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Intellectual Property, Patent Law, Patent Infringement Invalidity Regulatory Law Pharmaceutical
By Generic Drugs Frequently Asked Questions

In the case of Les Laboratoires Servier and Another v KRKA Polska SP.ZO.O. and Another [2006], the claimants made an application for an interim injunction to prevent the marketing and distribution of a drug which they claimed infringed their patent. The claimant companies were in the business of manufacturing and researching pharmaceutical products. The first claimant was the second largest French pharmaceutical company worldwide, and the second claimant was a wholly owned subsidiary that marketed and researched such products within the UK.

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

The claimants' most successful product from a sales standpoint was an angiotensin converting enzyme inhibitor drug by the name of Coversyl. That drug contained the active ingredient perindopril erbumine (“Perindopril”) in the alpha crystalline form. The claimants had registered patent EP (UK) 1 296 947, which related to the alpha crystalline form of Perindopril and the method of its preparation. That patent had been unsuccessfully objected to by the defendants. The appeal by the defendants in relation to that decision was still pending.

The claimants discovered that the defendants had obtained marketing authorisation for a generic Perindopril in the United Kingdom. That authorisation had been granted via a neutral recognition procedure, the reference state being Hungary, where the claimants had previously successfully prevented the defendants from marketing a generic alpha crystalline product.

Correspondence thus ensued between the parties, by which the claimants requested product descriptions and samples to be sent for independent analysis. Pending the outcome of the main action, the claimants issued proceedings and sought an interim injunction preventing the defendants from importing, offering to dispose of or disposing of within the United Kingdom, a generic pharmaceutical product containing, as its active ingredient, Perindopril in the alpha crystalline form.

The claimants had previously obtained such an injunction against another generic pharmaceutical manufacturer, and a further manufacturer had undertaken not to market such products until the determination of the main action. However, the defendants resisted that application, and sought summary judgment against the claimants on the basis that they had shown no reasonable prospect of succeeding due to the patent being invalid.

The claimant submitted that there was indeed a serious issue to be tried. In relation to the balance of convenience, it was submitted that if the defendants were allowed to market their generic product prior to the outcome at trial, the National Health Service (“NHS”) pricing policies relating to the prescriptions of generic pharmaceuticals would have caused irreparable continuing losses in respect of revenues and market share.

In addition, the claimants maintained that the patent was valid, and therefore the defendants had

failed to demonstrate that the claimants' action had shown no real prospect of success. The defendants submitted that the patent had been invalid on the following two grounds:

The court held that in this case, the issue of the validity of the alpha crystalline patent was undoubtedly a serious issue, and was one that fell to be determined at the trial of the main action. The defendants had strong arguments with which to question the validity of the patent on both grounds of challenge. However, the basis of the challenge on the ground of lack of novelty concerned the construction of a particular section of the methodology contained within patent 341.

Furthermore, whilst the defendants had shown that there had been a prior sale of the alpha crystalline variant, the evidence supporting the proposition that that sale would enable a skilled person to discover the manufacturing process had been based upon a number of assumptions. Although these assumptions were compelling, the evidence provided by the defendants had not demonstrated that the claimants' case had no real prospect of success.

The court therefore decided that in those circumstances, the irreparable, continuing, and unquantifiable losses that would have been suffered by the claimants (had the defendants been allowed to market their generic product pending the outcome of the trial) resulted in the balance of convenience falling in favour of the claimants. Therefore, the injunction that was sought would be granted.

© RT COOPERS, 2007. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.

If you require further information contact us at enquiries@rtcoopers.com

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