Federal Court Dismisses Janssen’s Applications To Prohibit NOC For Teva’s Bortezomib Product

Barnes J of the Federal Court of Canada recently released his public Judgment and Reasons dismissing two Applications by Janssen under thePatented Medicines (Notice of Compliance) Regulations, each seeking an Order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Teva Canada Limited (Teva) for a generic version of the Janssen Inc (Janssen) drug VELCADE® (bortezomib). Janssen markets VELCADE for the treatment of multiple myeloma and mantle cell lymphoma.

Janssen Inc v Teva Canada Limited, 2015 FC 184

In this decision, Barnes J held that Janssen had not shown that Teva’s obviousness allegation regarding Canadian Patent No. 2,435,146 (the 146 Patent) was not justified.

At issue was Claim 30 of the 146 Patent, which covers lyophilized (freeze-dried) mannitol ester of bortezomib. This compound forms as a reaction product when the bulking agent, mannitol, is combined with bortezomib.

Janssen defined the person skilled in the art (POSITA) of the 146 Patent by considering claim 30 in isolation. In Janssen’s view, the POSITA would be a formulation scientist who would not appreciate that bortezomib and mannitol would react to form an ester. Consequently, the POSITA would ignore prior art references describing the chemistry of bortezomib. Barnes J rejected this narrow definition, holding that the POSITA might be a character of composite skills and must be capable of understanding the entirety of the patent. This would include those parts speaking to chemical synthesis, as well as those speaking to formulation. This meant that a POSITA would expect the reaction between bortezomib and mannitol based on the prior art.

This led Barnes J to consider whether or not, given his understanding of the POSITA, it would be inventive to select mannitol as a bulking agent and to lyophilize the composition. He concluded it was not. Janssen argued that one of the named inventors was, in fact, not aware that he had created a mannitol ester when he lyophilized bortezomib with mannitol. In Janssen’s view, this meant the invention could not be obvious. Barnes J rejected this argument, finding that the inventor had obtained a workable formulation and that the later discovery of one of its inherent characteristics (i.e. the mannitol ester) did not add anything inventive over what had already been discovered. Further, the choice of a routine stabilizing method and a typical bulking agent for the bortezomib formulation could not be said to be inventive. In Barnes J’s view, these scant choices and the testing of the formulation for efficacy did not constitute inventive steps.

Janssen Inc v Teva Canada Limited, 2015 FC 247, aff’d 2015 FCA 36

In this decision, Barnes J held that Janssen had not shown that Teva’s obviousness allegation regarding Canadian Patent No. 2,203,936 (the 936 Patent) was not justified. The 936 Patent claims a broad genus of boronic acid dipeptides, including bortezomib. In this application, Janssen asserted only claims concerning bortezomib.

As a preliminary issue, Barnes J agreed with Teva that a prior patent disclosed a genus of compounds that included bortezomib, making the 936 Patent a selection patent.

Regarding obviousness, Barnes J found that the earlier patent provided the POSITA with “a clear roadmap to bortezomib”. He held that, although choices were still required to be made for all of the elements used to assemble the bortezomib molecule, those choices were rendered obvious by the teaching of the earlier patent. The POSITA would not be doing anything inventive in choosing options set out in the earlier patent and building a molecule that would be expected to work.

Barnes J also found that bortezomib did not possess a special property or a substantial advantage over the genus from which it was selected. He held that it did not matter that the earlier patent did not specifically describe bortezomib, it was sufficient that bortezomib was included in the genus of previously claimed compounds. In the absence of some special or unexpected advantage favouring bortezomib, the compound could not be reclaimed.

Janssen’s appeal of the decision of Barnes J was dismissed on the grounds of mootness, since Teva had been issued its NOC in the interim.