Wednesday, March 15, 2017

How Much Experimentation Is Permitted Before a Specification Is Insufficient?

Bombardier Recreational Products Inc v Arctic Cat Inc. and Arctic Cat Sales Inc, 2017 FC 207 Roy J
            2,293,106 / 2,485,813 / 2,411,964 / 2,350,264

As discussed in yesterday’s post, the Rider Position Patents at issue in Bombardier v Arctic Cat survived all validity attacks but one, and Roy J held they would have been infringed if valid. However, Roy J held the patents invalid for insufficiency, on the basis that the patents “do not describe how the inventions are to be put in operation [605]. That a person skilled in the art would be able to make the invention in light of the disclosure, was, according to Roy J, “beside the point” [561]:

Ever since Consolboard, the law has been clear that the specification alone is to be used to put the invention into practice, without the assistance of a minor research project.”

See similarly [549], [568], emphasizing that if even a “minor” research project is required, the specification is inadequate. The above reference to Consolboard notwithstanding, Roy J’s primary authority for this point is the Viagra decision, Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60, which was cited throughout Roy J’s decision.

The proposition that a specification is insufficient if it requires the skilled person to carry out a minor research project to put the invention into practice, is with due respect, an error of law. This proposition is not entirely novel. Some very early cases did indeed suggest that the specification had to explain in detail how to work the invention, “without the necessity of trying experiments” Turner v. Winter (1787) 99 Eng. Rep. 1274, 1276-77, 1 WPC 77, 80 (KB); and see R v Arkwright (1785) 1 WPC 64, 66; Morgan v Seaward (1836), 1 WPC 170, 175. But these cases did not address the precise degree of experimentation permissible. The difficulty with a strict rule excluding any experimentation at all, is that in almost any field there are some steps that require some degree of routine trial and error. To require a patentee to describe all steps with sufficient particularity to avoid such trials would leave the patent open to technical attacks. In some cases it might be impossible to frame a valid claim, even though a skilled person would easily be able to work the invention on the basis of the disclosure. Such remarks were therefore immediately tempered by the principle that they are addressed to a person skilled in the relevant art; as Jessel MR said in Otto v. Linford (1882) 46 L.T.(NS) 35 at 41, in the course of holding that the disclosure was not insufficient because it did not specify the precise proportions for fuel and air necessary for combustion, “[t]he first thing to be remembered, in specifications of patents, is that they are addressed to those who know something about that matter.” And even before that, in Morgan v Seaward, Alderson B at 175, stated that the specification “must actually and plainly set forth what the invention is, and how it is to be carried into effect, so as to save a party the trouble of making experiments and trials,” but he went on to say, at 176, that the workman brings his “ordinary knowledge” to the job and if the size of the parts is not specified, this is not fatal: “He says, ‘I see this will not work because it is too small,’ and then he makes it a little larger, and finds it will work.”

Thus it has long been clear that the specification is not insufficient simply because trials or experiments are required to work the invention. This established principle was reaffirmed in Wandscheer v Sicard Ltd, [1948] SCR 1, 17, in which the SCC stated (my emphasis):

That such a mechanic could produce such a machine from the Curtis patent is established by the evidence of the witness Ostrander. It is to be observed that it is not necessary that such a person should be able to do so without trial or experiments so long as the task involved does not require invention. In Edison & Swan Electric Light Co. v. Holland 16, Cotton L.J. said, at p. 277:

The objection taken as a whole, was that the specification did not sufficiently show how the invention is to be carried into effect. It is necessary that this should be done so as to be intelligible, and to enable the thing to be made without further invention—not, as was pressed upon us, by an ordinary workman, but by a person described by Lord Ellen-borough in Huddart v. Grimshow (1 Webs. R. pp. 85 to 87) as a person skilled in the particular kind of work or, as said by Lord Loughborough in Arkwright v. Nightingale (1 Webs. R. p. 60) a person conversant in the subject. But in my opinion it is not necessary that such a person should be able to do the work without any trial or experiment, which, when it is new or especially delicate, may frequently be necessary, however clear the description may be.

Similar statements can be multiplied almost indefinitely. In many jurisdictions it is said that the disclosure is sufficient unless “undue experimentation” is required: see eg Biogen v Medeva [1977] RPC 1, 16 (HL). This precise phrase is not as commonly used in Canadian courts, but the standard is essentially the same. So, in reversing the trial judge’s finding of insufficiency, the FCA in Mobil Oil 63 CPR(3d) 473, 494 (FCA) rev’g in part 57 CPR(3d) 488 (FCTD) stated:

Once it is established that the specifications did not have to go further as to the acceptable amount and the location of the slip agent contemplated, since a person skilled in the art could be expected to go through the testing and experimentation required to make the determination, what exactly can be seen as missing?

