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Summary

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Health law - Drugs - Notice of compliance - Patents - Genus and selection patents - Whether doctrine of selection patents can be reconciled with doctrine of double patenting and the Gillette defence to prevent evergreening of patents - Whether doctrine of selection patents can be reconciled with the statutory requirements of enabling disclosure, novelty and inventiveness to ensure that patent teachings are complete and not misleading.

On Sanofi’s motion, the Federal Court issued an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex for 75 mg clopidogrel bisulfate tablets, a generic version of Plavix, a blood-thinner. The prohibition order is in effect until Sanofi’s 777 patent on Plavix expires in 2012. An appeal to the Federal Court of Appeal was dismissed.

The patent in question (777) relates to the invention of clopidogrel, a process for its preparation and pharmaceutical compositions containing it. Clopidogrel is an isomer, one half of a larger chemical compound known as a racemate. Racemates contain equal amounts of two optical isomers - the dextro-rotatory isomer and the levo-rotatory isomer. Clopidogrel is the common name for the dextro-rotatory isomer, and it is more beneficial than the racemate because it provides the same benefits while being less toxic and better tolerated. Apotex alleged that some of the claims of the 777 patent were invalid because they were anticipated by the 875 patent issued on October 8, 1985, and on the basis of obviousness and double patenting. The 875 patent discloses and claims a large class of compounds useful in providing platelet aggregation inhibiting activity, and 21 identified derivative compounds, all of which are racemates. One is the racemate from which the separated isomers were obtained in the 777 patent. The 875 patent directly states the existence of isomers, but does not provide any teaching on how to separate the racemates into their isomers, nor does it mention that there are any pharmaceutical or toxicological differences between the isomers of the disclosed racemates with respect to activity or tolerability. The 875 patent expired in 2002. Apotex alleged that the compositions of clopidogrel contained in the 777 patent were already disclosed and claimed as inventions in the prior art of the 875 patent and that the 777 patent was therefore invalid.

Lower Court Rulings