Pharma In Brief - Patents Found Obvious; Subsequent Appeal Moot

Cases: Janssen Inc v Teva Canada Limited and Canada (Health), 2015 FC 184 (T-2195-12); and Janssen Inc v Teva Canada Limited and Canada (Health), 2015 FC 247 (T-2194-12) aff'd 2015 FCA 36

Drug: VELCADE® (bortezomib)

Nature of case: Prohibition proceedings pursuant to PM(NOC) Regulations

Successful Party: Teva Canada Limited

Dates of decisions: February 16, 2015 for T-2195-12 and February 26, 2015 for T-2194-12

Summary

Janssen Inc (Janssen) brought two Applications pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations for orders prohibiting the Minister of Health from issuing a Notice of Compliance to Teva Canada Limited (Teva) in respect of bortezomib (VELCADE®) until the expiry of Canadian Patent No. 2,203,936 ('936 Patent) and 2,435,146 ('146 Patent). The Applications were heard before Justice Barnes of the Federal Court.

The only issue before the Court in both proceedings was whether Teva's allegation of invalidity based on obviousness was justified. In T-2194-12, Justice Barnes held that the '936 Patent, which pertains to the compound bortezomib, was obvious because it was a selection from a genus but lacked "a special property of an unexpected character" or "a substantial advantage over the genus from which it is selected". Moreover, the genus patent contained a "clear roadmap to bortezomib", which rendered the '936 Patent obvious.

In T-2195-12, Justice Barnes held that the '146 Patent, which pertains to bortezomib ester, was obvious because the "choice of a routinely used stabilizing method and the selection of a routinely used bulking agent to formulate bortezomib cannot be said to be inventive."

Accordingly, the Federal Court refused to grant Janssen's Applications for prohibition orders in both proceedings.

Obviousness

With respect to the allegations of obviousness, the Federal Court referred to the four-part test set out by the Supreme Court of Canada in Sanofi-Synthelabo Canada.

The '936 Patent - T-2194-12 - 2015 FC 247

The '936 Patent is the compound patent for bortezomib.

Justice Barnes held that the inventive concept of the claim at issue was not limited to the compound bortezomib. This is because throughout the '936 Patent the compounds of the invention are discussed with respect to their function as proteasome inhibitors. Whereas the inventive concept of the '936 Patent includes functionality, it does not include potency or selectivity.

Teva argued, and Justice Barnes agreed, that the '936...