The Metropolitan Court has recently granted several preliminary injunctions against major pharmaceutical companies in Hungary on the basis of probable infringement of Pfizer's medical use patent covering its world-famous product Viagra.

Pfizer's product patent covering sildenafil - the compound used in Viagra - expired in June 2011, after which several generic competitors launched their own products for the treatment of erectile dysfunction. However, Pfizer still had a further patent application pending for the use or indication (ie, to treat erectile dysfunction with medication taken orally), which was granted by the Hungarian Intellectual Property Office in April 2012 after an extremely long examination period of 18 years, leaving barely two years of market exclusivity for the patentee.

However, Pfizer was keen to enforce its patent against the infringing products. It filed requests for preliminary injunctions without delay, suing several generic importers and manufacturers, as well as major wholesalers. This sparked fierce debate, both in and out of court, as to the validity of the newly granted patent and the balance of the benefits and detriments that such an injunction would produce. The latter debate took in the question of whether barring the generic products from the market would harm the legal interests of patients who had already begun taking one of the generic pills - a question that has assumed particular significance in recent preliminary injunction cases.

The court rendered its decisions on the injunctive measures in six parallel inter partes proceedings, without holding an oral hearing, within approximately one month of Pfizer filing the requests. In each case the court granted injunctive relief, prohibiting importers, manufacturers and wholesalers from distributing the respective products and ordering that the products be seized and withdrawn from pharmacies. However, the court required Pfizer to deposit a security bond in order to put the preliminary injunctions into effect.

The court explained that it had no doubt that each of the generic products in suit fell within the scope of Pfizer's patent. It also recognised Pfizer's position in view of the extreme length of the patent examination, acknowledging that the company had been unable to act earlier due to the absence of final patent protection. The court once again reaffirmed the strict bifurcation system in Hungary by disregarding invalidity arguments and referrals to foreign validity-related proceedings, finding that such considerations do not go beyond the normal uncertainty factor in similar cases.

On the basis of data from IMS Health and several graphs demonstrating market tendencies, the court also recognised a direct connection between the market launch of the generic products and the decline of Pfizer's sales in the segment after June 2011.

Regarding the interests of patients, the court took into account that the products in question were so-called 'lifestyle' products, which are taken by patients occasionally and belong to a higher price category, even in their generic versions; the price difference between the original product and its generic counterparts was therefore relative. The court saw no danger to the patients' interests, as they would be able to obtain the same active ingredient by changing to Pfizer's products.

Pfizer paid the bond on time and the preliminary injunctions came into effect. As the opposing parties appealed against the decisions, the battle will continue. Nevertheless, the preliminary injunctions are enforceable in the meantime, and the generic importers and manufacturers affected by them appear to have complied with their obligation to withdraw the products from the market. This is a promising sign that preliminary injunctions can be effective market protection tools for patent owners in Hungary.

For further information on this topic please contact Eszter Szakacs at DANUBIA Patent & Law Office LLC by telephone (+36 1 411 8800), fax (+36 1 266 5770) or email (eszter.szakacs@sarandpartners.hu).