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 “property 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 “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 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.

Thursday, June 26, 2014

Promise of the Patent Met on the Facts

Allergan Inc v Cobalt Pharmaceuticals Company 2014 FC 566 O'Reilly J
Allergan Inc v Apotex Inc 2014 FC 567 O'Reilly J
            2,585,691 / bimatoprost / LUMIGAN RC

The background to this decision is provided in yesterday’s post.

O’Reilly J began his discussion of utility by stating that “On my reading of the patent, the stated utility of the claims in issue is that new Lumigan would have a comparable effect to old Lumigan, with less [bimatoprost] (and, therefore, fewer side effects)” [37]. In fact, the claims themselves make no mention of efficacy or side-effects. This conclusion as to stated utility is evidently derived from O’Reilly J’s reading of the description, not just the claims. It is also evident that the utility identified by O’Reilly J is higher than would otherwise be necessary to satisfy the utility requirement, since it was not disputed that LUMIGAN RC is effective in treating glaucoma and an invention is useful if it affords the public a useful choice: Consolboard [1981] 1 SCR 504, 525. Therefore, this is a case in which utility was measured against the promise of the patent, without any thorough assessment of whether such a promise was made, and despite the FCA’s recent admonition in Plavix 2013 FCA 186 (blog) that the promise must be explicit and not every patent necessarily has a promise. Moreover, on my own reading of the description, I did not see a clear statement of an explicit promise. This could potentially be a problematic departure from the Plavix guidance, except that on the facts, the promise was met [45]. Consequently, I do not really see this as an aggressive application of the promise doctrine; given that the highest arguable promise was satisfied, it may have been simpler to deal with the issue on the evidence, rather than conducting a complex investigation as to whether a promise was made, and exactly what it might have been.

Similarly, O’Reilly J held that because the exact formulation of the claim in question had not been tested, utility had to be based on sound prediction [37]. He then accepted that both the factual basis for the prediction and the sound line of reasoning had to be set out in the patent. However, he concluded that both these requirements were met [39], so this challenge failed as well.

Wednesday, June 25, 2014

The Inventive Concept of the Claim Cannot Always Be Found in the Claim

Allergan Inc v Cobalt Pharmaceuticals Company 2014 FC 566 O'Reilly J
Allergan Inc v Apotex Inc 2014 FC 567 O'Reilly J
            2,585,691 / bimatoprost / LUMIGAN RC

In these companion cases, O’Reilly J granted an order prohibiting the Minister from issuing an NOC to Cobalt and Apotex for generic versions of LUMIGAN RC. The decision turned on the facts, though there are a couple points of some legal interest. The reasoning is the same in both cases, and the reasons themselves are largely identical, with some variation to deal with differing evidence and arguments. For convenience, paragraph numbers will refer to the Cobalt decision.

LUMIGAN and the newer LUMIGAN RC are eye drops used in the treatment of glaucoma and ocular hypertension [1]. The active ingredient in both is bimatoprost, which was apparently encompassed as a compound by patent 2,144,967, which expired in 2013. LUMIGAN contained 0.03% bimatoprost and 50 ppm benzalkonium chloride (BAK) as a preservative. LUMIGAN caused some dose dependent side-effects such as eye irritation. Allergan developed LUMIGAN RC to provide a comparable reduction of intraocular pressure (IOP), but with fewer side effects [6]. LUMIGAN RC has only a third as much bimatoprost and more four times as much BAK as LUMIGAN. The claims at issue in the 691 patent claim a composition with that formulation, namely comprising 0.01% bimatoprost and 200 ppm BAK, and the use of that composition for treating glaucoma [8].

The 691 patent was attacked for obviousness, lack of utility and anticipation. This post deals with obviousness, and tomorrow’s will deal with utility. I will not deal with the anticipation argument, as I do not see it as raising any interesting point of law.

