Apotex Inc. v. Canada (Minister of National Health and Welfare)

Apotex Inc. v. Canada (Minister of National Health and Welfare) Court (s) Database Federal Court of Appeal Decisions Date 2001-09-13 Neutral citation 2001 FCA 263 File numbers A-715-98 Notes Digest Decision Content Date: 20010913 Docket: A-715-98 A-716-98 Neutral citation: 2001 FCA 263 CORAM: ROTHSTEIN J.A. SEXTON J.A. EVANS J.A. BETWEEN: APOTEX INC. Appellant (Respondent) - and - BAYER AG AND BAYER INC. Respondents (Applicants) -and- THE MINISTER OF NATIONAL HEALTH AND WELFARE Respondent (Respondent) Heard at Toronto, Ontario, Wednesday, September 12, 2001 Judgment delivered from the Bench at Toronto, Ontario, on Wednesday, September 12, 2001 REASONS FOR JUDGMENT OF THE COURT BY: EVANS J.A. Date: 20010913 Docket: A-715-98 A-716-98 Neutral citation: 2001 FCA 263 CORAM: ROTHSTEIN J.A. SEXTON J.A. EVANS J.A. BETWEEN: APOTEX INC. Appellant (Respondent) - and - BAYER AG AND BAYER INC. Respondents (Applicants) -and- THE MINISTER OF NATIONAL HEALTH AND WELFARE Respondent (Respondent) REASONS FOR JUDGMENT OF THE COURT (Delivered from the Bench at Toronto, Ontario on Wednesday, September 12, 2001) EVANS J.A. These are appeals by Apotex Inc. ("Apotex") from a decision of Gibson J., now reported in (1998), 156 F.T.R. 303, granting an order prohibiting the Minister of National Health and Welfare from issuing to Apotex a notice of compliance pursuant to the Patented Medicines (Notice of Compliance) Regulations with respect to the drug ciprofloxacin hydrochloride ("ciprofloxacin"), an anti-bacterial and anti-microbial agent, until the expiry of Canadian Letters Patent Nos. 1,218,067 ("'067 Patent") and 1,322,334 ("'334 Patent") held by Bayer AG and Bayer Inc. The Judge rejected Apotex' allegation that Bayer's Canadian patents for ciprofloxacin were invalid by virtue of subsection 28(2) of the Patent Act, R.S.C. 1970, c. P-4, which precludes, subject to certain exceptions, an inventor from obtaining a patent in Canada when the inventor has already applied in another country for a patent for the invention. Counsel for Apotex raised two substantive issues on the interpretation of subsection 28(2): when a foreign patent "issued" and the date at which an application for a patent is made in Canada when a foreign patent has been issued. However, the "foreign patent bar" only applies with respect to the same invention. Counsel failed to satisfy us that Gibson J. erred in his conclusion that the Canadian patents were not for the same invention as the invention that was the subject of certain foreign patents held, or applied for, by Bayer. Accordingly, Apotex' appeal must fail. Although the other points decided by Gibson J. against Apotex on the interpretation of the Patent Act were fully argued by counsel, our finding on the threshold issue renders them moot and, in view of their relative novelty and complexity, their resolution can be left for another day. These reasons relate to the disposition of both appeals, A-715-98 and A-716-98, which arise from discrete notices of allegations issued by Apotex challenging the validity of Bayer's Canadian patents. Gibson J. had dismissed the proceeding that is the subject of A-716-98 for abuse of process. However, given the basis of our decision, it is unnecessary to decide this issue and the appeals need not be differentiated. Copies of the reasons will be inserted in each file Bayer had applied in a number of countries outside Canada, including Germany, Spain and Chile, for patents for a group of compounds, including ciprofloxacin, processes for making them, and their use in compositions that have antibacterial and antimicrobial properties. For present purposes, it is agreed that the inventions in the foreign patents were substantially the same; the Chilean patent was used during argument as the foreign comparator. What is in dispute, however, is whether the invention in Canadian patent '067 is identical to the invention in the Chilean patent. Since a different allegation made by Apotex against the '334 patent has been upheld in another proceeding, it is unnecessary to consider this patent further here. The principal difference relied on by Bayer in support of its position that the invention in its Chilean patent is not the same as that in the Canadian '067 patent is that the latter includes the disclosure of, and a claim for, a process, the malonic ester synthesis process, for making the final intermediate from which ciprofloxacin is ultimately produced. The '067 patent is for the products, including ciprofloxacin, produced by this particular process. The malonic ester synthesis process is not disclosed or claimed in the Chilean patent. Counsel for Apotex contends that, in finding that these differences rendered the inventions not "the same", Gibson J. erred because he based his conclusions largely on a comparison of the claims of the patents, and paid insufficient attention to their respective