Intellectual Property, Patent Law, Patent Infringement Invalidity Regulatory Law Pharmaceutical

In the case of Les Laboratoires Servier et al v Krka Polska Sp.zo.o. et al [2006], the plaintiffs request for an interim prohibition to prevent the marketing and distribution of drugs, which they claimed violated their patenta.Tužitelj companies are in business of manufacturing and researching pharmaceutical proizvoda.Prvi the applicant was the second largest French pharmaceutical company in the world, and the second applicant was a wholly owned subsidiary of the market and researching such products in the UK.

defendants were members of the group companies involved in the sale and distribution of a large number of generic pharmaceutical products in the world.

The plaintiffs' most successful product from a sales point of view of the angiotensin converting enzyme inhibitor drug called Coversyl. It is the drug contained the active ingredient perindopril erbumine ("perindopril") in the alpha crystalline form. The plaintiffs are registered patent EP (UK) 1296947, relating to the alpha crystalline form of perindopril and method of preparation. This patent was unsuccessfully objected to the optuženika.Žalbu defendant in relation to that decision was still pending.

Prosecutors have found that the defendants received a marketing authorization for generic perindopril in the UK. This approval is granted by a neutral recognition procedure, the reference country is Hungary, where the applicants had previously successfully prevented the defendants from marketing generic alpha crystalline product.

correspondence that passed between the parties, which the plaintiff asked for descriptions of products and samples to be sent for independent analysis. Until the outcome of the main action, the applicant issued proceedings and sought injunctive relief preventing the defendant from importing, offering to dispose of or delay in the UK, generic pharmaceutical products containing such active ingredient perindopril in the alpha crystalline form.

The plaintiffs had previously received such an order against another generic drug manufacturer, the manufacturer still has undertaken not to market these products to determine the main action. However, defendant resisted the application, and sought summary judgments against the applicant on the basis of which showed no reasonable prospect of success with respect to the patent is invalid.

The applicant contended that there was indeed a serious issue to be tried. In comparison to convenience, it is argued that if defendants were allowed to market its generic product prior to the outcome of the trial, the National Health Service ("NHS") pricing policies relating to the regulation of generic drugs continue to cause irreparable losses in respect of income and market share.

In addition, the applicants argued that the patent was valid, and therefore the defendants did not show that plaintiffs' actions showed no real prospect for uspjeh.Tuženici have argued that the patent was invalid on the following two reasons:

The lack of novelty and obviousness based on this prior patent, EP 0308341 (patent 341), described the manufacturing process for the alpha crystalline variant, and

Plaintiffs were caused prior to selling the alpha crystalline variant before the priority date, and that before the sale would enable the skilled person to discover the production process of alpha crystalline compound.

The three main issues fell to be decided in court, as follows:

Is there a serious issue to be tried,

If so, whether the accused has shown that in the case advanced by the plaintiffs held no real prospect of success, and

if not, whether the balance of convenience lay in favor of granting the ban.

the Court held that in this case, the question of the validity of the alpha crystalline patent is undoubtedly a serious problem, and it was one which fell to be determined at the trial of the main akcije.Optuženici are strong arguments that question the validity of a patent on the basis of both a challenge. However, based on a challenge based on lack of news regarding the construction of a part of the methodology contained within the patent 341st

In addition, while the defendants showed that there had been prior to the sale of the alpha crystalline variant, evidence supporting the contention that the sale will enable the skilled person to discover the production process is based on the number of assumptions. Although these assumptions were convincing evidence that the defendant has not shown that plaintiffs' case had no real prospect of success.

The Court thus decided that in these circumstances, irreparable, and on and unquantifiable losses that suffered by the applicant (the defendant is allowed to market its generic product until the conclusion of the trial) resulted in a decline in the balance of convenience favor of the plaintiff. Thus, an order which is sought to be approved.