The legal point of interest here is that the patent need not have one interpretation for all purposes. More specifically, “Cobalt maintains that the patent should be given only one interpretation for all purposes – infringement, obviousness, and utility” [23]. O’Reilly J held that while “the interpretation of the patent should be as consistent as possible across the various issues in play, . . . that does not mean that construction of the claims necessarily determines the inventive concept for purposes of the obviousness analysis” [24], [25]. In my view, read in context, O’Reilly J is clearly right on this point. As he pointed out, “Where the patent relates to a bare chemical formula, the court must refer to the claim and the specification to determine what the claim’s inventive concept is, [25, citing Sanofi, 2008 SCC 61, [77]). He is not saying that the claim is to be construed differently when assessing obviousness as compared with anticipation, or infringement, or anything else. This point must also be distinguished from the debate as to whether it is the inventive concept of the claim or the inventive concept of the patent which is at issue. The claim is always construed the same way, and in my view, is it is the inventive concept of the claim which is properly at issue, but the inventive concept of the claim is not the same thing as the claim itself, and it cannot always be discerned from the claim, as the example of a claim to a compound per se illustrates. It is well-established that a new compound is not patentable if it has no known use, even if it is new and not “obvious” in the narrow sense that no one would have had any motivation to make it. Such an invention is arbitrary, not inventive, as was explained by Jacob LJ in Actavis v Novartis [2010] EWCA Civ 82, [36], [37] discussing the "5¼ inch plate paradox." See also this post discussing the issue at more length. This is an instance where the EPO problem-solution approach is helpful. The problem faced by the inventors was to develop a formulation that was effective but with fewer side effects than LUMIGAN. The question then is whether a formulation with reduced bimatoprost and increased BAK was an obvious solution to this problem. It is still the claimed invention, which is defined by the claim as properly construed, and which is the same for all purposes, which must not be an obvious solution to the problem at hand; but whether it is an obvious solution cannot be determined by looking solely to the claim itself.

On the facts, O’Reilly J held that the claimed invention was not obvious, essentially because substantially reducing the amount of the active ingredient would be expected to reduce efficacy, and increasing the amount of BAK would be expected to increase side-effects, because BAK has its own side-effects [32]. It was therefore surprising that this combination would have similar efficacy and reduced side effects. It appears that this is because that formulation has greater permeability across the eye cell layers, which would not have been obvious to a skilled person [27].

Monday, June 23, 2014

Worldwide Interim Injunction Against Google

Equustek Solutions Inc v Jack, 2014 BCSC 1063

In Equustek Solutions, Fenlon J of the BCSC granted a worldwide interim injunction against Google Inc, ordering it to cease indexing or referencing in search results on its internet search engines certain specified websites operated by the defendants in the underlying action. While this isn’t a patent case, it’s interesting enough that I’ve decided to post on it. Given that the subject is outside my main expertise, this post is largely descriptive, but I will say that Fenlon J’s decision struck me as well reasoned. While this type of order has apparently never before been made by a Canadian court [107], I didn’t see any obvious gaps of law or logic. The result seems surprising, but it is important to recognize that “Google acknowledges that it can do what is being asked of it. Google does not assert that it would be inconvenienced in any material way or that it would incur expense to do so” [153].

Google is not a party to the underlying dispute, which related to passing off and the defendants’ use of the plaintiffs’ trade secrets. The defendants had failed to comply with various court orders made against them and continued to sell their product in violation of these court orders, including an order prohibiting the defendants from carrying on business through any website [7]. After that last order, Google voluntarily complied with the plaintiffs’ request to remove specific webpages or URLs from its search results (ie from searches originating in Canada), but it was unwilling to block an entire category of URLs from its search results worldwide [9].

