Legal Updates

Intellectual Property Law – European Patent – Pharmaceuticals – Amendment – Revocation of Patent – Stereochemistry of Nebivolol – Lack of Novelty – Lack of Inventive Step

The case of Actavis UK Ltd v Janssen Pharmaceutical NV [2008] concerned a revocation application regarding the amendments of claims in relation to a European patent. The claimant in this case sought the revocation of European patent No 0334429 (“the Patent”) which was held in the name of the defendant. The Patent concerned nebivolol (around the stereochemistry of the drug), which is an important drug for treating blood pressure.

The defendant applied to amend a number of specific claims in the Patent. The claimant argued that the Patent, even if it was amended, was invalid due to the lack of novelty and lack of inventive step.

The case concerned compounds with more than one chiral centre in relation to their stereochemistry.

Claim 1 of the Patent stated that:

“…The use for the manufacture of a medicament for potentiating the effects of blood pressure reducing agents having adrenergic and/or vasodilating activity, other than the agents of formula (I) ... of a compound of the formula (I) ... or a pharmaceutically acceptable acid addition salt...”.

Claim 3:  claimed the use according to claim 1 wherein the compound used was 1-nebivolol.

Claim 4: stated that:

“A pharmaceutical composition comprising a pharmaceutically acceptable carrier, a compound of formula (I) as defined in any of claims 1 to 3, and a blood pressure reducing agent having adrenergic and/or vasodilating activity, said agent being other than the said compound of formula (I)”.

In Claim 5 the defendant claimed a claim 4 composition selecting the blood pressure agent from a list of known agents.

In Claim 6 the defendant claimed a claim 4 composition with d-nebivolol as the agent.

In Claim 7 the defendant claimed claim 5 or 6 compositions where the molar ratio of the compositions was 1:1.

The defendant in this case had applied to amend claim 4 to substitute the words “consisting of” to “comprising”. The amendments were thought to have a narrowing effect on claims 5 to 7. It should be noted that the claimant did not oppose the amendment. However, it did argue that the claims as amended were obvious. They relied on a lack of novelty in light of a prior patent (362) and a scientific conference in Guildford in September 1987, which rendered the amended claims invalid for lack of novelty.

The court held that:

• By simply expanding on the mechanism underlying a use already described in a prior art, without any additional information, does not give rise to novelty under patent law.
• The amended claims were novel, on the grounds that a person skilled in the art was unable to make a pharmaceutical composition from directions given in 362 because there were no clear and unmistakeable directions in 362 to make such compositions.
• Claims 4, 5, 6 and 7 were not obvious in relation to 362.
• Claim 1 lacked novelty because of 362 and was obvious.
• Claims 4, 6 and 7 lacked novelty.

The application to amend therefore failed.

Note: A patent application must have sufficient information for the claims to be repeated.

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© RT COOPERS, 2008. 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.