Patent Listing Timing Turns on Date Submission is “Administratively Complete”

Eli Lilly Canada Inc. v. Canada (Attorney General) 2019 FC 5 Lafrenière J
            2,812,704 / pegbovigrastim / IMRESTOR

The PM(NOC) Regulations allow patents to be listed against a drug. The basic rule is that only patents which pre-date the NOC application are eligible for listing, on the rationale that subsequent inventions should not extend the duration of the linkage [12]. The Regulations implement this timing requirement with two provisions. Subsection 4(5) states that the patent list must be submitted at the time of filing the NDS, so that only patents that have already been granted can be listed under this provision. But it is not necessary that the patent has already been granted, so long as it has been applied for. Subsection 4(6) provides that a patent is eligible for listing if it has a Canadian filing date prior to “the date of filing of the [new drug] submission.” The question in this case is what is the date of filing of the NDS: is it the date at which the NDS is “administratively complete” or the date at which is it substantively or technically complete? Short answer: the former.

On June 21, 2011, Elanco submitted a Drug Submission Application form and some related forms, which got the ball rolling on the application process [20]. This material was received on June 24, 2011 and determined to be “administratively complete” as of that date. It was common ground that the submission was not substantively complete, in the sense that the efficacy data, animal safety data, etc required by subsection C.08.002(2) was not provided [20]. Elanco had been permitted to engage in a rolling submission process [19], and the bulk of the substantive information was provided over the year from March 2012 to March 2013. The Canadian patent filing date was September 22, 2011 [22], between these two dates. Thus, if it is enough that the NOC application is administratively complete, then the ‘704 patent was not eligible for listing as the patent filing date was after the NDS filing date. But if the NOC application has to be substantively complete, the timing requirement would be met, and ‘704 would be eligible for listing.

Health Canada’s position is that the date of filing is when the NDS is administratively complete. Accordingly, it refused to list the ‘704 patent. Elanco appealed. Lafrenière J, applying a deferential standard of review [50], upheld Health Canada’s position. (To be eligible for listing under s 4(6), it is also necessary that the patent be submitted for listing within 30 days of issuance. That requirement was met, and was not at issue [31].)

A key point is that “[n]either the Patent Act, the NOC Regulations or the FD Regulations define the term “date of filing” of a submission, nor do they establish rules for determining that date” [58]. Elanco relied on C.08.002(2) of the FD Regulations, which specify “A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including...” Elanco argued that “shall” was a mandatory provision. However, as Lafrenière J noted, “Subsection C.08.002(2) simply speaks to the contents of a NDS and not to when a NDS may be considered filed. All the provision does is to set out the information that a first person is required to provide in order for a submission to be processed” [59]. If it were mandatory in terms of timing, then the practice of allowing rolling submissions would not be permitted [60].

In the absence of governing statutory provisions defining the date of filing, it was open to the Minister to allocate a filing date for submissions [63]. Moreover, the rationale for using the date the filing is sound, because it promotes certainty [66]. Adopting a requirement of substantive completeness would introduce considerable uncertainty, both in light of rolling submissions and supplementary submissions.

FC Interpretation of Transitional Patent Listing Provisions Affirmed

Gilead Sciences Inc v Apotex Inc 2016 FCA 140 Boivin JA: Pelletier, Rennie JJA aff’g 2016 FC 295 (judgment), 2016 FC 231 (reasons) Heneghan J
            2,261,619 / tenofovir (PMPA) / TRUVADA

In brief reasons delivered from the bench, the FCA has affirmed Heneghan J’s decision in favour of Apotex (blogged here) which turned on the transitional provisions of the PM(NOC) Regulations relating to patent listing, saying “we see no error of law in the Federal Court Judge’s analysis and conclusions that would warrant this Court's intervention.” [1].

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.

