Kennedy Trust for Rheumatology Research, et al. v. Celltrion Healthcare Co., Ltd., et al.

(Federal) (Civil) (By Leave)


Intellectual property - Patents, Medicines - Intellectual property — Patents — Medicines — Patent found to be valid and infringed — On appeal, matter remitted to trial judge to reconsider issues of obviousness and anticipation — Whether inventive concept is a necessary component of the obviousness test — How is the inventive concept defined? — Is the state of the art subject to the discoverability criterion? — Does the “obvious to try” test apply to process or outcomes? — Can a speculative piece of art anticipate a patent? — Where a patent’s claims include the use of a known drug for a known medical purpose, with the alleged invention being the use of the drug to treat a patient population with a specific medical profile, should courts look to the substance of the patent’s claims to assess whether it is an unpatentable method of medical treatment? — Can a person be liable for infringing a patent by inducing a third party to infringe, if the alleged inducement does not relate to all of the essential elements of the patent claims?.


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Hospira Healthcare Corporation and the other plaintiffs (collectively “Hospira”) brought an action to impeach the 630 Patent. That patent is owned by the Kennedy Trust for Rheumatology Research (with the other respondents, collectively, “Kennedy”) and it counterclaimed for patent infringement. The 630 Patent details the adjunctive use of methotrexate (“MTX”) and the anti tumour necrosis factor a antibody “infliximab” for the treatment of rheumatoid arthritis (“RA”) and other autoimmune diseases. It is sold in Canada under the name “Remicade.”The 630 Patent expired on August 1, 2017. Hospira markets, uses and sells the biosimilar infliximab in Canada under the commercial name “Inflectra” as a treatment for RA. Prior to the 630 Patent, MTX was well known as a treatment for serious cases of RA but many patients with the disease did not completely respond to it. In the early and mid 1990s, existing treatments for RA were sub optimal with respect to efficacy and side effects. The inventors of the 630 Patent tried combining MTX and infliximab and obtained positive results, in terms of enhanced efficacy and sustained duration of effect. Hospira brought an action to attack the validity of the 630 Patent. Kennedy counterclaimed that the 630 Patent had been and would continue to be infringed. The trial judge dismissed Hospira’s action, and granted Kennedy’s counterclaim, finding that the patent was valid and infringed. This decision was overturned in part on appeal, on the basis that the trial judge had erred in his consideration of some of the prior art when determining the issues of anticipation and obviousness. The Federal Court of Appeal remitted the matter back to the trial judge to reconsider those two issues.