Monday, June 29, 2015

No New Cases for the Week of 22 June

No new patent / NOC / data protection cases were released for the week of 22 June 2015. Keep in mind that I do not normally blog on procedural cases. To keep up with all IP cases, I recommend Alan Macek's IPPractice Daily IP News service.

Tuesday, June 16, 2015

Canada / UK Contrast in the Test for Inducement Liability

Bayer Inc v Pharmaceutical Partners of Canada Inc / moxifloxacin (NOC) 2015 FC 388 Lafrenière J
            2,378,424 / moxifloxacin / AVELOX

Warner-Lambert Company, LLC v Actavis Group Ptc & Ors [2015] EWCA Civ 556 (28 May 2015)) rev’g [2015] EWHC 249 (Pat) (indirect infringement)
            EP 0 934 061 / pregabalin / LYRICA

Liability for inducing infringement raises the question of how the patentee’s rights should be protected when the defendant sells a product which is capable of non-infringing uses, but is likely to be put to an infringing use. This question often arises in the context of second medical use patents. The ‘424 patent at issue in Bayer v PPC / moxifloxacin is a formulation patent and PPC’s product can be used post-sale to make the formulation, so this case raises essentially the same question as second medical use patents. Lafrenière J struck the portions of Bayer’s application for an order of prohibition alleging that PPC would induce infringement of the ‘424 patent on the basis that Bayer had no reasonable chance of establishing inducement by PPC. The recent decision of the EWCA in Warner-Lambert v Actavis provides a helpful European perspective on the issue, albeit in the context of Swiss form claims. (An excellent summary is provided by the IPKat.) The comments in this post are tentative, as this issue deserves an article rather than a blog post.

The law of inducement seeks to encourage cost-effective enforcement of its rights by the patentee, while at the same time ensuring that the public is not impeded in engaging in non-infringing activity. The “cost-effective” part of the rationale is central. Inducement is not necessary to allow the patentee to enforce its patent rights, as inducement (normally*) requires an act of direct infringement and the patentee could in principle enforce its rights by proceeding against the direct infringer. But that is not always practical. It is often more efficient to pursue a single intermediary which in some way facilitates infringing activity, as Napster illustrates in the copyright context. But once we move away from direct infringement, we must be careful not to impede the defendant who facilitates non-infringing activity as well.

Friday, June 12, 2015

Jurisdictional Variation as to Whether Direct Infringement by a Single Actor is Required for Inducing Infringement

Warner-Lambert Company, LLC v Actavis Group Ptc & Ors [2015] EWCA Civ 556 (28 May 2015) aff’g [2015] EWHC 72 (Pat) (interlocutory injunction) rev’g [2015] EWHC 249 (Pat) (indirect infringement)
            EP 0 934 061 / pregabalin / LYRICA

Limelight Networks Inc v Akamai Technologies Inc, (USSC, 2014) rev’g 692 F.3d 1301 (Fed Cir 2012)(en banc)

In Akamai v Limelight the US Federal Circuit held that a party may be liable for inducing infringement of a method claim even if there was no direct infringement by any single actor, so long as all of the steps that constitute the infringement method were practiced. Consequently, an inducer would be liable if it practiced some of the steps and induced another to practice the rest. The USSC reversed, holding that inducement liability can only arise if there is direct infringement, and, on the authority of the Fed Cir Muniauction 532 F. 3d 1318 (2008) decision, direct infringement of a method claim requires that all the steps are performed by a single actor. Consequently, the USSC held that inducement liability only arises if all the steps of a method claim are performed by a single actor.

In contrast, in Warner-Lambert v Actavis the EWCA undertook a thorough review of the European case law, and noted that the courts of two EPC members states (Holland and Germany [106]) have concluded that indirect infringement can arise even in “the absence of a downstream event which, as a whole, can be regarded as putting the invention into effect” [135]-[136]. That is, indirect infringement does not necessarily require direct infringement. The EWCA did not give its own opinion on this matter, as the issue on appeal was only whether a claim for indirect infringement should be struck. But the EWCA did point to this view of the Dutch and German courts as reason for allowing the claim for indirect infringement to go to trial [136], [140].

Both US and European case law have to be treated with case. Both the US and European statutes define infringement (s 60 of the UK Act, s 271 of the US Act), while the Canadian Act has no explicit definition. The split between the US and European approaches is nonetheless instructive because the relevant European provisions derive ultimately (though loosely) from the US statute (see Grimme [2010] EWCA Civ 1110 ¶ 92), so the split is not just due to fundamentally different statutory provisions.

I have no opinion as to how this difficult question is best resolved, but the European developments do indicate that it would be wrong for Canadian courts to simply follow the recent USSC decision in Limelight v Akamai. That is particularly so because the US debate over the proper approach to inducing infringement is closely tied up with the Muniauction test for direct infringement. The USSC relied on Muniauction "[a]ssuming without deciding" that it is correct, and implied that any difficulties its holding might cause were attributable to Muniauction's strict approach to direct infringement. This might have been taken as an invitation to the Fed Cir to revisit that decision, but that invitation was declined in Akamai v. Limelight (Fed. Cir. 2015), on remand, which essentially reaffirmed Muniauction. Moreover, as explained here, it appears that in reversing the Fed Cir, the USSC didn’t fully understand the Fed Cir’s reasoning. It will be interesting to see how the issue of inducing infringement is treated in the UK now that Warner-Lambert v Actavis will proceed to trial on this issue.