No More Perfect Match Requirement for Patent Register Listing

Eli Lilly Canada Inc v Canada (Attorney General) 2015 FCA 166 Nadon JA: Boivin JA; Dawson JA concurring rev’g 2014 FC 152 Bédard J
            2,379,329 / TRIFEXIS

In Gilead / COMPLERA 2012 FCA 254 the FCA apparently held that a perfect literal match between the claims of a patent and the compounds set out in an NOC for a product is required before the patent can be listed on against that product on the Patent Register. In Lilly / TRIFEXISFC Bédard J, following Gilead, refused to allow the 329 patent to be listed against TRIFEXIS. The FCA has now reinterpreted Gilead and consequently set aside Bédard J’s decision. While this FCA decision evidently abolishes the perfect match requirement, it is not entirely clear what the new test is.

The facts in Lilly / TRIFEXIS are fairly simple. TRIFEXIS is authorized as an oral dosage form of a drug that contains two active medicinal ingredients: spinosad and milbemycin oxime. The 329 patent claims an “oral formulation” comprising spinosad [9]. “Oral formulation” was defined in the disclosure to include spinosad in combination with other compounds including “milbemycins” [9]. Consequently Bédard J construed the relevant claims to be directed "not only to a formulation including spinosad as the only active ingredient, but also to formulations that includes other active ingredients such as, but not restricted to, milbemycin oxime" [FC 69]. Thus she in effect held that a generic version of TRIFEXIS would necessarily infringe the 329 patent. She nonetheless refused to allow the patent to be listed against TRIFEXIS because in her view (and in my view as well, as discussed here), the FCA Gilead decision interpreted the product specificity requirement of s 4(2) of the PM(NOC) Regulations as requiring that all the ingredients be listed in the claims themselves.

The FCA has now reversed that decision. Dawson JA’s concurring opinion is straightforward. She was of the view that Gilead is not distinguishable from the case at hand, but that it was wrongly decided and should be reversed [100]. In her view, there is a sufficient nexus between the patent and the subject of the NOC if the patent claims the approved medicinal ingredient, in the sense that the approved product falls within the “boundaries” set out by the claims [107]. In my view Dawson J is entirely correct on all counts.

Affirmed that Perfect Match Required for Listing on Patent Register for Medicine as Well as Formulation

ViiV Healthcare ULC v Teva Canada Ltd 2015 FCA 93 Near J: Ryer, Rennie JJA aff’g 2014 FC 893 Hughes J (here) aff’g 2014 FC 328 Milczynski J (here)
            abacavir & lamivudine / KIVEXA / 2,289,753

In this decision the FCA affirmed that the “perfect match” requirement for listing of a patent on the Patent Register applies under all branches of the s 4(2)(a) of the NOC Regulations. That is, each medicinal ingredient must be explicitly named in a claim; it is not enough that the generic product would necessarily infringe the claim and it is not enough that all the ingredients are explicitly listed in the description.

This holding is not a surprise. I have argued that the perfect match requirement is not sound as a matter of policy, but, as discussed in my posts on the decisions under appeal (here and here) and as the FCA held [17], the case at hand is not distinguishable from the leading case, Gilead / COMPLERA 2012 FCA 254 (blogged here).

While the Minister argued in favour of the perfected match requirement in the cases in which the requirement was initially established, it argued against the requirement in this case. Industry Canada has recently indicated that the NOC Regulations will be amended to “confirm established Health Canada practices in relation to the policy intent of the NOC Regulations.” It sounds like this will reverse the rule in ViiV v Teva, but I doubt the amendments will be entirely satisfactory. As discussed here, the Minister's position is that a perfect match is required under para 4(2)(b), which applies to "a claim for the formulation that contains the medicinal ingredient," but not under para 4(2)(a), which applies to "a claim for the medicinal ingredient.” But as I explained in that earlier post, the perfect match requirement may result in pointless formalism even when applied solely under para 4(2)(b).

Must a Challenge to Listing Eligibility Be Brought on a 6(5) Motion?

