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Plaintiff cannot amend Statement of Claim more than 45 days after receipt of NOAs to plead infringement of further patents

On May 5, 2021, the Federal Court dismissed a motion by Biomarin Pharmaceutical Inc (Biomarin) to amend its Statement of Claim to allege infringement of two patents that had not been asserted within the 45-day deadline provided by subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations): Biomarin Pharmaceutical Inc v Dr. Reddy’s Laboratories Ltd, 2021 FC 402.

On January 13, 2021, Dr. Reddy’s Laboratories Ltd. (DRL) served Biomarin’s counsel with three Notices of Allegation (NOAs), one for each of the three patents listed on the Patent Register against Biomarin’s sapropterin dihydrochloride (KUVAN): Canadian Patent Nos. 2,682,598 (598 Patent), 2,545,584 (584 Patent) and 2,545,968 (968 Patent). However, Biomarin’s counsel mistakenly believed that they had been served with three copies of the same NOA addressing the 598 Patent and that the 584 and 968 Patents had not been addressed by DRL. Biomarin commenced an action under section 6(1) of the Regulations alleging that DRL’s proposed product would infringe only the 598 Patent. Biomarin also pleaded that since DRL had not addressed the 584 and 968 Patents in its NOA, a notice of compliance could not issue to DRL until after the 584 and 968 Patents expire or the requirements under section 7 of the Regulations are otherwise met. Biomarin’s counsel became aware of their mistaken belief 69 days following service of the NOAs and Biomarin moved for leave to amend its Statement of Claim to plead infringement of the 584 and 968 Patents.

Under section 6(1) of the Regulations, an innovator is required to bring an infringement action under the Regulations within 45 days of receipt of an NOA. Section 6.01 provides that an innovator may not bring an action for infringement after this deadline unless it can establish that it was not provided with a reasonable basis to determine that an action should be brought. The Regulatory Impact Assessment Statement for the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, 2017, SOR/2017-166 sets out potential circumstances in which the innovator may be found not to have had a reasonable basis for bringing an action within the 45-day period: “where the information provided by the second person was false, materially misleading, or materially incomplete”.

Biomarin argued that although section 6(1) of the Regulations may prevent a new action from being commenced beyond the prescribed 45-day period, it does not prevent amendments to pleadings in an existing action to address additional patents. Biomarin further asserted that there is no conflict or inconsistency between the Regulations and the Federal Courts Rules (Rules), and that since the Regulations are silent on amendments to pleadings, parties are permitted to address amendments under the Rules. The Court did not address whether section 6(1) of the Regulations is a bar to Biomarin’s proposed amendments or whether there is an inconsistency between the Rules and the Regulations. Instead, the Court focused on whether, even if Biomarin’s submissions on these issues were accepted, Biomarin’s proposed amendments arise out of substantially the same facts as the cause of action originally pleaded, as required under Rule 201 of the Rules.

The Court found that the Statement of Claim did not contain the material facts necessary for an allegation of patent infringement in relation to the 584 and 968 Patents (e.g. facts demonstrating Biomarin’s rights in the patents, facts regarding DRL’s specific acts of infringement of the patents), and noted this to be unsurprising given that the patents each disclose different inventions. The Court dismissed the motion as it was not satisfied that the proposed causes of action arose out of substantially the same facts as the cause of action in the Statement of Claim. Biomarin did not seek leave to appeal the decision.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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