Physicians as Patent Infringers? Putting Pharmascience into Perspective

Authored By: Professor Wissam Aoun, Associate Professor & Member of Windsor Law  LTEC Lab and Caitlyn Massad, JD Candidate at Windsor Law

1. INTRODUCTION

Pharmascience Inc. v. Janssen Inc.[1] is scheduled to be heard by the Supreme Court of Canada (SCC) this coming October. In Pharmascience, the SCC will revisit the decades old prohibition against patenting of methods of medical treatment. The case revolves around a fact pattern common to several recent ‘skinny label’ cases. What one sees in ‘skinny label’ cases is a common treatment practice where a patient is prescribed a loading dosage of a medication to increase the level of the active ingredient within their body followed by regular, and lower, maintenance doses. A patent will cover the entire dosing regimen- loading dose and maintenance doses. A generic manufacturer will market only the maintenance doses with a ‘skinny’ product label that does not explicitly direct physicians to prescribe the product as part of the overall dosing regimen.

In the foregoing scenario, a generic manufacturer avoids direct infringement given that they are not making and selling the patented combination of both loading and maintenance doses. However, in several recent ‘skinny label’ cases, generic manufacturers have been found liable for inducing infringement, whereby their actions, although not constituting direct infringement, have induced another party to directly infringe. In this scenario, who is the infringer that is being induced? The Federal Court of Appeal has recently stated that both physician and patient are direct patent infringers in this scenario —the physician when prescribing the dosing regimen and the patient when consuming it.[2]  As the SCC is deciding Pharmascience based on the patentability of methods of medical treatment, the question of whether physicians and/or patients should be considered patent infringers has received little attention.

This post attempts to provide some much-needed attention to the question of whether a physician in the above-referenced scenario should be considered a patent infringer. Although the Federal Court of Appeal has recently concluded that physicians are infringing, this post interrogates the line of cases cited by the Court in support of its conclusion, demonstrating that  these decisions provide fragile authority for this proposition.

2.  JURISPRUDENTIAL UNCERTAINTY

In the recent Apotex Inc. v. Janssen Inc.[3] judgement of the Federal Court of Appeal, a ‘skinny label’ companion to the forthcoming SCC Pharmascience case, the Federal Court of Appeal was called upon to assess whether a generic maintenance dose marketed along with instructions for its use as part of a claimed dosing regimen constituted inducing infringement. With respect to inducement, Locke J. stated that:

It is important to bear in mind that the ultimate act of direct infringement in the present case could be either by a prescriber (e.g. a physician or a nurse practitioner) or by a patient: Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, 2020 FCA 30, [2020] F.C.J. No. 179 at para. 40, citing AB Hassle v. Genpharm Inc., 2003 FC 1443, 243 F.T.R 6 at para. 127, aff’d 2004 FCA 413, [2004] F.C.J. No. 2079. The Federal Court recognized this at paragraphs 74 and 104 of its reasons. [4] [emphasis added]

The brevity of this statement could suggest that Canadian jurisprudence has authoritatively cemented this conclusion. This is not necessarily true. Most cases involving infringement of drug dosing regimen inventions have been decided under the somewhat summary Patented Medicines Notice of Compliance (PMNOC) proceedings framework and/or have been inherently intertwined with the issue of patentability of methods of medical treatment. Even where the Federal court has not only opined on the patentability of dosing regimens and methods of medical treatment but also found that the patent in issue claims patentable subject matter, the court has not explicitly stated that a physician prescribing the dosing regime in question necessarily infringes any such patent.[5]

Beginning with the cases directly cited by Locke J. in the above-referenced passage, these judgements do not provide air-tight support for the proposition that a physician prescribing a patented dosing regimen is necessarily an infringer. Beginning with the cited Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research[6], the cited para. 40 states the following:

The appellants criticize the Judge’s reliance on the following passage from AB Hassle v. Genpharm Inc., 2003 FC 1443, 243 F.T.R. 6, at para. 127, aff’d 2004 FCA 413, [2004] F.C.J. No. 2079 (AB Hassle): “Infringement of a use patent … is not limited to the act of the generic producer; it includes infringement by patients.” The appellant argues that the Judge read this passage to permit a finding of inducing infringement even without the element of influence by the alleged inducer. In my view, the appellants misread both the passage and the Judge’s use of it. By my reading, the Court in AB Hassle was simply observing that direct infringement of a use patent may be committed by a patient. It follows from this that use by a patient may satisfy the first prong of the test for inducing infringement.[7] [emphasis added]

