Intellectual Home – Patent Dispute – Pharmaceuticals – Patent Invalidity – Generic Medicines

The circumstance of Generics (British isles) Ltd and Many others v H Lundbeck A/S [2007] concerned a defendant which was a tiny research-centered pharmaceutical company located in Denmark. It held a European patent (&#147the Patent&#148) in regard of an anti-depressant drug, escitalopram. The Patent had a priority date of June 1988.

The drug had been created by the resolution of a racemate of an current drug, citalopram, so as to receive solitary enantiomers thereof. Accordingly it comprised the pure (+) enantiomer, while citalopram comprised both equally (+) and (-) enantiomers. The Patent comprised 7 promises. Declare 1 was a product or service assert directed to the (+) enantiomer, claim 3 associated to a pharmaceutical composition made up of the declare 1 compound, and claim 6 linked to a approach of making ready that compound.

The claimants introduced proceedings, searching for the revocation of the patent on account of the prior artwork drug, citalopram. It fell to be decided by the court whether:

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

§ Promises 1, 3 and 6 were invalid for obviousness in the light-weight of individuals patents and typical general know-how and

§ Promises 1 and 3 had been invalid for insufficiency as citalopram had been an clear target for resolution.

In relation to obviousness, the claimants submitted that by June 1988, it experienced been widespread general information that the organic exercise of enantiomers was most likely to be various from the racemate and that, for any racemate under advancement as a potential therapeutic agent, it was really attractive to take care of the racemate to decide the qualities of the enantiomers which it contained.

The court dominated the following:

If the declare in the Patent was just to the merchandise as these, then the monopoly would in fact go over that merchandise where ever it could possibly be uncovered. However, if the declare was to the isolated solution or to a pharmaceutical composition comprising that isolated solution as an lively ingredient, then the monopoly would not extend to that solution whichever type it took. It would be unlikely that the patentee supposed to include that which he experienced expressly described as becoming aged. Thus, in the situations of this circumstance, promises 1 and 3 of the Patent were being not invalid for deficiency of novelty. The citalopram racemate did not occur inside the description of claim 1, and a pharmaceutical composition comprising the racemate as an energetic component did not arrive in just the description of assert 3. The Patent not only recognised citalopram, particularly the racemate, as outdated, but was also plainly directed at the isolation of its person enantiomers.

In the courtroom&#146s application of established authority to the details of this case, it was held that promises 1, 3 and 6 ended up not invalid for obviousness. Investigation of the enantiomers of citalopram had been an apparent aim for the normal expert medicinal chemist in 1988. The variation amongst the prior artwork patents and the statements of the Patent was that the previous disclosed only the racemate and procedures which would only make racemic compounds. They did not describe any system for obtaining one enantiomers of citalopram. It would not have been evident to take care of citalopram making use of the adopted strategy in 1988. The regular skilled analytical chemist would have had no practical practical experience of that method and the standard expert medicinal chemist would almost certainly not have heard of it.

In the situations of this situation, statements 1 and 3 of the Patent were invalid for insufficiency. The creative phase taken by the defendant experienced not been selecting to different the enantiomers of citalopram, but getting a way it could be finished. Statements 1 and 3 of the Patent lined all approaches of building the (+) enantiomer. The to start with person to discover a way of reaching an certainly desirable aim was not permitted to monopolise each and every other way of accomplishing so. Statements 1 and 3 were for that reason as well wide. The courtroom held that they extended further than 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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