Wednesday, July 9, 2014

Enhanced Disclosure Requirement Only in New Use Cases

AstraZeneca Canada Inc v Apotex Inc 2014 FC 638 Rennie J
            2,139,653 – esomeprazole – NEXIUM

As noted in yesterday’s post, in Apotex / esomeprazole Rennie J held that the effect of the SCC’s obiter remarks in Teva / sildenafil 2012 SCC 60 is to overturn previous FCA decisions holding that the factual basis for utility must be disclosed in the patent itself in all cases of sound prediction [142]. On Rennie J's view, the disclosure requirement is now “limited to the context of ‘new use’ patents, assuming such a utility disclosure requirement exists at all” [141]. This holding was expressly obiter [139], because he held that “none of the studies, disclosed or otherwise, demonstrate or soundly predict” the promised utility [140]. Nonetheless, it was a clear holding arrived at after thorough consideration.

To begin, Rennie J noted that “it is not in dispute that disclosure is not required for the demonstration of utility” [130]. In context, “disclosure” refers to disclosure in the patent of evidence demonstrating utility. The holding that such disclosure is not required is established law (see eg 2010 FCA 197 [74]; 2010 FCA 242 [80]; 2008 FCA 108, [56-64]).

He then noted that Wellcome / AZT 2002 SCC 77 [70] requires “proper disclosure” as the third component of the test for sound prediction [138], and he acknowledged that the FCA has interpreted this as requiring proper disclosure in all cases of sound prediction [142]. Rennie J began his analysis of why this is no longer good law with the Patent Act. He pointed out that utility and disclosure are treated separately, and that “there is no statutory basis for a requirement to disclose either the factual basis or the sound line of reasoning required to support a sound prediction of utility” [144].

Rennie J then provided a very careful analysis of the crucial paragraph [70] of Wellcome / AZT . That paragraph begins by saying “The doctrine of sound prediction has three components,” which is no doubt why the courts have previously understood “proper disclosure,” the third component, to apply to all cases of sound prediction. But Rennie J notes [146] that in discussing proper disclosure, the SCC begins by noting that elevated disclosure is not normally required:

Thirdly, there must be proper disclosure. Normally, it is sufficient if the specification provides a full, clear and exact description of the nature of the invention and the manner in which it can be practised. It is generally not necessary for an inventor to provide a theory of why the invention works. Practical readers merely want to know that it does work and how to work it.

The structure of this paragraph implies that normally, even in cases of sound prediction (the topic of the paragraph as a whole), the requirement of proper disclosure is satisfied by the standard disclosure requirement. Rennie J points out [147, his emphasis] that any elevated disclosure is an exception to this rule:

In this sort of case, however, the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly.

The structure of this sentence implies that “this sort of case” is not all sound prediction cases, but only some sound prediction cases. As Rennie J says

[151] [I]t is clear from Justice Binnie’s reasoning that “this sort of case” is a subset of sound prediction cases and not a reference to all sound prediction cases. As he writes, “[i]n this sort of case, the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly” (at para 70). By implication, there are other “sort[s] of case[s]” where the sound prediction is not the quid pro quo offered by the applicant.

This seems to be to be right, as a matter of logic and grammar. I must admit that I had always read the three sentences of paragraph [70] beginning with “Normally,” as simply describing the normal disclosure requirement that applied in cases other than sound prediction cases. I had therefore taken the key issue to be what constitutes “proper disclosure” in sound prediction cases generally. (Presumably the FCA read the paragraph the same way.) But on reflection I think that Rennie J’s reading of paragraph [70], in which “normally” describes the normal requirement for sound prediction cases, with an exception for “this sort of case,” is a better textual interpretation – though the paragraph is certainly not free of ambiguity. (And of course, on Wellcome / AZT alone, the question of what constitutes proper disclosure even in “this sort of case,” is left open.)

On Rennie J’s reading, the key question is what the SCC meant by “this sort of case.” He held that “this sort of case” means new use cases. AZT was indeed a new use case, which supports that interpretation. Rennie J advanced a purposive analysis in addition to his textual analysis (his emphasis):

[152] Second, and even more critically, limiting “this sort of case” to new use cases, rather than sound prediction cases generally, is consistent with the rationale provided by Justice Binnie. In a new use case (which AZT was), there may be an enhanced disclosure requirement because utility is the only thing being offered in exchange for the patent monopoly since the compound itself was previously disclosed.

