Digests

Patents

Infringement

Application brought under Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 seeking order prohibiting Minister of Health from issuing notice of compliance to respondent Mylan Pharmaceuticals ULC until expiry of Canadian Letters Patent No. 2310950 ('950 patent) owned by Janssen Pharmaceutica N.V. and licensed to Janssen Inc. (collectively the applicants)—'950 patent listed in respect of applicants’ galantamine product Reminyl—Inventive concept of '950 patent limited to applicants’ claimed discovery that slow titration of galantamine improving patient tolerability for drug by reducing side-effects, resulting in ability to use lower maintenance dose than previously proven effective—Finding foundation for applicants’ assertion in '950 patent that method of slow titration effectively reducing adverse side-effects that would otherwise be experienced—Relevant claims of '950 patent constituting unpatentable subject-matter—Applicants’ claims of having discovered that slow titration of galantamine reducing patient side-effects unquestionably well-known in prior art; would therefore have been obvious to person of skill at relevant time—Patent claim over method of medical treatment by nature covering area for which physician’s skill or judgment expected to be exercised not patentable in Canada—Includes administration of drug where physician, while relying on patentee’s dosage advice, still expected to be alert, responsive to patient’s profile, reaction to compound—Titration regimen claimed by applicants can only be seen as recommendation to physicians—By attempting to monopolize effective titration regimen for galantamine, '950 patent interfering with physicians’ ability to exercise judgment in administering generic versions of drug—Application dismissed.

Janssen Inc. v. Mylan Pharmaceuticals Ulc (T-175-09, 2010 FC 1123, Barnes J., judgment dated November 10, 2010, 26 pp.)