Blogging Break

I'm taking a blogging break this week, as I'm on vacation (in beautiful Squamish, BC, home to some of the best mountain biking in the world). I'll be back to blogging in the middle of next week with a post on the overbreadth issue in Aux Sable.

Is Overbreadth the new Promise Doctrine?

I have a new draft paper available on SSRN, “Overbreadth in Canadian Patent Law.” Here is the abstract

Under the overbreadth doctrine, a claim that exceeds the scope of the invention disclosed in the specification is invalid. While the doctrine is well established, it is redundant in the great majority of cases in which it is invoked, as an overbroad claim typically encompasses subject-matter which is not new, lacks utility, or is obvious. When overbreadth is not redundant, a puzzle arises: what is the principled justification for striking down a claim to an invention which is in fact new, useful, non-obvious and sufficiently disclosed? In such a case, how can it be said that the claim is broader than the invention? This article argues that overbreadth properly arises as an independent ground of invalidity in the context of the “roads to Brighton” problem, in which the question is whether the first inventor to achieve a result known to be desirable may claim the result itself or may claim only their particular method of achieving it, but the answer to this question is controversial. Overbreadth was also applied as a truly independent ground of invalidity by the Federal Court of Appeal in Amfac Foods Inc v Irving Pulp & Paper, Ltd. This article argues that Amfac was wrongly decided, both on its facts, and in its approach to overbreadth. The article warns that the Amfac approach, if widely adopted, risks invalidating patents for inventions which are new, useful and non-obvious, on the basis of an arbitrary parsing of the disclosure, in a manner reminiscent of the promise doctrine.

Teaching Away Irrelevant to Anticipation

Aux Sable Liquid Products LP v JL Energy Transportation Inc 2019 FC 581 Southcott J
            2,205,670

Recall that the invention at issue relates to a method of adjusting the composition of natural gas for more efficient transportation by pipeline. Claims 1-8 related to the method, while Claims 9-10 claim “a gas mixture, for use in a pipeline,” with specified ranges of the proportion of various gases, as well as specified temperature and pressure ranges. Prior posts have dealt with the state of the art and utility. Aux Sable also raises a couple of points of minor interest regarding novelty in respect of Claims 9 and 10.

In attacking the patent for lack of novelty, Aux Sable relied on prior art disclosing a gas mixture falling within the claimed range. Southcott J noted that the prior disclosure of a point within the prescribed range is anticipatory [90]. Moreover, he held that so long as the prior art provided an enabling disclosure of a point falling within the prescribed range, it was irrelevant that the prior art taught away from the prescribed range [98], [108]. This follows from the basic rule that enabling disclosure establishes anticipation [108], and once that test is satisfied, additional information that might be found in the prior art is irrelevant. As support, Southcott J at [98], [108] cited Snider J’s decision in Schering-Plough 2009 FC 1128 [87] which held that it was irrelevant that the prior art might teach non-infringing formulations.

I’d add only a couple of points. First, I happened to come across this pithy statement to the same effect, by Stafford Cripps KC in argument at trial in Sharp & Dohme Inc v Boots Pure Drug Co Ltd (1927) 44 RPC 367 (Ch) at 378:

“When one is dealing with anticipation, a, single document that tells one what is in the patent specification is sufficient to defeat the patent, even if the other documents say that it is nonsense.

The point was accepted by Astbury J at 395, though not in quite those terms.

The second point is that Southcott J also relied on Merck & Co v Pharmascience Inc, 2010 FC 510, [166]-[168] in which Hughes J held that a claim to the use of finasteride for the treatment of baldness in a dosage of about 1.0 mg, was anticipated by a prior patent disclosing the use of finasteride in a range of dosages, with doses from 5 mg/day to 2000 mg/day disclosed as examples. I must say that in my view Hughes J was very clearly wrong in so holding, in light of the well-established rule of the highest authority that “A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee”: General Tire [1972] RPC 457 (CA) at 486; Free World 2000 SCC 66, [26]; Sanofi 2008 SCC 61, [21]. While I agree that the law as stated by Southcott J was correct, his point was not aided by citing this particular decision.

Turning to a different legal issue, another piece of prior art was a Handbook entitled “Properties of Natural Gases and Volatile Hydrocarbon Liquids.” It was undisputed that this was widely used by those working in the field of transporting natural gas by pipeline [105]. The Handbook disclosed a gas falling within the specified range, but did not expressly state that the gas was for use in a pipeline, which was an explicit element of the claim. JL Energy submitted “that one cannot employ an inference in performing an anticipation analysis” [114]. This submission was no doubt based on the rule that trial and error is permitted at the enablement stage but not at the disclosure stage. Southcott J rejected this submission, noting “the inference represents simply the process by which the Skilled Person’s [sic] employs the CGK to interpret the prior art. Anticipation is assessed based on the prior art as the Skilled Person would understand it, and the Skilled Person can use his or her CGK as part of the analysis” [114]. That must be right – the Handbook, after all, was all about gases for use in a pipeline, and it is a good illustration of the point made by Lord Hoffmann in Synthon [2005] UKHL 59 [32] that at the disclosure stage “the skilled person is taken to be trying to understand what the author of the description meant. His common general knowledge forms the background to [that] exercise.”

When Is Utility “Related to the Nature Of” the Invention?

Aux Sable Liquid Products LP v JL Energy Transportation Inc 2019 FC 581 Southcott J
            2,205,670

Monday’s post dealt with the issue of what constitutes the state of the art for an obviousness attack, which was raised as a pure question of law. A number of other interesting legal issues were raised on the facts. This post provides an overview of the facts and discusses one such issue, namely what it means for utility to be “related to the nature of the subject-matter” of the invention.

The invention relates to the transportation of natural gas by pipeline. Finding ways to pump gas more efficiently, thereby using less energy, is evidently desirable. Natural gas is primarily methane, CH4, with one carbon atom. Heavier weight hydrocarbons, such as ethane and propane, are heavier, and so require more energy to transport, but they are also more compressible, which makes them easier to pump. The inventors of the 670 patent discovered that because of this tradeoff, it turns out that the right amount of heavier weight hydrocarbons can provide a net benefit, so the gas requires less energy to pump [5]-[6].

Ethane and propane are referred to as C2 and C3 hydrocarbons because they have two and three carbon atoms, respectively. The key parameter for determining the energy reduction is the “zMw product” (the product of the molecular weight (Mw) and the compressibility (z) [7]). Claim 1 of the 670 patent claims a method of transporting natural gas by adding sufficient C2 and C3 hydrocarbon so as to ensure the zMw product is lowered [51]. Claims 2-8 are dependent claims particularizing various parameters. All of these claims were held to be valid [2]. Claim 9 is to the gas mixture itself, specified in terms of temperature, pressure and hydrocarbon composition. Claim 10 is dependent with further particularization. Claims 9 and 10 do not include the two elements of adding C2 and/or C3 and evaluating zMw [52]-[54]. Both Claims 9 and 10 were held to be invalid for overbreadth, inutility, anticipation and non-patentable subject matter [2].

