if your anxiety causes gi distres
Ala
Canada: Court Finds AstraZeneca Patent To Esomeprazole (NEXIUM) Invalid For
Lack Of Sound Prediction And Obviousness
Intellectual property group
13 September 2010
AstraZeneca Canada Inc. v. Apotex Inc., 2010 FC 714
This was an application brought by AstraZeneca under the provisions of the
Patented Medicines (Notice of Compliance) Regulations for an order
prohibiting the Minister of Health from issuing a notice of compliance to
Apotex for 20 and 40 mg esomeprazole magnesium tablets until after the
expiry of Canadian Patent No. 2,139,653 (the '653 patent). If successful on
the application, this would have prevented Apotex from marketing a generic
version of NEXIUM in Canada for treating conditions wherein a reduction of
gastric acid secretion is required until May 27, 2014. Apotex, on the other
hand, sought early market entry by arguing that the '653 patent was invalid
for lack of sound prediction, anticipation (or lack of novelty), and
obviousness.
The '653 patent relates to an improved process for preparing highly
optically pure esomeprazole, one of the enantiomers of the racemate
omeprazole, that is stable against racemisation (i.e. recombination). Claim
8 was the claim at issue and could be read as claiming a salt (e.g.
magnesium) of esomeprazole having an optical purity of 99.8% or greater.
There was no provision as to utility (or use of the invention) in claim 8.
This was an important fact, as the Court noted that where the invention
relates to a new compound, utility does not need to be included in the
claim, so long as it is described in the description portion of the patent.
On the other hand, when the patent relates to a new use for an old, known
compound, that new use must be set out in the claims. In this case, claim 8
was not directed to a new compound; it was directed to a previously known
compound having a particular purity.
Moreover, utility of the compound was simply described in the description of
the patent as follows:
It is desirable to obtain compounds with improved pharmacokinetic and
metabolic properties which will give an improved therapeutic profile such as
a lower degree of interindividual variation. The present invention provides
such compounds, which are novel salts of single enantiomers of omeprazole.