Rennie J also appealed to the passage from Teva / sildenafil in which the SCC made some obiter remarks regarding sound prediction, including the following:

[38] As the courts below noted, all that is required to meet the utility requirement in s. 2 is that the invention described in the patent do what the patent says it will do, that is, that the promise of the invention be fulfilled

After quoting a passage from Wellcome / AZT [56] in which demonstrated utility and sound prediction are discussed together, the SCC went on to say:

[40] Nothing in this passage suggests that utility is a disclosure requirement; all it says is that "the utility required for patentability (s. 2) must, as of the priority date, either be demonstrated or be a sound prediction". Utility can be demonstrated by, for example, conducting tests, but this does not mean that there is a separate requirement for the disclosure of utility.

Rennie J interpreted this as saying that there is no heightened utility requirement for sound prediction generally, so overruling FCA decisions to the contrary. While that is a reasonable interpretation of the quoted passages, I’m not sure it was so broadly intended. The SCC began this discussion by saying “ I am of the view that this is not a case about sound prediction and that Teva's argument [that Claim 7 is invalid for insufficient disclosure of sound prediction] on this point must fail” [36]. What follows can be taken as an explanation of why Teva’s claim must fail, given that it is not a sound prediction case, in which case the remarks are directed at demonstrated utility, not sound prediction generally. This is consistent with the SCC’s concluding statement that “Since sound prediction is not an issue, the question whether there is an "enhanced" or "heightened" disclosure requirement with respect to sound predictions does not arise in this case and need not be addressed” [43]. However, as with para [70] from Wellcome / AZT this passage is ambiguous, and Rennie J may well be right.

Whether or not Teva / sildenafil overruled prior FCA authority, Rennie J has made a strong argument based on Wellcome / AZT that any enhanced disclosure requirement should apply only in new use cases, not all cases of sound prediction. (And of course, the SCC did not hold that there was any enhanced requirement in any kind of case, only that there was the possibility of some kind of enhanced disclosure in “this sort of case”.) But the question remains as to what that enhanced disclosure might be. Rennie J stated that disclosure of evidence of utility should be required in new use cases because

[152] Theoretically, without such an enhanced disclosure requirement in new use cases, a new use patent could consist of a single sentence alleging a new use and a reference to a prior patent disclosing the compound to which the use attaches. None of the research or studies supporting that new use would have to be disclosed. While new uses can be of tremendous importance (see AZT), such seemingly sparse patents would fairly raise concerns for the court when evaluating the bargain between innovators and the public.

I don’t see this as a particular cause for concern. The evidence supporting the new use would not have to be disclosed in the patent, but it will have to exist. It is clear on existing law that a claim to an entirely new compound could confine itself to a statement of its use, without supporting evidence of that use in the patent itself, though such evidence would have to exist, and I don’t see a principled distinction between those situations. Indeed, I am not sure that Rennie J himself was entirely persuaded by his own argument on this point, as he did not elaborate on the “concerns” that might be raised. It may be that he simply felt bound by prior FCA decisions to hold that there must be an elevated disclosure requirement in “this sort of case”. That suspicion is reinforced by his opening statement that the disclosure requirement is limited to the context of new use patents, “assuming such a utility disclosure requirement exists at all” [141].

With that said, Rennie J’s focus on new use patents is persuasive and thought-provoking. If we accept that enhanced disclosure arises in new use cases, and not sound prediction case generally, perhaps the requirement is simply to disclose the use, but not the supporting evidence. After all, from Consolboard, as affirmed in Teva / sildenafil, it is not generally necessary to make any disclosure of utility at all, so a requirement to disclose the use is enhanced relative to that standard.

In any event, Rennie J’s very careful analysis of the law related to proper disclosure is a welcome re-assessment of this difficult area, which he clearly sees as being problematic. I am very gratified that he quoted at [158] a concluding passage from my article, “Must the Factual Basis for Sound Prediction be Disclosed in the Patent?” (2012) 28CIPR 39, and he stated that “I generally agree with [Professor Siebrasse's] observations.” It will be interesting to see what, if anything, the FCA chooses to do with this issue on appeal. Rennie J has certainly given them a great deal to think about:

[160] In conclusion, I am of the view that there is no enhanced disclosure requirement in all sound prediction cases. Utility and disclosure are treated separately under the Patent Act, and consequently, should be treated separately in the jurisprudence as well.