While the obviousness issue discussed in the last post related to Claims 1-8, most of the other interesting legal issues related to Claims 9-10. One of these concerns utility. On all these points, nothing turns on the difference between Claims 9 and 10, so I will refer to Claim 9. Recall that Aux Sable, the accused infringer, is the plaintiff in this impeachment action, while JL Energy, the patentee, is the defendant [10].

Claim 9 claims “a gas mixture, for use in a pipeline,” with specified ranges of various gases, in particular “from 68 to 92% by volume of methane, from 6 to 35% by volume of ethane, from 0 to 9% by volume of propane” [50]. Ranges for other gases, as well as temperature and pressure ranges were also specified. First, “JL Energy acknowledges that if there is any combination of composition, pressure and temperature, within the ranges prescribed by either of these claims, that lacks that scintilla of utility, then the claim is invalid” [81]. I’m not sure such a concession was warranted, particularly if the inoperable embodiments could have been identified without undue effort: see here, here and here. But since it was conceded, I will accept the point for the remainder of the discussion, as did Southcott J. Moreover, because of this concession, the facts were not developed in detail, and it may be that there was a substantial range which did not deliver benefits, or that identifying the beneficial combinations would have been unduly difficult.

Recall that the aim of the 670 patent was improved efficiency in transportation of gas in pipelines. The unchallenged evidence of Aux Sables established that the mixture specified in Claim 9 did not have improved efficiency across the full range [82]. JL Energy argued that this does not matter, and that utility is established if the claimed gas mixture is capable of being transported by pipeline [83], which it clearly was. The question then, is whether, to establish utility, it is enough that the specified mixture was capable of being transported by pipeline, or was it required that the mixture had improved efficiency, at least to some modest degree.

As Southcott J noted [76], in AstraZeneca 2017 SCC 36 [53] the SCC held that only a scintilla of utility is required, but it must be a scintilla “related to the nature of the subject-matter” of the invention: “a proposed invention cannot be saved by an entirely unrelated use. It is not sufficient for an inventor seeking a patent for a machine to assert it is useful as a paperweight.”

The question then is whether usefulness in being capable of being pumped through a pipeline is related to the nature of the invention. Southcott J held not, on the view that “the subject matter of the invention . . . relates to the efficient transport of natural gas” [85]. JL Energy’s argument that the mere fact that the gas mixtures claimed are capable of being transported in a pipeline is sufficient “is not quite as extreme as submitting that an otherwise useless machine has utility as a paperweight (per paragraph 53 of AstraZeneca). However, in my view, it reaches in that direction” [87].

My intuition is Southcott J’s analysis is right, but the problem is a tricky one that raises some basic conceptual questions regarding “the nature of the invention” for the purposes of utility. It is now clear law that to be useful, the invention must have a scintilla of utility that is related to the nature of the invention. This raises two question: (1) how much is a “scintilla”? and (2) what is the nature of the invention? We have many cases exploring the first issue, but few exploring the second. In most cases in which the invention lacks utility, the only utility asserted clearly is related to the nature of the invention, and utility is lacking because it has not even a scintilla of such utility. So, with pharmaceuticals, the question is whether the drug is useful in treating a disease. In Wandscheer [1948] SCR 1, the question was whether the snow-blower could actually throw snow. These cases raise the question of how much is a “scintilla”.

The problem here concerns branch (2), the nature of the invention. The gas mixture at issue, even if it did not deliver efficiency advantages, could certainly be pumped through a pipeline and burned at the other end. This is much more than a scintilla of utility – if that type of utility is relevant. The question of the nature of the utility is normally raised using hypothetical examples, such as using the invention as a paper weight, or a throw-away utility, such as using a complex invention as landfill. These examples make the basic point, but are so extreme as to be unhelpful when it comes to nuances. As Southcott J noted, this case is more difficult. Being pumped through a pipeline is much closer to the “nature of the invention” in this case than being used as a paperweight.

The “nature of the invention” should be given a purposive interpretation, consistent with the purpose of the utility requirement, which is to prevent speculative claiming [AstraZeneca 56]. This might suggest that the mixture should be held to lack utility if it does not deliver even a scintilla of efficiency improvement. Otherwise, a patentee might patent all sorts of novel gas mixtures, so long as they could actually be pumped through a pipeline, in the hopes that some of those mixtures would later prove to have some advantageous properties. On the other hand, perhaps it is enough that the new mixture gives “a useful choice”: Consolboard [1981] 1 SCR 504, 525. I must admit that I find the approach adopted in the seminal EPO decision in T 0939/92 AgrEvo, to be very intuitively appealing, at least on these facts. AgrEvo concerned claims to a genus of compounds, some of which, at least, were said to have herbicidal activity. However, it was not plausible that all the compounds in the genus would have the alleged herbicidal activity [2.2.2], and the Board held the claims invalid, not for lack of utility (industrial applicability), but for lack of an inventive step, on the view that the compounds which were not herbicidal were not an inventive solution to the problem of providing herbicidal compounds [2.7], but rather “a mere arbitrary choice” [2.5.3]. On the AgrEvo approach, the gas mixtures at issue here would be considered to have utility, because they could be pumped through the pipeline, but would nonetheless be invalid, as being an arbitrary selection. But I won’t push this too far; maybe AgrEvo itself should have been decided on utility grounds.

I won’t pursue this further. For now, suffice it to say the facts raise a very nice example for considering what constitutes the nature of the invention for the purpose of utility.

What is the State of the Art for the Purpose of an Obviousness Attack?

Aux Sable Liquid Products LP v JL Energy Transportation Inc 2019 FC 581 Southcott J
            2,205,670

The invention at issue in Aux Sable v JL Energy is relatively straightforward, but the decision raises several interesting legal issues. One of the key points is a pure question of law: what qualifies as part of the state of the art for the purpose of an obviousness attack? As it happens, I wrote an article on this topic a few years ago, "What is the State of the Art for the Purpose of an Obviousness Attack?” (2012) 27 CIPR 385, though it was not cited in the decision.

The main attack on Claims 1-8 was based on obviousness. The third step of the Windsurfing / Pozzoli test, as adopted in Sanofi 2008 SCC 61, [67] asks what differences, if any, “exist between the matter cited as forming part of the ‘state of the art’ and the inventive concept of the claim or the claim as construed.” The question then, is what constitutes the “state of the art”? Traditionally there was a distinction between the prior art which could be raised in an attack based on anticipation, and the state of the art which might form the basis of an obviousness attack. The prior art comprises all subject matter which was available to the public at the relevant date, while the state of the art was a subset of the prior art, comprising only that which was generally known to a person skilled in the art, or which would be discovered by a skilled person in a reasonably diligent search prior to addressing the problem at hand (the “reasonably diligent search test” [144]): and see eg 2006 FC 1234 [57] aff’d 2007 FCA 217 [37]; 2009 FCA 222 [73]. However, the amendment which came into effect in 1996, codifying the obviousness requirement in s 28.3, describes the subject matter which can be raised in an obviousness attack in exactly the same terms as for anticipation in s 28.2, namely information disclosed “in such a manner that the information became available to the public in Canada or elsewhere.” The question is whether this codification was intended to change the law, so that the state of the art for the purposes of an obviousness attack is now co-extensive with the prior art available for anticipation. Aux Sable, the accused infringer, and the plaintiff in this impeachment action, argued that state of the art is the same as the prior art [136], while the patentee, JL Energy, argued that the reasonably diligent search test applied in determining the state of the art for purposes of obviousness [137].

