Pharma In Brief - Canada: Federal Court Upholds Validity Of GLEEVEC® Patent

Case: Teva Canada Limited v. Novartis AG, Apotex Inc. v. Novartis AG

Drug: Imatinib Mesylate (GLEEVEC®)

Nature of case: Patent Impeachment Actions and PM(NOC) Prohibition Applications

Successful party: Novartis AG

Date of decision: February 19, 2013

Summary

Teva Canada Limited ("Teva") and Apotex Inc. ("Apotex") wish to sell generic versions of GLEEVEC®, a highly effective drug for the treatment of chronic myeloid leukemia (CML). The active ingredient in GLEEVEC® is imatinib mesylate. Imatinib and its salt, imatinib mesylate, are protected by Canadian Patent No. 2,093,203 (the "'203 Patent") owned by Novartis AG ("Novartis").

Teva and Apotex commenced actions against Novartis seeking declarations under s. 60(1) of the Patent Act, R.S.C. 1985, c. P-4 that the claims of the '203 Patent are invalid (the "Impeachment Actions"). Teva and Apotex also served Novartis with Notices of Allegation in respect of the '203 Patent. In response, Novartis defended the Impeachment Actions and brought applications under the Patented Medicines (Notice of Compliance) Regulations ("NOC Regulations") for an Order, inter alia, prohibiting the Minister of Health from authorizing Teva and Apotex to market imatinib until the expiry of the '203 Patent (the "Prohibition Applications"). The Impeachment Actions and the Prohibition Applications were consolidated for trial and heard by Justice Snider.

The Court concluded that the utility of Claims 5, 7, 29, 44 and 46 of the '203 Patent had been demonstrated or could be soundly predicted as of the filing date, and that the '203 Patent met the disclosure requirement of s. 27(3) of the Patent Act. The Court also held in separate Reasons for Judgment that Teva and Apotex's allegations of invalidity were not justified in light of its decision in the Impeachment Actions.

Background of the '203 Patent

The essence of the '203 Patent is selective inhibition of particular protein kinases that are responsible for transmitting signals to the nucleus to cause cell growth and proliferation. The primary kinases referred to in the '203 Patent are ABL Kinase, PDGF-R Kinase and the family of PKC Kinases, all of which were being investigated for their connection to various forms of cancer at the relevant date. In April 1992, a patent was filed in Switzerland for a group of PKC inhibitors (the "Group 1 Compounds"). It is the priority application to which the '203 Patent refers.

Two important discoveries occurred in the year between the filing of the priority application and the Canadian patent application: (1) chemists created molecules that could inhibit PDGF-R Kinase and ABL Kinase in addition to PKC; and (2) the synthesis of a molecule that was selective for PDGF-R and ABL Kinase, but did not inhibit PKC (the...