Memantine aftermath: will the national courts be influenced?

Up to date, almost 150 SPC applications have been examined by the State Office for Inventions and Trademarks (OSIM) and the majority have been granted.

The SPC applications for medicinal products placed on the Romanian market before the entry into force of the national law implementing the Council Directive 65/65/EEC were initially rejected by the patent examining division of OSIM.

The originators appealed these decisions before the boards of appeal which maintained the solution, but with a separate divergent opinion.

The OSIM decisions have been challenged in court. The Bucharest Tribunal admitted all the appeals against these decisions. OSIM filed a second appeal with the court of second instance against some of these decisions, but they were all dismissed.

The generic pharmaceutical companies intervened in two cases in the second appeal filed by OSIM (olanzapine and anastrozol). Although the interventions were held admissible by the court, they were in the end unsuccessful and they were dismissed together with the second appeal filed by OSIM.

Patent protection was thus extended for several active pharmaceutical ingredients (APIs) such as sildenafil, candesartan, olanzapine, donepezil, to name a few. All these APIs were already on the market in Romania on January 1 2000, albeit under legal provisions not yet harmonised with the Directive 65/65/EEC.

Interventions in the first appeal discussing the merits of the case would have had a higher chance of success, but the generic companies decided to intervene while the first appeals were already concluded.

OSIM and generic pharmaceutical companies requested the court to refer questions on the interpretation of several articles of the regulation to the Court of Justice of the European Union (CJEU). The requests have been rejected by the court.

"RECENT DEVELOPMENTS IN THE CJEU JURISPRUDENCE MIGHT INFLUENCE THE FUTURE DECISIONS OF ROMANIAN COURTS IN SUPPLEMENTARY PROTECTION CERTIFICATE CASES."

These cases were decided upon in the two procedural stages by almost all the judges in the intellectual property specialised sections of the court. Therefore, a very consistent and unitary jurisprudence has been established in these cases, a jurisprudence that would normally mean that all similar cases would have a similar result. However, recent developments in the CJEU jurisprudence might influence the future decisions of Romanian courts in SPC cases and determine a change in the jurisprudence.

The recent CJEU memantine and galantamine rulings held SPCs for old medicinal products invalid, clarifying the scope of Article 2 of the Council Regulation no. 1768/92 (now Council Regulation no. 469/2009).

The CJEU ruled that Article 2 of Council Regulation no. 1768/92 must be interpreted as meaning that a product which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65 is not within the scope of the Council Regulation no. 1768/92 and may not, therefore, be the subject of an SPC.

The same question arises with respect to the scope of Article 19a (l) of the Council Regulation no. 1768/92. May a medicinal product which was already placed on the market in Romania before obtaining a marketing authorisation in accordance with Council Directive 65/65 be the subject of an SPC?

In our opinion it may not. However this is a question which remains to be answered by the Romanian courts in the light of the new CJEU rulings.

With respect to the old products sold in Romania before January 1, 2000, discussed above, we have to mention that most of the appeals have been finally decided before the opinions of the Advocate General on the memantine and galantamine referrals have been made public.

In the light of these two new referrals decided by the CJEU, we consider that the national case law with respect to medicinal products sold in Romania before January 1, 2000, could be changed.

There is one pending revocation action against an SPC granted further to court proceedings (candesartan). However, in order to make a difference, generic pharmaceutical companies should take action and challenge more of the wrongly granted certificates to obtain the referral of questions on the interpretation of the Article 19a (l) of the Council Regulation to the CJEU.

Dragosh Marginean is a senior partner at Ratza & Ratza in Bucharest, Romania. He can be contacted at: dm@ratza-ratza.com