Bortezomib - Canada

On July 18, 2018, Federal court of Canada found Velcade® patents invalid & not infringed by Teva’s generic version.

This action began as a claim by plaintiff, Teva Canada Limited (Teva), against Janssen Inc. (Janssen) and Millennium Pharmaceuticals, Inc. (Millennium) for compensation under s. 8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [the Regulations] for losses suffered during the time that Teva was kept off the market for its version of a drug for treating cancer that is marketed in Canada by Janssen under the name Velcade. Teva’s product is called Teva-bortezomib. Janssen had rights in Canada to Canadian Patent Nos. 2,203,936 (Compound Patent) and 2,435,146 (Composition Patent) as well as Canadian Patent No. 2,738,706 (Process Patent).

In 2012, it commenced two applications under the Regulations against Teva seeking orders prohibiting the issuance of a notice of compliance (NOC) to Teva until expiration of the 936 and 146 Patents, respectively. Both applications were dismissed by decisions of Justice Robert L. Barnes concluding that the claims in issue of each of the 936 and 146 Patents were invalid for obviousness. These decisions are cited as Janssen Inc v Teva Canada Limited, 2015 FC 247 and Janssen Inc v Teva Canada Limited, 2015 FC 184, respectively. Teva subsequently obtained its NOC and commenced the present action.

The parties have managed to reach agreement on a number of issues, including the quantum of any compensation or damages that may be payable. The parties have indicated that only the following issues remain in dispute:

Ø  With regard to the 936 Patent (whether claims 37 and 69 are obvious);

Ø  With regard to the 146 Patent (whether the asserted claims are obvious); and

Ø  With regard to the 706 Patent (whether Teva‑bortezomib infringes)

Conclusions of Court:

Ø  Claims 37 and 69 of the 936 patent are invalid for obviousness.

Ø  Solution provided by the 146 patent lyophilisation of bortezomib and mannitol, would have been obvious to try.

Ø  Teva-bortezomib does not infringe claim 1 & dependent claims of the 706 patent.