Aux Sable made a straightforward argument. The plain meaning of the text of s 28.3 – “in such a manner that the information became available to the public in Canada or elsewhere” – captures the prior art, without qualification by the reasonably diligent search test [147]. Further, it was common ground that s 28.2 does not require that a prior art reference be locatable by a reasonable diligent search in order to be citable for an anticipation allegation, and since the language is the same in both sections, this implies the test must be the same [147], [150]. In reply JL Energy, relied on jurisprudence post-dating the amendments, which it argued continued to endorse or apply the reasonably diligent search test. Southcott J carefully reviewed the case law [152]-[174], and concluded, in my view correctly, that it provided little assistance either way, generally because the point was not fully argued, or the decision was ambiguous (see the synopsis below). Southcott J therefore concluded that:

[176] I find Aux Sable’s statutory interpretation arguments compelling, and I disagree with JL Energy’s response that this issue has been settled in its favour by existing jurisprudence.

He therefore held that “a prior art reference which was disclosed to the public, prior to the applicable date prescribed by s 28.3, forms part of the prior art for purposes of an obviousness analysis, regardless of whether the reference would have been locatable through a reasonably diligent search” [176].

This analysis is sound so far as it goes. The text of the Act undoubtedly supports Southcott J’s conclusion, and while the text is not determinative of the correct interpretation, it is dominant. Consequently, a strong argument based on legislative history, policy or established case law would be required to overcome the plain meaning of the text: Canada Trustco Mortgage Co 2005 SCC 54 [10]; Biolyse Pharma 2003 FCA 180 [13].

I would suggest, however, that there is a strong argument, or at least one worth considering, based on the legislative history and policy, which supports the view that the codification was not intended to change the law. I made an argument to that effect in my article “What is the State of the Art for the Purpose of an Obviousness Attack?” (2012) 27 CIPR 385. This article was not referred to by Southcott J, presumably because it was not cited to him by JL Energy. Perhaps it was not the kind of reference that would be found in a reasonably diligent search?

I won’t go through the entire article, but I will address one point. Southcott J suggested, at [174], that:

a patent monopoly should not result from an obvious advancement upon prior art, regardless of whether the prior art would have been located in a diligent search. . . . JL Energy has not offered any policy argument as to why the locatability of a piece of prior art should matter for purposes of obviousness if it does not matter for anticipation.

I suggest that there is a relevant difference between obviousness and anticipation. In Graham v John Deere (1966) 383 US 1 at 11, the US Supreme Court explained the justification for the non-obviousness requirement as follows:

[T]he underlying policy of the patent system [is] that "the things which are worth to the public the embarrassment of an exclusive patent" ... must outweigh the restrictive effect of the limited patent monopoly. The inherent problem was to develop some means of weeding out those inventions which would not be disclosed or devised but for the inducement of a patent.

That is, an invention should be considered obvious if it would have been developed even without the lure of a patent, and conversely, it should be considered non-obvious if the patent reward was required to bring it forth.

The obviousness implements this “but for” approach on the view that the lure of a patent would not be required if the invention could easily be made by a person of ordinary skill in the art when faced with the problem at hand. It has therefore traditionally been understood as an essentially factual inquiry as to whether the invention would have been obvious to a person skilled in the relevant art. As an essentially factual inquiry, the state of the art for the purposes of obviousness must be that which an actual skilled person would have had at hand. The factual nature of the inquiry is reflected in the famous Cripps question, formulated by Sir Stafford Cripps in argument in Sharp & Dohme v Boots Pure Drug Co (1928), 45 RPC 153 (CA), at 162-63 and adopted by Lord Hanworth MR at 173, which is the basis of the test set out in the Act:

"The real question is: was it for all practical purposes obvious to any skilled chemist in the state of chemical knowledge existing at the date of the patent which consists of the chemical literature available (a selection of which appears in the Particulars of Objections) and his general chemical knowledge, that he could manufacture valuable therapeutic agents by [the process specified in the patent]

Anticipation aims at the same purpose, to weed out patents for inventions which did require the lure of the patent monopoly, but the question is in some ways simpler. Instead of asking whether a skilled person would have invented it without the patent lure, we simply ask whether it has already been made public; if so, the lure of a patent is evidently not required to deliver the knowledge to the world.

My article also discusses various points of legislative history, suggesting that these also point in the same direction. Whether such considerations are sufficient to displace the prima facie interpretation based on the text of the Act is a different issue. I must admit that I am disappointed that Southcott J did not have these arguments before him.

After all that, Southcott J considered all the references advanced by Aux Sable, including those which would not have been found in a reasonably diligent search, and he nonetheless held the claims at issue to be valid. Thus the holding that the state of the art includes the entire prior art did not ultimately affect the result.

Here is a synopsis of Southcott J’s review of the cases. Starting with the FCA cases, JL Energy sought to rely on a passage from Mishan 2015 FCA 163 [18]-[23], but Southcott J noted that the FCA at [21] had expressly left that question open, and it could not be taken as having settled the issue [155]. Southcott J then considered Ciba 2017 FCA 225. I had interpreted the majority (Pelletier and Rennie JJA) as holding that all prior art that is available in a novelty attack is also part of the state of the art for the purposes of an obviousness attack [51]-[63], though Woods JA dissented, on the view that “[t]he issue is better addressed in an appeal where it is relevant to the outcome and in which the Court has the benefit of full submissions from counsel, which was not the case here” [156]. I noted in my post on Ciba that I agreed entirely with Woods JA, and I am pleased to see that her dissent was given significant weight by Southcott J in holding that Ciba had not settled the point either, though he also discussed significant ambiguity in the interpretation of the majority decision [157-60].

Southcott J then reviewed a number of post-1996 cases which referenced or applied the reasonably diligent search test, but he agreed with Aux Sable’s position that the issue had not been squarely raised, and so were not strong authority for the proposition that the amendment had changed the law [161]-[164]. This strikes me as sound. He then noted that while Novartis 2015 FC 770 supported JL Energy’s position, it had considered only case law, and not the statutory interpretation arguments [166]. Southcott J found more comfort in Locke J’s decision in Pollard 2016 FC 883, which I described as being “clearly sympathetic to the argument that the state of the art should comprise all public prior art,” but Southcott J recognized that Locke J had canvassed the arguments [170], and while it supported Aux Sable’s position, it was more a matter of raising some persuasive considerations, than a determinative decision [174].

When Is an Invention Made?