Bayer Inc v Apotex Inc / drospirenone (NOC) 2014 FC 436 Hughes J
            2,382,426 / drospirenone & ethinylestradiol / YAZ

In Apotex / YAZ, Apotex argued that the 426 patent is ineligible for listing on the Patent Register. The main legal question of interest is whether Apotex could even raise the issue at the hearing, or whether it must bring a prior motion under s 6(5)(a) of the NOC Regulations. Hughes J noted at [72] that in 2005 FC 1421 Mosley J had held that Apotex was not required to make a motion under subsection 6(5), and at [74] Hughes J noted that he had commented in obiter to the same effect in 2013 FC 985 [109]. He also relied at [73] on the FCA decision in 2007 FCA 187, as being to the same effect, but it must be said that that case was about the interpretation of “claim for the medicine itself” under s 2, and not about subsection 6(5). And on the other hand, in 2008 FC 308, [65]-[66], Gauthier J after a review of the case law, held that she did not have jurisdiction to consider eligibility issues in a s 6(1) motion, as they had to be decided as a part of a s 6(5) motion. After all this, Hughes J said “It is time to put the matter to rest” [76], and held, contrary to Gauthier J, that eligibility can be raised in a s 6(1) motion, nothwithstanding that no motion was brought under 6(5). Given that Gauthier J is now in the FCA, I am not sure that Hughes J’s holding will put the matter to rest, but at least his decision does frame the issue and the split case law for the FCA to resolve.

Turning then to 426 patent, Apotex argued that it could not be listed against YAZ because the ethinylestradiol in YAZ is contained as a clathrate (a solid mixture in which small molecules of one compound are physically trapped in the holes of the crystal lattice of another substance [88]), and ethinylestradiol as claimed in the 426 patent does not encompass a clathrate. An initial question is whether a patent claiming a clathrate is eligible for listing, recalling that a patent is only eligible if it contains “a claim for the medicinal ingredient,” which excludes “different chemical forms of the medicinal ingredient.” However, a Health Canada policy statement (albeit one issued before subsequent changes to the NOC Regulations), did define the active moiety of the medicinal ingredient to include a clathrate [87]-[88], and this interpretation appears to have been accepted by Hughes J. The next question was whether ethinylestradiol in the claim included a clathrate. Hughes J held it did, based both on a straightforward grammatical analysis [91]-[92], and on Apotex’s own use of the term in its ANDS as including a clathrate [95]-[96].

Perfect Match Required for Listing on Patent Register for Medicine as Well as Formulation

ViiV Healthcare Ulc v Teva Canada Ltd 2014 FC 328 Milczynski J
            abacavir & lamivudine. / KIVEXA / 2,289,753

In Purdue / TARGIN 2011 FCA 132 (blogged here) and Gilead / COMPLERA 2012 FCA 254 (blogged here), the FCA established what has been aptly called a “perfect match” requirement for listing a patent against a drug on the Patent Register, so as to require a generic to address the patent before obtaining an NOC. This decision reaffirms that the perfect match requirement applies under all branches of s 4(2)(a) of the NOC Regulations.

A perfect match requires that each medicinal ingredient be explicitly named in a claim; it is not enough that the generic product would necessarily infringe the claim, and it is not enough that all the ingredients are explicitly listed in the description. So, in this case, the 753 patent claims abacavir (Claim 1) [4], as well as abacavir in combination with any nucleoside reverse transcriptase inhibitor (NRTI) (Claim 32). The 753 patent also disclosed that abacavir can be used in combination with other therapeutic agents, specifically naming lamivudine, which is an NRTI [16]. KIVEXA is a fixed dose dual combination drug containing abacavir and lamivudine. Consequently, it is clear that a combination drug containing abacavir and lamivudine would infringe both Claim 1 and Claim 32. The 753 patent was listed on the Patent Register against KIVEXA

Teva argued successfully that the listing was improper, notwithstanding that a generic version of KIVEXA would necessarily infringe the 753 patent, because there was no claim that specifically named abacavir and lamivudine in the claim itself. It does not matter that Claim 32 specifies a class that uncontroversially includes lamivudine, and it does not matter that lamivudine was specifically named in the description.

