Friday, March 11, 2016

Transitional Troubles with Perfect Match Listing Requirement

Gilead Sciences Inc v Apotex Inc / (NOC) 2016 FC 231 Heneghan J
            2,261,619 / tenofovir (PMPA) / TRUVADA

Section 4 of the PM(NOC) Regulations governs whether a patent is eligible for listing on the patent register. In Gilead / COMPLERA 2012 FCA 254 (blogged here) and ViiV Healthcare 2015 FCA 93 (here) the FCA interpreted s 4 as requiring a perfect match between the patent claims and the medicinal ingredients in the approved drug – each of the medical ingredients in the drug would have to be specifically named in the a claim – before the patent can be listed. So, if a drug contained two medicinal ingredients, and the patent claimed one of those ingredients but not the other, the patent could not be listed. On 19 June 2015, shortly after Viiv was decided, the Regulations were amended by SOR/2015-169, to provide in s 4(2.1) that a patent is eligible for listing even if the drug contains more medicinal ingredients than are listed in the patent. The express intent of the amendment as set out in the accompanying RIAS was to reverse Gilead / COMPLERA and Viiv. To complicate matters, just before the amendment came into force, the FCA released its decision in Eli Lilly / TRIFEXIS 2015 FCA 166, which distinguished Gilead / COMPLERA, albeit not very convincingly, in my view, and allowed a patent to be listed even though the claims did not perfectly match the medicinal ingredients.

The overarching issue in this case is whether the ‘619 patent is eligible for listing against TRUVADA [1]. (While this is an NOC proceeding, a patent that is not eligible for listing need not be addressed pursuant to paragraph 6(5)(a) of the Regulations.) TRUVADA has two medicinal ingredients and the ‘619 patent did not claim one of them [117]. Thus, it was common ground that the ‘619 patent was not eligible for listing if Gilead / COMPLERA and Viiv stated the applicable law.

There were two sub-issues. First, did the amended Regulations apply? If not, did Eli Lilly / TRIFEXIS reverse Gilead / COMPLERA and Viiv?

On the first issue, the transitional provisions provide that the amended Regulations would apply to “any ongoing application. . .that are initiated during the period that begins on May 2, 2015 and ends on the day on which this section comes into force [June 19, 2015]” [19]. Heneghan J held, I think rightly, that the “plain and ordinary meaning” of those words “is that the Unamended Regulations apply in respect of any motion that was filed before May 2, 2015.” Since Apotex filed its Notice of Motion on March 6, 2015, it followed that unamended Regulations applied [113]. While Gilead raised a variety of counter-arguments, the strongest – or at least the most interesting – is that the RIAS expressly stated that the amendments “would restore the intent of the original and amended PM(NOC) Regulations, and clarify ambiguities regarding the listing requirements.” In Merck Frosst v Apotex / norfloxacin 2011 FCA 329, discussed here the FCA held that a clarifying provision is not retroactive and “is not evidence of a change of approach by legislators, but rather a desire to ensure that earlier laws ‘reflect the principles [legislators] had in mind and communicated when the law was passed’” [50]. The RIAS echoes this language, saying that the amendments were intended to “capture the original policy intent of the listing requirements.” If the amendments were merely clarifying, then they should apply regardless of when the motion was filed, as the law should not be taken to have changed. The difficulty with this argument is that if it was true that the amendments were merely clarifying, the transitional provision itself would be redundant and meaningless. Evidently the legislators recognized that while the amendments were restoring the original intent of the Regulations, they were changing the law which was set out in Gilead / COMPLERA and Viiv.

On the next issue, Gilead argued that even if the amended Regulations did not apply, the effect of Eli Lilly / TRIFEXIS was to reverse the earlier FCA cases. I have a great deal of sympathy for this view: my post on TRIFEXIS was titled “No More Perfect Match Requirement for Patent Register Listing.” But Heneghan J held that TRIFEXIS “made a distinction on the facts.” That is very reasonable view of the majority decision – indeed, it is how the majority in TRIFEXIS characterized its own decision: “this examination of the facts and holdings in Gilead FC and Gilead FCA distinguishes these decisions from the present appeal” [88]. I must add that Dawson JA in her concurrence could not see the basis for the distinction, and neither can I. And while Heneghan J said “I agree with Apotex that the three decisions can be read consistently” [112], she did not explain how that could be done. Nonetheless, Heneghan J was undoubtedly entitled to take the majority’s explanation of its decision at face value. The difficulty, as I said in my post on TRIFEXIS, is that “[t]he main justification for adhering to precedent is to provide certainty. But an unfounded distinction does the opposite; we now have two irreconcilable decisions that are both formally good law.” The result in any given case will turn on which of the two lines of precedent the subsequent court chooses to follow. Fortunately, the conflict between these FCA cases will be moot in future cases in which the amended Regulations apply.

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