The foregoing passage refers only to patients, without any reference to physicians. Furthermore, the foregoing passage provides a truncated citation from AB Hassle v. Genpharm Inc.[8] The actual citation states the following:

Infringement of a use patent, under the [PMNOC] Regulations, is not limited to the act of the generic producer; it includes infringement by patients. Infringement is made out when patients use a medicine sold by a generic producer even if there is no inducement or procurement by the generic producer Genpharm Inc. v. Minister of Health et al. (2002), 2002 FCA 290 (CanLII), 20 C.P.R. (4th) 1 (F.C.A.).[8] [emphasis added]

Once again, the passage in question limits its discussion to patients. Furthermore, the truncated portion left out from the Hospira citation explicitly references the PMNOC Regulations and cites Genpharm Inc. v. Minister of Health et al.[10] as authority for this proposition. If we look back at this cited authority, we see that Genpharm references a specific section of the then in-force (and now repealed) PMNOC Regulations. The Regulations in question allowed the Minister to issue a Notice of Compliance (NOC) to a generic manufacturer if “no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.” It is because of the specific language of this Regulation that the Federal Court of Appeal in Genpharm ruled as it did:

The phrase "would be infringed" is not qualified. In other words, subparagraph

5(1)(b)(iv) does not say, as Genpharm argues, that the act of infringement must be the act of the generic producer. Indeed, by expressly referring to sales by the generic producer ("the selling by that person"), the Governor in Council turned his mind to when it is relevant to associate actions with the generic producer under the Regulations. By not using that same phrase "by that person" in respect of the act of infringement within the same subparagraph, the Governor in Council cannot be said to have intended that infringement must necessarily be limited to acts of the generic producer itself. For Genpharm to suggest that the act of infringement must be by the generic producer reads words into the Regulations which the Court must not do.

In the case of a use patent, if the generic producer sells its product and infringement results by patients using the product for a use protected in a patent, there will be infringement of that patent for purposes of the Regulations. The connection between the generic producer and infringement by the patient is in the generic producer selling its product.[11] [emphasis added]

These cases only reference patients as infringers and find their authoritative origin in what are now repealed section of the PMNOC Regulations. Even still, other judgements following this line of cases have reluctantly, and with skepticism, accepted them as authority for the proposition that patients are infringers, let alone physicians.[12] 

This is not to suggest that there is no jurisprudential support at all for the possibility that a physician prescribing a claimed drug regimen is infringing. However, all such cases seem to qualify the proposition,  or approach it with a level of apprehension. Some cases decided under PMNOC proceedings have suggested that if a “physician were to prescribe [a drug]… for one of the uses claimed” then that “physician … may be infringing the claims” of the patent.[13] Furthermore, it has been said that generic manufacturers may be liable “if physicians engage in ‘off label’ use by prescribing [a drug] for something other than the approved use” and if they are “implicated in inducing the infringing use by a physician or pharmacist.”[14] However, as the foregoing demonstrates, the line of cases cited by the Federal Court of Appeal in Apotex Inc. v. Janssen Inc. provides what is at best a weak foundation for the proposition that physician prescription of a patented drug regimen undoubtedly constitutes infringement.

In Janssen Inc v Mylan Pharmaceuticals ULC,[15]  Barnes J. provides one of the few explicit statements in Canadian jurisprudence that a physician is infringing on account of prescribing a medication:

In conclusion, I have no doubt whatsoever that the '950 Patent relevant claims cover a method of medical treatment.  By attempting to monopolize an effective titration regimen for galantamine, the '950 Patent interferes with the ability of physicians to exercise their judgment in the administration of generic versions of the drug.  This is because, absent a license from Janssen, any physician attempting to administer a generic version of galantamine to treat Alzheimer’s disease by the method claimed by the '950 Patent would infringe.  Indeed, in theory, any physician who attempted to prescribe Reminyl to a patient without Janssen’s permission in the manner claimed by the '950 Patent would also infringe.[16]