Les Laboratoires Servier v Apotex Inc 2019 FC 616 Roy J
            2,423,825 / perindopril arginine / VIACORAM / NOC

This decision, as well another released last week, Aux Sable 2019 FC 581, invalidated significant claims on the basis of overbreadth. In both these cases the reasoning was, with respect, dubious, though in different ways. I suggest this is primarily due to defects in the doctrine itself. While the principle is clear enough – a patentee may not claim more than it has invented and disclosed – there is no clear methodology associated with the overbreadth doctrine. In particular, there is no well-established way of determining what is “the invention” which is to be compared with the claims. (Though that is not the main problem with the reasoning in the case at hand.) I have a draft paper on overbreadth which I hope to post later this week or early next week exploring this issue in more depth.

Turning to the case at hand, perindopril is used for treating hypertension and related cardiovascular disorders. Servier invented perindopril and received Canadian patent 1,341,196 for the compound per se [9], which it marketed as COVERSYL [10]. The 196 patent expired in March of 2018. In the meantime, Servier developed and received marketing authorization for the arginine salt (marketed as VIACORAM). This is protected by the 825 patent, which claims the arginine salt of perindopril and its hydrates as Claim 1 (“Sel d'arginine de périndopril ainsi que ses hydrates”). Apotex, wishing to sell a generic version of perindopril arginine, which it concedes will infringe the 825 patent, attacked the validity on a variety of grounds, including overbreadth [5]-[6].

A preliminary point of claim construction is helpful in understanding the overbreadth issue. Arginine is an amino acid, and it is a chiral compound which exists as both dextro- and levo-rotatory, forms, as well as a racemic mixture. L-arginine is the naturally occurring form [19]. While the disclosure identified the preferable form as L-arginine [19], [69], Claim 1 simply claimed “arginine.” Servier argued that this should be construed as L-arginine [159]. Roy J ultimately rejected this, essentially on the basis that the patent itself acknowledged the difference between the various forms of arginine, and to construe the claim as referring to L-arginine would read a limitation from the disclosure into the claim [172]-[179]. There was also an issue as to whether the reference in the claim to “hydrates” was restricted to crystal hydrates, or included any form incorporating water into the salt. Roy J again concluded the broader construction was correct [179].

The key reasoning on overbreadth is brief (my emphasis):

[205] The principle is simple enough on its face. A patent cannot validly claim more than has been invented. The claims may not be broader than the invention (Schering-Plough Canada Inc. v Pharmascience Inc., 2009 FC 1128). As usual, Professor Vaver captures in a few words what is at stake in his Intellectual Property Law, Irwin Law, 2nd Edition (2011):

The game for patent holders, especially in highly competitive industries, is to reveal as little and to claim as much as possible. The less disclosed, the more that can be retained as competitive edge. The wider one claims, the tougher it is for imitators and competitors. But the specification must stay clear of the known and the obvious. It must demonstrate and claim only something over and above existing technology. Much patent drafting involves trying simultaneously to achieve these aims. Along the way several obstacles must be avoided, lest the claims or the whole patent end up invalid. [p. 346]

This is all unobjectionable, but it does not provide any test for overbreadth. Schering-Plough 2009 FC 1128 has only a very brief discussion at [211]-[215], dismissing the attack on the facts, and Professor Vaver’s discussion is clearly not a legal test, but rather a discussion of the problem. No other authority is cited.

The key paragraphs follow:

[206] Apotex challenges the validity of the '825 on the ground that its claims are broader of the invention in two aspects: first, Servier claimed the arginine salt of perindopril, which includes the D-arginine and the racemate arginine salt of perindopril; second, Servier claimed the hydrates of perindopril arginine. In both cases, Apotex argues that there is no evidence in this whole record that Servier made the D-arginine or the racemate arginine salt of perindopril or that Servier made a hydrate of perindopril arginine.

[207] If either one of those obligations is accepted, it will be fatal to the validity of '825.

This statement is quite perplexing. On its face, Roy J is saying that if Servier claimed the D-arginine salt but never physically made it, then the claim is, for that reason, overbroad. This suggests that the test for overbreadth which he is applying is that a claim is overbroad if the patentee did not make every embodiment falling within its scope. This is confirmed particularly by the discussion on the facts of the hydrates, where Roy J emphasized that “The evidence in this case did not disclose that a hydrate of perindopril arginine was ever made" [229], and “there is no proof that Servier ever made a hydrate” [230]. The discussion of the D-arginine was concerned entirely with the claim construction point [210]-[222], of whether the claim to “arginine” encompassed D-arginine at all. It appears that Servier did not really address the overbreadth point as such [210] – perhaps implicitly conceding that the claim was overbroad if D-arginine had not been physically made?

I’m really not sure where this comes from. While overbreadth doctrine is not very well developed, the most prominent test is that a claim is overbroad if an essential element of the invention is omitted from the claim: see eg Amfac 80 CPR(2d) 59 (FCTD) at 80 aff’d 12 CPR(3d) 193 (FCA) at 196, 204. This was not the approach applied by Roy J; there was no discussion of the essential elements of the invention before concluding the claims were too broad. It is also very common that if a claim is overbroad, it is also invalid for some other reason, perhaps most often lack of utility, because in omitting an essential element, the claim encompasses something old, or useless. While Roy J did go on to discuss sound prediction of utility, this was after he had already concluded that the claims were too broad [222 re D-arginine, 231 re hydrates]. Moreover, the discussion of sound prediction was largely an aside, as “[i]t is not completely clear that Servier invoked the doctrine of sound prediction to justify the hydrates being included in claim 1" [241].

Perhaps the idea that a claim is invalid if it encompasses something which has not been physically made is derived from an overly literal reading of the famous statement by Thurlow J in Farbwerke Hoechst AG v. Commissioner of Patents, [1966] Ex CR 91 at 106:

There are two fundamental limitations on the extent of the monopoly which an inventor may validly claim. One is that it must not exceed the invention which he has made, the other is that it must not exceed the invention he has described in his specification.

But “made” in this statement does not mean “physically synthesized.” If it did, every genus patent would be invalid. A genus patent claims a broad range of related compounds, the vast majority of which will never have been synthesized, yet it is well established that a genus claim will be valid if there is a sound prediction of utility across its full scope, based on an extrapolation from the few compounds which were made and tested. Indeed, selection patents are possible only because so many compounds, and often the most desirable, falling within the genus were never made, so that the species selected is new, notwithstanding the genus. And every patent is a genus patent in some sense: a claim to “the wheel” encompasses not just the particular wheel that the inventor might have made and tested, but all wheels, including those made well after by some other person out of different materials. Saying a claim to arginine is overbroad because it encompasses D-arginine when the inventor had only made L-arginine, is like saying that a claim to the wheel is overbroad because it encompasses a wheel made out of birch when the inventor had made his prototype out of maple.

The broader point is that an invention is not a thing, but information: see Aerotel [2006] EWCA Civ 1371 [32]. The physical embodiments are merely a reflection of that information. As the SCC stated long ago, in Ball v Crompton Corset Co (1886), 13 SCR 469 at 477, quoting with approval the Supreme Court of the United States in Smith v Nicholls 21 Wall. 118:

A patentable invention is a mental result. It must be new and shown to be of practical utility. Everything within the domain of the conception belongs to him who conceived it. The machine, process or product is but its material reflex and embodiment.

