Tuesday, May 28, 2019

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.

Friday, May 24, 2019

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.

Thursday, May 23, 2019

Teaching Away Irrelevant to Anticipation

Aux Sable Liquid Products LP v JL Energy Transportation Inc 2019 FC 581 Southcott J

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.”

Wednesday, May 22, 2019

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

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.

Monday, May 20, 2019

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

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].

Thursday, May 16, 2019

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.

Wednesday, May 15, 2019

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].

Sunday, May 5, 2019

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].