Intellectual House – Patent Dispute – Pharmaceuticals – Patent Invalidity – Generic Medications

The scenario of Generics (United kingdom) Ltd and Many others v H Lundbeck A/S [2007] associated a defendant which was a tiny research-based pharmaceutical firm found in Denmark. It held a European patent (&#147the Patent&#148) in respect of an anti-depressant drug, escitalopram. The Patent had a priority date of June 1988.

The drug had been produced by the resolution of a racemate of an present drug, citalopram, so as to get single enantiomers thereof. Accordingly it comprised the pure (+) enantiomer, whilst citalopram comprised the two (+) and (-) enantiomers. The Patent comprised seven promises. Declare 1 was a merchandise claim directed to the (+) enantiomer, assert 3 connected to a pharmaceutical composition that contains the assert 1 compound, and assert 6 relevant to a approach of getting ready that compound.

The claimants brought proceedings, searching for the revocation of the patent on account of the prior art drug, citalopram. It fell to be established by the court docket regardless of whether:

§ Promises 1 and 3 of the Patent had been invalid for deficiency of novelty over the prior artwork patents

§ Statements 1, 3 and 6 were being invalid for obviousness in the light-weight of those patents and prevalent standard know-how and

§ Claims 1 and 3 ended up invalid for insufficiency as citalopram experienced been an evident target for resolution.

In relation to obviousness, the claimants submitted that by June 1988, it experienced been frequent standard know-how that the organic activity of enantiomers was most likely to be unique from the racemate and that, for any racemate under advancement as a possible therapeutic agent, it was extremely fascinating to solve the racemate to identify the properties of the enantiomers which it contained.

The court docket dominated the next:

If the assert in the Patent was just to the merchandise as this kind of, then the monopoly would in fact go over that item wherever it may possibly be observed. Nonetheless, if the claim was to the isolated item or to a pharmaceutical composition comprising that isolated solution as an energetic component, then the monopoly would not lengthen to that product regardless of what type it took. It would be unlikely that the patentee meant to include that which he had expressly described as staying outdated. For that reason, in the situation of this situation, promises 1 and 3 of the Patent were not invalid for lack of novelty. The citalopram racemate did not occur within the description of claim 1, and a pharmaceutical composition comprising the racemate as an active component did not arrive within the description of claim 3. The Patent not only recognised citalopram, particularly the racemate, as previous, but was also plainly directed at the isolation of its unique enantiomers.

In the courtroom&#146s application of founded authority to the facts of this situation, it was held that statements 1, 3 and 6 were not invalid for obviousness. Investigation of the enantiomers of citalopram experienced been an evident purpose for the everyday experienced medicinal chemist in 1988. The variation in between the prior artwork patents and the promises of the Patent was that the former disclosed only the racemate and techniques which would only make racemic compounds. They did not explain any strategy for acquiring single enantiomers of citalopram. It would not have been clear to solve citalopram utilizing the adopted system in 1988. The common qualified analytical chemist would have experienced no sensible encounter of that method and the everyday expert medicinal chemist would most likely not have read of it.

In the situations of this circumstance, promises 1 and 3 of the Patent were invalid for insufficiency. The ingenious stage taken by the defendant had not been determining to separate the enantiomers of citalopram, but locating a way it could be done. Promises 1 and 3 of the Patent protected all methods of generating the (+) enantiomer. The to start with individual to uncover a way of attaining an certainly appealing intention was not permitted to monopolise every single other way of performing so. Claims 1 and 3 were as a result as well wide. The court held that they extended beyond any technical contribution designed by the defendant.

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© 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.

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