Since an invention is information, making an invention is not a physical act. The question of when an invention was made arose regularly under the first-to-invent scheme of the old Act, and the invention was considered to have been first made by the person who “formulated, either in writing or verbally, a description which affords the means of making that which is invented”: Christiani and Nielsen v Rice [1930] SCR 443 at 456; and see also Ernest Scragg & Sons Ltd v Leesona Corp (1964) 45 CPR 1 at 31-32. That is, an invention is “made” when it is described – when the information has been provided which allows a skilled person to make and use it. This is why the disclosure, and not the physical embodiment, is the quid pro quo for the patent monopoly: Consolboard [1981] 1 SCR 504 at 517.

Perhaps I have misunderstood Roy J’s reasoning on this issue, but the proposition that a claim is overbroad if it encompasses embodiments which have not been physically made is supported neither by the cases nor by sound principle. This would not affect the result: as discussed in yesterday’s post, the claims at issue were also held invalid for obviousness.

Arginine Salt Obvious to Try

Les Laboratoires Servier v Apotex Inc 2019 FC 616 Roy J
            2,423,825 / perindopril arginine / VIACORAM / NOC

The most interesting aspect of this decision concerns overbreadth, which was also raised in another decision released last week, Aux Sable 2019 FC 581. I’ll deal with overbreadth in a subsequent post. This post provides an overview and deals with the finding that the invention was obvious.

Perindopril is used for treating hypertension and related cardiovascular disorders. Servier invented perindopril in the early 1980s, and ultimately received Canadian patent 1,341,196 for the compound per se [9], which it marketed as the erbumine salt under the brand name COVERSYL [10]. The 196 patent expired in March of 2018. The erbumine salt had stability problems, particularly in hot and humid conditions, that adversely affected shelf life [15], [34]. These problems had been raised early on in the development of perindopril. At that time one of the inventors of the 825 patent had suggested pursuing alternative salt forms and did some preliminary experiments with the arginine salt. However, pursuing a different salt form was not a priority for Servier, which initially dealt with the stability problem by using “tropicalized” packaging for some countries [31], and accepting a limited 2 year shelf life. Eventually though, in the late 1990s, Servier decided to pursue a new salt form, and returned to further development of the arginine salt. In 2002 Servier filed the application which matured to the 825 patent. Claim 1 is to the arginine salt of perindopril and its hydrates (“Sel d'arginine de périndopril ainsi que ses hydrates”). Servier markets the arginine salt as VIACORAM. Apotex, wishing to sell a generic version of perindopril arginine, which it concedes will infringe the 825 patent, attacked the validity on a variety of grounds, including obviousness and overbreadth [5]-[6].

The obviousness attack succeeded, on a fairly straightforward application of the obvious-to-try test. There was no real difficulty in testing and making the arginine salt, so the real question was whether selecting it to try involved inventive ingenuity. At the time the inventors had initially suggested the arginine salt, they had never heard of it being used to to form a salt of an active ingredient [31], and Roy J remarked that the decision, at the time, may have involved a spark of ingenuity [244], [252]. However, that was in the early 1980s and salt screen methods had moved on by the claim date in 2002. Roy J accepted the evidence of Apotex’s expert that a routine structured salt screen would have succeeded in identifying perindopril arginine as a suitable salt. In particular, the expert  identified arginine as one of only nine salt formers that would be selected for the initial structured salt screen [286].

One point that I found a bit confusing is that Roy J referred to Apotex’s expert as having been “blinded” [140], [290], and “truly blind” [292], but his expert report appears to take into account the particular properties of perindopril in identifying suitable salt formers for the initial screen [286]. In any event, it appears that by 2002 arginine was fairly commonly used as a salt former [292], [294].

I would also note that Roy J interpreted the principle that it should be “more or less evident that what is being tried ought to work,” as meaning that there should be a high expectation that a salt screen would identify a suitable salt, and not that there should be a high expectation that the arginine salt itself would work [285].

Much Ado About Protective Orders

dTechs EPM Ltd v British Columbia Hydro & Power Authority 2019 FC 539 Lafrenière J

Paid Search Engine Tools, LLC v. Google Canada Corporation 2019 FC 559 Phelan J

Canadian National Railway Company v. BNSF Railway Company 2019 FC 281 Locke J

The law relating to protective orders has been developing rapidly. Until recently, the Court would grant protective orders more or less routinely, particularly on consent or when unopposed. A recent series of decisions has indicated a more restrictive approach: see Live Face on Web 2017 FC 858 Tabib J; Seedlings Life Science 2018 FC 443 Tabib J rev’d 2018 FC 956 Ahmed J (blogged here and here); and CNR 2019 FC 281 Locke J. The even more recent decisions of Lafrenière J in dTechs and Phelan J in Paid Search, in contrast, seek to turn the wheel back, holding that protective orders should normally be granted when sought on consent or when unopposed. Thus there is presently a split in the FC case law, which will no doubt be resolved by the FCA in CNR, which has been appealed [539-39]. No matter the outcome, the journey will not have been in vain, as a number of issues relating to protective orders will have been clarified.

A confidentiality order governs the filing of confidential documents and information on the court record. A “protective order” governs the way parties designate and treat confidential information that they exchange between themselves in the pre-trial phase of the action [559-19], [539-32]. The two are distinct — “The designation of a document as confidential under a protective order does not permit the document to be filed confidentially with the Court” [539-32] — but the distinction between the two has not always been as clear as it is now, in part because the terminology was used loosely until quite recently, and in part because of hybrid orders which combine features of both [443-8], [539-23], [559-27], [539-35], [281-10].

Caution as to Whether a Single Direct Infringer Is Required for Inducement

Packers Plus Energy Services Inc v Essential Energy Services Ltd 2019 FCA 96 Gleason JA: Boivin, Rivoalen JJA aff’g 2017 FC 1111 O’Reilly J
            2,412,072

In this decision, the FCA upheld O’Reilly J’s finding that Packers Plus’ 072 patent was invalid for obviousness, essentially on the basis that absent an extricable error of law, the standard of appellate review is deferential [29]-[31], and the appellant's arguments either mischaracterized O’Reilly J’s findings or attempted to reargue findings on which deference was owed [34].

O’Reilly J had also addressed anticipation and obviousness, holding that the patent was invalid as anticipated, but if it had been valid, it was not infringed. Perhaps the most interesting aspect of the FCA decisions is the remark that in light of its holding regarding obviousness “it is unnecessary to address the arguments regarding anticipation and infringement, other than to note that these Reasons should not be viewed as endorsing the Federal Court’s findings or Reasons in respect of these issues” [3]. This of course does not mean that O’Reilly J’s holding was wrong on either of these points, but it does mean that his holdings on these issues should be treated cautiously, and do not carry the same weight as a matter of comity that they might otherwise. In my view, discussed here, the most problematic aspect of his decision related to infringement by inducement. The first branch of the Weatherford test for inducement requires that “the act of infringement must have been completed by the direct infringer” 2011 FCA 228, [162]. Even though the patented invention had been performed [38], O’Reilly J held the first branch had not been established because there was no single party who had performed it [55]. That is, he read the test as requiring not just that the act of infringement be completed, but that it must have been completed by a single direct infringer. This point had not established in the prior case law. It may be that it was this point that the FCA intended should remain open (though it may also have been some point related to anticipation, discussed here).