The bulk of the decision concerns jurisdictional questions. Justice Fenlon held that the British Columbia courts have territorial competence, in large part because Google does business in the jurisdiction by selling advertising to British Columbia clients, including to the defendants [50]. Google argued that this analysis would give every state in the world jurisdiction over Google’s search services, but Fenlon J noted that this “flows as a natural consequence of Google doing business on a global scale, not from a flaw in the territorial competence analysis” [64]. She then held that the BC courts were an appropriate forum as compared with the California courts. Google’s primary contention on this point was the difficulty of enforcing a Canadian judgment in California, which is the location of Google’s head office. Fenlon J noted that while Canadian courts are reluctant to grant injunctive relief against extra-territorial parties for this reason, the law did recognize exceptions to this general rule; there were some sanctions which the BC court could take in relation to Google’s activities in BC; Google had not established that the Canadian order would be unenforceable under California law; and in any event, Google had not shown that a California order (assuming one could be obtained) would be more appropriate than a BC order, as Google had not shown that the technical steps needed to carry out the order would be carried out in California. Fenlon J also noted that even though Google was not actively aiding the defendant’s contempt, that is not the sole ground for making orders against a non-party, including those outside the jurisdiction, as Norwich orders and particularly Mareva injunctions illustrate.

On the question of whether the injunction could be granted on the facts of the case, Google made four main arguments. First, Google argued that it cannot, as a practical matter, monitor content or arbitrate disputes over content. Fenlon J responded by noting that Google was not being required to monitor the content of the defendants’ websites, or the content of other websites that might provide information about the defendants’ products, but only to block the particular URLs which were specified in the order itself [137].

Second, Google submitted that de-indexing entire websites without regard to content of the specific URLs would constitute undue censorship. Fenlon J responded by noting that “Google acknowledges that it alters search results to avoid generating links to child pornography and ‘hate speech’ websites. It recognizes its corporate responsibility in this regard, employing 47 full-time employees worldwide who . . . take down specific websites, including websites subject to court order” [139].

Third, Google argued that an order affecting searches might “put Google in the impossible situation of being ordered to do something that could require it to contravene a law in another jurisdiction” [140]. Fenlon J noted that this concern could be addressed in appropriate cases by inserting a so-called Baltic proviso, such as was recognized in Bank Of China v NBM LLC & Ors [2001] EWCA Civ 1933, excusing the non-party from compliance with the order if to do so would breach local laws [143]. In any event, in this case, Fenlon J noted that most countries recognize the importance of protecting trade secrets, and Google did not suggest that the order sought would in fact offend California law, or the law of any other specific state or country in which a search could be conducted [144].

Fourth, Google argued that no court should make an order that has a reach that extends around the world. Fenlon J noted that the order need only be enforced in the particular jurisdiction from which the search engine is controlled. The effect of the order might be felt around the world, but that might also be true of any order relating to physical goods. " For example, a non-party corporation that warehouses and ships goods for a defendant manufacturing company might be ordered on an interim injunction to freeze the defendants’ goods and refrain from shipping them. That injunction could affect orders received from customers around the world" [147].

Finally, with all these preliminaries out of the way, the question remained as to whether the order should be granted on the facts of the case. This turned on whether the plaintiffs had made out a good arguable case, and then on a balance of the interests of the parties. On the first point, “the plaintiffs have not only raised an arguable claim; two of the defendants’ defences have been struck and they are presumed to have admitted the allegations” [151]. As for the balance of interests, the plaintiffs established that they are suffering irreparable harm by the defendants’ ongoing sale of the disputed product on the internet, and they had also established that blocking the defendant’s use of Google’s search services would cripple the defendants’ sales. On the other hand, “Google acknowledges that it can do what is being asked of it. Google does not assert that it would be inconvenienced in any material way or that it would incur expense to do so. The balance of convenience thus favours granting the injunction” [153].

Fenlon J therefore ordered that

Within 14 days of the date of this judgment, Google Inc. is to cease indexing or referencing in search results on its internet search engines the websites contained in Schedule A to the notice of application.