Tuesday, July 8, 2014

Promise of the Patent is Alive and Well Post-Plavix FCA

AstraZeneca Canada Inc v Apotex Inc 2014 FC 638 Rennie J
            2,139,653 – esomeprazole – NEXIUM

Rennie J’s decision holding AstraZeneca’s esomeprazole patent invalid is interesting in several respects. Most importantly, Rennie J held that the effect of the SCC’s obiter remarks in Teva / sildenafil 2012 SCC 60 is to overturn previous FCA decisions holding that the factual basis for utility must be disclosed in the patent itself in all cases of sound prediction [142]. On Rennie J's view, the disclosure requirement is now “limited to the context of ‘new use’ patents, assuming such a utility disclosure requirement exists at all” [141]. On the other hand, his decision also shows that the promise doctrine is alive and well post-Plavix FCA 2013 FCA 186. This is not surprising, as the FCA affirmed the doctrine, and held only that the promise must be explicit. Rennie J’s decision makes no new law in this respect, though it gives some guidance as to what will be considered an “explicit” promise. On a third point, Rennie J also has an interesting analysis of what is meant by the “inventive concept” in the obviousness analysis. Ultimately, Rennie J held the ‘653 patent invalid solely for failure to meet the promise of the patent. This post will provide background and deal with the promise issue. Subsequent posts will deal with disclosure and obviousness.

The claims at issue, primarily claims 7 and 8 of the ‘653 patent [79], are compound claims to six specified salts of esomeprazole of high optical purity. “Esomeprazole,” is synonymous with the (-) enantiomer of omeprazole [61]. As of the priority date, the skilled person would have known that omeprazole is a racemate, containing equal amounts of (-) and (+)-omeprazole; that omeprazole is a proton pump inhibitor (PPI) and is useful as an inhibitor of gastric acid secretion and for the treatment of gastric acid-related diseases; and that omeprazole is a very safe and effective drug [64].

In current Canadian law, a patentee will be held to every “promise” made in the specification, though failure to meet a goal, or “a hoped-for advantage of the invention,” will not invalidate the patent. Rennie summarized the difference between a promise and a goal as follows [117, his emphasis]:

In sum, promises are explicit and define guaranteed or anticipated results from the patent (depending on whether the promise is demonstrated or soundly predicted), whereas goals merely relate to potential uses for the patent.

There was considerable dispute over exactly how to characterize the putative promises, and of course over whether the statements in question were actually promises or merely goals, but in the end, Rennie J held that two promises were made respecting the claimed invention, namely

(1) that it was useful as use as a proton pump inhibitor (PPI); and
(2) that it had an improved therapeutic profile such as a lower degree of interindividual variation [214].

He held that the first promise was met [165], while the second was not [195], [214], and consequently the patent is invalid for lack of utility. (AstraZeneca argued that the second promise was, at most, of improved therapeutic profile, but that truncated promise would not have altered the outcome, as it was not met either [198].) Note that the promise (1), use as a PPI, is the same utility as omeprazole itself. Therefore it is clear that the claimed compound, high-purity esomeprazole, has sufficient utility to support a valid patent, and the patent was invalid solely because of the failure to meet the higher utility that was promised in the patent. Moreover, the elevated promise of improved therapeutic profile was found solely in the disclosure; the claims themselves were to the compound, with no mention of its properties or advantages. This case is therefore a clear example of the promise doctrine in action.

The second promise, which was determinative of invalidity, turned entirely on the interpretation of the following passage from the ‘653 patent [113, Rennie J’s emphasis]:

It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole.

Ultimately, Rennie J’s conclusion that this passage promised an improved therapeutic profile turned on the word “will” [119-20]. By way of contrast with this imperative language, he noted that in another case he found that “an object a clause beginning with ‘it is a particular object of the present invention to,’ merely described a goal that the patent strived to achieve” [117]. As another example of language indicating a mere goal, “[h]ad the patent stated that such compounds 'may' or 'could' give an improved therapeutic profile, then the argument that such statements referred merely to a goal would be more compelling” [120].

If we accept the premise of the promise doctrine, that patentees intend to make promises of utility in the disclosure which will determine the validity of the patent, then Rennie J’s conclusion that the word “will” signifies a promise strikes me as sound as a matter of textual interpretation, and as being consistent with prior cases. As noted, while the FCA held that a promise must be explicit in its Plavix 2013 FCA 186, blogged here, it also clearly re-affirmed that if a promise is explicit, the patentee will be held to it. Since no patent ever says “I promise [heightened utility]," it is not surprising that affirmative language such as “will” is taken as a sufficiently explicit promise.

