Generics Can Enter Market

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Published in “Managing Intellectual Property”, 2010

Romanian court has ruled in a first linkage related trial: price approval of generic medicinal products does not amount to infringement of the patent of the reference product.

While no linkage of pricing for generic medicinal products to the status of a patent for the originator reference product is currently regulated by Romanian legislation, (part of) originator companies present on the Romanian market insist on claiming that obtaining of pricing by generic medicinal product before the expiry of the patent protection over the reference product amounts to patent infringement.

Based on such interpretation, in November 2009, H Lundbeck A/S has filed with Bucharest Tribunal a request for preliminary injunction against Teva Pharmaceuticals SRL by which it requested the court that, until the main claim regarding breach by defendant of the plaintiff’s rights over the transitional protection certificate no. 2.135T (as prolonged by the supplementary protection certificate no. c002 2007 until 2014) covering active ingredient Escitalopramum (not yet filed at the date the request for preliminary injunction was registered with the court), to order Teva to abstain from any act or fact that might represent infringement of Lundbeck’s intellectual property rights, including, but not limited to manufacture, use, offer for sale, sale or importation with view to use of the generic product containing the same active ingredient.

Thus, in the plaintiff’s view (as expressed in the request for the preliminary injunction), generics may only be produced and commercialized after the protection granted through patent to the original products expires, and it is only after this date when producer of generic products may take any steps with view to commercialize such products.

Further, the plaintiff claims that the defendant’s request for approval of the price for its generic Escitalopramum products, followed by the inclusion of the approved prices in the National Catalogue of Prices for Medicinal Products for Human, represents a preliminary act to the subsequent launch of the generic product on the Romanian market, which, in accordance with the provisions of Romanian legislation, represents breach of Lundbeck’s patent rights.

In addition to legal arguments related to potential infringement of originator’s patent by the obtaining the approval for the price of generic products, the plaintiff has also raised the issue of reference price in the reimbursement system.

Besides addressing the procedural flaws of the plaintiff’s claim for preliminary injunction (lack of urgency and temporary character), in its answer in defense the defendant has also raised the fact that it has actually already renounced to the effects of the ministry of health’s approval for its Escitalopramum generic products (and for that matter that the products have already been excluded from the National Catalogue of Prices for Medicinal Products for Human Use), thus expressly manifesting its decision of not marketing in the future products containing such active ingredient.

Further, the defendant has shown that by requesting the approval of the price for its generic products in the first place, it has not in fact performed any of the acts expressly and exhaustively defined as patent infringement by Romanian legislation.

Moreover, referring to the point of view expressed by the European Commission in the Final Report of the Pharmaceutical Sector Inquiry adopted on 8 July 2009, the defendant has shown to the court that, as it is commonly agreed (including by EFPIA, the European association representing originator companies) that applications for marketing authorizations by generic companies do not amount to a violation of patent law, the same logic should apply to applications for pricing.

Based on the parties’ arguments (as partly detailed above), in March 2010, the court has denied the plaintiff claim as not grounded.

Also, although not analyzing the plaintiff’s claim related to patent infringement on merits, the court has expressly stated in its decision regarding the preliminary injunction that application for and obtaining of the marketing authorization, as well as inclusion of the prices of the defendant’s generic products in CANAMED may not be deemed, by themselves, as breaching the patent rights of the plaintiff.

The reasoning of the decision was communicated to the parties in October 2010.

As the plaintiff decided not to challenge the decision issued by Bucharest Tribunal, this remained final and irrevocable. It thus appear that the plaintiff adhered to the court’s point of view, as, moreover, no action in infringement was yet filed by Lundbeck against Teva with respect to generic products containing Escitalopramum.

This decision of Bucharest Tribunal, the first to be issued by a Romanian court of law that had to deal with whether application for pricing amounts to patent infringement, represents a cornerstone for the generic medicinal products industry, as it smoothen the way for generic companies when dealing with entering into the market, by allowing such to apply for and obtain prices for their generic medicinal products even before the expiry of the patent protection.

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