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[55] It would have been better if doctors had been provided with a defence, or the restriction on methods of treatment repealed altogether.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

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