This is even though there was expert evidence that “it was not obvious nor easy to determine how to put the slip agent into the film and test its effect,” (494-95); the FCA dismissed this, saying “is that not a difficulty which simply necessitates proper experimentation and testing?” See also Merck & Co. v. Apotex Inc., 60 CPR(3d) 356 (FCA) aff’g on this point 59 CPR(3d) 133 (FCTD), in which the specification was sufficient because the defendant was able to practice the invention“by experimentation, albeit with some difficulty.”

Thus, it is clearly wrong as a matter of law to say that the specification is insufficient if it requires even a minor research project. On the contrary, it has been established for almost 200 years that some experimentation is permitted, and the degree of experimentation may be considerable.

Consolboard [1981] 1 SCR 504, 520, is not to the contrary. In the passage emphasized by Roy J at [561], the SCC quoted with approval Thorson P’s statement in Minerals Separation [1947] Ex CR 306, that the patentee must be able to put the invention into effect “having only the specification” (Roy J’s emphasis). But this means only what it says; it does not say that the skilled person, armed with the specification, is prohibited from undertaking experiments.

Nor did Viagra [aka Teva] 2012 SCC 60, change the law on this point. Roy J relied on paragraphs [73], [74] in particular, which were quoted at [549], [550] (Roy J’s emphasis), and cited again at [568]:

[74] The disclosure in the specification would not have enabled the public “to make the same successful use of the invention as the inventor could at the time of his application”, because even if a skilled reader could have narrowed the effective compound down to the ones in Claim 6 and Claim 7, further testing would have been required to determine which of those two compounds was actually effective in treating ED. As the trial judge stated, at para. 146, “[a] skilled reader would then conduct tests on those two compounds and determine which of those compounds worked”. And as he also stated, at para. 135, “the skilled reader must undertake a minor research project to determine which claim is the true invention”.

[75] Pfizer argued in the Court of Appeal that Teva had already been able to make the same use of the invention having only the specification, because it had filed a submission with the Minister of Health for a drug product containing sildenafil (F.C.A., at para. 48). However, this does not change the fact that the specification required, at a minimum, “a minor research project” in order to determine whether Claim 6 or Claim 7 contained the correct compound. The fact that Teva carried out this minor research project is irrelevant to Pfizer’s obligation to fully disclose the invention. More importantly, what must be considered is whether a skilled reader having only the specification would have been able to put the invention into practice. The trial judge clearly found that the skilled reader would have had to undertake a minor research project to determine what the true invention was.

It is understandable that Roy J would have relied on this statement by the SCC, which appears to be on point, especially as it seems that counsel for BRP did not focus on the insufficiency argument: [542], [554]. Moreover, it must be said that Viagra is obscure at a doctrinal level. As the saying goes, “hard cases make bad law” – or, as a Glanville Williams is reputed to have said, “What is certain is that cases in which the moral indignation of the judge is aroused frequently make bad law." That is what seems to have happened in Viagra. The specification disclosed that “one of the especially preferred compounds induces penile erection in impotent males” – but it did not specify which one. As Kelen J remarked at trial, 2009 FC 638, [135] “the disclosure plays games with the reader.” The SCC picked up on this statement, saying that the “key issue” in the appeal, is that “patentees cannot be allowed to ‘game’ the system in this way” [80]. While the Court expressed this as a conclusion, it appears to have been really the premise of the Court’s reasoning. The patentee would not be allowed to game the system, and the only question was how this result would be achieved. Unfortunately, as I argued in my article, The Wrong Tool for the Job, (2013) 25 IPJ 269, the particular doctrinal tools at hand were not well suited to the task. The consequence, as that article explains in more detail, was a doctrinal morass. As a decision of the SCC, Viagra is binding law, but its opaque reasoning must be interpreted carefully. For the most part, the Federal Court has done a very good job of interpreting Viagra appropriately, recognizing that it was responding to the unique facts of the case: see 2013 FC 141 (blogged here); 2013 FC 283 (here); 2015 FC 770 (here); 2014 FC 314 (here).

Consequently, read a whole, Viagra itself does not support Roy J’s interpretation of the phrases he emphasized from paragraphs 74 and 75. The degree of experimentation in implementing the invention was not at issue, and the SCC should not be taken to have been overturning 200 years of precedent, including SCC precedent, without discussing that precedent, on an issue that was not before it. Instead, as the SCC immediately went on to explain:

[76] Pfizer had the information needed to disclose the useful compound and chose not to release it. Even though Pfizer knew that the effective compound was sildenafil at the time it filed the application, it limited its description to the following statement [that one of the especially preferred compounds had been tested.]

