (five claims instead of the initial eight). A further amendment of this new set of claims was performed during the proceedings, with the last version having only four claims.

Considering this new set of claims, the opposition division decided to reject the opposition and upheld the patent in its new, four-claim, form. The decision was promptly appealed by five of the eight opponents. The appeal is currently pending before the EPO.

Within this background, two of the generics companies involved in the opposition proceedings decided to launch their products in a number of jurisdictions, including Romania, immediately after the expiration date of the first patent covering the active substance (ibandronic acid).

Naturally, this did not sit well with Hoffmann La Roche which acted promptly and filed preliminary injunction requests, as well as infringement actions, against both generics companies.

The amended version resulting from the opposition proceedings is not valid in Romania because the appeal filed against the opposition decision has suspended the effects of the decision. As a result, the version of the patent upheld in the opposition proceedings will not produce any effects.

Similar jurisprudence from other European jurisdictions was provided in support of these claims.The injunction requests and infringement actions were based on the amended version of the patent as modified in the opposition proceedings (ie, the four-claim version).

The generics companies claimed that this version of the patent is not valid in Romania. The only version of the patent that could be considered valid in Romania was the initial eight-claim version.

"The amended version resulting from the opposition proceedings is not valid in Romania because the appeal filed against the opposition decision has suspended the effects of the decision."

The Bucharest Municipal Court heard both preliminary injunction requests. Although the court agreed with the position of the generics companies and found that the amended version of the patent is not valid in Romania, the court considered that, of its own motion, it has the right and obligation to examine whether an apparent infringement of the initial version of the patent does exist. Following the reasoning above, the court found that the conditions were met for the granting of a preliminary injunction based on the initial version of the patent.

As expected, both decisions issued by the court were promptly appealed by the generics companies.

The appeals were heard by the Bucharest Court of Appeals and two very similar decisions were issued. This time, however, the court found in favour of the generics companies and considered that since the injunction requests were based on the amended version of the patent which is not valid in Romania, the court had no choice but to reject the request.

The appeals were heard by three-member panels, and in one case one judge had a divergent opinion, proving that the issue has raised some serious problems for the courts hearing the cases and that, although the final decisions were both in the same direction, we can not yet state that an established jurisprudence in this matter exists.

The decisions of the Court of Appeals prompted F. Hoffmann La Roche to modify the infringement actions filed against the same generics companies to include the initial version of the patent.

However, it is very likely that by the time a decision is taken in the infringement cases, the EPO will issue a decision in the appeal proceedings, which will definitively settle the fate of the patent and consequently have an impact on the infringement proceedings in Romania.