Teva’s 802 Patent claims a dosing regimen for treating multiple sclerosis with Copaxone (glatiramer acetate). The Federal Court held the 802 Patent valid and infringed by Pharmascience in 2020 FC 1158, the Court of Appeal affirmed this decision in 2022 FCA 2, and the Supreme Court denied leave to appeal. Teva was represented by Aitken Klee LLP.
While the litigation was ongoing, Pharmascience also filed a request for re-examination of the 802 Patent with the Commissioner of Patents. In July 2020, the Re-examination Board issued a preliminary opinion that it viewed the 802 Patent as obvious. The re-examination was stayed pending completion of the Federal Court litigation (2021 FC 367). Once the stay was lifted and after supplemental submissions from Teva, the Board concluded, contrary to its preliminary opinion, that the 802 Patent is valid and not obvious.
Teva argued the Board was bound by the Court decisions, which held the 802 Patent valid and considered the same prior art that was before the Board. The Board did not address this issue but reconsidered its opinion in light of Teva’s supplemental submissions regarding validity. The Board’s reasons focused on a reconsideration of the common general knowledge (CGK) of the person skilled in the art (PSA).
The 802 Patent claims 40 mg of Copaxone administered three times per week. The Board’s preliminary opinion found the CGK included certain prior art documents which indicated that the previously known 20 mg/day dose was not the optimal dosage. However, in its final opinion, the Board agreed that none of these documents were part of the CGK. CGK depends on what would in fact be known to the PSA. The Board held that individual articles can be CGK if they are generally known by the bulk of those engaged in the relevant art, whereas individual patent specifications do not normally form part of the CGK. There was no evidence that this prior art would be generally known by the bulk of those in the field. None were established reference works. Rather, they consisted of discrete articles, conference abstracts and a patent application that disclosed only small pilot or Phase II clinical studies. Conversely, the PSA would have accepted the press release concerning the clinical trial that identified 20 mg/day as the optimal dosage and would have understood that 20 mg/day had been identified as the optimal dosage regimen in the usual manner.
The Board’s preliminary opinion found the CGK “particularly relevant” to the PSA’s motivation in the obvious-to-try analysis. Having revised its opinion on the CGK, the Board found that the PSA would not have been motivated to pursue a lower dosing frequency. The Board relied on expert evidence from the Federal Court trial (which was subsequently submitted to the Board) and found that, if the PSA was motivated to reduce side effects while maintaining efficacy, they would not have looked to a lower dosing frequency but would have looked to other options such as oral formulations, or sustained release injectables or patches. The Board’s preliminary opinion had “attributed significant weight” to the PSA’s motivation and, after reconsidering this factor, the Board’s final conclusion was that the 802 Patent was not obvious-to-try.
A copy of the Re-Examination Board’s decision can be found here.