Thursday, June 11, 2015

EWCA Criticizes Prohibition on Patenting Methods of Medical Treatment

Warner-Lambert Company, LLC v Actavis Group Ptc & Ors [2015] EWCA Civ 556 (28 May 2015) aff’g [2015] EWHC 72 (Pat) (interlocutory injunction) rev’g [2015] EWHC 249 (Pat) (indirect infringement)
            EP 0 934 061 / pregabalin/ LYRICA

The decision of the EWCA in Warner-Lambert v Actavis / pregabalin is an appeal from two decisions of Arnold J, refusing to grant an interlocutory injunction and striking a claim of indirect infringement. Despite the preliminary nature of the decisions on appeal, the EWCA is a must-read on methods of medical treatment, Swiss form claims, and direct and indirect infringement of second medical use patents. The IPKat has an excellent summary of the key holdings.

In this post I’d like to highlight the court’s remarks on methods of medical treatment. Methods of medical treatment are unpatentable under the EPC, as they are in Canada. The basis for the prohibition in the EPC is statutory (Art 53(c)), while in Canada it is a judge-made exception (see here). European law therefore cannot necessarily be assumed to reflect the same principles, but the basic rule is sufficiently similar that European jurisprudence may at least cast some light on the Canadian rule.

In Warner-Lambert v Actavis the EWCA ntoed that Swiss forms claims arose from the need to provide protection for second-medical use inventions in the face of the rule that “for reasons connected with protecting medical practitioners from claims for patent infringement, a patent cannot be granted for a method of treatment of humans with a therapy using the compound in question” [51]. We see here that the EWCA is of the view that the main reason for the rule against patenting methods of medical treatment is to ensure that physicians can treat their patients as is medically required, without being inhibited by fear of a patent infringement action.

The EWCA then pointed out that Swiss form claims are not necessarily effective in achieving this goal , because a Swiss form claim is a process claim, so “its direct product, the medicine, is an infringement, and all those who use or dispose of the product will infringe” [54]. Consequently,

[55] It would have been better if doctors had been provided with a defence, or the restriction on methods of treatment repealed altogether.

Or both, I might add, which is essentially the situation in the US; claims to methods of medical treatment are permitted, while physicians are provided with a defence under 35 USC § 287(c)(1). This makes perfect sense: if the underlying policy is to provide doctors with a defence, surely the best way to implement that policy is to provide doctors with a defence. Attempting the same thing indirectly, through a prohibition on methods of medical treatment, is both over- and under- inclusive; it does not adequately protect physicians, but at the same time makes it difficult to protect valuable second-medical use inventions.

I would add that another rationale is sometimes advanced for refusing to allow patents for methods of method treatment, and the exercise of professional skill more generally, in those cases where the inventive contribution cannot be precisely defined or reliably replicated. As I said in a previous post:

Professional skill often reflects a multitude of subtle practices that have accumulated over years of experience. These skills can be capable of general definition, yet precisely because the general strategy is instantiated by a variety of specific practices, it may be difficult to define how to practice the skill. For example, a lawyer who is skilled in cross-examination may say "I like to establish a rapport with the witness" or "I like to intimidate the witness," but how exactly this is done is difficult to define. A few tricks might be described, but the skill must ultimately be learned by experience and practice - which is why it is referred to as a skill rather than a rule. It seems evident that such skills should not be patentable, and I suggest that this may underpin the intuition that professional skills are unpatentable. But this rationale only applies to certain types of professional skill, namely those which cannot be precisely defined. Any claim to such a skill would be unpatentable in any event, as being vague or insufficiently disclosed. This objection does not apply to skills that can be sufficiently precisely defined to be susceptible of effective use on the disclosure in a patent.

This rationale is compelling, but it does not require that methods of medical treatment or the exercise of professional skill be unpatentable, because such claims would be invalid for ambiguity in any event. If this problem of replicability is the real issue, excluding claims to the exercise of professional skill is both under-inclusive, because it only catches a subset of claims in which replicability is a problem,  and over-inclusive, because replicability is not a problem in all exercises of professional skill.

Tuesday, June 9, 2015

FCA Affirms Validity of LUMIGAN RC Patent on the Facts

Apotex Inc v Allergan Inc 2015 FCA 137 Dawson JA: Webb, Boivin JA aff’g 2014 FC 567 O'Reilly J
            2,585,691 / bimatoprost / LUMIGAN RC

O’Reilly J’s holding that the ‘691 patent turned largely on the facts, and, unsurprisingly, the FCA has affirmed on the basis that O’Reilly J made no legal error and there was no palpable and overriding error in his factual findings.

O’Reilly J held, on the authority of Sanofi, 2008 SCC 61, [77], that it is sometimes necessary to look to the disclosure to determine the inventive concept of the claims. In my post on that aspect of his decision, I remarked that “O’Reilly J is clearly right on this point,” and the FCA has now affirmed that principle, on the same authority [7.1]

On appeal Apotex also argued that the utility of the invention was not soundly predicted “because the line of reasoning from which the desired result can be inferred was not explicitly disclosed in the patent” [8]. The FCA held that “[t]hose elements of the doctrine of sound prediction that would be self-evident to the skilled person need not be explicitly disclosed in the patent” [9]. This strikes me as no more than an explicit statement of what is implicit in the principle that the patent is addressed to a skilled person, and it does not represent any change in the practice in this respect. (See here for my discussion of the FC holding on this point.)

The FCA also affirmed at [10] that a genus patent does not anticipate a selection if the special advantages of the selection are not disclosed in the genus. As the FCA pointed out, this point was established in Sanofi [32].