Saturday, 5 July 2008

Nebivolol: Janssen’s key patent invalidated in UK due to lack of novelty

Actavis (Generic) seeks revocation of EP0334429 whose assignee is Janssen (Innovator). The Patent covers method of use with stereochmical concept of an important antihypertensive beta blocker Nebivolol. Janssen has applied to amend certain claims of the Patent. Actavis maintains that the Patent, even if so amended would remain invalid for lack of novelty and lack of inventive step.
In Nebivolol, there are four pairs of enantiomers and two meso forms, a total of ten enantiomers. Nebivolol comprises a 1:1 mixture of two isomers: the SRRR and the RSSS. The former is referred to as d-nebivolol and the latter as l-nebivolol.
In the prior art discussion of ‘429 the patent describe US4,654,362 (cited as prior art in this case) which covers a class of 2,2'-iminobisethanol derivatives having ß-blocking activities.
The judge Floyd concluded that claims are not novel in the light of 362 disclosures and rejected the important claims. Judge observed that merely explaining the mechanism which underlies a use already described in the prior art cannot results into novelty and claimed invention in '429 lacks novelty and inventive step.
The above decision is an example to snub patent ever-greening attempts of innovator.
(Link to opinion)

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