Janssen Inc. v. Teva Canada Limited, 2015 FC 184 (Barnes, J.)
February 16, 2015
Jamie Mills, Chantal Saunders, Beverly Moore and Ryan Steeves, counsel for Janssen Inc.
David Aitken, Bryan Norrie and Jeffery Warnock, counsel for Teva Canada Limited
In this PM(NOC) Application, Janssen Inc. sought an order prohibiting the issuance of an NOC to Teva for generic Velcade bortezomib mannitol boronic ester for injection. The patent in issue was Canadian Patent No. 2,435,146. The only allegation at issue was obviousness of Claim 30 of the 146 Patent.
The 146 Patent relates to formulation stability. Claim 30 of the 146 Patent is for the lyophilized (freeze-dried) mannitol ester of bortezomib, which forms as a reaction product when the bulking agent, mannitol, is combined with bortezomib. The claimed compounds were not limited to those constituted through lyophilisation although that was said to be a preferred embodiment. Similarly, mannitol was not asserted to be an essential embodiment but it was said to be preferred.
The person skilled in the art was found to have the composite expertise of a formulator and medicinal chemist. Janssen submitted that the inventive concept of Claim 30 was the invention of a pharmaceutically stable formulation of bortezomib that readily achieves a pharmaceutically active form upon dissolution, namely the lyophilized mannitol ester of bortezomib.
Justice Barnes found that when faced with a compound that was unstable in solution, the skilled person would consider two well-known solid state formulation options: lyophilisation and powder filling. He also found that due to the size of the molecule, bortezomib was a good candidate for lyophilisation. The bulking agent chosen, mannitol, was found to be a well-known bulking agent and stabilizer.
Justice Barnes characterized the effort that went into the development of Claim 30 as “competent and detailed but, nevertheless, routine”. He found that the inventor applied a formulation technique known to provide stability to an unstable compound and a well-known bulking agent (mannitol). Despite the fact that the inventor worked on other options in tandem, Justice Barnes found that nothing taught away from the approach chosen, and there was no reason to believe that what was tried was unlikely to work.
Justice Barnes found that Teva’s obviousness allegation was justified and dismissed the application.
By: Greg Beach, Belmore Neidrauer LLP