Mental Home – Patent Dispute – Prescription drugs – Patent Invalidity – Generic Medication

The scenario of Generics (United kingdom) Ltd and Other people v H Lundbeck A/S [2007] involved a defendant which was a small study-based pharmaceutical firm positioned in Denmark. It held a European patent (&#147the Patent&#148) in regard of an anti-depressant drug, escitalopram. The Patent experienced a precedence day of June 1988.

The drug had been developed by the resolution of a racemate of an present drug, citalopram, so as to obtain solitary enantiomers thereof. Accordingly it comprised the pure (+) enantiomer, whereas citalopram comprised the two (+) and (-) enantiomers. The Patent comprised 7 promises. Declare 1 was a products assert directed to the (+) enantiomer, declare 3 associated to a pharmaceutical composition made up of the declare 1 compound, and assert 6 associated to a strategy of planning that compound.

The claimants introduced proceedings, trying to get the revocation of the patent on account of the prior art drug, citalopram. It fell to be decided by the court no matter whether:

§ Promises 1 and 3 of the Patent had been invalid for lack of novelty in excess of the prior artwork patents

§ Claims 1, 3 and 6 were being invalid for obviousness in the light of these patents and typical common know-how and

§ Promises 1 and 3 ended up invalid for insufficiency as citalopram had been an noticeable goal for resolution.

In relation to obviousness, the claimants submitted that by June 1988, it experienced been prevalent typical awareness that the biological activity of enantiomers was most likely to be diverse from the racemate and that, for any racemate under advancement as a prospective therapeutic agent, it was very appealing to take care of the racemate to establish the attributes of the enantiomers which it contained.

The court ruled the subsequent:

If the declare in the Patent was simply to the product or service as this sort of, then the monopoly would indeed include that products wherever it might be located. However, if the declare was to the isolated solution or to a pharmaceutical composition comprising that isolated products as an lively component, then the monopoly would not extend to that products whatsoever sort it took. It would be unlikely that the patentee supposed to cover that which he experienced expressly described as remaining old. For that reason, in the instances of this circumstance, claims 1 and 3 of the Patent had been not invalid for deficiency of novelty. The citalopram racemate did not appear in the description of declare 1, and a pharmaceutical composition comprising the racemate as an active component did not occur within the description of declare 3. The Patent not only recognised citalopram, namely the racemate, as previous, but was also plainly directed at the isolation of its unique enantiomers.

In the court&#146s application of established authority to the points of this situation, it was held that claims 1, 3 and 6 were not invalid for obviousness. Investigation of the enantiomers of citalopram had been an obvious objective for the normal skilled medicinal chemist in 1988. The big difference amongst the prior art patents and the claims of the Patent was that the former disclosed only the racemate and methods which would only make racemic compounds. They did not describe any process for acquiring single enantiomers of citalopram. It would not have been noticeable to take care of citalopram making use of the adopted technique in 1988. The normal skilled analytical chemist would have had no realistic working experience of that approach and the ordinary proficient medicinal chemist would most likely not have listened to of it.

In the circumstances of this scenario, claims 1 and 3 of the Patent had been invalid for insufficiency. The creative phase taken by the defendant experienced not been determining to individual the enantiomers of citalopram, but locating a way it could be performed. Claims 1 and 3 of the Patent protected all ways of earning the (+) enantiomer. The initial human being to find a way of reaching an clearly fascinating aim was not permitted to monopolise every other way of performing so. Statements 1 and 3 had been as a result way too wide. The court held that they prolonged over and above any technical contribution made 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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