On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for losses suffered while market entry of Teva’s bortezomib product was delayed by Janssen’s applications under the PMNOC Regulations relating to Patents Nos. 2,203,936 (936 Patent) and 2,435,146 (146 Patent). Teva had succeeded on allegations of obviousness in both proceedings: 2015 FC 247 and 2015 FC 184. Janssen markets its bortezomib product as VELCADE.
Millennium Pharmaceuticals (the 936 patentee and licensor under the 146 Patent) and Janssen argued that Teva was not entitled to section 8 damages because Teva would have infringed the 936 Patent, 146 Patent and the Patent No. 2,738,706 (706 Patent). Millennium, Janssen and additional plaintiffs brought a counterclaim for infringement of the same patents. Justice Locke rejected this defence and dismissed the counterclaim, finding that the relevant claims of the 936 Patent and 146 Patent were obvious and the 706 Patent was not infringed: Teva Canada Limited v Janssen Inc and Millennium Pharmaceuticals, Inc, 2018 FC 754.
Compound patent (obviousness)
The 936 Patent is a compound patent with claims covering bortezomib (claim 69) and a group of six compounds including bortezomib (claim 37). Bortezomib is a proteasome inhibitor, used in the treatment of certain blood cancers. It is a boronic acid analog of a dipeptide. The Court concluded that both claims were obvious and that the 936 Patent failed to meet the criteria for a valid selection patent.
According to Justice Locke, bortezomib fell within the scope of compounds identified in a PCT application and, accordingly, the 936 Patent was “effectively a selection patent”. While bortezomib was not previously identified and no one had made the selection of its characteristic components, Justice Locke held that the selection of its components was not inventive for a number of reasons, including that it was obvious to try boronic acids as proteasome inhibitors. Justice Locke also held that selection of the components in combination was not inventive, finding that “[t]here are a finite number of possible practical combinations to try, and any of them would have been expected to offer some potency. The testing involved would have been routine and there was nothing inventive in the decision to conduct such testing.”
Not a valid selection patent. As part of his obviousness analysis, Justice Locke also concluded that the 936 Patent was not a valid selection patent since the selection is not “in respect of a quality of a special character peculiar to the selected group”. There was no evidence that the claimed compounds (including bortezomib) performed better than the other compounds considered or were selected based on the potency testing in the patent.
Commercial success of VELCADE. Justice Locke found that the success of Janssen’s commercial product did not impact the obviousness analysis. Bortezomib alone – considered separately from the commercial formulation – “is too unstable to be commercially practical.”
Formulation patent (obviousness)
The 146 Patent addressed the challenge of finding “formulations of boronic acid compounds that are conveniently prepared, bioactive when administered, and more stable than free boronic acid.”
According to the Court, for the claims at issue, the difference between the state of the art and the inventive concept “is the use of mannitol and lyophilisation to form an ester of bortezomib.” Justice Locke found the invention “obvious to try” because “[i]t was obvious to try lyophilisation and, having decided to do so, it was obvious that a bulking agent would be needed. Moreover, it was obvious to try mannitol as the bulking agent.” Specifically, Justice Locke addressed the “obvious to try” factors as follows:
- Lyophilisation was well-known as one of a finite number of known solutions. The skilled person would expect improved stability.
- Justice Locke discarded much of the inventors’ actual course of conduct as of “limited assistance” to the question of obviousness. Moreover, while the inventors tried many different solutions, their work did not appear “arduous or outside the routine”.
- The skilled person would be motivated to try lyophilisation, consistent with an inventor’s view that “he would be remiss not to try it." The skilled person would have known, as part of their common general knowledge, that a bulking agent would be required; it would be obvious to try mannitol, which was “one of the most popular”.
Commercial success of VELCADE. Similar to the 936 Patent, the commercial success of Janssen’s product did not impact the Court’s obviousness analysis. The commercial formulation offered improved solubility and dissolution properties that did not form part of the claimed invention.
U.S. CAFC decision not persuasive. The Court’s conclusion on obviousness differed from the decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) on the equivalent U.S. patent. Justice Locke did not find the CAFC’s reasons persuasive because of differences in (a) the standard required to find invalidity, (b) the definition of the skilled person, and (c) the prior art.
Process patent (infringement)
The 706 Patent claims cover a process for the “large scale” production of “bortezomib or a boronic acid anhydrate thereof”. The Court concluded that the processes for manufacturing Teva-bortezomib and Act-bortezomib (relevant as a result of Teva’s amalgamation with Actavis) do not infringe the 706 Patent. Justice Locke provided limited details regarding the processes at issue, but indicated that infringement turned on construction issues decided in favour of Teva. This included rejection of Millennium’s argument that use of certain solvents referred to in the claims is not essential because the skilled person would have known of alternatives that could be substituted without changing the way the invention works. Justice Locke found them to be essential as the terms used are “clear and unambiguous”.
In view of the above findings, Justice Locke granted the section 8 claim (the parties had agreed upon the amount of compensation, which was not disclosed) and dismissed the counterclaim.
Milllennium et al may appeal, as of right.