On 18 July 2018 Justice Locke of the Federal Court granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) (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 2,203,936 (the 936 Patent) and 2,435,146 (the 146 Patent). Teva had succeeded on allegations of obviousness in both proceedings.(1) Janssen markets its bortezomib product as Velcade.
Millennium Pharmaceuticals (the 936 patentee and the licensor under the 146 Patent) and Janssen argued that Teva was not entitled to Section 8 damages because it would have infringed the 936 Patent, the 146 Patent and Patent 2,738,706 (the 706 Patent). Millennium, Janssen and additional plaintiffs brought a counterclaim for infringement of the same patents. The judge rejected this defence and dismissed the counterclaim, finding that the relevant claims of the 936 and 146 Patents were obvious and that the 706 Patent had not been infringed.(2)
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 the judge, bortezomib fell within the scope of compounds identified in a Patent Cooperation Treaty application and, accordingly, the 936 Patent was "effectively a selection patent". While bortezomib had not previously been identified and no one had made the selection of its characteristic components, the judge 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. The judge also held that the selection of the components in combination was not inventive, finding as follows:
There 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.
Invalid selection patent As part of his obviousness analysis, the judge 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.
Velcade's commercial success The judge found that the success of Janssen's commercial product did not impact the obviousness analysis. Bortezomib alone – considered separately from the commercial formulation – was deemed to be "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 an inventive concept "is the use of mannitol and lyophilisation to form an ester of bortezomib". The judge ruled that "it 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, the judge addressed the 'obvious to try' factors as follows:
- Lyophilisation was well known as one of a finite number of known solutions. A skilled person would expect improved stability.
- The judge discarded much of the inventors' actual course of conduct due to it being 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".
- A skilled person would be motivated to try lyophilisation, consistent with an inventor's view that they "would be remiss not to try it". A 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".
Velcade's commercial success Similar to the 936 Patent, the commercial success of Janssen's product did not affect the court's obviousness analysis. The commercial formulation offered improved solubility and dissolution properties that did not form part of the claimed invention.
US decision not persuasive The court's conclusion on obviousness differed from the US Court of Appeals for the Federal Circuit's decision on the equivalent US patent. The judge did not find the US court's reasons persuasive because of differences in:
- the standard required to find invalidity;
- the definition of the 'skilled person'; and
- the prior art.
The 706 Patent claims covered 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) did not infringe the 706 Patent. The judge provided limited details regarding the processes at issue, but indicated that infringement turned on construction issues decided in Teva's favour. This included the rejection of Millennium's argument that the use of certain solvents referred to in the claims was not essential because a skilled person would have known of alternatives that could be substituted without changing how the invention works. The judge found them to be essential as the terms used were "clear and unambiguous".
In view of the above findings, the court granted the Section 8 claim (the parties had agreed the amount of compensation, which was not disclosed) and dismissed the counterclaim.
Millennium may appeal, as of right.
For further information on this topic please contact Brandon Heard at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
Endnotes
(1) 2015 FC 247 and 2015 FC 184.
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