Friday, June 13, 2014

Evergreening Patent Held Invalid by the FCA

Pharmascience Inc v AstraZeneca Canada Inc / NEXIUM (NOC) 2014 FCA 133 Pelletier JA: Sharlow, Mainville JJA rev’g 2012 FC 1189, 105 CPR(4th) 267 O’Keefe J
            2,290,531 / esomeprazole / NEXIUM

In Pharmascience / NEXIUM the FCA held that O’Keefe J at first instance had erred in law in failing to apply the correct legal standard to the question of the burden of proof of utility [38], [42]. The FCA therefore reviewed the evidence de novo [43], and concluded that AstraZeneca had not satisfied the onus of showing that Pharmascience’s allegations of lack of utility was unjustified [43], [58]. Consequently, the application for a prohibition order was dismissed. Though there is no hint of it in the decision, I suspect that the FCA’s approach to the utility question was motivated by the “evergreening” nature of the 531 patent.

The patent claims an enteric coated formulation comprising (es)omeprazole*, an enteric coating, and a separating layer, in which the separating layer is hydroxypropyl methylcellulose (HPMC) with a specified cloud point (CP) [FC 13], [14]. The separating layer is used to prevent reactions between the API and the enteric coating which may lead to problems such as discoloration [FC 33]. HPMC was known in the prior art for use in the separating layer, and the technical contribution disclosed by the patent lay in the discovery that use of HPMC with the specified CP results in a higher release rate for the API [FC 47], and that there is variation in CP between batches of HPMC. The practical advantage of this is that if each batch of HPMC is checked for CP prior to tableting, and only batches with the specified CP are used, discard of the final product for failure to meet regulatory requirements for API release rate requirements will be reduced, thus reducing costs [FC 98, 100], [531 p4].

The utility point turned essentially on the question of whether it was true that the specified CP gives a higher release rate. But ignore this question for the moment. Suppose it is true, and the patent was valid. The result would be that a generic which produced a version of NEXIUM using what I understand to be the old method – that is, not by screening batches of HPMC for CP, but simply by using whatever came through the door and then screening the final product for release rate – would nonetheless infringe the patent. This is because the patent does not claim a method of production comprising screening HPMC for CP, and using only batches with the specified CP; it claims the pharmaceutical composition as such.** Assume it is true, as the patent asserts, that there is batch variation in HPMC. Because of that batch variation, even a generic using the old method would produce at least some lots of tablets which fall within the claims of the patent. The net result is that a technical contribution which provides a cost reduction in the production of esomeprazole tablets could be used to entirely block sales of such tablets, even if the production method did not take advantage of the technical teaching of the patent.

In the FC, this point was addressed largely via the argument that the 531 patent is not an invention because it merely verifies the properties of HPMC. O’Keefe J responded that

[176] On review of the evidence and the ‘531 Patent, I agree with AstraZeneca that the patent provides more information than merely identifying inherent physiochemical properties of a known substance. Rather, as submitted by AstraZeneca, the patent delves into batch-to-batch variations of a single low viscosity HPMC product and a property that can be tested to ensure consistent release of omeprazole in accordance with the marketing standard.

While it is all true (at least on the evidence as found by O’Keefe J), the problem is that the patent does not claim such an invention. The patentee is entitled to claim the practical embodiment of the new information it provides, and so the inventors would have been entitled to claim a method comprising testing for batch variation prior to tableting. But instead the patent claimed the formulation itself, even, on its face, if produced under the previously known method. Similarly, AstraZeneca argued that:

[100] When properly construed, the patent does not merely contribute a verification of the CP but also teaches that by selecting low viscosity HPMC above the claimed CP, a pharmaceutical formulator can reduce the amount of product discard that does not meet omeprazole release specifications. This was a surprising and unexpected teaching offering a substantial advantage.

The patent taught that, but it is not enough to teach a new invention; that invention must also be claimed. To my mind, this case is like the classic case of BVD Co [1937] SCR 441, in which the patentee invented and disclosed a good invention, but failed to claim it.

From a policy perspective, the patentee should be entitled to the exclusive right to exploit the advantage provided by its invention. In this case, the practical advantage is reduced production costs. What the 531 patent should give AstraZeneca is the right to compete against generics using a lower cost process, so it can afford to undercut the generics and still make a profit. The technical advance disclosed in the patent does not justify a monopoly on the production of enteric coated esomeprazole. (I should say that none of this has anything to do with the degree of ingenuity involved in the patent. It may require a stroke of genius to devise a new production method that reduces costs by 1%. The patent reward should be commensurate with the benefit to society, not with the degree of ingenuity.)