Is ‘But for’ Causation Necessary to Establish Inducement?

I have a working paper entitled "Is ‘But for’ Causation Necessary to Establish Inducement?" which is now available on SSRN. Comments are welcome. Here is the abstract:

The established Weatherford test for inducing patent infringement requires, as its second branch, that inducement by the indirect party be the “but for” cause of the direct infringement. This article shows that such a requirement of “but for” causation leads to problematic results, particularly when the evidence indicates that the direct infringers do not heed the encouragement provided by the indirect party. The article argues that while the “but for” causation requirement is often stated, it has rarely actually been applied, and there are several cases which suggest a less stringent requirement. This article argues that the best way to reconcile the cases is to recognize that causation in the second branch of the inducement test may be established on the basis of material contribution, rather than “but for” causation, while also recognizing that “but for” causation remains necessary for an award of any monetary remedy. This approach, combining material contribution as the substantive causation requirement at the second stage of the inducement test, with “but for” causation in awarding monetary remedies, also appropriately balances the policy concerns of ensuring effective enforcement of the patentee’s rights while avoiding the problem of overbroad enforcement.

Contributory Infringement in Canadian Law

I have a new paper entitled "Contributory Infringement in Canadian Law," forthcoming in the CIPR. A draft version is available on SSRN. Here is the abstract:

Contributory infringement arises when a party knowingly supplies a direct infringer with a product especially adapted for use in a patented invention. Canadian courts have regularly stated that there is no liability for contributory infringement in Canadian law, in the absence of inducement. This article shows that there are nonetheless few cases actually refusing to impose liability on a contributory infringer, and none at the appellate level. The article argues that the reasoning and results in almost all the leading cases support a rule that supply of a product especially adapted to infringe, and with no substantial non-infringing use, constitutes indirect infringement, even in the absence of active inducement. The current shape of the law is a result of a misreading of the early leading case of The Copeland-Chatterson Company Ltd v Hatton, in combination with the problematic decision in Slater Steel Industries Ltd v R. Payer Co, which is the only prominent case refusing to impose liability in such circumstances. Slater Steel has been confined to its facts in both subsequent Court of Appeal decisions to address it, and this article argues that Slater Steel was wrongly decided on its facts. The article concludes that it is open to the courts to recognize that liability for contributory infringement may be imposed in Canadian law.

Medical Records Patents Valid and Infringed

Bessette c. Québec (Procureure générale du Québec) 2019 CF 393 LeBlanc J

2,233,794 / 2,329,598 / Distributed network system for management of medical records

This very long decision, holding M Bessette’s 794 and 598 patents to be infringed and most of the key claims to be valid, turned largely on the evidence. M Bessette was an emergency physician at a Montreal hospital in the 1990s. Patient information was held in multiple locations and even when found, the crucial information was often buried in detail. He conceived of a system which enable medical staff to quickly access relevant medical information. Rather than collecting all the information in one place, the system used a data structure with pointers to the remote location for retrieval on demand [4], [60]-[65]. The 794 patent related to a distributed network system for accessing medical records. The 598 patent was an improvement which enabled automatic “push” updating of the information [5].

While a system of this type would doubtless have been developed eventually as a result of increasing pervasiveness of distributed internet based database systems, M Bessette’s thinking was ahead of its time – exactly how far ahead is a matter for the obviousness discussion. In any event, it was certainly a very good idea. In 1998 M Bessette set out to commercialize his invention. He initially attracted considerable interest from a number of parties, including private sector technology firms, and the Quebec government, which would have had to implement the system in the Quebec hospital system. For reasons that are not entirely clear, the Quebec government ultimately lost interest by about 2000 [66]-[77]. Several years later, in around 2005, the Quebec government again decided that an internet based medical records system was a good idea. After several years of development, the accused infringing system, the Dossier Santé Québec [DSQ], was implemented in 2013 [2], [253]-[257]. There seems to be an interesting business school case study here regarding government nimbleness in innovation, but that is not really relevant to the patent case.

So far as infringement is concerned, there was the usual detailed construction of the terms of the claims (all of which were agreed to be essential [108], [242]). But the 794 patent was quite broad, and while the DSQ system had a number of features not disclosed by the 794 patent, the question, of course, is not whether the patent discloses all of the features of the allegedly infringing system, but the opposite, whether the defendant’s system incorporates all the essential features of the patented system [295], [331]. At the end of the day, Claims 1 to 8 of the 794 patent were infringed [320], as were many of the claims of the 598 patent.

The main invalidity attack on the 794 patent was based on anticipation. While various prior publications had disclosed aspects of the patented inventions, no single publication disclosed everything. One key difference was that the invention used pointers, and particularly a two-component pointer [412], [425], [427].

Given the rapid development of internet based data systems, a key question related to the 794 patent in particular would seem to be whether it was truly an inventive technical advance, or whether M Bessette was simply the first to see an opportunity which was obvious in light of the rapidly advancing state of the art. This situation calls to mind the infamous Selden automobile patent, which essentially claimed the automobile. It is now generally considered to have been a paradigmatic example of a bad patent, as the true advance in the basic automobile was not the concept of putting an engine on a cart, but rather the development of a light enough engine. Now, all inventions are obvious once the state of the art has advanced far enough, and it is entirely possible that M Bessette was sufficiently visionary that his conception would have been inventive at the relevant time. It is also possible that his particular implementation, using pointers, was inventive. But one way or the other, this would seem to be the key question. Curiously, the expert for the defendants barely touched on this issue, with a few conclusory statements rather than a detailed analysis [437]. The expert for the plaintiff therefore was instructed not to address the issue either [438]. Consequently, LeBlanc J was left to decide the issue of obviousness largely without the benefit of expert evidence on this factually driven inquiry [439]. Remarking that the obviousness argument “repose sur une preuve largement déficiente” [443], he rejected the attack, partly on the basis of the burden [441], and partly on what evidence was available [442].

The 598 patent was attacked for obviousness, insufficiency and overbreadth [448]. The key point on obviousness was the use of “push” notifications, and those claims which omitted this feature were held to be obvious [488], while the attack was otherwise rejected. The overbreadth and insufficiency arguments were also rejected on the facts.

The trial was bifurcated and damages was not addressed.

Short Blogging Break

Exam period is upon us, and I'll be taking a short blogging break to make up and grade exams. I'll return soon and start with any decisions I might have missed, including the very long Bessette c. Québec 2019 CF 393.

