What Is a “Method of Medical Treatment”?

Novartis v Cobalt / zoledronate (NOC) 2014 FCA 17 Sharlow JA: Webb, Near JJA aff’g 2013 FC 985 Hughes J
            2,410,201 – ACLASTA – zolendronate

In a four paragraph decision in Cobalt / zolendronate, the FCA has affirmed Hughes J’s decision that Novartis’s ‘201 patent is invalid for claiming methods of medical treatment. The patentability of methods of medical treatment is a difficult area of Canadian law. There are two questions: Are methods of medical treatment patentable? What is a method of medical treatment? The answer to the first question is a clear "no," at least at the FCA level, but the answer to the second question remains obscure, with the result that we know that methods of medical treatment are unpatentable, but we don’t know how to tell whether or not a claimed invention is a method of medical treatment.

On the first question, the FCA has consistently held that methods of medical treatment are not patentable, relying, as in this case [3], on the SCC decision in Tennessee Eastman [1974] SCR 111. When Tennessee Eastman was decided, s 41 of the Act (now repealed) provided that substances intended for medicine could not be patented as such, but only in a product-by-process claim. As the SCC explained, this directly implies that a method of medical treatment consisting of using a compound to treat a disease cannot be claimed, or s 41 could be circumvented by claiming that method using the compound “however prepared” (177). But the SCC decision did not turn solely on the need to prevent an end-run around s 41. The decision also suggests that methods of medical treatment are unpatentable as not being within the definition of “invention.” However, the SCC’s reasoning on this point was extremely cursory. After noting that medicinal compounds and processes for making them were clearly “invention[s]”, the Court said:

But what of the method of medical or surgical treatment using the new substance? Can it too be claimed as an invention? In order to establish the utility of the substance this has to be defined to a certain extent. In the case of a drug, the desirable effects must be ascertained as well as the undesirable side effects. The proper doses have to be found as well as methods of administration and any counter-indications. May these therapeutic data be claimed in themselves as a separate invention consisting in a method of treatment embodying the use of the new drug? I do not think so, and it appears to me that s.41 definitely indicates that it is not so.

Text, context and purpose must all be considered in interpreting a statute. As I read Tennessee Eastman, the SCC is saying that s 41 is an important part of the context for interpreting “invention” which led it to conclude that methods of medical treatment did not fall within that definition. 

The problem is that s 41 was subsequently repealed: what does this mean for the interpretation of “invention”? Should we say that methods of medical treatment are excluded on the basis of “I do not think so,”; or should we say that just as s 41 implied that “invention” does not include methods of medical treatment, so the repeal of s 41 implies a corresponding amendment to the definition of “invention”? This question has no easy answer. The SCC subsequently addressed Tennessee Eastman in Wellcome / AZT 2002 SCC 77, [49] saying

Tennessee Eastman was concerned with the patentability of a surgical method for joining incisions or wounds by applying certain compounds. The decision was based on the former s. 41 of the Patent Act, now repealed. The Court concluded that the method (apart from the compounds) was not patentable. The policy rationale, as explained by Wilson J. in Shell Oil, supra, at p. 554, was that the unpatentable claim was

essentially non-economic and unrelated to trade, industry, or commerce. It was related rather to the area of professional skills.

The statement that “The decision was based on the former s. 41 of the Patent Act, now repealed,” implies that Tennessee Eastman really turned on s 41, which would imply that the definition of "invention" may have changed. But the statement regarding the policy rationale is much broader, and does not turn on s 41 at all, which would imply that the definition has not changed. And the notion that methods of medical treatment are “essentially non-economic” is a meaningless fiction, as the HCA authoritatively explained in its recent decision in Apotex v Sanofi-Aventis / leflunomide [2013] HCA 50, so that gives us no guidance one way or the other.

In the end, the FCA’s view that Tennessee Eastman is authority for the proposition that methods of medical treatment are not patentable is certainly a reasonable interpretation of that decision, but at the same time I am confident that the SCC would not feel itself bound by Tennessee Eastman to hold that methods of medical treatment are not patentable, if that question came before it today.

