Wednesday, October 23, 2013

How (Not) to Cure an Inadvertent False Promise in a Granted Patent

F. Hoffmann-La Roche AG v. Commissioner of Patents 2013 FC 1001 Roy J
            Capecitabine / XELODA / 2,103,324

As reaffirmed in the recent FCA decision in Sanofi-Aventis v Apotex / clopidogrel 2013 FCA 186, the promise of the patent doctrine is now firmly established in Canadian law. If a patent promises a particular utility, utility will be measured against that promise: ibid [47]. However, there is no requirement that a patent contain a promise, and if it does not, the invention need have a “mere scintilla” of utility: ibid [49]. In the future, applicants may be able to draft patents that will avoid making promises, but what can be done about patents that have already been granted, but not yet litigated? This was the question faced by Hoffmann-La Roche, the applicant in this motion. While Roy J refused the application, the decision suggests the possibility that s 53(2) of the Act might be available to rectify a false promise in litigation.

The specific problem faced by Hoffmann-La Roche was that its specification contained the statement that the claimed compounds have “selectively improved pharmacokinetic profiles in monkeys, viz., 4 to 7 times higher maximum concentration” of the active metabolite than other compounds [9]. The abbreviation “viz” means “that is to say” [12], and so this statement might be construed as promising that all the claimed compounds would have such properties. In fact, not all of the compounds reached the plateau of 4 to 7 times higher maximum concentration, though some did [13]. If that statement were construed as a promise, the weaker compounds would lack utility under the promise doctrine, even though they might be patentable on the “scintilla” standard. Hoffmann-La Roche therefore sought a declaration amending the patent to remove “viz” and perhaps substitute another term, such as “eg”. It may seem odd that the validity of the patent could turn on such a minor change, but that is certainly possible under the promise doctrine. Many cases have turned on equally fine parsing of the statutory language, as I discuss in §4.3 of my False Promise article.

The two obvious routes to amendment of a granted patent are a reissue under s 47 or disclaimer under s 48. Section 48 was not available to Hoffmann-La Roche in respect of this patent because it may only be invoked within four years from the date of the patent [21]. The disclaimer provision was available, but undesirable, as the Hoffmann-La Roche would have had to disclaim potentially valuable and patentable compounds which did not meet the threshold of 4 to 7 times increase in efficacy.

Consequently, Hoffmann-La Roche tried the unusual course of seeking a remedy under ss 53(2) of the Act, independently of ss 53(1):

53. (1) A patent is void if any material allegation in the petition of the applicant in respect of the patent is untrue, or if the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made, and the omission or addition is wilfully made for the purpose of misleading.

53(2) Where it appears to a court that the omission or addition referred to in subsection (1) was an involuntary error and it is proved that the patentee is entitled to the remainder of his patent, the court shall render a judgment in accordance with the facts, and shall determine the costs, and the patent shall be held valid for that part of the invention described to which the patentee is so found to be entitled.

Hoffmann-La Roche wanted to avoid ss 53(1), which applies if a material allegation “is untrue.” While Hoffmann-La Roche was concerned that “viz” might be taken to imply a promise, it expressly did not concede as much. Construction of the promise is an uncertain exercise, and while Hoffmann-La Roche had reason to be concerned about how “viz” might be interpreted in litigation, it certainly did not want to concede that it did imply a promise. For this reason, Hoffmann-La Roche sought to rely on ss 53(2) alone.

The difficulty with this argument, as Roy J held, is that “[a] plain reading of the section in its entirety suggests strongly that subsection (2) must be read together with subsection (1). One cannot be divorced from the other” [26]. Section 53(1) provides that a patent is void if it contains certain errors which were willfully made for the purpose of misleading. Adverting to both the reference to ss 53(1) in ss 53(2), and to the fact that the provision had once been a single provision, which was separated only as a matter of drafting style, Roy J held that “it does not suffice that an involuntary error has been alleged for the remedy in ss 53(2) to be available. It must be an error that relates back to ss 53(1). That subsection declares that a patent will be void if some conditions are met” [34]. In this case, however, “there is no allegation before this Court that the ‘324 Patent is void” [35], and as a result, ss 53(2) is not available [36].

While the provision is not artfully drafted, I agree with Roy J’s analysis on this point. The reference in ss (2) to “the omission or addition referred to in subsection (1),” is apparently a reference to “any material allegation in the petition of the applicant in respect of the patent [which] is untrue, or if the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made.” So, ss (2) only applies if there is an error, in which case ss (2) is a saving provision [38]. If there is no error, then ss (2) has no application, as the patent is valid even without it.

Roy J referred to some additional persuasive considerations supporting this view. He noted that the heading to the provision is “Legal Proceedings in Respect of Patents”, which suggests that the provision is engaged in litigation, rather than by way of an application [39]. I would add that this is reinforced by the remedial aspects of ss (2), which provides that “the patent shall be held valid” for that part of the invention which is cured by ss (2). It would odd to have a patent “held valid” in an ex parte application.

Another consideration is that allowing this kind of application would allow an end run around the four year limitation period for a reissue under s 47. While Roy J did not accept s 47 would be rendered meaningless by allowing this application, he acknowledged that there is at least an overlap. A reissue is prima facie the appropriate route for amendment of a patent, which is what the applicant in effect sought, and that remedy has various safeguards, of which the limitation period is only one. In the view of Roy J, it would be wrong for a court to judicially dismantle this safeguards by the creation of a new remedy [44]. Here again, I agree. While I am not a fan of the promise doctrine, it should be addressed at the source, and not by distorting the remedial framework of the Act.

I would add one further point supporting Roy J’s conclusion. As discussed in my False Promise article, the doctrine that a false promise will invalidate a patent is ultimately based on the view that a patent is granted on the faith of the promises of utility made in the specification. If a promise is false, the courts cannot be sure that the patent would have been granted, and it is not for the courts to second guess the Crown in the exercise of its discretion in granting a patent. Now, I have also argued that the whole doctrine is wrong-headed because, in contrast to the situation in England at the time the doctrine developed, the Crown in Canada does not have any discretion to refuse a patent for an invention that meets the statutory criteria. But given that the doctrine is established, its basis is that the court should not substitute its judgment for that of the Crown in the grant of a patent when a promise has not been met. If that is so, then it reaffirms Roy J’s view that the appropriate remedy, if any, is a reissue under s 47.

While Hoffmann-La Roche was unsuccessful in this application, Roy J’s decision does raise the possibility that s 53(2) could be used to remedy a false promise in litigation, so long as the error giving rise to the false promise could be shown to be an “involuntary error.” However, this would also raise difficult questions, which Roy J did not need to address, as to whether the remedial aspects of s 53(2) would encompass a cure for a false promise. In particular, it is not clear what is meant by “the remainder” of his patent, and “that part of the invention described to which the patentee is so found to be entitled.” Alternatively, if the patent was granted within the last four years, a reissue might be sought; but it is not clear whether the requirements of s 47 will allow a reissue to effectively cure an inadvertent false promise.

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