Intellectual Home – Patent Dispute – Prescribed drugs – Patent Invalidity – Generic Medicine

The circumstance of Generics (British isles) Ltd and Other individuals v H Lundbeck A/S [2007] included a defendant which was a modest research-based mostly pharmaceutical corporation located in Denmark. It held a European patent (&#147the Patent&#148) in respect of an anti-depressant drug, escitalopram. The Patent experienced a priority date of June 1988.

The drug experienced been generated by the resolution of a racemate of an current drug, citalopram, so as to attain single enantiomers thereof. Appropriately it comprised the pure (+) enantiomer, while citalopram comprised both (+) and (-) enantiomers. The Patent comprised 7 promises. Declare 1 was a solution assert directed to the (+) enantiomer, assert 3 associated to a pharmaceutical composition containing the claim 1 compound, and claim 6 relevant to a method of making ready that compound.

The claimants introduced proceedings, trying to find the revocation of the patent on account of the prior artwork drug, citalopram. It fell to be identified by the court docket no matter whether:

§ Statements 1 and 3 of the Patent were being invalid for absence of novelty more than the prior artwork patents

§ Statements 1, 3 and 6 had been invalid for obviousness in the light-weight of all those patents and popular standard information and

§ Statements 1 and 3 ended up invalid for insufficiency as citalopram had been an noticeable focus on for resolution.

In relation to obviousness, the claimants submitted that by June 1988, it had been typical typical information that the biological exercise of enantiomers was probably to be distinctive from the racemate and that, for any racemate underneath improvement as a potential therapeutic agent, it was very desirable to resolve the racemate to identify the houses of the enantiomers which it contained.

The court dominated the adhering to:

If the claim in the Patent was basically to the product or service as this kind of, then the monopoly would certainly protect that product anywhere it might be observed. Nevertheless, if the claim was to the isolated merchandise or to a pharmaceutical composition comprising that isolated merchandise as an lively ingredient, then the monopoly would not extend to that merchandise whatsoever form it took. It would be not likely that the patentee intended to cover that which he had expressly described as being outdated. For that reason, in the circumstances of this scenario, statements 1 and 3 of the Patent had been not invalid for absence of novelty. The citalopram racemate did not occur inside the description of assert 1, and a pharmaceutical composition comprising the racemate as an active component did not occur within just the description of assert 3. The Patent not only recognised citalopram, particularly the racemate, as aged, but was also plainly directed at the isolation of its specific enantiomers.

In the court&#146s software of recognized authority to the info of this scenario, it was held that promises 1, 3 and 6 ended up not invalid for obviousness. Investigation of the enantiomers of citalopram had been an obvious objective for the everyday experienced medicinal chemist in 1988. The variance in between the prior artwork patents and the statements of the Patent was that the former disclosed only the racemate and solutions which would only make racemic compounds. They did not describe any strategy for obtaining single enantiomers of citalopram. It would not have been evident to take care of citalopram utilizing the adopted method in 1988. The common experienced analytical chemist would have had no functional knowledge of that approach and the normal skilled medicinal chemist would in all probability not have listened to of it.

In the circumstances of this case, promises 1 and 3 of the Patent ended up invalid for insufficiency. The creative step taken by the defendant experienced not been selecting to independent the enantiomers of citalopram, but discovering a way it could be carried out. Promises 1 and 3 of the Patent coated all means of making the (+) enantiomer. The initial person to locate a way of obtaining an clearly attractive goal was not permitted to monopolise each other way of performing so. Promises 1 and 3 were being hence too broad. The courtroom held that they prolonged further than any technical contribution built by the defendant.

If you need further information and facts make contact with us at [email protected]

Go to or [

© 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.

More From My Blog