In Teva / KIVEXA both the patentee and the Minister argued that a perfect match is not required for listing under s 4(2)(a) of the NOC Regulations. Ths Minister’s position in noteworthy because both of the FCA cases establishing the perfect match requirement arose from the Minister’s refusal to list a patent; in this case, in contrast, the Minister is of the view that the patent is eligible.

The Minister’s position was that a perfect match is required under para 4(2)(b), which applies to “a claim for the formulation that contains the medicinal ingredient,” but not under para 4(2)(a), which applies to “a claim for the medicinal ingredient” [22]. The Minister’s view is that a perfect match should not be required under 4(2)(a) because when the basic breakthrough is the identification of a new drug, it is normal that the treatment is subsequently refined by combining that drug with other ingredients, and the innovator should be able to list that basic breakthrough invention against the subsequent improvements [23]. In contrast, if the technical contribution is the particular combination, then there a perfect match should be required under 4(2)(b) [22]. This explains why the Minister refused listing in Gilead under 4(2)(b), but supports it now under 4(2)(a). 

There is considerable logic to the Minister’s policy position, though I can’t agree with it entirely. If the technical contribution is the recognition that a particular known drug interacts advantageously with an entire class of other compounds, the innovation is a formulation, so it falls under 4(2)(b), and yet a perfect match requirement strikes me as too stringent; the effect is to require the patentee to list each complementary drug by name in the claim, rather than referring to the class as a whole, which strikes me as pointless formalism. 

In any event, while we can quibble about policy and logic, as a matter of law the Minister’s position runs squarely up against Gilead / COMPLERA. While the Minister in Gilead opposed registration under 4(2)(b), the FCA refused registration under 4(2)(a). Thus Gilead is not distinguishable from this case, and Milczynski J was right to hold that “The requisite degree of product specificity is the same for section 4(2)(a) of the PMNOC Regulations as it is for each of sections 4(2)(b), (c) and (d)” [29].

This decision makes no new law, but it does illustrate once again the absurd nature of the perfect match requirement.

Literal “Perfect Match” Construction of Claims Required for Patent Register Listing

Eli Lilly Canada Inc. v. Canada (Attorney General) 2014 FC 152 Bédard J
             2,379,329 / spinosad / TRIFEXIS

Bédard J’s Lilly / TRIFEXIS decision applies what is now the FCA’s established interpretation of the product specificity requirement in s 4(2) of the NOC Regulations to hold that the 329 patenet cannot be listed on Patent Register against TRIFEXIS, notwithstanding that a generic version of TRIFEXIS would necessarily infringe. As Bédard J pointed out, she was bound to come to this conclusion by the FCA decisions in Purdue / TARGIN 2011 FCA 132 (blogged here) and Gilead / COMPLERA 2012 FCA 254 (blogged here), which held that all the active ingredients in the product must be specifically mentioned by name in the claims. While there is no new law here, the decision illustrates the extreme nature of the product specificity requirement. Bédard J held expressly that a generic version of TRIFEXIS would infringe, and the description specifically mentioned the ingredient that was missing from the claims; but as Bédard J pointed out, neither of these points is a principled basis for distinguishing the prior FCA decisions. This further emphasizes that in order to ensure that a patent will be listable against the commercial product, it is not enough that the commercial product would clearly infringe, or even that the patent specifically describes all the ingredients of that product. The claims must specifically name the all of exact compounds found in the NOC. Bédard J aptly referred to this as a requirement of a “perfect match” [73]. References to a class of compounds, that would enable fewer, shorter, and clearer claims, do not suffice to allow listing, no matter whether they are fully adequate for infringement; all the members of the class must be listed in the claims themselves in order to ensure that a patent can be listed against the ultimate commercial product. This is a purely formal requirement, since all of the specific compounds could in principle be named in the claim itself, without changing the meaning of the claim, though it would make the claims bloated and difficult to interpret. This product specificity requirement also has the perverse effect of making it relatively easy to list an “evergreening” patent, in which a very specific change is made to an existing formulation, while making it almost impossible to list a true breakthrough patent, where the precise formulation of the ultimate commercial product is unknown at the time of filing.