With all that said, given that the FCA has consistently maintained its view of Tennessee Eastman since ICI (1986) 9 CPR(3d) 289, it is clearly settled at the FCA level that methods of medical treatment are not patentable, and unless and until the SCC grants leave, the more pressing question is "What is a method of medical treatment"?

In my view, to answer this question it is essential to have a clear understanding of the rationale for the exclusion of methods of medical treatment. As noted, text, context and purpose are all important to statutory interpretation, and when the text at issue, namely “art” or “process,” is ambiguous, purpose plays a correspondingly more important role. Unfortunately, we do not have any clear rationale for the exclusion.

The rationale that methods of medical treatment are “essentially non-economic” has support in the jurisprudence, but it a fiction which provides absolutely no guidance as to where to draw the line between claims which are patentable and those which are not.

The rationale with probably the most support in the jurisprudence worldwide, is that medical practitioners should not be restrained from treating patients according to their best medical judgment out of fear of a patent infringement action. This rationale does provide guidance as to what kinds of claims should be unpatentable. It implies that claims which cannot be infringed by doctors should be patentable. This rationale also has some support in Wellcome / AZT 2002 SCC 77. Regardless of what it said about methods of medical treatment generally, the SCC was very clear that the claim at issue which was “A pharmaceutical formulation for use in the treatment or prophylaxis of AIDS comprising an effective amount of [AZT],” was not a method of medical treatment:

50 The AZT patent does not seek to "fence in" an area of medical treatment. It seeks the exclusive right to provide AZT as a commercial offering. How and when, if at all, AZT is employed is left to the professional skill and judgment of the medical profession.

However, on this rationale the Swiss form claims at issue in Cobalt / zolendronate should have been patentable, as explained in my post on Hughes J’s decision.

A third rationale, adopted by Hughes J in the Cobalt / zolendronate is that claims which "include that which lies within the skill of the medical practitioner” are unpatentable [93] However, as I also discussed in my post on Hughes J’s decision, Hughes J interpreted this as meaning that any claim which requires medical skill to implement the invention is therefore unpatentable. So, the ‘201 patent at issue in this case directed that precise dosage “may be selected by the attending physician” [94], and therefore medical skill was required to practice the invention. Hughes J concluded that this meant the claims lay within the skill of the medical practitioner and were therefore unpatentable. However, this is very difficult to reconcile with the claim at issue in Wellcome / AZT which in the claim itself specified an “effective” amount of AZT. Determining the amount that is “effective” clearly requires the exercise of medical skill.

In summary, while we know that methods of medical treatment are not patentable, there is no clear rationale for this rule, and without a rationale, the scope of its application remains arbitrary and uncertain.

Thirty Years and Counting

University of California v. Commissioner of Patents 2014 FC 80 is an application for judicial review of an evidentiary decision by the Commissioner of Patents in a conflict proceeding involving patent applications which were filed more than 30 years ago. I don’t think I need to say any more about it.

Must the Factual Basis for Utility Be Disclosed in the Patent?

Pfizer Ireland Pharmaceuticals v Apotex Inc 2014 FCA 13 Sharlow J: Dawson, Mainville JJ aff’g 2012 FC 1339 Zinn J
            2,163,446 / VIAGRA / sildenafil

I hesitate to post this comment, because if I have understood the Apotex / Viagra decision correctly, the FCA, in a couple of short paragraphs which cite no authority, has wrought a major change in the law which is arguably inconsistent with SCC precedent, by requiring disclosure of the factual basis for demonstrated utility in the patent itself. This change is so radical and thinly reasoned that I can hardly believe that I have interpreted it correctly, hence my hesitation in posting. [UPDATE: On reconsideration, I've realized that my initial reading was indeed wrong: please see the update at the end of this post.] The decision is very short, and deserves to be read in full by every patent practitioner, so I hope that readers with a different interpretation of the holding will correct me.*

