Leave Granted to Amend Statement of Defence and Includes Bases of Invalidity not Contained in Notice of Allegation

In Boehringer Ingelheim (Canada) Ltd v JAMP Pharma Corporation, 2023 FC 1414, Associate Judge Cotter of the Federal Court granted JAMP’s motion for leave to serve and file an amended statement of defence. In the underlying proceeding under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, Boehringer asserts JAMP’s products would infringe or induce infringement of Canadian Patent 2,591,083 and Canadian Patent 2,726,267. In its statement of defence, JAMP submits that the 083 Patent and the 267 Patent are invalid.

JAMP’s proposed amendments to its statement of defence allege that the 083 Patent is anticipated by PCT application number 2004/017948 (issued as Canadian Patent 2,495,350) and that there is double patenting with the 350 Patent.

In its opposition to JAMP’s proposed amendments, Boehringer argued that one paragraph of the proposed amended statement of defence (paragraph 119N) is irrelevant and does not raise a reasonable defence. Boehringer also relied on the Federal Court of Appeal’s decision in Sunovion Pharmaceuticals Canada Inc v Taro Pharmaceuticals Inc, 2021 FCA 113 and submitted that it is not in the interests of justice to permit JAMP to argue new bases of invalidity that were not alleged in its notice of allegation.

Paragraph 119N of JAMP’s proposed amended statement of defence submits that the listing of the 350 Patent on the patent register for OFEV (nintedanib) capsules is an admission by Boehringer that the 350 Patent “contains at least one claim that is a claim for the medicinal ingredient […], the formulation that contains the medicinal ingredient […], the dosage form, or the approved use of the medicinal ingredient […] in respect of OFEV (nintedanib) capsules.”

Boehringer submitted that paragraph 119N impermissibly seeks to rely on extrinsic evidence to construe the claims of the 350 Patent for the purpose of assessing double patenting. In response, JAMP argued that Boehringer was assuming the argument relied on extrinsic evidence. In addition, JAMP submitted that there is no case law confirming whether the prohibition on the use of extrinsic evidence applies to the construction of patents other than the one asserted by a plaintiff.

Associate Justice Cotter found that, while JAMP’s argument may be novel, it was not plain and obvious that paragraph 119N does not have a reasonable prospect of success or that it would be struck out if it were already part of the statement of defence.

As part of determining whether it was in the interests of justice to permit the proposed amendments, Associate Justice Cotter considered whether the “proposed amendment seeks to introduce allegations of which the moving party was aware when its NOA was served”. In the present case, there was no specific evidence as to whether or not JAMP was aware of the new invalidity allegations when its NOA was served. Associate Justice Cotter found it was not necessary to decide the motion based on this issue as it was in the interests of justice to permit the proposed amendments.

According to Associate Justice Cotter, it was in the interests of justice to permit the proposed amendments based on the following:

• There was no issue regarding the timeliness of the motion in the context of the status of the action;
• There was no suggestion that the trial would be delayed as a result of the proposed amendments;
• Boehringer did not argue that JAMP’s original position had led Boehringer to follow a course of action in the litigation that would be difficult or impossible to alter;
• It is in the interests of justice for the trial judge to be in possession of all the relevant references because the issue of the validity of the 083 Patent goes beyond the parties to this litigation;
• There was no suggestion that JAMP had benefited from waiting until this point to raise the allegations in the proposed amendments;
• There was no suggestion that additional discovery would be needed;
• Boehringer would have more than 4 months from when it became aware of the proposed amendments before any expert reports are due and approximately 7 months before its responding expert reports on validity are due;
• The proposed new invalidity allegations, although not included in the NOA, are based on WO 948 and the 350 Patent, which are not new documents and are included in the NOA and the statement of defence; and
• Boehringer did not argue that it would be prejudiced if the proposed amendments were allowed.

As a result, Associate Justice Cotter granted JAMP leave to serve and file its proposed amended statement of defence. He awarded costs of the motion to JAMP in the amount of $3,500.

A copy of the decision is available here.