TRIFEXIS is authorized as an oral dosage form of a drug that contains two active medicinal ingredients: spinosad and milbemycin oxime. The 329 patent claims an oral “formulation” of spinosad. The patent description defines “oral formulation” as follows (Bédard J’s emphasis, [9]):

The formulations of this invention may further include, in combination with the spinosyn component, one or more other compounds that have activity against the specific ectoparasite or endoparasite to be controlled, such as, for example, synthetic pyrethroids, natural pyrethins, organophosphates, organochlorines, carbamates, foramidines, […].milbemycins, […]

The term “oral formulation” means that the spinosyn component or components, either alone or in combination with one or more of the other types of compounds listed supra, formulated into a product or formulation suitable for administering to the animal by mouth.

Consequently, Bédard J construed the relevant claims of the 329 patent to be directed “not only to a formulation including spinosad as the only active ingredient, but also to formulations that include other active ingredients such as, but not restricted to, milbemycin oxime” [69]. Thus she in effect held that a generic version of TRIFEXIS would necessarily infringe the 329 patent.

However, this was not enough. While it is permitted for a patentee to create their own dictionary in the specification for the purposes of claim construction in the context of infringement, this is not permitted for the purposes of the product specificity requirement. The product specificity requirement of s 4(2)(b), requires “a claim for the formulation that contains the medicinal ingredient.” Notwithstanding that the claim of the 329 patent literal “contains” a claim to spinosad, “the medicinal ingredient” has been construed by the FCA as meaning all of the specific ingredients. It is “insufficient for a patent to meet the product specificity requirement by referring to a class of compound rather than to a specific medicinal ingredient” [84]. Rather, as Bédard J put it, there must be “a perfect match” between what is claimed and what has been authorized [73]. Note that the Minister’s position is that the exact text appearing in the NOC must appear in the claim. There are various types of milbemycins, and the Minister’s position was that it would not have been enough to refer to “milbemycin” in the claim; it would be necessary to refer to “milbemycin oxime” [12]. It is not entirely clear whether Bédard J accepted this position. She held that “Referring to the general family of milbemycins in the definition of oral formulation is not specific enough to conclude that the claims match the formulation contained in Trifexis” [85]. It is not entirely clear to me whether what was inadequate was the reference to the general family, or the fact that the reference was only in the specification, or both. That is, would the product specificity requirement have been satisfied if the claims, and not just the disclosure, had referred to milbemycins, but without reference to milbemycin oxime in particular? It is, however, clear that the Minister’s position is that a reference to milbemycin oxime in the claim itself is necessary, and this does seem to follow from the stringent nature of the product specificity requirement.

It must be emphasized that the specificity requirement is purely formal. By defining “oral formulation” in the disclosure, the claims were made more compact, but without changing the meaning of the claim at all, the definition might have been included in the claim by specifically listing synthetic pyrethroids, natural pyrethins, organophosphates, organochlorines, carbamates, foramidines, avermectins, milbemycins, insect growth regulators, nitromethylenes, pyridines and pyrazoles as compounds which would also be included in the formulation. Of course, according to the Minister this would not suffice. It would be necessary to specifically list the various types of milbemycin, namely (according to Wikipedia) milbemectin, milbemycin oxime, moxidectin, and nemadectin; and all the specific types of all the other possible components, such as organophosphates, would have to be similarly extensively listed in the claim itself. None of this would change the substantive meaning of the claim; it would be purely a formal change – and a formal change very much for the worse, as it would bloat the claim, making it much harder to understand.

I must say that I really cannot understand what purpose is served by this purely formal requirement. It is a dramatic departure from the general principle of purposive construction that is otherwise universally used in Anglo-Canadian law for the interpretation of patents and contracts, not to mention statutes. It has a perverse effect of making it relatively easy to list an “evergreening” patent, in which a very specific change is made to an existing formulation, while making it almost impossible to list a true breakthrough patent, where because the precise formulation of the ultimate commercial product will rarely be known at the time of the pioneer patent. Perhaps the answer is that no purpose is served, as the holding of the FCA in Gilead / COMPLERA 2012 FCA 254 (blogged here), was based on a textual analysis. In any event, Bédard J did not address any of these problems of principle, for the very good reason that these problems are inherent in the holdings of the FCA in Purdue / TARGIN and Gilead / COMPLERA, and she is bound by those decisions [73].