Tests Conducted by a Third Party Without Notice Held to Be Admissible Evidence

AbbVie Corp v Janssen Inc, 2014 FC 55 Hughes J

2,365,281 / anti-IL-12 antibodies / STELARA

One evidentiary point in AbbVie is worth noting. Janssen’s STELARA product was alleged to infringe AbbVie’s ‘281 patent, but only AbbVie, and not Janssen, conducted tests on the Janssen product [62]. For at least some of this testing, no prior notice was given to Janssen, and no one from Janssen attended [67]. Janssen moved to exclude the evidence as to this testing conducted by third parties at the request of AbbVie [63]. Hughes J refused to exclude the evidence. He noted:

[64] Unlike the practice in the United Kingdom as described in the “White Book”, Civil Procedure, Volume 2, 2013, Sweet & Maxwell, London at page 730, there is, as of yet, no Federal Courts of Canada Rule specifically directed to testing conducted for the purposes of trial. In Omark Industries (1960) Ltd v Gouger Saw Chain Co, (1965) 1 Ex C R 457 at page 516, Justice Noel discussed a “salutary” rule to the effect that an opposite party should be given notice of and an opportunity to attend at such experiments. He did, however, also say that an ex parte test may be admissible, subject to weight, particularly where, in his case the opposite party could readily have conducted the same test. Most recently Justice O’Reilly of this Court in Apotex Inc. v. Pfizer Canada Inc., 2013 FC 493 at paragraph 40,held that where a party had ample notice as to the testing and ample knowledge as to what would be done, a party cannot be held to say that the testing results are inadmissible because the party did not attend.

Hughes J reviewed the evidence briefly and held

[70] Given the evidence that I have, and having reviewed the criticisms made by Janssen and, given that Janssen did have a opportunity to cross-examine Dr Hughes, and that Janssen has provided no test results whatsoever, I conclude that the evidence of both tests is admissible. . .

New Biologics, Old Principles

AbbVie Corp v Janssen Inc, 2014 FC 55 Hughes J

2,365,281 / anti-IL-12 antibodies / STELARA

This decision comes via Alan Macek’s IPPractice, who reports that it is “the first biologic patent infringement trial decision of the Federal Court.” [But see update below] Despite the new subject matter, the decision is a fairly straightforward application of old principles.

The invention relates to human antibodies that bind human interleukin 12 (“IL-12"). Interleukins generally, and IL-12 in particular, were known to be implicated in immune system function [14]. Consequently, methods for inhibiting the activity of IL-12 were known to be likely candidates for treating diseases related to immune system disorders. Antibodies are components of the immune system which are capable of binding with great specificity to particular targets, such as IL-12, so one known strategy to inhibit the effect of IL-12 was to develop antibodies which would bind to IL-12, thereby blocking its function.

No Costs Awarded Due to Poor Case Management

AbbVie Corp v Janssen Inc, 2014 FC 55 Hughes J

2,365,281 / anti-IL-12 antibodies / STELARA

I’ve just finished reading the AbbVie decision, and I will post on the substantive issues shortly. But for this first post, I will start with the very last issue – costs. Unusually, Hughes J held that each party will bear their own costs. Here are the relevant paragraphs in full:

[186] I come to the issue of costs. As I expressed to Counsel during the trial, I am extremely disappointed that they did not take advantage of the Case Management and Trial Management process so as to narrow the issues, make appropriate agreements as to facts, and otherwise get this matter ready for trial; focusing on the important issues. The case has been instituted some four years ago, yet even up to and during the trial, Counsel was going back and forth as to issues and factual concessions. Expert reports were served that never were made part of the record. Letters rogatory were issued, yet never used. Other witnesses, whose names were mentioned from time to time, were never called. Discovery of the parties and named inventors were prolonged and numerous tedious motions were brought to compel yet further discovery. Scant portions of the discovery transcripts were deemed read in at trial; most of which could have been dealt with by an agreement as to facts. In all, the parties have not made full or proper use of the pre-trial process and management procedures, notwithstanding abundant applications to the Court about this or that point. We expect better.