Of course, in my view it is wrong to suppose that a patentee ever intended to make promise in the disclosure, which is intended to disclose the invention, not define it: see my article “The False Doctrine of False Promise,” (2013) 29 CIPR 3 (draft version available here). But until the SCC addresses this doctrine, perhaps in the upcoming Plavix case, Apotex / esomeprazole illustrates a fairly straightforward application of the current state of the law relating to the promise of the patent.

To conclude, I should mention a couple of preliminary issues. One was the standing of AstraZeneca Canada, which Apotex challenged because there is no express license agreement between AstraZeneca Aktiebolag, the patentee, and AstraZeneca Canada, which distributed and sold NEXIUM in Canada [9-10]. Rennie J held that standing may be based on an implied licence [10], and that can probably be established solely by the fact that the patentee and the purported licensee are both joined before the court seeking recovery for infringement [11]. In any event, an implied licence may certainly be inferred from the conduct of the parties, and the facts in this case clearly allowed such an inference [23]. This holding strikes me as a straightforward application of Apotex Inc v Wellcome Foundation Ltd, [2001] 1 FC 495 (FCA), which had similar facts.

Rennie J also held that while an NOC proceeding is not res judicata in respect of a subsequent infringement action, which is well established, the doctrines of issue estoppel and abuse of process remain open [30]. However, on the facts he held that it was not an abuse of process for AstraZeneca to shift its argument relating to the promise of the patent between the NOC litigation and the infringement action [41]. Nor, while he found it “more problematic” [46], was AstraZeneca’s changed position regarding the moitivation of a skilled person to separate the enantiomers. On the whole, it seems that while issue estoppel and abuse of process remain open, they will not be lightly invoked to constrain a patentee from changing its litigation strategy between the NOC proceeding and the infringement action.

Finally, I’m a bit late with this post, as I had an enforced long weekend, after storm Arthur left me (and most of Fredericton, NB) without power for three days.

Thursday, July 3, 2014

Different Claims Lead to Different Results in US and Canadian STELARA Litigation

Abbvie Deutschland Gmbh & Co v Janssen Biotech, Inc (2013-1338, -1346, Fed Cir)
            US Pat 6,914,128 & 7,504,485 / anti-IL-12 antibodies / STELARA

Thanks to Alan Macek’s IPPractice for alerting me to the US Fed Cir STELARA decision, which addresses patents similar to those in AbbVie Corp v Janssen Inc 2014 FC 55, blogged here. Together, these decisions provide for an interesting comparison between the US written description requirement and the Canadian overbreadth objection. The Fed Cir affirmed that the claims at issue were invalid as lacking an adequate written description, while in the Canadian litigation, Hughes J held that the claims were not overbroad. But despite the differing results, there is no inconsistency between the decisions, as the claims at issue were different in an important respect. While the results were consistent in these cases, I am inclined to prefer the Canadian approach; the written description inquiry into whether the inventor “had possession” of the claimed invention strikes me as a Procrustean framework for what is essentially an overbreadth analysis.

To recap the facts, which are described in more detail in my post on Hughes J’s decision, the invention relates to human antibodies that bind human interleukin 12 ("IL-12"). Interleukins generally, and IL-12 in particular, were known to be implicated in immune system function, and antibodies capable of inhibiting the activity of IL-12 were known to be likely candidates for treating diseases related to immune system disorders. AbbVie and Janssen both developed human anti-IL-12 antibodies with similar affinity and potency, but they were developed independently using entirely different technologies, and they have different amino acid sequences, different variable region binding sites, and they bind to different epitopes. The evidence on this was consistent in the US and Canadian litigation.

The claims at issue in the US litigation were to an anti-IL-12 antibody with a specified binding affinity (slip op 7). The claimed antibodies were described functionally, by the binding affinity, not structurally. The question therefore was whether, having discovered one way of making such anti-bodies, AbbVie should be entitled to claim all antibodies with the specified binding affinity. The Fed Cir noted that the purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification” (slip op 21). That is, the patentee cannot claim more broadly than it has invented. The written description requirement polices this principle by insisting that the patent applicant “must describe his or her invention so that the public will know what it is and that he or she has truly made the claimed invention” (slip op 20). In this case

analogizing the genus to a plot of land, if the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it.

Because the antibodies developed by AbbVie “are not representative of the full variety or scope of the genus,” (slip op 24), the written description was inadequate.