What Is a “Formulation”?

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)

            2,512,475

A question left aside in last week’s week post on this decision was whether the patent in question claimed a medicinal ingredient, and so would be eligible for listing under NOC Reg s 4(2)(a), or a formulation, eligible under 4(2)(b).

The ‘475 patent at issue includes a claim to two medicinal ingredients, tenofovir and emtricitabine, in combination with a third medicinal ingredient from the class of non-nucleoside reverse transcriptase inhibitors [claim 34; FC 24]. A “claim for the formulation” is defined (emphasis added) under the NOC Regs s 2 as

"claim for the formulation" means a claim for a substance that is a mixture of medicinal and non-medicinal ingredients in a drug and that is administered to a patient in a particular dosage form;

As the FCA emphasized, this definition requires that a formulation contain non-medicinal ingredient [27]. The relevant claims do not. Consequently, the FCA held that the eligibility of this claim turned on para 4(2)(a), not (b)[32].

This is a straightforward conclusion on the text of the provision. Why then did the Minister argue, in a point accepted by Mosley J, that the listing should be considered under 4(2)(b) [FC 37]? I think the key to the argument is captured in a statement by Russel J in Bayer Inc v Canada (Minister of Health), 2009 FC 1171 [80], aff’d 2010 FCA 161, quoted by Mosley J at [FC 41]:

The essence of a compound patent is the medicinal ingredient; the essence of a formulation patent is the mixture of ingredients.

In this case, the inventive concept was the discovery that tenofovir and emtricitabine are chemically stable when combined with a third anti-viral of the claimed class [FC 25]. The essence of the invention was the mixture of ingredients, not the discovery of any new medicine. Thus a purposive perspective suggests that the Minister and Mosley J were correct in their interpretation. But text, context and purpose must all be read together, and “[w]hen the words of a provision are precise and unequivocal, the ordinary meaning of the words play a dominant role in the interpretive process” Canada Trustco 2005 SCC 54 [10]. In this case, my view is that the text was sufficiently unequivocal that it should dominate, so that the FCA was correct in its interpretation. However, this case does illustrate a shortcoming in the drafting of 4(2)(b), in that the text is inconsistent with the apparent purpose. In this case no harm was done, as the FCA held that the claim was eligible under 4(2)(a). This implies that a mixture of medicinal ingredients is eligible under 4(2)(a) even when the mixture is desirable for reasons of formulation, and not because of a new medicinal effect. That conclusion is perhaps problematic from a purposive perspective, but it does solve the problem of this type of claim falling between the cracks of 4(2)(a) and (b).

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.

What Is the Difference Between Dosage Form and a Device?

Novartis Pharmaceuticals Canada Inc v Canada (Attorney General) 2012 FC 836 Martineau J

Pat No. 2,304,819; Tobi Podhaler®

My previous post discussed the product specificity aspect of this decision. An interesting point is also raised in respect of para 4(2)(c), which allows listing if the patent contains a claim for the dosage form. According to the RIAS to the 2006 amendments introducing the new listing requirements, a claim for a dosage form

must contain a claim that includes within its scope the approved medicinal ingredient. This latter requirement is meant to ensure that a patent directed solely to a device, such as an intravenous stand or a syringe, does not meet the definition of "dosage form" and remains ineligible for listing.

