a patent infringement claim

a patent infringement claim
At Les Laboratoires Servier and another v KRKA Polska Sp z oo and another [2006], the applicants submit an application for an injunction to prevent the marketing and distribution of a drug, which claimed that it violates their patent . The plaintiffs were in the field of exploration and production of pharmaceutical products. The first plaintiff was the second largest French pharmaceutical company worldwide and the second claimant was a wholly owned subsidiary, which marketed and investigated these products within the United Kingdom.

The defendants were members of a group of companies involved in the sale and distribution of a variety of generic drugs worldwide.

The plaintiffs' most successful product from a sales perspective was an angiotensin-converting enzyme inhibitor drug, called Coversyl. The medicine contains the active ingredient perindopril erbumine (perindopril) in the alpha crystalline form. The plaintiffs had patent EP (UK) 1 296 947, which related to the alpha crystalline form of perindopril and the type of preparation. The patent was unsuccessfully against the defendant. The appeal of the defendant in respect of this decision has not yet been completed.

The plaintiffs that the defendants had obtained approval for a generic perindopril in the UK. This permit was issued by a neutral recognition procedure, based on status to Hungary, where the plaintiff previously successfully prevent the defendant from marketing a generic alpha crystalline product.

Followed a correspondence between the parties with which the plaintiff desired product descriptions and samples for independent analysis. Until the results of the most important measures that the applicants, the procedures and an injunction to prevent the importation of the accused, to eliminate or remove, the United Kingdom, a generic pharmaceuticals, as the active ingredient, in the Perindopril Alpha - crystalline form .

The plaintiff had such an injunction against a generic pharmaceutical manufacturer, and another manufacturer has undertaken to carry out such products on the market until the identification of key actions. But the defendants resisted that application, and sought summary verdict against the plaintiff on the basis that they had shown no reasonable prospect of success by the patent is invalid.

The plaintiff argued that it is indeed a serious problem. In relation to the balance of convenience, it was argued that if the defendants were its generic product before the outcome of litigation, the National Health Service (NHS) the pricing policies associated with the requirements of the generic drugs would cause have sustained irreparable losses in terms of turnover and market share.

In addition, the plaintiffs alleged that the patent is valid and therefore the defendant had not demonstrated that the plaintiffs' action had shown no real prospect of success. The defendant argued that the patent was invalid on two grounds :
# Lack of novelty and obviousness, that on the basis of an earlier patent EP 0 308 341 (Patent 341), described the manufacturing process for the variant alpha-crystalline and
# The claimant had prior to the sale of the alpha crystalline variant before the priority date, and that sales would have a qualified person to the manufacturing process of the alpha-crystalline connection.

The three most important issues to decide before the court, namely:
# Whether it is a serious problem to be;
# If so, whether the defendant had shown that the case of the plaintiff was no real prospect of success, and
# If not, whether the balance of convenience lay down for the granting of the order.

The court held that in this case, the question of the validity of the patent alpha crystalline was undoubtedly a serious problem, and was one noticed that determined at the trial of the action. The defendant had strong arguments with which the question of the validity of the patent on two grounds of challenge. However, the basis of the challenge on the ground of lack of novelty relates to the construction of a particular section of the methodology within patent 341st

Even if the defendants had shown that there is a prior sale of the alpha crystalline variant, the evidence supporting the theory that the sale would allow a qualified person to the manufacturing process was based on a series of assumptions. Although these assumptions were convincing evidence that the defendant had not demonstrated that the applicants' case had no real prospect of success.

The court therefore decided that in these circumstances, the irreparable, continuing, and non-quantifiable losses would have been the plaintiff (the defendant had permission to market their generic product pending the outcome of the procedure) resulted in the balance of convenience, the in favor of the plaintiff. It is the arrangement that it was granted.

© RT Coopers, 2007. This background information is not a comprehensive or complete statement of the law on the issues can not be considered legal advice. It is only on general issues. Specialist legal advice should always be sought in relation to the particular circumstances.

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