Digests

Procter & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health)

T-155-02

2004 FC 204, Snider J.

12/2/04

54 pp.

Application for order of prohibition pursuant to Patented Medicines (Notice of Compliance) Regulations, (Regulations) s. 6(1) preventing Minister of Health (Minister) from issuing Notice of Compliance (NOC) under Food and Drug Regulations, s. C.08.004(4) to respondent, Genpharm Inc. (Genpharm), for its product "Gen-Eti-Cal Carepac"-- Applicants make and sell only approved etidronate disodium drug product for treatment of osteoporosis in Canada, Didrocal® kit--Kit used in intermittent cyclical therapy (ICT) --Kit and ICT protected by patent--Genpharm serving Notice of Allegation (NOA) that its product will not infringe patent and that patent invalid due to obviousness--Essential elements of invention identified--Date at which to test obviousness presumed to be priority filing date of June 6, 1985--Test for obviousness: whether skilled technician would be led, based on state of the art, to claimed invention without conducting further experiments, serious thought or research-- "Mere scintilla of invention" sufficient to support validity of patent--Rebuttable statutory presumption of validity of patent --Also rebuttable presumption facts alleged by Genpharm true--Onus on patent owner to prove, on balance of probabilities, allegations of invalidity, obviousness not justified--Relevant art canvassed--Court accepted limited effective dose (LED) of etidronate claimed in patent would not have been "crystal clear" or "plain as day" to skilled technician at critical date--Etidronate dosage range claimed by applicants in patent not obvious to skilled technician at critical date--Literature reviewed--Intermittent administra-tion of etidronate not obvious at critical date--ICT in patent not including use of activator--Based on evidence, Court finding not obvious to skilled technician that bone cell activator not essential component for osteoporosis treatment-- Kit claimed in patent described as means "for having the components arranged in a way as to facilitate compliance with the regimen"--At critical date, skilled technician could easily make kit facilitating compliance with applicants' ICT--Such kit obvious given contraceptive kits would form part of common general knowledge at that time--But heart of invention not each of these elements in isolation, but rather their combined use--Test for obviousness not to be applied to each element discretely, but to combination of elements as whole--Thus, even if all elements of patent known previously, must ask whether their combination, embodying idea in practical form, constitutes inventiveness--Cases wherein patents found invalid distinguished--At issue here is whether very specific method of using etidronate, at LED, intermittently and cyclically, for treatment of osteoporosis, obvious at critical date--Prior art not rendering invention obvious--Unimaginative skilled technician at critical date would not have come directly and without difficulty to solution in patent--Allegation of invalidity not justified--As to allegation of non-infringement of "kit" claims, for Regulations to apply, first person must have claim for medicine or use of medicine contained on patent register-- Genpharm submitting claims 1 to 16 of patent should not be subject of proceedings under Regulations, as not containing claim for medicine itself, or claim for use of medicine, and are analogous to system for administering therapeutic regimen-- Applicants submitting Court should not consider this issue as not "put into play" in NOA, but raised in memorandum of fact and law--Court disagreeing--NOA contained clear state-ment providing clear notice to applicants this issue in play-- Substance of allegation that "kit" claims on which applicants relying not claiming medicine itself or use thereof and, therefore, sale of Genpharm's product will not infringe any such claim--Applicants submit claim to kit not claim to physical thing used to administer drug in question--Arguing kit essential and integral part of ICT and, as such, "kit" claims are claims to medicine itself--Test for determining whether substance "medicine" under Regulations described in Novartis Pharmaceuticals Canada Inc. v. Canada (Minister of Health) (2003), 28 C.P.R. (4th) 1 (F.C.A.): is kit administered to patient or is it system for administering substance to patient? --Applicants' kit not administered to patients, but system for facilitating compliance with ICT regimen--Device used to administer medicine not "medicine" within meaning of Regulations--Kit facilitating compliance little different than patch ensuring medicine delivered to patient in proper doses --"Kit" claims relate to system for administering ICT therapy and should not be subject of proceedings under Regulations-- Consequently, no need to allege non-infringement with respect to "kit" claims--Order of prohibition should issue as patent valid--Allegation of non-infringement of kit claims considered in case conclusion on patent validity or application of Regulations to "kit" claims wrong--Genpharm's kit facilitates compliance with ICT regimen--Therefore, allegation "kit" claims in patent will not be infringed not justified--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(1) (as am. by SOR/98-166, s. 5)--Food and Drug Regulations, C.R.C., c. 870, s. C.08.004(4) (as am. by SOR/95-411, s. 6).