A Stay in Favour of Provincial Superior Courts Will Be Granted Only in the Clearest of Cases

Stelpro Design Inc. v. Thermolec Ltée, 2019 FC 363 St-Louis J

While the Federal Court has exclusive jurisdiction to annul a patent (Federal Courts Act s 20(1)), its jurisdiction in respect of infringement is concurrent with that of the provincial superior courts: s 20(2). In Stelpro, the patentee, Thermolec, brought an action in the Superior Court of Québec, and Stelpro defended there in part on the basis that the patent was invalid. Stelpro then brought an impeachment action before the Federal Court. Stelpro moved to have Quebec action stayed; that motion was refused by the Quebec court: [9]. Thermolec in turn sought to have the Federal Court action stayed by the Federal Court. That motion was also refused by St-Louis J in this decision.

The facts are similar to those in Safilo Canada Inc v Contour Optik Inc 2005 FC 278, in which Safilo brought action for impeachment in the Federal Court a few hours before the patentee, Contour, brought an action in the Superior Court of Québec. (In Safilo it is clear that the patentee was motivated to bring its action in the Quebec courts in part by the prospect of obtaining an interlocutory injunction, which is of course essentially impossible for a patentee to obtain in the Federal Court, and which was granted by the Quebec court. One might speculate that Thermolec’s motivation was the same, as it was also granted an interlocutory injunction in Quebec).

In considering whether to grant a stay, both de Montigny J in Safilo and St-Louis J in the case at hand, referred to the list of relevant factors summarized by by Dubé J. in White v EBF Manufacturing Ltd, 2001 FCT 713:

1. Would the continuation of the action cause prejudice or injustice (not merely inconvenience or extra expense) to the defendant?

2. Would the stay work an injustice to the plaintiff?

3. The onus is on the party which seeks a stay to establish that these two conditions are met.

4. The grant or refusal of the stay is within the discretionary power of the judge.

5. The power to grant a stay may only be exercised sparingly and in the clearest of cases.

6. Are the facts alleged, the legal issues involved and the relief sought similar in both actions?

7. What are the possibilities of inconsistent findings in both Courts?

8. Until there is a risk of imminent adjudication in the two different forums, the Court should be very reluctant to interfere with any litigant's right of access to another jurisdiction.

9. Priority ought not necessarily be given to the first proceeding over the second or, vice versa.

Two important additional factors emerged in Safilo.

First, only the Federal Court can rule on the in rem validity of the patent and dispose of it at a national level, while the Superior Court judgment would only be valid between the parties and in Quebec. This strongly suggests that the FC action should not be stayed. To address this difficulty, the patentee in Safilo, who was seeking to pursue the action in Quebec, gave an undertaking that if the final result in the Quebec litigation was that the patent was invalid as between the parties, the patentee would agree to the striking out of the patent by the Federal Court [33]. (This practice was derived from the copyright case of Apotex v Astrazeneca [2003] 4 FC 826.) A similar undertaking was given in this case. In Safilo de Montigny J indicated that an undertaking “makes moot the distinction between the in rem and in personam nature of the remedies which the Federal Court and Superior Court may grant respectively” [34]; in this case, St-Louis J quoted this statement and remarked “I have no reason to disagree” [45]. The undertaking thus removes one major substantive objection to staying the FC action.

As noted by St-Louis J at [42], a second important consideration emerging from Safilo is the relative state of advancement in the proceedings in each of the courts. In Safilo, de Montigny J granted the stay, essentially on basis that case was further advanced in Quebec and in light of undertaking to expunge given by the patentee [38]. (And see also YKK Zipper v Wahl Bros (1972), 8 CPR(2d) 131, also granting a stay when the proceedings in the Superior Court of Québec were very far advanced when the FC action was initiated.)

In Stelpro, in contrast, St-Louis J refused to stay the Federal Court action. The decisions are straightforwardly distinguishable, because, as St-Louis J emphasized, in Stelpro, unlike in Safilo, the proceedings on the merits were at an early stage in both courts [47].

St-Louis J concluded that

[48] As per the Safilo Canada guidelines, the power to grant a stay may only be exercised sparingly and in the clearest of cases. As can be shown from the paragraphs above, I have not been convinced that this is “the clearest of cases”, and will thus not grant the stay.

This is despite the undertaking given by Thermolec to agree to consent to the entry of a judgment in the Federal Court that mirrors the Superior Court’s future decision on the validity of the patent [9], and despite the fact that a stay had been refused by the Superior Court of Québec, giving rise to a real prospect of duplicative litigation and conflicting outcomes.

This illustrates that the principle that a stay will granted only in the rarest of cases is an important one. Per the 8^th point from White v EBF, “the Court should be very reluctant to interfere with any litigant's right of access to another jurisdiction.” While I acknowledge the force of that principle, and St-Louis J’s decision in this case does appear to be consistent with the prior caselaw, I must say that the result does not seem entirely satisfactory.

UKSC Weighs in on Obvious to Try and Golden Bonus

Actavis v ICOS [2019] UKSC 15 (27 March 2019) Lord Hodge: Lady Hale, Lords Kerr, Sumption, Briggs aff’g [2017] EWCA Civ 1671 Kitchin LJ: Lewison, Floyd LLJ rev’g [2016] EWHC 1955 (Pat) Birss J

EP (UK) 1,173,181 / tadalafil dosage / CIALIS

In Actavis v ICOS the UKSC has affirmed the decision of the EWCA holding ICOS’s dosage patent for tadalafil to be obvious on an obvious-to-try analysis. As discussed here, the EWCA decision was consistent with the way the obvious-to-try analysis has consistently been applied by the Federal Courts. The decision of the UKSC provides further reassurance, if any was needed, that the Canadian approach is sound. Along the way, the UKSC expressly affirmed the “golden bonus” rule: if a particular invention is obvious for one reason, it does not become non-obvious simply because it had additional unexpected or non-obvious advantages.

The obvious-to-try analysis was endorsed by the SCC in Sanofi 2008 SCC 61, where the Court stated that:

[65] I am of the opinion that the “obvious to try” test will work only where it is very plain or, to use the words of Jacob L.J., more or less self-evident that what is being tested ought to work.

This might lend itself to the view that it must be self-evident, prior to any experimentation, that the claimed invention will solve the problem at hand. But the Court immediately went on to say that for an invention to be “obvious to try”, there must be evidence that it was “more or less self-evident to try to obtain the invention” [66]. That is, it is trying that must be self-evident, not that that the specific claimed invention would work. In Actavis v ICOS, the UKSC addressed exactly this question.

The facts in Actavis v ICOS are simple, and raise a paradigmatic version of the obvious-to-try analysis. The key claim was to a 5mg daily dose of tadalafil for the treatment of ED.^* Tadalafil was known to be an effective oral treatment for ED, but the optimal dosage was not part of the the prior art [23]. It was obvious to carry out a dose-ranging study to determine the appropriate dose. The initial dose ranging study would be of on demand dosing using 25, 50 and 100mg doses. This study would have revealed a therapeutic plateau in that range [35]-[36]. Birss J held that it was “very likely” that a skilled team would then investigate lower doses. Both the EWCA and the UKSC treated this “very likely” finding as meaning that it would have been obvious to do so; ie, that it would have been obvious to try lower doses. Birss J held that if they had done so they would have discovered that a 5mg dose tadalafil was efficacious and had reduced side effects; that is, the posita would have discovered the invention. There would, however, have been no prior expectation that a dose of 5mg would have been efficacious; on the contrary, it would have been surprising that such a low dose would be effective [37]. It would have doubly surprising that the 5mg dose also had reduced side-effects [37].

