Intellectual Property, Patent Law, Patent Infringement Invalidity Regulatory Law Pharmaceutical
By www.menhealthonline.biz
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