It may be that I haven’t fully understood the facts or the proper construction of the patent, as the case was not argued in exactly the way I have discussed, and consequently many of these issues were not discussed. But it does seem clear that a minor technical advance was being used to block competition in the market for enteric esomeprazole. This seems to be a true example of evergreening, in the pejorative sense. While the FCA took a stringent approach in its utility analysis, I would not read too much into that analysis beyond a desire to strike down what appears to be clearly a bad patent.

*Note: the 531 patent covers formulations of both omeoprazole and esomeprazole. The FC decision states that Pharmascience’ ANDS compared its capsultes to AstraZeneca’s NEXIUM, which is esomeprazole [3]. The FCA, on the other hand, says that the order sought was to prohibit an NOC “to Pharmascience for its version of the drug omeprazole “ [1], and the FCA also states that “Losec is a commercially marketed formulation of enteric coated esomeprazole, the (-) enantiomer of omeprazole.” [15]. As I understand it, LOSEC is omeoprazole, not esomeprazole. I take it that the FC was right that the case is really about esomeprazole. Nothing turns on this error by the FCA, but comparing the FC and FCA decisions can be confusing unless this point is kept in mind.

**In addition to claiming the formulation itself, the patent also claims the process of manufacture using HPMC of the specified CP, but it does not specify prior selection of the HPMC prior to tableting, so that again, the old method would infringe. This is as I construe the claims; the issue was not addressed in the decisions

Thursday, June 12, 2014

Permanent Injunction Not Available as of Right

Abbvie Corp v Janssen Inc / Injunction 2014 FC 489 Hughes J
            2,365,281 / anti-IL-12 antibodies / STELARA

This decision raises a number of important points relating to the availability of a permanent injunction to a successful patentee. Hughes J makes it clear that a permanent injunction is discretionary in principle, though it will normally be awarded to a successful patentee absent unusual circumstances. Such unusual circumstances are not a purely theoretical possibility; on the facts, a complete permanent injunction was refused. The decision also shows that the question is not simply whether a permanent injunction should be granted or refused; the question is how a permanent injunction should be crafted to balance the relevant interests. On the whole, this case shows that Canadian law related to permanent injunctions is well-placed to deal with issues such as injunctions sought by non-practising entities and standard-essential patents, if and when those questions surface in Canadian litigation, but without over-reacting against patentees generally. An equivalent to eBay Inc v MercExchange (2006) 547 US 388, is not necessary or desirable in Canada.

This trial has been not just bifurcated, but trifurcated. In the first part on infringement and invalidity, Hughes J held that AbbVie’s 281 patent was valid and infringed by Janssen’s STELARA [1]: 2014 FC 55, blogged here. The remedies portion was further bifurcated into the question of injunctive relief, and damages or profits. Consequently, this AbbVie / Injunction decision deals only with the issue of whether the successful plaintiff, AbbVie, is entitled to a permanent injunction, and if so, on what terms.

Hughes J reviewed the law relating to the grant of permanent injunctions, and held that “An injunction normally will follow once the Court has found that a patent is valid and has been infringed” [35]” The word “normally” is important here, as it is clear from the permissive wording of the s 57 [34], the prior case law [35]-[38], and equitable nature of injunctive relief [35], that injunctive relief is a discretionary remedy, which is not available as of right, even though it will be granted except in “rare circumstances” [36]-[37].

(Hughes J also held at [38] that the RJR-MacDonald [1994] 1 SCR 311 test for an interlocutory injunction is not the test which should be applied in respect of a permanent injunction, citing the Ontario and BC Courts of Appeal: 2014 ONCA 125, 2010 BCCA 396. For what it’s worth, I agree with the reasoning expressed in those decisions, and in the passage quoted by Hughes J at [38].)

