Federal Court Dismisses Motion for Early Dismissal of Action Brought Under the New PM(NOC) Regulations

Federal Court Dismisses Motion for Early Dismissal of Action Brought Under the New PM(NOC) Regulations

Genentech, Inc v Amgen Canada Inc, 2018 FC 694

This case establishes the threshold required to bring a motion for early dismissal under the new Patented Medicines (Notice of Compliance) Regulations (“Regulations”). The Federal Court (“FC”) confirms that such a motion will only be granted “in the clearest of cases”, where the claim is “so clearly futile that it has not the slightest chance of success”. [42-43]

The FC dismissed Amgen Canada Inc’s (“Amgen”) motion to dismiss Hoffmann-La Roche’s (“Roche”) and Genentech Inc’s (“Genentech”) action, stating that the action raises some arguable cases, and that it is not “plain and obvious” that their claims have no chance of success. [57, 62]

Background

HERCEPTIN (trastuzumab) is a drug that was approved in Canada in or around 1999 and is marketed for the treatment of early breast cancer, metastatic breast cancer (“MBC”) and gastric cancer. Roche has listed six patents on the Patent Register related to HERCEPTIN, which are owned by Genentech. [2-3] HERCEPTIN’s product monograph includes a reference to the standard of care (which was based on the CLEOPATRA clinical trial): “HERCEPTIN can be used in combination with PERJETA® (pertuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease”. [9-10]

Amgen filed a new drug submission to obtain a notice of compliance for a product, KANJINTI, a biosimilar of trastuzumab. In its notice of allegation, Amgen seeks to market KANJINTI for the same indications as HERCEPTIN. [26-27] The Plaintiffs brought an action in December 2017 pursuant to section 6 of the Regulations seeking an order prohibiting the Minister from issuing a notice of compliance to Amgen for KANJINTI until after the expiry of the Canadian Patent Nos. 2,376,596 (“596 Patent”) and 2,407,556 (“556 Patent”) to avoid an inducement infringement. [30, 46]

In the context of that action, Amgen brought a motion to the FC, seeking an order pursuant to section 6.08 of the Regulations to dismiss the action. Amgen contends that there is insufficient evidence to support the Plaintiffs’ claims, that they “are so clearly futile that they have not the slightest chance of success.” [1]

Extraordinary Remedy; High Threshold

This was the first motion brought under section 6.08 of the new Regulations. Prothonotary Aylen explains that the language under section 6.08 is very similar to the language of section 6(5)(b) of the earlier version of the Regulations, and therefore the case law established under section 6(5)(b) should apply to a section 6.08 motion. [37-39] The FC notes that the consequences of granting a motion under section 6.08 are more significant than under the previous section 6(5)(b): if the claim is struck under section 6.08, section 6.01 of the Regulations precludes the plaintiff from commencing an action against the defendant. [41-42] To strike the action under section 6.08, Amgen has the onus of demonstrating that the claim is “so clearly futile that is has not the slightest chance of success” or in other words, that it is “plain and obvious” that the claim has no chance of success. [43]

The FC states that there are three elements to meet for the inducement test: 1) the act of infringement was or will be completed by the direct infringer; 2) the completion of the acts of infringement were or will be influenced by the acts of the alleged inducer to the point that, without influence, direct infringement would not take place; and 3) the inducer knows that this influence will result in the completion of the act of infringement. [48] The FC notes that the Plaintiffs did not provide evidence suggesting direct infringement by Amgen of the 596 and 556 Patents. [54, 58]

The Plaintiffs Have an Arguable Case

Amgen argued that it is plain and obvious that the claim of inducement in relation to the 596 Patent and the claim regarding the 556 Patent have no chance of success. Amgen contends it did not do “something more” than simply applying to make KANJINTI available on the market, and there is no evidence to satisfy the other prongs of the inducement test. Any physician who would prescribe KANJINTI in combination with PERJETA would be doing so under the current standard of care, and not under Amgen’s draft product monograph, as it specifically leaves out any reference of PERJETA. [55] Amgen adds that the Plaintiffs would have to demonstrate that Amgen told third parties to test patients twice using the specific testing methodologies in the 556 Patent to be found liable. [59]

The Plaintiffs argue that Amgen did “something more” which a trial judge could consider an influence leading to direct infringement by physicians and patients. The Plaintiffs submit that Amgen’s argument that if doctor prescribe KANJINTI in combination with PERJETA they will only be following the current standard of care is without merit, citing Abbott Laboratories Limited v Canada (Ministry of National Health and Welfare)2006 FC 1411. The global marketing documents for KANJINTI demonstrate that Amgen plans on answering questions about whether KANJINTI can be used in combination with pertuzumab to treat MBC in a manner that will promote the use of KANJINTI with pertuzumab. Amgen’s failure to expressly prohibit the combination of KANJINTI with PERJETA grounds an inference that Amgen intends to induce third parties to combine KANJINTI with pertuzumab. [56] As for the 556 Patent, the Plaintiffs assert that Amgen has effectively admitted on the motion that direct infringement by third parties will occur. “There is clear evidence put forward by the Plaintiffs that the KANJINTI draft product monograph is directed to medical oncologists and clear evidence as to how medical oncologists would interpret the product monograph.” [60]

The FC could not conclude that it is plain and obvious that the Plaintiffs’ claims of inducement have no chance of succeeding, and that the Plaintiffs have risen an arguable case in relation to each prong of the test for inducement such that it is not plain and obvious that their claim will fail. [61-62]

Commentary

In this decision, Prothonotary Aylen confirms that a motion for early dismissal under the new Regulations must meet a high threshold. In such a motion, the FC’s role is not to weigh in on the merits of the case, nor to determine if there has been an infringement or inducement. The FC will determine “whether the plaintiff raises an arguable case such that it is not plain and obvious that the action will fail”. [46] In this case, the FC found that “it is at least arguable that Amgen has done “something more” within the meaning of the case law that a trial judge could ultimately consider to be the requisite influence leading to direct infringement by physicians and patients”. [57] Since the Plaintiffs have raised an arguable case of inducement against Amgen, the FC dismissed Amgen’s motion to strike the action.

CSP