The ‘819 patent does claim a medicinal ingredient in generic terms such as “bioactive agent” and “antibiotic,” and presumably the product specificity requirement would have been satisfied if it had explicitly listed tobramycin. But even apart from the requirement of product specificity, there is still the question of whether the ‘819 patent claims a dosage form. To my mind, the perforated microparticles of the ‘819 patent are somewhere near the boundary of a dosage form and a device. Martineau J addressed this by saying:

[64] There is no doubt that the approved dosage form of Tobi Podhaler is more complex and more nuanced than an intravenous stand or a syringe. However, the rationale remains the same because the delivery system on the grounds of which the applicant seeks to list the ‘819 patent, including its different components, is one that can be used in association with a broad range of medicinal ingredients and is therefore insufficient to help the ‘819 patent qualify under paragraph 4(2)(c) of the Regulations.

This indicates that a broadly applicable delivery vehicle cannot be listed, even if it specifically refers to medical ingredients. This is a reasonable interpretation of the provision. Presumably the intent of the Regulations is that a patent for a new syringe could not be listed, even if it was claimed “for the purpose of delivering a bioactive agent.” But on the other hand, the RIAS explains that para 4(2)(c) was included because

the Government has come to the view that inventions in this area merit the special protection of the PM(NOC) Regulations. This is particularly true where biologic drugs are concerned, as effective administration of the medicinal ingredient is often dependent on the development of new and innovative delivery mechanisms.

If new and innovative delivery mechanisms are worthy of protection under the Regulations, why is a new and innovative delivery mechanisms excluded from listing simply because it can be used with a wide range of drugs? Arguably a delivery system that can be widely used is even more deserving of protection that one that is tailored to a particular drug. Perhaps the objection is that it would be wrong to allow a patent for a new delivery system to trigger the statutory stay for every new drug, simply because the drug could be delivered by that delivery system. This is a fair point, but it seems to me that it could be accommodated by a requirement that the delivery system would certainly or almost certainly be used (and so infringed) in order to be listed against a particular product. It must also be acknowledged that simply because the NOC Regulations exist, does not mean that they should apply to every type of patent, even if it is one that would necessarily be infringed, as the patent holder can always turn to an infringement action. But these kinds of questions make it difficult to see what general principle underlies the listing requirements.

Product Specificity Requires Explicit Naming of Medicinal Ingredient

Novartis Pharmaceuticals Canada Inc v Canada (Attorney General) 2012 FC 836 Martineau J

Pat No. 2,304,819; Tobi Podhaler®

Martineau J’s decision refusing to allow Novartis’ ‘819 to list its patent against its Tobi Podhaler® product follows and applies the existing case law that interprets the principle of product specificity as requiring that a patent explicitly name the medicinal ingredient in the claims in order to be eligible for listing against a drug product. While this case illustrates once again some of the conceptual peculiarities of this approach to the product specificity requirement, it does not change the law in this respect. The decision does raises some interesting questions as to the boundary between a device such as a syringe which does not qualify as a dosage form at all, and once which might quality if it otherwise meets the product specificity requirements, which will be discussed in a subsequent post.

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 Cervélo 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.)

Exact Matching Required in PM(NOC) Listing of Dosage Claims

Purdue Pharma v Canada (Attorney General) / TARGIN 2011 FCA 132 Layden-Stevenson JA: Blais CJ, Stratas JA aff’g 2010 FC 738 Crampton J

As described in the previous post, Purdue Pharma sought to list 2,098,738 against TARGIN. TARGIN is a controlled release combination of two active ingredients, oxycodone and naloxone. The ‘738 patent claims a controlled release oxycodone formulation “comprising” oxycodone in a matrix. None of the claims expressly mention naloxone. Yesterday's post critiqued the FCA’s suggestion that the ‘738 patent was restricted to drugs containing only oxycodone, so that TARGIN could not infringe. If TARGIN could not infringe, the ‘738 patent would not be eligible for listing. However, even if TARGIN might fall within the scope of the ‘738 patent, it does not follow that the ‘738 patent can be listed. Since the 2006 amendments it is clear that list eligibility and infringement do not exactly coincide: it is not true that any patent that would be infringed by production of a particular drug is therefore eligible for listing against that drug (RIAS to SOR/2006-242 at 1512). Even if TARGIN potentially infringes, listing eligibility is a distinct question. This is the issue of “product specificity.” Is the match between the product and the patent sufficiently close?