[187] Therefore, each party will bear its own costs, except where there has been a particular Order of this Court awarding costs. Where costs have been left to the Trial Judge or in the cause, there will be no costs. 

Patent for Form I Efavirenz Not Infringed on the Facts

Bristol-Myers Squibb & Gilead Sciences v Teva / efavirenz (NOC) 2014 FC 30 Barnes J
             2,279,198 / efavirenz / ATRIPLA

In this NOC proceeding Barnes J dismissed Merck’s application for an order of prohibition in respect of Teva’s generic version of ATRIPLA on the basis that Merck had failed to establish infringement. The decision turns entirely on the facts, and raises no new issue of law.

ATRIPLA is an anti-viral used in treating HIV/AIDS which contains efavirenz as one of its three active ingredients. The ‘198 patent claims a particular crystalline form of efavirenz, Form I, and a process for producing it. It was common ground that Teva’s starting medicinal compound, “Form Teva,” does not contain Form I efavirenz [7]. It was also undisputed that
Form I is the most stable crystal form of efavirenz and, “with the input of sufficient energy, all metastable crystal forms of efavirenz, including Form Teva, will convert to Form I” [9]. The question on infringement is “whether Form Teva will convert in some measure to Form I during Teva’s tablet manufacturing process” [7]. In particular Barnes J held that “Claims 1 and 2 would be infringed if any detectable amount of Form I is found in Teva’s efavirenz product. It does not matter that the amount may be so small that it provides no medicinal advantage” [16].

The resolution of this question turned on the facts. Merck manufactured a sample of the Form Teva efavirenz and asked a Dr Taylor to subject it to processing intended to mimic the commercial manufacturing process. Dr Taylor’s process resulted in a very small amount of Form I being produced [35] and “The central issue in dispute between the parties is whether the mortar and pestle grinding carried out in Dr. Taylor's laboratory is a reliable proxy for the [omitted] that Teva employs in its manufacturing process” [38]. Barnes J concluded that the process used by Dr Taylor was sufficiently different from Teva’s tabletting process that it could not be inferred that any amount of Form I would be present in Teva’s tabletted product [45]. The process used by Dr Taylor would result in significantly more energy being put into the product than commercial tabletting, with the result that Form I was less likely to be created during Teva’s process. Consequently, Merck failed to meet its burden of proving that Teva's tablets would infringe [46].

A couple of notes. The applicants were Bristol-Myers Squibb & Gilead Sciences, the licensees, and Merck, the patentee. Barnes J used “Merck” as including all the applicants, which is why the decision refers to Merck while the abbreviated style of cause does not.

The ‘198 patent had previously been before Barnes J in Bristol-Myers Squibb Co. v. Mylan / efavirenz (NOC) 2012 FC 1142, which concerned SUSTIVA, which contains only efavirenz, in contrast to the ATRIPLA combination product. The same question of infringement was at issue in the SUSTIVA decision, and Merck lost there as well, but the evidence before Barnes J was substantially different and the reasoning was not the same. SUSTIVA is blogged here in respect of the ‘198 patent and here in respect of the other patent at issue.

Teva’s NOA also alleged the ‘198 patent was invalid, as did Mylan in SUSTIVA. Barnes J did not find it necessary to address these allegations in light of his conclusions regarding infringement, but he did say that "Teva presented a stronger case for invalidity on the ground of obviousness than was before me in the Mylan proceeding” [6].

When Is Identity of Medical Ingredients Determined for an ANDS?

Apotex Inc v. Canada (Health) 2013 FC 1217 Kane J
            Apo-telmisartan / MICARDIS

The abbreviated new drug submission process allows a generic manufacturer to obtain an NOC for its generic version of a new drug without submitting safety and effectiveness data, if it can establish that its generic version is the “pharmaceutical equivalent” of a Canadian reference product: Food and Drug Regulations C.08.002.1(1)(a). "Pharmaceutical equivalent" means a drug that contains identical amounts of the “identical medicinal ingredients,” but that does not necessarily contain the same non-medicinal ingredients: C.08.001.1. But what does “identical medicinal ingredients” mean, and at what point in the drug production and delivery cycle is identity established?

