Thursday, May 10, 2012

Patent Listing Refused Though Generic Formulation Would Necessarily Infringe

Gilead Sciences Canada, Inc. v. Canada (Minister of Health) / COMPLERA 2012 FC 2 Mosley J

The purpose of the PM(NOC) Regulations is to provide a pharmaceutical patentee with what amounts to an automatic interlocutory injunction when faced with generic entry into the market: 2010 FCA 155 [36]. A crucial difference is that instead of the assessment of the likelihood of success on the merits that would be undertaken in an application for an interlocutory injunction, the trigger for the statutory stay is simply that the patent is listed against the drug on the Patent Register. There is nonetheless a functional parallel between these requirements. Likelihood of success in a patent action depends on likelihood of success on both validity and infringement. The fact that the patent has been examined and granted establishes some likelihood of success in respect of validity. The likelihood of success in respect of infringement, on the other hand, is determined by the criteria for listing the patent against the drug on the Register. As explained in the RIAS to the 2006 Amendments, under the original Regulations, as interpreted by the courts, the criteria for listing were too generous, with the consequence that a patent could be listed, and thus trigger the automatic stay, even though the patent might be irrelevant to the drug at issue. As I have discussed in a previous post, the FCA interpretation of the new Regulations has been very strict, but the results in those particular cases were arguably justifiable, as it was not clear on the facts that a generic version of the drug would necessarily infringe the patent in question. In the COMPLERA case Mosley J took the next step, and upheld the decision of the Minister of Health to refuse to list a patent which would necessarily be infringed by any generic version of COMPLERA. In my view, COMPLERA shows that the pendulum has now swung too far the other way.

The facts are relatively simple. COMPLERA is formulated with three medicinal ingredients: (1) tenofovir; (2) emtricitabine; and (3) rilpivirine [3]. The ‘475 patent at issue includes formulation and compound claims to tenofovir and emtricitabine in combination with a non-nucleoside reverse transcriptase inhibitor (NNRTI) [24]. Rilpivirine is an NNRTI [10]. None of this is contested. While Mosley J noted that rilpivirine is not expressly referenced in any of the claims “and can be included only by deductive reasoning because it falls within a named class” [28], the necessary deduction is purely a matter of logic. Thus it is perfectly clear that a generic form of COMPLERA would infringe the ‘475 patent. 

Mosley nonetheless held that the ‘475 patent cannot be listed, essentially because it does not claim a combination specifically naming rilpivirine. Mosley J explained that “[o]n a plain and ordinary reading of paragraph 4(2)(b), all of the ingredients in the NDS have to be found in the formulation in the claim” [47]. I agree with that interpretation of the Regulation, but I don't see how  it justifies the result, as it seems to me that all of the ingredients in the NDS, namely tenofovir, emtricitabine and rilpivirine, are indeed found in the formulation in the claim. The formulation lists an NNRTI, rather than rilpivirine specifically, but I fail to see why this matters. If I point at a shipping container and say that “a Volkswagen Golf, a Ford F150 pick-up truck, and a bicycle are found in this container,” then my statement is true if the container holds a Volkswagen Golf, a Ford F150 pick-up truck, and a CervĂ©lo R5ca bicyle, notwithstanding that I used the generic term “bicycle” rather than specifying the make and model.

Nor is a requirement to specifically name the compound is sensible on a purposive interpretation. Suppose a patentee discloses and claims a revolutionary new class of drugs that cures cancer. As is commonly the case, the best species of the class may be developed afterwards, and so is not disclosed in the pioneer patent. Consequently, under the COMPLERA decision, the pioneer patent could not be listed. At the same time, there might be no patent at all claiming the species specifically, if, for example, it was the result of routine refinements that simply had not yet been carried out at the time of the pioneer patent.

The requirement of product specificity in listing patents on the register plays a parallel role to the requirement of a likelihood of success in seeking an interlocutory injunction. It is important to strike the right balance in so-called "product specificity" in order to ensure that the NOC Regulations provide adequate protection to a patentee, without allowing abuse by listing of irrelevant patents. The old Regulations, as interpreted, adopted an extreme position by allowing a patent to be listed even though it was irrelevant to the formulation in question, and so could not possibly be infringed by a generic version of the drug. The COMPLERA decision adopts another extreme position by refusing to list a patent that must necessarily be infringed by a generic version of the drug. A caveat is that it may be appropriate to refuse to list a patent that would necessarily infringe if the technical advance disclosed by the patent is too minor to warrant the protection of a statutory stay: this, presumably, is the policy behind the exclusion of different chemical forms from the definition of “claim for the medicinal ingredient” in s 2. But that caveat does not justify the COMPLERA decision, as is illustrated by my example of the blockbuster pioneer patent.

(Note that this decision was rendered in January of this year, but it was only recently made available on the FC website.)

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