Federal Court allows pharma company to amend its defence in a patent infringement case

It was in the interests of justice to permit the proposed amendments: court

Federal Court allows pharma company to amend its defence in a patent infringement case

The Federal Court has granted JAMP Pharma Corporation leave to amend its statement of defence in a patent infringement case.

In Boehringer Ingelheim (Canada) Ltd. v. Jamp Pharma Corporation, 2023 FC 1414, Boehringer Ingelheim (Canada) Ltd. and Boehringer Ingelheim International GmbH, collectively known as BI, sued JAMP, alleging that JAMP’s products would infringe or induce infringement of certain claims of BI’s Canadian patent – the “083 Patent” and “267 Patent.”

JAMP asserted in its statement of defence that BI’s patents are invalid. JAMP brought a motion for an order granting it leave to serve and file an amended statement of defence relating to its allegation of the 083 Patent’s invalidity. Specifically, JAMP’s proposed amendment alleged anticipation and double patenting.

BI opposed JAMP’s motion to amend its statement of defence, arguing that the proposed amended defence does not disclose a reasonable defence and that it is not in the interests of justice to permit JAMP to amend to plead the new bases of invalidity not alleged in its Notice of Allegation (NOA).

The Federal Court noted that under the present PM(NOC) Regulations, a defendant is not limited to invalidity allegations made in its NOA. The threshold issue on a motion to amend a pleading is whether the proposed amendment has a reasonable prospect of success.

BI pointed to a particular paragraph of the proposed amended defence concerning JAMP’s intention to rely on extrinsic evidence to construe the “350 Patent” claims to assess double patenting. BI argued that this paragraph was irrelevant and did not disclose a reasonable defence.

JAMP argued that the proposed paragraph does not seek to use extrinsic evidence to construe the 083 Patent. JAMP contended that there is no case law on whether the prohibition on using extrinsic evidence applies to patents other than the one asserted by a plaintiff. While this may be a novel argument, the court noted that it was not plain and obvious that the paragraph concerned would be struck out if it were already part of the statement of defence or did not have a reasonable prospect of success.

BI further argued that it was not in the interests of justice to permit the proposed amendments because these specific invalidity allegations were not included in the NOA. BI asserted that JAMP has a “common law burden to lead evidence” on the invalidity allegations it was aware of.

However, when JAMP served its NOA, the court found no specific evidence that JAMP was aware of the invalidity allegations in the proposed amendments. Moreover, the court said that even if JAMP knew of the new invalidity allegations when it served the NOA, the court found that it was in the interests of justice to permit the proposed amendments considering the overall circumstances of the case. These circumstances include the timeliness of the motion and the fact that the proposed amendments will facilitate the court’s consideration of the actual substance of the dispute on its merits.

The court noted that BI has not asserted that it would be prejudiced if the proposed amendments were allowed. Accordingly, the court granted JAMP leave to serve and file its proposed amended defence.

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