Canada: Sanofi’s Canadian Patent On Plavix Valid And Infringed By Apotex

On July 24, 2013 the Federal Court of Appeal released its decision reversing the trial court's ruling that Sanofi's patent covering Plavix is invalid.  For the full written decision see: Apotex Inc. v. Sanofi-Aventis, 2013 FCA 187.

In its decision, the Court of Appeal provides clarification on invalidity in light of the so-called promise of the patent.  Not all patents contain a promise.  For there to be a promise, it must be both explicit and specific.  The Court of Appeal also reiterates the requirement that for an invention to be obvious, it must be self-evident that what is obvious to try will work.

Law of Utility and the Promise of the Patent Clarified

A patentee need not describe the utility of her invention in the patent itself.  Where a lack of utility is alleged, a patentee must show that at the time that the patent was applied for, the utility of the invention could either be demonstrated or soundly predicted.  This is where the notion of the promise of the patent is relevant.

According to the Court of Appeal, "[t]he promise of the patent is the standard against which the utility of the invention described in the patent is measured."  The Court of Appeal notes that an inventor need not describe the utility of her invention in the patent; however, if she does, then she will be held to the promise made.  Where there is no explicit promise of a specific result, the test for utility is a "mere scintilla".  However, where an explicit promise of a specific result is made, utility will be assessed "by reference to the terms of the explicit promise."

What does that mean?

First the Court of Appeal clarifies that not every patent contains an explicit promise of a specific result.  A court must therefore construe the patent to determine if it would be understood by a skilled person to contain an explicit promise that the invention will achieve a specific result.  If not, then there is no promise and only a mere scintilla of utility is required.

Part of the debate in this appeal revolved around whether the '777 Patent contained an explicit promise regarding a specific result in humans.  The trial judge had found that it did based on expert testimony from one expert who came to that conclusion on the basis of inferences drawn from expressions used in the patent.  However, the Court of Appeal views those inferences as being equivocal.  The Court of Appeal also notes that the trial judge drew on additional inferences that he found from his reading of the patent and states that construing the patent in such a way is an "unreliable guide to the skilled persons reading of such a document."

Importantly, the Court of Appeal indicates a distinction in the jurisprudence between "the potential use of an invention and an explicit promise to achieve a specific result".  That should guide the interpretive exercise in future cases.

The key takeaway here seems to be that with regard to the promise of the patent, the promise must be explicit and it must be of a specific result.  Efforts to impute a promise to the patent through inferences and implicit suggestion will be rarely, if ever, permissible in law.

Canadian Law of Obviousness Remains Unchanged

On the issue of obviousness the Court of Appeal reiterates that the Canadian test for obviousness is not met where the inventive concept of a patent and the common general knowledge cannot be bridged by routine experimentation because results of such experimentation are unknown.

More to come

These parties have been involved in litigation over Plavix for quite some time.

In Canada, the PM(NOC) case went to the Supreme Court of Canada.  The resulting decision has been heralded as the leading case on the Canadian law of obviousness: Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61.

Although Sanofi was successful against Apotex in its PM(NOC) case, Apotex commenced an action in the Federal Court seeking a declaration that Sanofi's Plavix patent (the '777 Patent) is invalid.  Sanofi countered for damages owing due to Aptoex's infringement.

Following a 26 day trial, the Federal Court found the '777 Patent invalid: Apotex Inc. v. Sanofi-Aventis, 2011 FC 1486.  That ruling was made on the basis that the promise of the patent was neither demonstrated nor soundly predicted:  In addition, and somewhat surprisingly, the trial judge also found that the invention in the '777 Patent was obvious despite the Supreme Court finding the opposite in 2008.

The Federal Court of Appeal reversed the trial judge on both accounts.  Apotex is now an adjudged infringer and will be subject to a damages case.

We should know in about six months whether the Supreme Court of Canada will once again consider a Plavix appeal.  In the meantime, Sanofi may pursue its damages claim against Apotex.

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