INNsight article by Carlos Jiménez de Laiglesia

In February 2008, the Barcelona Court of Appeal ruled in favour of Eli Lilly (and research based pharmaceutical companies) by declaring that Lilly's olanzapine (Zyprexa) patent is valid as a product patent in Spain.

This deals a blow to generic manufacturers in the country - in particular Kern Pharma, Cinfa and Alter who were planning to launch generic versions of Zyprexa in Spain using olanzapine manufactured by Dr Reddy's. The companies had already filed a non infringement claim for Dr Reddy's manufacturing process and were hoping that the olanzapine product patent would be declared invalid.

In this case the court declared that the TRIPS agreement, signed by Spain in 1995, creates rights that can be relied on by individuals in proceedings before the national court and overrides a derogation from the European Patent Convention that rendered product claims in patents filed before 07 October 1992 ineffective in Spain. Before that date, the only patent protection available for pharmaceutical companies in Spain was process patents ("patentes de procedimiento"). In this case the court held that TRIPS obliges Spain to permit product protection in granted patents that had not expired when TRIPS came into force. This is significant as Eli Lilly's application for a European patent for Olanzapine was filed in 1991. Following this ruling, it should be possible for other companies to add pharmaceutical product claims to those process patents filed before October 1992 and which are still in force. As many as 20 other products in Spain could have their patents extended by up to four years.

"This demonstrates a willingness of the Spanish courts to register and uphold the rights of patent holders" comments Carlos Jimenez de Laiglesia, head of life sciences of Simmons & Simmons Mochales & Palacios. "If, as Lilly did, the patent holders of the other 20 products can convert their process patents to product patents, it would result in a significant improvement in the protection of research based pharmaceutical products in Spain."

The generic manufacturers are to appeal against this decision in the Supreme Court on the basis that extending the scope of protection of patents in this way would be contrary to the principles of legal certainty and non retroactivity.