| In the case of Les Laboratoires Servier and Another | | | | were allowed to market their generic product prior to |
| v KRKA Polska SP.ZO.O. and Another [2006], the | | | | the outcome at trial, the National Health Service |
| claimants made an application for an interim injunction | | | | ("NHS") pricing policies relating to the prescriptions of |
| to prevent the marketing and distribution of a drug | | | | generic pharmaceuticals would have caused |
| which they claimed infringed their patent. The | | | | irreparable continuing losses in respect of revenues |
| claimant companies were in the business of | | | | and market share. |
| manufacturing and researching pharmaceutical | | | | In addition, the claimants maintained that the patent |
| products. The first claimant was the second largest | | | | was valid, and therefore the defendants had failed to |
| French pharmaceutical company worldwide, and the | | | | demonstrate that the claimants' action had shown no |
| second claimant was a wholly owned subsidiary that | | | | real prospect of success. The defendants submitted |
| marketed and researched such products within the | | | | that the patent had been invalid on the following two |
| UK. | | | | grounds: |
| The defendants were members of a group of | | | | Lack of novelty and obviousness on the basis that a |
| companies involved in the sale and distribution of a | | | | previous patent, EP 0 308 341 (patent 341), |
| large number of generic pharmaceutical products | | | | described the manufacturing process for the alpha |
| worldwide. | | | | crystalline variant; and |
| The claimants' most successful product from a sales | | | | The claimants had caused prior sales of the alpha |
| standpoint was an angiotensin converting enzyme | | | | crystalline variant before the priority date, and, that |
| inhibitor drug by the name of Coversyl. That drug | | | | prior sale would have enabled a skilled person to |
| contained the active ingredient perindopril erbumine | | | | discover the manufacturing process of the alpha |
| ("Perindopril") in the alpha crystalline form. The | | | | crystalline compound. |
| claimants had registered patent EP (UK) 1 296 947, | | | | Three main issues fell to be decided before the |
| which related to the alpha crystalline form of | | | | court, namely: |
| Perindopril and the method of its preparation. That | | | | Whether there was a serious issue to be tried; |
| patent had been unsuccessfully objected to by the | | | | If so, whether the defendants had demonstrated |
| defendants. The appeal by the defendants in relation | | | | that the case advanced by the claimants held no real |
| to that decision was still pending. | | | | prospect of success; and |
| The claimants discovered that the defendants had | | | | If not, whether the balance of convenience lay in |
| obtained marketing authorisation for a generic | | | | favour of granting the injunction. |
| Perindopril in the United Kingdom. That authorisation | | | | The court held that in this case, the issue of the |
| had been granted via a neutral recognition procedure, | | | | validity of the alpha crystalline patent was |
| the reference state being Hungary, where the | | | | undoubtedly a serious issue, and was one that fell to |
| claimants had previously successfully prevented the | | | | be determined at the trial of the main action. The |
| defendants from marketing a generic alpha crystalline | | | | defendants had strong arguments with which to |
| product. | | | | question the validity of the patent on both grounds |
| Correspondence thus ensued between the parties, | | | | of challenge. However, the basis of the challenge on |
| by which the claimants requested product | | | | the ground of lack of novelty concerned the |
| descriptions and samples to be sent for independent | | | | construction of a particular section of the |
| analysis. Pending the outcome of the main action, the | | | | methodology contained within patent 341. |
| claimants issued proceedings and sought an interim | | | | Furthermore, whilst the defendants had shown that |
| injunction preventing the defendants from importing, | | | | there had been a prior sale of the alpha crystalline |
| offering to dispose of or disposing of within the | | | | variant, the evidence supporting the proposition that |
| United Kingdom, a generic pharmaceutical product | | | | that sale would enable a skilled person to discover |
| containing, as its active ingredient, Perindopril in the | | | | the manufacturing process had been based upon a |
| alpha crystalline form. | | | | number of assumptions. Although these assumptions |
| The claimants had previously obtained such an | | | | were compelling, the evidence provided by the |
| injunction against another generic pharmaceutical | | | | defendants had not demonstrated that the claimants' |
| manufacturer, and a further manufacturer had | | | | case had no real prospect of success. |
| undertaken not to market such products until the | | | | The court therefore decided that in those |
| determination of the main action. However, the | | | | circumstances, the irreparable, continuing, and |
| defendants resisted that application, and sought | | | | unquantifiable losses that would have been suffered |
| summary judgment against the claimants on the basis | | | | by the claimants (had the defendants been allowed |
| that they had shown no reasonable prospect of | | | | to market their generic product pending the outcome |
| succeeding due to the patent being invalid. | | | | of the trial) resulted in the balance of convenience |
| The claimant submitted that there was indeed a | | | | falling in favour of the claimants. Therefore, the |
| serious issue to be tried. In relation to the balance of | | | | injunction that was sought would be granted. |
| convenience, it was submitted that if the defendants | | | | |