Birss J held that claims at issue to be non-obvious, essentially because “the claimants failed to prove that efficacy at 5mg tadalafil was predictable or worth considering by the skilled team based on the properties of tadalafil as compared to sildenafil,” and “[a]ssuming a 5mg/day dose of tadalafil was tested, it would not be tested with a reasonable expectation of success” [38]. In other words, Birss J held that the 5mg dose was not obvious because, if the skilled team had been asked, prior to testing, whether a 5mg dose would have been efficacious, the answer would have be "probably not". In Birss J's view, the conclusion of non-obviousness followed notwithstanding that the entire course of research leading to the invention would have been obvious to try. The EWCA reversed, and Lilly (the exclusive licensee), appealed.

The key question was summarized in Lilly’s central submission [50]:

the question which the Court of Appeal should have asked was whether at the priority date, before the skilled team embarked on its investigation, it was obvious in the light of [the knowledge that tadalafil is effective for treating ED], and without knowledge of the alleged invention, that a 5mg per day dose of tadalafil would be a safe and effective treatment, with minimal side effects, for sexual dysfunction.

That is, the invention is not obvious unless there would be a reasonable expectation, prior to undertaking the dose-ranging study, that the 5mg dose would work. A reasonable expectation that some minimum dose would be safe and effective, and that the minimum could be determined from a dose-ranging study, would not suffice, unless there was a reasonable expectation that the 5mg dose in particular would work.

The UKSC rejected this submission [52]: “uninventive steps which the skilled team would take after the priority date to implement the [knowledge that tadalafil is effective in treating ED] are not excluded from consideration in assessing the obviousness of the alleged invention at the priority date” [59]. On the facts, the UKSC affirmed the EWCA in holding the patent to be obvious [105]. This is a clear holding that the mere fact that there would be no reasonable prior expectation that the particular claimed invention – the 5mg dose – would work, does not in itself mean the invention is non-obvious.

The UKSC elaborated with nine points.

First, “it is relevant to consider whether at the priority date something was ‘obvious to try’” [65]. I take this to mean the same as the SCC meant in Sanofi when it held at [64] that the “obvious to try” inquiry is one factor to be considered in the obviousness inquiry. An invention which is obvious to try is not necessarily obvious for that reason alone, as there may be invention in getting it to work.

The second point was that “the routine nature of the research and any established practice of following such research through to a particular point may be a relevant consideration” [66]. Even if it was not obvious in advance that the invention would work, it may nonetheless be obvious, if the route to success was obvious to try, and there were no difficulties along the way requiring invention. The Court continued by saying that this is “weighed against the consideration that the claimed process or product was not obvious to try at the outset of a research programme” [66]. This is a bit obscure to me. The point appears to be that the fact that the particular claimed product – the 5mg daily dose – was not obvious to try at the outset is a consideration. I’m not sure why that should be a consideration, as the premise here is that the specific claim product would not have been predicted in advance, even though it was the outcome of a routine investigation.

“Thirdly, the burden and cost of the research programme is relevant” [67]. The parallels the Sanofi factor asking as to the “extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine?” [69] Even trials that are technically routine might nonetheless rise to the level of invention if sufficiently arduous: “A patient searcher is as much entitled to the benefits of a monopoly as someone who hits upon an invention by some lucky chance or an inspiration” (Halocarbon [1979] 2 SCR 929).

“Fourthly, the necessity for and the nature of the value judgments which the skilled team” [68]. Routine work is no longer routine if it requires extensive exercise of judgment.

“Fifthly, the existence of alternative or multiple paths of research will often be an indicator that the invention contained in the claim or claims was not obvious” [69]. Again, this corresponds to Sanofi (by coincidence also at [69]): “Are there a finite number of identified predictable solutions known to persons skilled in the art?”

“Sixthly, the motive of the skilled person is a relevant consideration. The notional skilled person is not assumed to undertake technical trials for the sake of doing so but rather because he or she has some end in mind. It is not sufficient that a skilled person could undertake a particular trial; one may wish to ask whether in the circumstances he or she would be motivated to do so” [70]. The invention may lie in the decision to try a pursue a particular line of investigation, even if the inquiry is routine after that decision is made. Put another way, an invention that is not obvious to try, is not obvious under the obvious to try test. The invention may lie either in the decision to pursue a particular line of inquiry, or in overcoming obstacles along the way.

“Seventhly, the fact that the results of research which the inventor actually carried out are unexpected or surprising is a relevant consideration as it may point to an inventive step, at least in so far as it suggests that a test was not obvious to try or otherwise the absence of a known target of the research which would make it less likely that the skilled person would conduct a test” [71]. I take this to be related to the previous point. Mere unexpected results – as on the facts, the unexpectedly low effective dosage – does not establish non-obviousness, but the unexpected nature of the results may be relevant to the extent that it supports a finding that the inquiry was not obvious to try in the first place.

“Eighthly, the courts have repeatedly emphasised that one must not use hindsight, which includes knowledge of the invention, in addressing the statutory question of obviousness” [72]. This point is very well recognized by the Canadian courts.

The ninth point is particularly significant, as it is the first time, to my knowledge, that the UKSC has expressly affirmed the “golden bonus” rule. If a particular invention is obvious for one reason, it does not become non-obvious simply because it had additional unexpected or non-obvious advantages. The leading case is Hallen & Co v Brabantia (UK) Ltd [1991] RPC 195 (EWCA), in which it was obvious to coat a corkscrew with slippery PTFE in order to aid its penetration into the cork. The EWCA held that the invention did not become non-obvious simply because it turns out that it also had a non-obvious benefit of improving extraction of the cork. That holding has now been approved in principle by the UKSC [73], and also apparently applied it on the facts, as the 5mg dosage had a surprising beneficial property of minimal side effects, which nonetheless did not make that dosage regime an invention [31].

While the UKSC held the claims at issue to be obvious, the Court took pains to say that dosage patents are not suspect per se, approving the view that: “there [is] no policy reason why a novel non-obvious dosage regime, which was the product of expensive and unpredictable research, should not be rewarded with a patent of a Swiss-form claim” [76], [103]. Moreover, there is no general rule “that the product of well-established or routine enquiries cannot be inventive” [103]. 

It should not be very surprising that the SCC and UKSC jurisprudence on obvious-to-try are consistent, given that the SCC in Sanofi relied heavily on the prior UK case law. It is nonetheless reassuring that a consistent body of jurisprudence has developed, as this indicates that the charted path was the right one.

*The representative claim was Claim 7, which was effectively to a dosage form of tadalafil suitable for oral administration up to a maximum total dose of 5 mg per day, for the treatment of sexual dysfunction.