PATENTS
Infringement
Plaintiffs owner of, licensees under Canadian patent 1275350 ('350 patent) directed to class of chemical compounds stated to be useful in treating hypertension—Lisinopril one such compound—Some of plaintiffs selling drugs in Canada incorporating lisinopril—Defendant producing, selling in Canada generic version of some of plaintiffs’ lisinopril drugs—Plaintiffs alleging infringement; defendant counterclaiming, alleging invalidity—In another action dealing with related patent pertaining to enalapril, patent held to be valid, infringed by Apotex—'350 patent but one of many patents originating from parent '340 application filed in 1979—'350 patent is result of application “divided out” from parent '340 application in 1989—As such dealt with under provisions of old Patent Act (R.S.C., 1985, c. P-4)—Other divided out applications including claims to class of compounds including enalapril, which ultimately matured to patent 1275349 ('349 patent)—Description of '350 patent essentially unchanged from that of parent '340 application—Stated uses, dosages, combination with other material same as those found in parent '340 application— Construction of claims, specifications of '350 and parent '340 application—As to parent application, specification directed to class of compounds, divided into three classes: preferred, more preferred, most preferred—Lisinopril, enalapril, enalaprilat specifically exemplified, claimed as compounds—No data given in respect of any compound, no comparison made between any compounds—Lisinopril not separated from “most preferred” class of compounds—'350 patent containing almost precisely same description—Apotex questioning whether parent '340 application describing one invention, i.e. class of compounds, or many separate inventions, one being class and others being those specifically stated, such as lisinopril, enalapril, enalaprilat—Meaning of “invention”—Although '340 specification compelling conclusion but one invention (as majority concluded in May & Baker Limited et al. v. Boots Pure Drug Company Limited (1950), 67 R.P.C. 23 (H.L.) concluded), Exchequer Court in two decisions, both of which upheld by S.C.C., has, in respect of patents having disclosures and claims stikingly similar to that of '340 application, held otherwise—No substantive distinction between this case and Boehringer Sohn, C.H. v. Bell-Craig Ltd., [1962] Ex. C.R. 201; affd [1963] S.C.R. 410 and Hoechst Pharmaceuticals of Canada Ltd. et al. v. Gilbert & Company et al., [1965] 1 Ex. C.R. 710—Judicial comity requiring finding '340 application disclosing separate inventions to each of the class, to lisinopril, to enalapril, to enalaprilat—Apotex also urging Court to conside extrinsic evidence, including communications between Merck’s United States patent attorneys and United States Patent Office during prosecution of priority application filed there in construction of patent application—But such extrinsic evidence resisted because patent should stand on its own—Furthermore, general rule that extrinsic evidence inadmissible for purpose of construing patent specification necessarily extending to testimony of inventor pertaining to proper construction of specification—'350 patent claims construed as of date patent issued, granted—Apotex admitting infringement of claims 1, 2, 5 if found valid, subject to following exemptions: (1) old Patent Act, s. 56 exempting material acquired before '350 patent granted in 1990; (2) compulsory licence issued to Delmar under '350 patent exempting certain quantities of lisinopril manufactured by Delmar and ultimately acquired by Apotex; (3) Patent Act, s. 55.2 permitting Apotex to use, retain certain quantities of lisinopril for submissions as required by government authorities; (4) common law respecting patents permitting non-infringing use of certain quantities of lisinopril for experimental purposes—Apotex precluded from challenging validity of claims—(1) Three lots of lisinopril at issue with respect to s. 56 exemption—Essentially same issue arising as to enalapril in Merck & Co. v. Apotex Inc., [1995] 2 F.C. 723 wherein Federal Court of Appeal holding s. 56 only applying to material in satisfactory condition as to be considered by manufacturer as something that could be shipped to customer—Batchers at issue not usable for anything as of critical date—S. 56 exemption not applicable—(2) As to Delmar’s compulsory licence, lisinopril made by Delmar during licence period, during which title but not possession passed to third party—Apotex ultimately acquired both title, possession to this lisinopril well after licence period expired—Earlier decisions of Federal Court Trial Division ((1994), 59 C.P.R. (3d) 133) and of Federal Court of Appeal ([1995] 2 F.C. 723) dealing with similar licence to Delmar for enalapril, confusing as consideration of licence mingled with consideration of s. 56, which appears to be irrelevant to licence issue—Subsequently S.C.C., in case involving different parties, considered effect of terminated compulsory licence in Eli Lilly & Co. v. Novopharm Ltd., [1998] 2 