The facts in this case were indeed very unusual. AbbVie does not practice the 281 patent, but neither is it a patent assertion entity or “troll.” Janssen’s infringing product is STELARA, a biologic used to treat psoriasis, which, in its severe form, can be disabling [17]. Three other biologics are also approved in Canada for treating proriasis: HUMIRA, sold by AbbVie, REMICADE (Janssen) and ENBREL (Amgen) [21]. All four treatments have significant market share, and none except STELARA fall within the scope of the 281 patent [15]. By keeping STELARA off the market, AbbVie is seeking to preserve the largest possible “footprint” for HUMIRA in the market for prosiasis treatments [45]. The twist is that these products are not perfect substitutes. STELARA operates by inhibiting IL-12, while the other three target TNF-α [21]. Even the TNF-α drugs are not perfects substitutes with one another, and it was a common treatment scenario for the physician to switch the patient among the TNF-α drugs before going to the sole IL-12 drug (STELARA) [23].

A permanent injunction would therefore have allowed AbbVie to prevent the sale of drug which AbbVie itself does not supply, and which for some patients is the only effective treatment for a disabling condition. On these unusual facts, AbbVie, no doubt wisely, did not even seek a complete permanent injunction. In broad terms, AbbVie sought an injunction, with an exception for existing patients, and restrictions on new patients. All the sales permitted under the exception would be subject to an continuing royalty [43]. Nonetheless, the discretionary nature of a permanent injunction was squarely at issue because Hughes J refused to grant the injunction in precisely the terms sought by Abbvie. As Hughes J put it:

[16] Thus, the Court is required to balance on the one hand, the rights of a patentee to the exclusive use of their claimed invention, including the right to control, by licence, others who wish to use the claimed invention, with the commercial desire of the Defendant to sell the infringing drug and, with a medical need by some members of the Canadian public to have continued access to the infringing drug.

In particular, AbbVie has sought to require physicians to formally certify that the patient has a medical need for Stelara that cannot be met by Humira before prescribing Stelara to new patients [63], and Hughes J refused to impose this requirement [66]. AbbVie did not seek to restrain dissemination of technical information regarding STELARA [68], but it sought to restrain active marketing by sales reps or a “detail” person. Hughes J agreed to this [71]. AbbVie proposed that Janssen be required to approach the formularies with new critiera for listing [73], and that Janssen be ordered to comply only with lawful requests from Health Canada [77], and to write a letter to physicians stating that STELARA infringes AbbVie’s patent [78] Hughes J refused all of these requests. With respect to the letter, Hughes J noted that a “forced” letter implicates freedom of expression, and such a letter “is an exceptional thing” [81]. On the other hand, Hughes J did order a prohibition on Phase IV studies of STELARA in Canada, although this apparently turned, at least in part, on the fact that none were planned [87].

While the details of the injunction may no doubt be debated, in my view Hughes J’s decision represents a sound approach to balancing the various interests. At this point, I have to point out the theoretical counter-argument. In principle, if AbbVie were granted a complete injunction, prohibiting any sales of STELARA without AbbVie’s permission, this does not mean, at least in theory, that patients who need STELARA would be forced to go without. If a patient is not responding to AbbVie’s HUMIRA, and does respond to STELARA, it would be in AbbVie’s own interest to allow Janssen to sell the STELARA, subject to a royalty negotiated with AbbVie. The general point here is that injunctive relief does not necessarily mean that the prohibited activity will not take place; it just means that the terms on which it takes place will be dictated by the patentee. If a complete injunction were granted, AbbVie would decide the royalty payable on sales of STELARA to patients who did not respond to HUMIRA, while given the limited injunction that was granted, the royalty will be decided by the court in the third stage of this trial.

The obvious rejoinder to this analysis is that the question is not just as to the royalty: if an injunction were granted, AbbVie, and not the patient’s physician, would ultimately be responsible for deciding whether STELARA was medically necessary for the patient. It is an interesting theoretical question as to whether, in principle, there is a divergence between AbbVie’s interests and those of the patient, such that we should expect sub-optimal outcomes if an injunction were granted, assuming that AbbVie acted purely rationally. But whatever the outcome of such an analysus, it would take a compelling practical argument that the patient’s health would not suffer, and not merely a theoretical one, before the courts should be willing to put a patient’s health in the hands of a patentee.

