Canada: HERCEPTIN Patents Survive Preliminary Non-Infringement Challenge In The First Motion Under Section 6.08 Of The Patented Medicines (Notice Of Compliance) Regulations

In one of the first actions brought under the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”), Genentech and Roche sued Amgen for infringement over its KANJINTI product, a biosimilar of Roche’s trastuzumab (HERCEPTIN) product. Amgen recently brought a motion under section 6.08 of the Regulations (the first one under this section) to dismiss the action with respect to Canadian Patent Nos. 2,376,596 and 2,407,556 (there are also two other patents at issue in the action). This section permits the Court to dismiss a patent infringement action brought under the Regulations if it is redundant, scandalous, frivolous, or vexatious, or is otherwise an abuse of process. Prothontary Aylen dismissed Amgen’s motion (reported at 2018 FC 694), finding that it was not plain and obvious that Genentech’s infringement claim with respect to the 596 and 556 Patents would fail. 

As background, section 6.08 came into force in September 2017 as part of a significant overhaul to the Regulations. Prior to the amendments, proceedings under the former Regulations were summary applications. They determined only whether to prohibit the Minister of Health from issuing marketing authorization of a medicine to a generic (the “second person” under the Regulations), based on the generic’s allegations of patent non-infringement or invalidity. They were not determinative of the parties’ substantive rights. This scheme frequently resulted in a multiplicity of proceedings (applications under the Regulations, followed by full patent impeachment or infringement actions). Since the amendments came into force, proceedings under the Regulations are now full actions, with discovery and a trial. They are determinative of patent infringement and validity.

The Court noted that the language of section 6.08 is essentially the same as former section 6(5)(b) of the Regulations, and the jurisprudence of that section applies. The threshold to succeed is high, and the moving party bears the onus of demonstrating that the claim is so clearly futile that it does not have the slightest chance of success. In other words, it must be plain and obvious that the claim has no chance of succeeding. The Court noted that in theory it should be easier for a plaintiff to resist a section 6.08 motion, because the plaintiff is now entitled to discovery of the defendant (which it was not under the former Regulations). 

Importantly, the Court observed that the consequences of granting a motion under section 6.08 are more significant than under former section 6(5)(b). This is because if it strikes the claim, section 6.01 precludes the plaintiff from subsequently commencing an action for infringement (which was open to it under the former Regulations). Therefore, the Court should have a heightened level of caution in striking claims under section 6.08, and it should grant such motions only in the clearest of cases. 

The Court also noted that its role on this type of motion is simply to determine whether the plaintiff raises an arguable case such that it is not plain and obvious that the action will fail. It is not a hearing on the merits, and generally, substantive arguments regarding claim construction and non-infringement should be addressed at trial.   

There were two patents at issue on Amgen’s motion – the 596 Patent and the 556 Patent. The 596 Patent relates to the biologic drug pertuzumab (marketed by Roche under the name PERJETA). Several claims relate to the use of pertuzumab in combination with trastuzmab. 

The 556 Patent relates to the use of trastuzumab in a patient whose her2 gene in tumour cells has been found to be amplified (for example as measured by fluorescent in situ hydridization or “ISH”), and whose tumour cells have HER2 expression level of 0 or 1+ as determined by immunohistochemistry (“IHC”).

Amgen moved to dismiss the action on the basis that it would not infringe the 596 or 556 Patents.  Regarding the 596 Patent, Amgen argued that it was not seeking approval for the use of KANJINTI in combination with PERJETA, and it expressly carved out such combination therapy from its draft product monograph which makes no mention of it. Any physicians who prescribe KANJINTI in combination with PERJETA would be doing so simply in furtherance of the current standard of care, not because of Amgen’s influence. Amgen argued that it was not doing “something more” than selling the product, for an old use (monotherapy). It must do “something more” to induce infringement.

Genentech argued that KANJINTI would be publicly funded for use in combination with PERJETA. Also, there is a factual dispute whether prescribing KANJINTI in combination with PERJETA would be an off-label use, or whether it is consistent with its overall metastatic breast cancer indication. Even if physicians prescribe KANJINTI in combination with PERJETA in accordance with the current standard of care and not the product monograph, it may still be the “something more” required to find inducement. Amgen’s express failure to prohibit combination therapy in its product monograph, together with the other outlined factors, supports a finding of inducement. The trial judge must determine these contested matters.

The Court found that given these contentious matters, the plaintiffs have at least an arguable case of inducing infringement in relation to the 596 Patent, and it was not plain and obvious that they could not succeed at trial.

Regarding the 556 Patent, Amgen argued that it would not induce infringement because the manner in which the patient’s HER2 status is determined will not play any role in Amgen’s marketing plans. The product monograph directs third parties to test HER2 status by either immunohistochemistry or in situ hybridization. Therefore, it would not induce any physician or patient to use both tests. Amgen also argued that the meaning of the patent claims was clear and no claims construction analysis is required.  The claims relate to a new way of identifying patients who would benefit from HERCEPTIN treatment.

Genentech argued that the claims are not about identifying patients. Rather, they relate to treating patients with HERCEPTIN if they fall within the specific patient population of those having her2 gene amplification and who are IHC 0 or 1+. Amgen made the deliberate decision to refer to ISH testing in its product monograph. It could have referred only to IHC testing, like the original product monograph for HERCEPTIN. This shows Amgen’s intent to influence physicians to use both IHC and ISH testing. Amgen cannot seriously dispute that its intention is to treat the 556 Patent patient population, and it cannot simply ignore the inevitable infringement that it puts in motion.

After reviewing the evidence and submissions, the Court found that there was a debatable issue about the meaning of the 556 Patent’s claims. Because of this, and the evidence on the motion, the Court held that it was not plain and obvious that the plaintiffs’ claim for infringement by inducement could not succeed. 

Accordingly, Prothonotary Aylen dismissed Amgen’s motion with costs.

While most of the Court’s decision turned on facts and arguments specific to the case at hand, of specific note was the Court’s rationale that defendants should be held to a higher standard when moving to dismiss an action under section 6.08 than under the former section 6(5)(b). Given the Court’s cautionary warning, it will be interesting to see how law develops under section 6.08, and in particular, under what circumstances a defendant will be able to establish the necessary facts to meet such a high threshold.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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