In contrast, in the Canadian litigation, while the patent at issue did have a functional claim to anti-IL-12 antibodies with specified binding affinity, the only claims at issue were to the use of those antibodies “to treat psoriasis.” As in the US litigation, Janssen argued that AbbVie had claimed too broadly

[168] Janssen argues, as a policy issue, whether "functional claiming" should be allowable. It argues that, having discovered one antibody that binds to IL-12 so as to treat psoriasis, can AbbVie claim any antibody that binds to IL-12 and treats psoriasis?

But as Hughes J pointed out:

This argument does not come to grips with the fact that AbbVie was the one who confirmed that if an antibody did bind to IL-12, then psoriasis could be treated. Before AbbVie’s confirmation there was only hope or speculation, numerous other cytokines or a combination of one or more of them might have been the proper target [168].

That is, what AbbVie had discovered was not just one way of making anti-IL-12 antibodies; it had discovered that such antibodies could be used to treat psoriasis, and this, on the facts, was an inventive step.

The general problem of overbreadth was captured in the “roads to Brighton” metaphor, a century and a half ago:

It is extremely desirable that when a beneficial idea has been started by one man, he should have the benefit of his invention, and that it should not be curtailed or destroyed by another man simply improving upon that idea; but if the idea be nothing in the world more than the discovery of a road to attain a particular end, it does not at all interfere with another man discovering another road to attain that end, any more than it would be reasonable to say that if one man has a road to go to Brighton by Croydon another man shall not have a road to go to Brighton by Dorking.
Curtis v Platt (1863), 3 Ch D 135, quoted in (1995) 61 CPR(3d) 499 (FCA)

I suggested in my post on Hughes J’s decision that the discovery that anti-IL-12 antibodies could treat psoriasis is not a “road to Brighton”.

Rather than being a road to Brighton, it was the equivalent of an eighteenth century road from Europe to Australia. With a little historical licence, we might say that if Captain Cook was the first to discover a route to Australia, it would not be so unreasonable to give him a monopoly over all routes to Australia, given that it was not the route he really discovered, so much as the fact that Australia existed at all.

Where the inventor discovers one route to a goal which is known to be desirable, then it may claim only that one route, which is its contribution. But when the inventor reveals a goal which was never before suspected, its contribution is the very existence of that goal, and consequently it may claim any route to get there. The desirability of human anti-IL-12 antibodies was well-known before AbbVie found a way to get there, so making those antibodies was a road to Brighton. That such antibodies could treat psoriasis is a discovery analogous to eighteenth century Australia, and AbbVie was consequently entitled to a claim to any method of treating psoriasis with those antibodies.

I am inclined to think that the Canadian approach to this question, which asks simply whether the claim is overbroad, is preferable to the US approach, which asks whether the inventor “had possession” of what was claimed. Suppose the claim to the use of anti-IL-12 antibodies to treat psoriasis had been at issue in the US litigation. Would AbbVie’s discovery of one method of making such antibodies have given them “possession” of that invention? Has the inventor described the entire plot of land, or only a part of it? The Fed Cir cautioned that

It is important not to take the analogy of a plot of land too far in thinking of written description issues because, even if one builds a house only in one corner of the plot, one may still own the whole plot. One describes a plot of land by its furthest coordinates, in effect drawing a perimeter fence around it. That may be akin to the function of patent claims to particularly point out and distinctly circumscribe the outer boundaries of a claimed invention. With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.

This seems to suggest that the claim to treat psoriasis would not be adequately described because AbbVie has discovered only one way to get there, and the species do not encompass the breadth of the genus. This seems to me to be the wrong result (always assuming that the discovery that anti-IL-12 antibodies could treat psoriasis was truly inventive). Alternatively, we might enter into a debate as to what exactly is the “genus.” If the genus is not the antibodies, but the treatment of psoriasis, then maybe describing one route does encompass the genus.

This convoluted analysis illustrates the limitations of the written description approach. The validity of functional claims should not turn on strained analogies to a plot of land. The real question is whether the patentee’s contribution is commensurate with the scope of the claims. This is no doubt a difficult question to answer, but at least it is the right question. It is made more difficult, not less, by asking whether the inventor “has possession” of the invention. My sense is that the US courts have latched onto the written description requirement in order to have a statutory hook for the overbreadth requirement. This may be satisfying from a statutory interpretation perspective, but it is analytically problematic. My inclination is to think that the Canadian approach, which simply recognizes overbreadth as an independent ground of attack, is preferable.