CasesJanssen 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

DrugVELCADE® (bortezomib)

Nature of caseProhibition proceedings pursuant to PM(NOC) Regulations

Successful PartyTeva Canada Limited

Dates of decisionsFebruary 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 Patent amounts to a selection from the ‘904 Patent, which is a genus patent that discloses bortezomib. Justice Barnes held that a “person of skill is not doing anything inventive when he chooses options provided in a prior patent to build a molecule that he expects will work.” Furthermore, bortezomib does not possess “a special property of an unexpected character” or “a substantial advantage over the genus from which it is selected”.

The ‘936 Patent was also considered obvious because the use of a pyrazinecarbonyl group for N-terminal protection of peptides was known in the prior art, and, regardless, most any blocking group would work due to proteases being relatively insensitive to the precise identity of the N-terminal blocking group.

Justice Barnes also held that Janssen’s course of conduct was not “arduous or fraught with difficulty” and “was a matter of routine benchwork.” Janssen “simply selected a blocking group from among a group of available choices with an expectation that it would provide the requisite protection to the active part of the bortezomib molecule.”

Justice Barnes held Teva’s allegation of obviousness was justified and refused to issue a prohibition order.

The ‘146 Patent – T-2195-12 – 2015 FC 184

The ‘146 Patent is the patent relating to bortezomib ester. Janssen and Teva disagreed as to the qualifications of the POSITA. Janssen argued that within a single patent, “specific claims can be parsed from the whole and construed in isolation from the rest of [the] patent by persons of skill with varying qualifications.” Justice Barnes rejected this approach and held that since patents are to be read as a whole and a POSITA may have composite skills, the POSITA in the instant case has the composite expertise of both a formulator and a medicinal chemist.

With respect to the inventive concept of the ‘146 Patent, Janssen asserted the inventive concept of the ‘146 Patent as the identification of a pharmaceutically stable formulation of bortezomib that also readily achieves a pharmaceutically active form upon dissolution. Teva characterized the inventive concept as the lyophilized mannitol ester of bortezomib yielding a suitable stable formulation acceptable for use in pharmaceutical preparations. Justice Barnes preferred Teva’s submissions on  this point.

Janssen argued that a “very wide gulf” existed between the prior art and the invention of the ‘146 Patent. This was because a POSITA would not find it self-evident that bortezomib would form a stable ester with mannitol, nor would it be self-evident that it would be possible to obtain a workable formulation. On the other hand, Teva argued that it was self-evident that the stability of bortezomib could be enhanced by preparing a lyophilized formulation with mannitol.

Justice Barnes recognized that there were but a few avenues to try to arrive at the invention of the ‘146 Patent, however this was not conclusive of an obvious invention. Instead, Justice Barnes held that the invention in the ‘146 Patent 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.” Justice Barnes held that a POSITA would choose lyophilization - as the inventor did - and that mannitol was one of only a few bulking agents to try. Moreover, there was no “teaching away” from either lyophilization or mannitol. Thus, the discovery of the invention in the ‘146 Patent was “routine” and “there was no reason to believe that what was tried was unlikely to work.” Accordingly, there were no material differences between what was known in the prior art and what was claimed in the ‘146 Patent.

Justice Barnes held Teva’s allegation of obviousness was justified and refused to issue a prohibition order.

Janssen’s appeal

Janssen appealed from T-2194-12, which is the proceeding that pertained to the ‘936 Patent. This appeal was dismissed on the basis of mootness as previously reported in our Pharma in Brief dated February 20151.  

Link to decisions:

The Federal Court T-2195-12 decision may be found here.

The Federal Court of Appeal mootness decision may be found here.

Pharma in Brief re Federal Court of Appeal mootness decision may be found here.