Sunday, October 14, 2012

Extreme Application of Product Specificity Requirement Affirmed

Gilead Sciences Canada, Inc v Canada (Minister of Health) / COMPLERA 2012 FCA 254 Trudel JA: Sharlow, Mainville JJA, aff’g 2012 FC 2 Mosley J (blogged here)

In this decision the FCA has affirmed a very strict application of the already strict product specificity requirement for listing a patent against a drug on the Patent Register that it set out in Purdue Pharma / TARGIN 2011 FCA 132 (blogged here). In my view, the requirement as set out by the FCA is overly strict and is not consistent with a purposive interpretation of the relevant provisions of the NOC Regulations.

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 a claim to tenofovir and emtricitabine in combination with a non-nucleoside reverse transcriptase inhibitors (NNRTI) [claim 34; FC 24]. Rilpivirine is not expressly referenced in any of the claims, but it is uncontested that rilpivirine is an NNRTI. Thus it is perfectly clear that a generic form of COMPLERA would infringe the ‘475 patent.

Eligibility for listing turns on s 4(2) of the NOC Regulations. While Mosley J in the FC accepted the Minister’s submission that the applicable provision was s 4(2)(b) (formulation), the FCA held that the correct provision was s 4(2)(a) (medicinal ingredient). This has no effect on the product specificity requirement which was ultimately the crux of the case. Section 4(2)(a) provides:

A patent on a patent list in relation to a new drug submission is eligible to be added to the register if the patent contains (a) a claim for the medicinal ingredient and the medicinal ingredient has been approved through the issuance of a notice of compliance in respect of the submission

Since an NOC had been issued for COMPLERA, the ‘475 patent is eligible for listing against COMPLERA under s 4(2)(a) if the '475 patent "contains a claim for the medicinal ingredient.”

The question therefore is whether claim 34 claims “the medicinal ingredient” in COMPLERA. The FCA held that it does not, on the basis that it does not satisfy the requirement of product specificity. In effect, the FCA interpreted s 4(2) as requiring that the ingredients must be listed by name: “in the case at bar, 'the' medicinal ingredients, i.e., tenofovir, emtricitabine, and rilpirivine, must be set out in the patent claims and the NOC for the patent to be eligible on the register” [40]. In my view this interpretation is wrong as it is not consistent with the purpose of the listing requirement.

The modern approach to interpretation has been summarized by the SCC in Canada Trustco 2005 SCC 54 [10]:

The interpretation of a statutory provision must be made according to a textual, contextual and purposive analysis to find a meaning that is harmonious with the Act as a whole. When the words of a provision are precise and unequivocal, the ordinary meaning of the words play a dominant role in the interpretive process. On the other hand, where the words can support more than one reasonable meaning, the ordinary meaning of the words plays a lesser role. The relative effects of ordinary meaning, context and purpose on the interpretive process may vary, but in all cases the court must seek to read the provisions of an Act as a harmonious whole.

It is always necessary to consider the purpose of a provision. As I explained in my post on the FC decision, 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 in the market. 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 on 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 noted by the FCA [43], the 2006 revisions were intended to make the listing requirements stricter. But that does not tell us how strict. Given that the purpose of listing is to ensure a sufficient likelihood of infringement to warrant granting an automatic stay, in my view it follows that the patent should be eligible for listing if a generic version of the drug would necessarily infringe the patent.

The principle that a statute should not be interpreted so as to give absurd consequences is a kind of sanity check for a purposive interpretation. If an interpretation would give an absurd result in light of the purpose of the provision, then it is not consistent with that purpose. In my view the extreme product specificity requirement insisted upon by the FCA leads to absurd consequences. For example, as I noted in my post on the FC decision, suppose a patentee discloses and claims a revolutionary new class of drugs that cures cancer. Routine work subsequently leads to the identification of the specific species of that class that is most effective, and the patentee obtains an NOC for that species. Under the FCA interpretation of the product specificity requirement, the genus patent could not be listed against the species drug, notwithstanding that any generic version would necessarily infringe and no patent could be obtained for the species. How far will specificity go? As another example, suppose that patent for a new drug claims “compound X and its pharmaceutically acceptable salts” as well as several specific salt forms. Through routine testing the patentee subsequently discovers that another salt, not specifically named, is preferable, and gets an NOC for that salt form. Could the patent be listed against that drug? In that case it might be said that the medicinal ingredient is compound X, not the salt. But if that is true, why isn't it also true that "the" medicinal ingredient in COMPLERA is the NNRTI, which happens to be riplivine?

The FCA interpretation emphasized the use of the definite article “the medicinal ingredient” in the regulations [39]. While it is true that the provision uses the definite article, I do not see how that compels the FCA’s conclusion. To simplify, suppose that the patent claimed NNRTIs and the drug was rilpivirine alone. It seems to me that as a matter of ordinary grammar, that patent “contains a claim for the medicinal ingredient.” Even accepting that the medicinal ingredient is rilpivirine, and not any NNRTI, the patent contains a claim “for” riplivirine, in the sense that the sale or manufacture of riplivirine would infringe. At the very least the words of the provision are “reasonably capable of bearing” that interpretation, and so should be interpreted in accordance with the purpose of the legislation.

In summary, at one extreme, a patent should not be eligible for listing if it could not possibly be infringed by a generic version of the drug; at the other extreme I would have thought that it must be eligible for listing if it would necessarily be infringed by a generic version. There is a great deal of room between these two extremes for debate as to where the precise line might be drawn. But I must admit that I find it very difficult to understand why the Minister and the FCA have adopted a position that lies at the extreme end of the spectrum.

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