Wednesday, June 11, 2014

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].

Tuesday, June 10, 2014

Experimental Use Exception to Anticipation

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

The anticipation argument in Apotex / YAZ turned on clinical trials conducted by Bayer in the US and Europe more than one year before the filing date, in which samples which embodied the invention were delivered to trial participants and their doctors. The doctors and participants did not know the precise ingredients (they knew of the active ingredients and dosage, but apparently not the micronized form) [100]. While Bayer took reasonable precautions to require participants to return unused samples [112], it appears that neither the doctors nor participants had signed confidentiality agreements [99]. While there was no evidence that anyone had ever actually analyzed the tablets [111], , and there was evidence that it was inevitable that some tablets would not be returned, given the large scale nature of the trials [113]. On these facts, Hughes J held

there has been established a ‘theoretical’ possibility that a tablet could have been kept and analyzed, [and] therefore the requirements of subsection 28.2(1) (a) of the Patent Act have been met” [118].

While Hughes J drew on European case law, and did not cite the recent FCA decision in Wenzel Downhole Tools 2012 FCA 333, it seems to me that this holding is consistent with the test set out by the majority in Wenzel [74, original emphasis] that it is sufficient that “there was an opportunity to access the relevant information.”

However, this did not end the matter. Hughes J held that “The law in Canada has long been established that experimental use in order to bring the invention to perfection, does not constitute public use” [119]:

[121] In the present case clinical studies were necessary to prove that the drug was safe and effective and, thereby, gain government approval for sale. Until this had been demonstrated, no commercial sale of the drug could have been made. Bayer took reasonable steps to ensure the confidentiality of the relevant documents and to ensure that unused tablets were returned. The theoretical possibility that some tablets were retained and analyzed is just that, theoretical. This theoretical possibility does not preclude the fact that the studies were experimental, and of necessity, conducted by the provision of tablets to members of the public. Thus these clinical studies are exempted from public use.

This seemingly establishes a broad experimental use exception to what would otherwise be anticipating disclosure, which applies to any clinical trial, so long as reasonable steps are taken to ensure that the unused tablets are returned.

As authority, Hughes J relied on Conway v Ottawa Electric Railway Co., (1904), 8 ExCR 432, 442; Gibney v Ford Motor Co. of Canada, [1967] 2 ExCR 279 [49], citing Elias v Grovesend Tinplate Co. (1890), 7 RPC 455, 466; and Hi-Qual Mfg Ltd v Rea’s Welding & Steel Supplies Ltd (1994), 55 CPR(3rd) 224, aff’d 61 CPR(4th) 270 (FCA). Of these cases (and I will not go into all of the other case law cited in those cases), Conway does stand for a broad experimental use exception to anticipation, but the others are weaker authority. Gibney and Elias both insisted that the experiments must be kept secret if anticipation was to be avoided, and in both cases the patents were held to be invalid as anticipated. In Hi-Qual the experimental nature of the use was an alternative ground for holding that patent not anticipated, the first ground being that the invention was not publically available. (The invention, relating to farm equipment, was outdoors on the inventor’s property, but the property was not open to the public, and the invention could not be seen from public property.)

It seems to me that one decision more than a century old is not strong enough authority to say this point is well-established. With that said, while old, Conway raises an interesting point which is directly applicable to clinical trials. The invention in question was a snow-plow for clearing street car tracks. An important feature of the plow as compared with the prior art was that it was adapted so as to accommodate the irregularity of real street surfaces. Consequently, it was only possible to develop the invention by experimenting in public, and this fact was relied on by the court in holding the experiments did not destroy novelty. Evidently, with a mechanical snow-plow, even more than with pharmaceuticals, if the device is operated in public it will be disclosed to any knowledgeable observer, and it is impossible to exclude the pubic from the public streets. This suggests that it is impossible to develop the invention in secret, an experimental use exception may be required. With that said, it is not clear that Bayer could not have filed a patent prior to conducting its clinical trials, as clinical trials are not necessary to establish patentable utility. But in any event, the problem of inventions which must be developed in public is an interesting one in principle.

