Biogen Canada Inc et al v. Taro Pharmaceuticals Inc; Pharmascience Inc., 2020 FC 621 (Fampridine*)
Justice Manson - 2020-05-15
Read full decision. Automatically generated summary:
These proceedings involve two patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations. The Plaintiffs allege infringement of the 277 Patent. The Defendants, Taro and Pharmascience, deny infringement and allege the patent is invalid for lack of patentable subject matter, anticipation, and obviousness. Issues of validity were heard concurrently for both actions, based on the same allegations of invalidity and evidence, along with infringement with respect to Taro. If necessary, the infringement portion of the Pharmascience action is scheduled to take place later this year. ... Despite the lack of results from the MS-F202 study, the disclosure requirement is satisfied if performing what is described in the prior art reference would necessarily result in infringement ... Following the MS-F202 protocol, the POSITA would be able to perform the claimed invention without the exercise of inventive ingenuity or undue experimentation, even after discovering that the primary endpoint of improvement in average walking speed using the Timed 25 Foot Walk had failed. ... These claims are therefore anticipated. ... The POSITA would have understood that 10 mg bid dosing of fampridine SR was therapeutically effective to improve walking and increase walking speed for at least some patients with MS, and would have routinely verified this understanding by studying fixed doses of 10 mg bid fampridine SR. Specifying dosing every 12 hours, rather than twice a day, is not inventive. ... In this case, all Asserted Claims are limited to fixed dosages and intervals of administration. Following the Federal Court of Appeal’s approach in Hospira, the Asserted Claims are therefore not invalid as methods of medical treatment.
Decision relates to:
- T-1163-18 - BIOGEN CANADA INC ET AL v. TARO PHARMACEUTICALS INC
- T-220-19 - BIOGEN CANADA INC. et al. v. PHARMASCIENCE INC.
- A-145-20 - which is an appeal from this decision