S.C.R. 129—Held, in absence of express conditions to contrary, purchaser of such licensed product free to deal with product without fear of infringing upon patents in question—Federal Court of Appeal later considered Eli Lilly in Apotex Inc. v. Merck & Co., [2003] 1 F.C. 242, holding Eli Lilly not representing change in law—Bur for that decision, Apotex may properly have asserted grant of licence by Commissioner including right to make, sell invention (lisinopril) for preparation or production of medicine—No restriction in licence that person preparing, producing medicine be Delmar or agent of or under contract with Delmar—Delmar able to sell lisinopril to others to prepare or produce medicine—But since 2002 F.C.A. decision, involving same parties in respect of compulsory licence identical in terms with that at issue here, involving patent arising from same parent application as '350 patent, deciding Apotex prevented from relitigating issue of licence, Apotex cannot now raise '350 licence as defence to infringement—While that decision binding, this Court of view licence, even if extinguished still runs with goods made before extinguished thus affording good defence to infringement—Patent Act Amendment Act, 1992, s. 12(2) providing no action for infringement lies in respect of any act done before commencement date—(3) S. 55.2(1) providing not infringement to make, use, sell patented invention solely for uses reasonably related to development, submission of information required under any law regulating manufacture, use, sale of product—Drug manufacturers required to retain samples on ongoing basis by both Canadian, United States federal regulatory authorities—Lisinopril, materials incorporating lisinopril prepared, used to obtain permission to make drugs containing lisinopril, exempt under s. 55.2—Samples retained by Apotex for future reference in accordance with regulatory requirements never enter stream of commerce, ultimately destroyed—Such samples also exempt under s. 55.2—(4) (i) As to common-law exemptions respecting patent infringement, use of lisinopril in ongoing research, development of alternate formulae, alternate techniques for tablet making falling within “fair dealing” exemption provided in Smith Kline & Micro Chemicals Limited v. French Inter-American Corporation, [1972] S.C.R. 506—(ii) Dedication of certain claims of 1276559 patent directed to particular uses of lisinopril specifically not affection enforceability, validity of undedicated claims i.e. claims 1, 2, 5 of '350 patent—Exemptions found to be proper apply only to activity taking place on, after January 26, 2000 (six years before Apotex’s pleading amended so as to include plea to such exemptions): Patent Act, s. 55.01—Apotex challenging validity of claims 1, 2, 5 of patent '350 on grounds of delay, double patenting, improper divisional—Plaintiffs relying on Patent Act, s. 45 i.e. patent, in absence of evidence to contrary, presumed valid—Claims in '349 patent relating to enalapril already held valid, infringed by Federal Court, Federal Court of Appeal—Review of cases dealing with finality of litigation—Sane issues could have been raised in earlier litigation, but were not—Apotex precluded from raising attacks as to validity of '350 patent based on delay, improper divisional, double patenting—Nonetheless those arguments dealt with, dismissed on their merits—If several patents claiming same invention granted, application of principles of double patenting providing sufficient remedy as to validity—Lisinopril and enalapril plus diuretic not “identical or coterminus” inventions—'350 patent not invalid for reasons of double patenting over '684 patent—Took almost 12 years from original priority filing or almost 11 year from original Canadian filing for '350 patent to mature into granted patent—Merck provided timely response to Patent Office where requested—No evidence Merck wilfully delayed issue of '350 patent—Neither Canadian case law nor Patent Act addressing consequences of delay in prosecuting patent application other than abandonment if timely responses, fee payments not made—Critical examination of remedies for patent infringement—Plaintiffs clearly entitled to damages—Action taking 10 years to get to trial—When Apotex came into market with broad range of tablet strenghts in 1999, Merck and Astra left market to Apotex—That plaintiffs essentially “threw in the towel” and left action to proceed at leisurely pace leading to conclusion should not be entitled to elect award of profits—Apotex enjoined from making, using, selling products containing lisinopril until expiry of '350 patent—“Elevated” damages not awarded as no pleading respecting such damages—Pre-judgment, post-judgment interest awarded—Patent Act, R.S.C., 1985, c. P-4, ss. 45 (as am. by S.C. 2001, c. 10, s. 1), 55.01 (as enacted by S.C. 1993, c. 15, s. 48), 55.2 (as am. by S.C. 1993, c. 44, s. 194), 56 (as am. by S.C. 1993, c. 44.2, 194)—Patent Act Amendment Act, S.C. 1993, c. 2, s. 12(2).
Merck & Co., Inc. v. Apotex Inc. (T-2792-96, 2006 FC 524, Hughes J., judgment dated 26/4/06, 88 pp.)