Update: Apotex has appealed.
On March 8, 2021, the Ontario Superior Court of Justice granted Eli Lilly’s (Lilly) motion for summary judgment and dismissed Apotex’s claims under the Statutes of Monopolies, Trademarks Act, and common law conspiracy relating to Apo-Olanzapine: Apotex Inc. v Eli Lilly Canada Inc., 2021 ONSC 1588. The action was one of several novel claims by Apotex seeking damages pursuant to the Ontario and English Statutes of Monopolies and Trademarks Act. This action related to Canadian Patent No. 2,041,113 (113 patent) for olanzapine. While Lilly obtained an order of prohibition against Apotex, affirmed on appeal, the patent was later found invalid in an action against Novopharm (see here; affirmed on appeal see here). Apotex sought damages from Lilly arising from acts performed by Lilly while the patent was in force, including the listing of the 113 patent on the Patent Register and pursuit of the proceeding under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations).
The Court determined that the Patent Act and the PMNOC Regulations constitute a complete code governing the issuance and use of patents, including available remedies. None of Apotex’s claims were stand alone claims “totally independent of the regulatory regime”. Lilly’s activities relating to the 113 patent were “authorized by law and flowed from the operation of law”. A patent holder does not become liable for acts that it had a right to perform while the patent existed, even if the patent is later found invalid.
The Court rejected Apotex’s monopolies claims as the Statutes of Monopolies do not prohibit patents for new inventions, a category which includes the 113 patent. Moreover, Apotex’s assertion that it was harmed by the 113 patent could not succeed as it was inconsistent with Apotex’s position that the 113 patent was void ab initio and deemed never to have been granted.
Similar to the “complete code” analysis, the Court rejected Apotex’s Trademarks Act claims as Lilly had the right to list the 113 patent on the Patent Register, which was the sole basis of Apotex’s claim. Lilly did not make any false or misleading statements, or disparage or discredit Apotex.
Finally, the Court rejected Apotex’s claim that the defendants (Lilly-related companies) conspired to restrain trade and to monopolize the olanzapine market by, among other things, the prosecution of the prohibition proceedings, as Apotex led no evidence of any such conspiracy.
Apotex may appeal as of right.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
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