Thursday, March 12, 2009

Justice Hughes attempts roadmap for counsel seeking to apply Supreme Court's Sanofi decision

Here's a recent article by Nathaniel Lipkus, which I neglected to post when it first came out...

The Federal Court denied Bristol-Myers Squibb’s application to prevent Apotex from entering the Canadian cefepime market, and in doing so attempted to bring much-needed certainty to the law of obviousness and anticipation in Canada.

On February 10, 2009, the Federal Court of Canada released its decision in Bristol-Myers Squibb Canada Co. v. Apotex Inc., 2009 FC 137. In his decision, Justice Hughes attempts to summarize developments in the law of obviousness and anticipation of patents in Canada, following the Supreme Court’s November 2008 decision in Apotex Inc. v. Sanofi-Synthelabo Inc., 2008 SCC 61.

The recent BMS case is a proceeding under the Patented Medicines (Notice of Compliance) Regulations involving Canadian Patent No. 1,213,882, a patent claiming the monohydrate form of cefepime dihydrochloride, which is an antibiotic marketed by BMS in Canada as MAXIPIME. Apotex made several allegations of invalidity. Justice Hughes accepted Apotex’s allegations of obviousness and double-patenting but denied its anticipation argument.

After Apotex filed its Notice of Allegation in respect of cefepime, BMS made a partial disclaimer of its asserted claims. Nonetheless, Justice Hughes ruled on the versions of the patent claims as they existed at the time of Apotex’ NOA.

In applying the law of anticipation, Justice Hughes had regard to the Sanofi decision, and also to his recent ruling in Abbott Laboratories v. Canada (Minister of Health), 2008 FC 1359. Sanofi had required explicit consideration of disclosure and enablement in determining whether a patent claim had been anticipated. In Abbott, Justice Hughes had added to the list of considerations in assessing disclosure and enablement, finding that a disclosure need not have been recognized at the time as such, and that determinations of disclosure and enablement are to be made on a balance of probabilities.

Apotex had conducted extensive testing modeled after the experiments in the 882 Patent, intended to demonstrate that the monohydrate form of cefepime had been formed in the testing in the 882 Patent. However, Apotex had conducted its experiments before serving its NOA and without disclosing the experiments in the NOA. Consequently, Justice Hughes accorded the testing little weight. Finding that Apotex bore the burden in demonstrating anticipation, Justice Hughes did not find the asserted claims to be anticipated.

In summarizing the legal principles relating to obviousness, Justice Hughes had regard to the Sanofi decision, as well as the Federal Court of Appeal’s recent decision in Apotex Inc. v. Pfizer Canada Inc., 2009 FCA 8. Justice Hughes recognized and applied the Windsurfing questions adopted by the Supreme Court in Sanofi, modified by the Federal Court’s observation in Pfizer that “the mere possibility that something might turn up is not enough”.

Justice Hughes slavishly answered the Windsurfing questions and concluded that asserted claims of the 882 Patent were obvious. Apotex relied upon a Greek patent application that was nearly identical to the 882 Patent, except in respect of disclosures of the monohydrate as having improved stability compared to the anhydrate. Acknowledging this as the only difference between the prior art and the 882 Patent, Justice Hughes found obviousness of the 882 Patent, and in doing so, offered the following analogy, which will surely be cited by patent defendants in upcoming cases:

"[160] Is it unexpected that given a class of materials all having excellent stability, that one member of the class, when tested once, would exhibit superiority over another? All members of a professional basketball team are accomplished players, it is not unexpected that on a particular day one player will perform better than one of the other players. That does not mean that such a player is surprisingly or unexpectedly better than all or most of the rest of the team."

Despite alluding to the controversial concept of selection patents in the above passage, Justice Hughes shied away from undertaking a selection patent analysis apart from his obviousness and anticipation analyses, finding that “there is a danger in giving names to certain patents and then, having given such names, arguing whether the patent meets criteria for such names … there is no need to somehow further the discussion through any lens created by labelling the patent a selection patent.”

It is too early to say whether BMS will generate the much-needed certainty in patent law that plaintiffs and defendants alike are looking for after Sanofi. However, in BMS, Justice Hughes does provide litigation counsel a clear roadmap for applying the tests laid out in Sanofi, as he sees them. Time will tell whether appeal courts will vindicate his attempt at simplification.

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