However, even this case provides some qualification to this proposition. In a passage worth quoting in its entirety, Barnes J. expresses disbelief that no one, including the witnesses in the case, tackled the issue of physician infringement head on:

The argument by Janssen and its witnesses that the '950 Patent is helpful to physicians and therefore does not interfere with their skill and judgment misses the point of concern in the authorities.  The concern with the patenting of a dosage regimen is that the physician may be prevented from exercising skill and judgment in using a known compound for an established purpose absent a license from the patentee.  It is surprising to me that the Janssen witnesses failed to address the problem of imposing a monopoly over the prescribing practices of the medical profession.  When Dr. Gauthier was asked about this, it was evident that he had no idea that the enforcement of the '950 Patent might impose practice limitations on physicians attempting to prescribe galantamine. 

When counsel for Mylan pressed Dr. Gauthier on this point, Janssen’s counsel responded that this was really a question of law that the witness was not qualified to answer.  While there is undoubtedly a legal aspect to this question, all of Janssen’s witnesses could have been asked to comment on how the ‘950 Patent’s proposed monopoly over a medicinal dosing regimen using an old drug for an established purpose might affect the ability of physicians to appropriately treat their patients.  It is only within that framework that the question of whether the '950 Patent covers a method of medical treatment could be fairly and properly addressed - and here the Janssen witnesses failed to squarely speak to it.[17] [emphasis added]

3. CONCLUSION

As the foregoing analysis demonstrates, the proposition that a physician prescribing a dosing regime is undoubtedly infringing a patent covering such dosing regimen stands on shaky jurisprudential ground. Existing case law can hardly be said to have established the veracity of this proposition, and most judges who have accepted that they are bound by this principle have done so while expressing skepticism towards its justification. Although the SCC will soon decide Pharmascience entirely on the basis of patentability of methods of medical treatment, hopefully the Court will touch on this issue, even if in obiter, to bring more clarity on physician liability for patent infringement.

[1] Pharmascience Inc. v. Janssen Inc., 2024 FCA 23, leave to appeal to SCC granted, SCC File No. 41209 (19 September 2024).

[2] Pharmascience Inc. v. Janssen Inc., 2024 FCA 23 at para 7.

[3] Apotex Inc v Janssen Inc, 2024 FCA 9.

[4] Ibid at para 24.

[5] See for example AbbVie Biotechnology Ltd v Canada (Attorney General), 2014 FC 1251 involving an appeal of the Commissioner of Patents refusal to grant the patent in question on the ground that it constituted a method of medical treatment. Kane J. reversed the Commissioner’s finding of non patentable subject matter, but as infringement was not an issue, no discussion of who might be an infringer of said patent was discussed.

[6] Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2020 FCA 30.

[7] Ibid at para 40.

[8] AB Hassle v Genpharm Inc, 2003 FC 1443.

[9] Ibid at para 127.

[10] Genpharm Inc v Minister of Health et al, 2002 FCA 290.

[11] Ibid at paras 43–4.

[12] See Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, supra note 4 at para 328 where Phelan J. states “I cannot accept Kennedy’s argument that, on the one hand, the 630 Patent is directed toward a drug company and not a practising rheumatologist so it is not a method of medical treatment, and yet, on the other hand, patients will infringe the 630 Patent by receiving adjunctive treatment with MTX and Inflectra. If not for AB Hassle v Genpharm Inc, 2003 FC 1443 at para 127, 243 FTR 6, aff’d 2004 FCA 413 (“[i]nfringement of a use patent, under the Regulations, is not limited to the act of the generic producer; it includes infringement by patients”), I would be disinclined to find inducement.”

[13] Sanofi-Aventis Canada Inc v Novopharm Ltd, [2007] FCJ No. 582 at para 10.

[14] Pfizer Canada Inc v Canada (Minister of Health), [2007] FCJ No. 871 at para 31.

[15] Janssen Inc v Mylan Pharmaceuticals ULC, 2010 FC 1123.

[16] Ibid at para 52.

[17] Ibid at para 51.