Janssen Inc. v. Teva Canada Ltd., 2020 FC 593 (Paliperidone*)
Justice Manson - 2020-05-05
Read full decision. Automatically generated summary:
This is a patent infringement action pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations. ... The invention relates to dosing regimens for long acting injectable paliperidone palmitate formulations for treatment of schizophrenia. ... For the reasons that follow, I find that: The Asserted Claims are not obvious, and are valid. Teva will directly infringe claims 1 to 16 and 33 to 48 of the 335 Patent if it comes to market with its paliperidone palmitate product in accordance with its ANDS. Claims 17 to 32 will not be directly infringed, and Teva will not induce infringement of any of the Asserted Claims. ... A purposive construction of a maintenance dose on a “continuous schedule” can only result in a finding that it means maintenance dosing on an ongoing basis, not one dose. ... Having considered the composite POSITA and their common general knowledge as defined, in light of the numerous steps required to even begin evaluating possible dosing regimens using the dose amounts, dosing schedules, and injection sites disclosed in Citrome, the POSITA would have had to carry out prolonged and arduous experimentation to the point that the trials would not be considered routine. ... Teva will not induce infringement of the 335 Patent if it comes to market with its paliperidone palmitate product. Teva must be aware that at least some infringement by third parties will occur, but this infringement is the result of prescribing physicians’ skill and judgment applied to specific patient characteristics, rather than influence exercised by Teva via its PM.
Decision relates to:
- T-353-18 - JANSSEN INC. ET AL v. TEVA CANADA LIMITED
- A-131-20 - which is an appeal from this decision