Thus, the “minor research project” being referred to is the need to discover which of the especially preferred compounds had actually been tested; it was not a research project as to how to synthesize sildenafil, or otherwise put the invention into practice. This is consistent with the view, noted above, which the court expressed four paragraphs later, that the real objection is to the patentee trying to “game” the system, by choosing not to disclose key information. There is no suggestion in Roy J’s reasoning that the patentee in this case was doing anything of the sort.

I’ll briefly mention a couple more points. First, Roy J seemed to suggest that the specification should have explained how the new invention was different from the prior art: “The nature of the invention is that once reconfigured, the rider would be sitting in a different position. But the Patents are silent as to how much of a change constitutes a reconfiguration. There is no indication as to what were the measurements on a conventional snowmobile such that the skilled person could see what difference is contemplated” [560]. But it is clear law that it is not necessary for the specification indicate in what way the invention is different from what had gone before: Consolboard [1981] 1 SCR 504, 531-32.

More importantly, Roy J, [553], appealed to the “bald men” metaphor from Free World Trust 2000 SCC 66, [32, SCC emphasis]:

As stated, the ingenuity of the patent lies not in the identification of a desirable result but in teaching one particular means to achieve it. The claims cannot be stretched to allow the patentee to monopolize anything that achieves the desirable result. It is not legitimate, for example, to obtain a patent for a particular method that grows hair on bald men and thereafter claim that anything that grows hair on bald men infringes.

Roy J interpreted this as standing for the proposition that “what counts in the patent is not so much the desirable result but rather how to achieve the result” [553]. With respect, that is not what that passage stands for. The bald men metaphor is concerned with overbreadth: “It is not legitimate. . . to obtain a patent for a particular method that grows hair on bald men and thereafter claim that anything that grows hair on bald men infringes.” If the patentee has only invented one method of growing hair on a bald man, it can only claim that “particular method,” not any method, no matter how different. But conversely, “[i]f the invention discloses a principle capable of general application, the claims may be in correspondingly general terms”: Biogen Inc v. Medeva Plc [1996] UKHL 18, [63]. As I understand the facts in this case, BRP had indeed invented a new general principle, namely the forward seating position. If this were a case where the desirability of a forward seating position was generally known, and the patentee had invented one particular method of carrying it out, then the “bald men” metaphor would be appropriate; but it is not such a case.

On the whole, it seems that Roy J’s real concern was that the specification did not describe how to build the thing itself. That is evident especially in his general discussion of the patent. While the patent defined the new position clearly – clearly enough, in any event, that Roy J had no difficulty concluding the claims were infringed – it did not explain how to actually construct a snowmobile with those measurements:“How does one go from measurements to the reconfiguration contemplated by the Patents?” [212]. Instead it said, in effect, we have discovered that a rider forward position is superior. On the facts, that was new and inventive. And there is nothing wrong with such a claim, so long as a skilled person, armed with that knowledge, can indeed construct such a snowmobile without undue effort. A truly innovative pioneering invention requires an equally general claim. As the SCC noted in Burton Parsons [1976] 1 SCR 555, 565, “if, in order to guard against possible invalidity, some area is left open between what is the invention as disclosed and what is covered by the claims, the patent may be just as worthless as if it was invalid. Everybody will be free to use the invention in the unfenced area.”

Finally, Roy J did state that “The only evidence in this case is not that the skilled person would have to undertake a minor research project, which is already too much (Teva, para 75). It is a major research project” [568]. However, this does not rescue his holding. The question isn’t whether the research project is minor or major, it is whether it is the kind of ordinary workshop effort that a skilled person could be expected to undertake.

Addendum: The decision of the FCA in Teva v Leo Pharma 2017 FCA 50, which was posted to the FCA website on the 21st, confirms my understanding of the Viagra decision. Like Arctic Cat in this case, Teva had argued that Viagra had changed the standard for sufficiently, so that not even a minor research project is permitted [57]. The FCA rejected this:

[58] The case before us is very different from the one that was before the Supreme Court of Canada in Sildenafil, where the patentee had deliberately omitted essential information, thereby obscuring the fact that only one of the compounds claimed actually worked (Sildenafil at paras 72, 73 and 76) . Thus, the invention itself was not even properly disclosed.

[59] Furthermore, the Supreme Court refers to the factual findings of the Federal Court in Sildenafil which found that in that case, one would require a minor research project to determine the true invention. This statement of Justice Lebel is, as mentioned, perfectly in line with the law as I understand it, not only in Canada but elsewhere, such as the U.K. and Europe, which recognizes that some non-inventive trial and error may be required to put a properly disclosed invention into practice. Had the Supreme Court wished to change the law on this point in Sildenafil, one would have expected a much more fulsome analysis of the issue and discussion of the relevant authorities. In the absence of such a discussion, I do not believe that the Supreme Court changed the law in Sildenafil in the manner Teva argues.

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