A different consideration is that it does appear that if the inventors had signed all the doctors and participants to a confidentiality agreement, then the invention would not have been available to the public in the first place. But is this mere legal formalism? It is not clear that signing a confidentiality agreement would have been any more effective than the (unspecified) reasonable steps Bayer actually took to ensure the unused product was returned. Perhaps the law should recognize that taking reasonable steps to ensure product is returned is tantamount to a confidentiality agreement, at least when dealing with unsophisticated patients in a clinical trial. As the Fed Cir put it in Dey v Sunovion

The fact that a tiny fraction of the thousands of vials were lost without penalizing the responsible test subject(s), or that the practicalities of the study required self-administration at home rather than physician administration in a closed facility, does not preclude a reasonable jury from concluding that the use of Batch 3501A was sufficiently controlled and restricted, rather than unfettered and public.

As noted, strictly, this goes to the question of whether there is disclosure to the public in the first place, rather than whether there is an experimental use exception, but this logic does reach the same result as Hughes J on the same factual basis. A response to this argument, as to the point above, may be that the pharmaceutical company should get its patent before starting clinical trials. (Note that in Dey prior trials by the accused infringer were at issue.)

In summary, while there is some case law supporting Hughes J’s position, I would not say that the experimental use exception to anticipation is well-established, and the policy issues are difficult. This aspect of his decision raises important legal and policy questions for the FCA, which might be dealt with either in terms of an experimental use exception, or by a refinement of the Wenzel approach to disclosure. Patently-O posts here and here discussing the same issue indicate that there has been a shift in US case law which has narrowed the experimental use exception, while at the same time adopting a more restrictive test for what constitutes public use.

Addendum: When I wrote this post, I was focused on the interesting legal issue of whether there is an experimental use exception to anticipation, and I glossed over the prior issue of whether there was disclosure to the public in the first place. On further reflection, I do not find the analysis of that point to be entirely satisfactory (though of course this may be a consequence of the way the case was argued). A disclosure to a party under an obligation of confidence is not a disclosure to the public, and while it appears that neither the doctors nor participants had signed confidentiality agreements, it is clear law that an explicit confidentiality agreement is not required to establish an obligation of confidence. The question is whether the product was conveyed in circumstances giving rise to an obligation of confidence: see generally Corlac v Weatherford 2011 FCA 228 [36]- [65], which is now the leading FCA case on the point, and which was not cited by Hughes J. The question of whether the circumstances were such as to give rise to an obligation of confidence is ultimately one of fact. From this decision, all we really know of the relevant facts is that Bayer “took reasonable precautions so as to keep relevant information confidential and to require participants to return any unused tablets” [112]. That at least raises a serious issue as to whether the circumstances were such as to give rise to an obligation of confidence. The simple fact that there was no explicit written or oral confidentiality agreement is “ significant, but not dispositive” (Corlac [53]). On the whole, I am inclined to think that this case should really turn on whether the circumstances were such as to give rise to an obligation of confidence. If such an obligation did arise, then there is no need to invoke an experimental use exception to anticipation; if it did not, then it is difficult to see why an exception should be invoked to protect a party which had disclosed an invention to the public without adequate regard to its confidentiality. Furthermore, whether or not such an exception is desirable is a matter for the legislature. Canadian law does have a grace period for disclosure by the inventor, but many jurisdictions do not. Whether such a grace period is desirable is a debatable matter of policy, and one of the most contentious issues is the uncertainty which it can create (see Part I of the recent Tegernsee Group report). If a further exception is to be made for experimental disclosure, this should be done by the legislature, rather than through an open-ended and poorly defined judicial exception.