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News from Members NNDKP Secures New Milestone Victory for Generic Drug Producers

NNDKP Secures New Milestone Victory for Generic Drug Producers

by NNDKP July 4, 2013

Website www.nndkp.ro

Nestor Nestor Diculescu Kingston Petersen (NNDKP) successfully represented Zentiva a.s., a generic drug producer, in a dispute related to Pfizer Limited’s request for a supplementary protection certificate. The Bucharest Court of Appeals admitted the second appeal filed by OSIM and Zentiva, annulled the initial decision of the Bucharest Court and dismissed the motion to issue a supplementary protection certificate for the Sildenafil product.

The decision rendered by the Bucharest Court of Appeals confirms the point of view for which NNDKP has been advocating since as early as 2008 with respect to the scope of Regulation 1768/1992 on the territory of Romania, and in support of which NNDKP raised arguments that draw on the case law of the European Court of Justice.

NNDKP’s point of view in this type of disputes rests on the fact that the European regulation is intended to compensate patent holders for not being able to use their invention until they obtain a marketing authorization as part of a highly complex procedure.

“A patent holder cannot benefit from an extension of the protection period (by obtaining a supplementary certificate) if the product was initially launched on the Romanian market based on a procedure that has not been yet aligned to the provisions of the European Commission directive (65/65/EEC). Even if the patent holder subsequently obtained the authorizations required under the European law, it is still not possible to issue a supplementary protection certificate as the patent holder was not prevented from commercially using its invention and from recovering its investment in the pharmaceutical research”, declared Sorina Olaru (Creþu), partner in the Dispute Resolution Department.

The project involved a cross-disciplinary team coordinated by partner Sorina Olaru (Creþu), consisting of litigators and a reputed intellectual property counsel (Adina Bãdãrãu) with expertise in trademarks and patents.

NNDKP’s Pharmaceutical and Healthcare Practice provides ongoing advisory services to some of the largest drug producers (Zentiva, Ferring Pharmaceuticals, Dr. Reddy's) or distributors (Romastru Trading) with respect to a wide range of legal and regulatory matters, such as review of commercial contracts, determination of drug prices, clawback tax and specific issues related to medical devices.


For more information please contact:

Irina Melecciu | Director of Marketing and Communication
Nestor Nestor Diculescu Kingston Petersen
Attorneys & Counselors | Intellectual Property Counseling| Tax Advisory Services
Tel: (40-21) 20 11 200 | Fax: (40-21) 20 11 210 | M: (40-72) 86 66 232
irina.melecciu@nndkp.ro | www.nndkp.ro | www.facebook.com/nndkp

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