So, suppose the pure API for the branded product for which an NOC has been granted is a weak base, but it is formulated as a salt form. Can the branded product be used as a reference product if the generic drug is formulated as a pure base? That is, are the salt and the base considered to be the “identical medical ingredient”? Alternatively, once the tablets are swallowed, the salt of the branded product dissolves into the acid and base, and the active moiety in the blood stream is again the base. Can the branded product be used as a reference product on the basis that the medical ingredient is identical in the bloodstream, even if it is not identical in the tablet?

Springboard Injunction Against Non-Infringing Goods Permitted in the UK

The EWHC decision in Smith & Nephew Plc v Convatec Technologies Inc [2013] EWHC 3955 (Pat), summarized by the IPKat here, is interesting for holding that an injunction might properly be awarded against non-infringing goods, though on the facts Birss J declined to do so. Infringement turned on claim construction, and Birss J ultimately held that Smith & Nephew’s commercial product did not infringe Convatec’s patent [80], but four development experiments did infringe [110]. The data from the infringing experiments was a necessary part of the application for regulatory approval for the commercial product [111]. Even though the regulatory experiments were infringing, and the commercial product was not, the approval based on the infringing product was wide enough to authorize sale of the commercial product [112].

Convatex requested a “springboard” injunction restraining Smith & Nephew from selling its non-infringing commercial product until the date it would have obtained authorization if it had not infringed the patent. After reviewing the law, Birss J held that this type of injunction was permitted in a proper case [130]. He relied primarily on the decision of Judge Fysh in Dyson v Hoover (No. 2) [2001] RPC 27 and the CJEU in Generics v Smith Kline & French C-0316/95 (1997). In Dyson Judge Fysh QC reviewed the law relating to post-expiry injunctions. He noted that the issue before him was novel in that injunctions had been previously been granted against post-expiry sale of infringing goods which were in existence, and so infringed the patent, while he was being asked to grant an injunction against goods which would only come into existence after expiry [21], but he concluded that the court did indeed have the jurisdiction to grant such orders [36]. In Generics the CJEU, on reference from a Dutch court, held that an injunction could be granted to restrain post-expiry sales based on data derived from infringing products. Both Generics and Dyson might be narrowly distinguished on the basis that in both cases the commercial product sold post-expiry was within the scope of the claim, whereas in this case the commercial product was non-infringing [162], but Birss J concluded that “the essential point [is] that the court can intervene to deprive an infringer of an unwarranted advantage gained from their act of infringement” [129]. However, Birss J acknowledged that this injunction "would prevent Smith & Nephew from doing something which does not and never would have infringed a valid patent,” and while “[t]his is not a reason to refuse springboard relief altogether but it is a factor to take into account in deciding if the unwarranted advantage obtained would support it” [162].

He also noted that springboard damages are clearly permitted on the authority of Gerber v Lectra [1995] RPC 383 (Pat) aff’d [1997] RPC 443 (CA), and “If damages are in principle recoverable then I do not see why an injunction should not be able to be granted to prevent the harm occurring in the first place” [130]. Birss J also noted that the fact that springboard damages are available does not mean that an injunction should not be granted because damages are difficult to quantify [161], and so would not be an adequate remedy.

Ultimately Birss J concluded on the facts that Smith & Nephew would have been able to obtain marketing authorization by the time of his decision even if they had never infringed, as sufficient time had passed to allow them to obtain that authorization on the basis of the non-infringing process. He therefore refused to grant the springboard injunction [168].

Update: See Professor Tom Cotter's discussion of the case here, indicating that such injunctions are not available in US law, though this turns on the wording of the relevant provision of the Patent Act, rather than on general principles of equity.