disclosures. Counsel points out that, considered as a whole, the specifications of the Chilean and the Canadian patents are very similar. In particular, both include the compound ciprofloxacin, the same final step in the process for producing it, and the same uses for it. Hence, in so far as the Chilean and Canadian patents concern the same product, the same final step in the process for making it, and the same uses for it, they are for the same invention. At most, he argues, Bayer is entitled to a patent in Canada for the malonic ester synthesis process for making the final intermediate compound used ultimately for making ciprofloxacin. Despite counsel's thorough submissions, we can find no error in the manner in which Gibson J. approached the task of determining whether the Canadian and Chilean patents were for the same invention. He examined and compared the claims of each patent, and the disclosures, that is, the descriptive part of the patent application, which he used to elucidate the claims, but not to alter their scope when that was clear and unambiguous. This approach is not inconsistent with the "purposive approach" to the construction of patents endorsed by the jurisprudence. Thus, for example, in the most recent statement on the subject by the Supreme Court of Canada, Binnie J. said in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, at paragraph 49, that, while a patent must be given an interpretation that "best ensures the attainment of its objects", the purposive construction does not require a court to go "outside the four corners of the specification" and "properly limit[s the courts] ... to the words of the claims interpreted in the context of the specification as a whole." Counsel for Apotex responded by saying that the question that we must ask when examining the patents is, "What is the invention?" He submitted that the approach to patent construction endorsed in Whirlpool, supra, relates to the somewhat different question, "What is the scope of the monopoly claimed by the patent?" Whether or not counsel is correct in this latter submission, we find it difficult to avoid the conclusion that the invention in the '067 patent is for a group of compounds, including ciprofloxacin, made by the malonic ester synthesis process, whereas the invention in the Chilean patent is for a somewhat larger group of compounds, including ciprofloxacin, made by processes that do not include the malonic ester synthesis process. There is no evidence before us on whether the malonic ester synthesis process has significant technical or commercial advantages over the processes claimed and disclosed in the Chilean patent. And, in the absence of an allegation by counsel for Apotex that the malonic ester synthesis process was "obvious", there is no analogy between this case and what Binnie J. in Whirlpool, supra, at paragraph 67, referring to Commissioner of Patents v. Farbwerke Hoechst Aktiengelleschaft Vormals Meister Luvius & Bruning, [1964] S.C.R. 49, called the second branch of the prohibition against double patenting. Counsel relied on F. Hoffmann-La Roche & Co. Ltd. v. Commissioner of Patents, [1955] S.C.R. 414 for the proposition that the differences in the processes for making ciprofloxacin claimed in the two patents were not legally relevant. In that case it was held that, when an applicant for a patent invented a new process for the production of a chemical that had been invented previously, a patent could be obtained only for the process, and not for the product as produced by that process. In our view, however, that case is readily distinguishable from the case at bar. In particular, the issue in Hoffmann-La Roche, supra, was whether the patent application satisfied the requirement in paragraph 28(1)(b) of the Patent Act that a patent may only be obtained for an invention to the extent that it contains an element of novelty. This is not the question before us. What we must decide is whether the inventions that are the subject of the Chilean and Canadian patents are the same invention. And, as counsel for Bayer points out in his memorandum, Apotex did not allege in any of its notices of allegations that the product by process patent obtained in Canada for ciprofloxacin was invalid because ciprofloxacin had already been invented, and that the use of the malonic ester synthesis process to produce an intermediate could not therefore render the invention novel. For these reasons, we have concluded that there is no warrant for interfering with Gibson J.'s conclusion that, looking at the whole of the specification, the invention in Canadian patent '067 was not the same as that in the Chilean patent. Having failed on this point, Apotex cannot succeed in its appeal. Therefore, without analysing Apotex' other submissions, we would dismiss the appeal with one set of costs. "John M. Evans" J.A. FEDERAL COURT OF CANADA Names of Counsel and Solicitors of Record DOCKET: A-715-98 A-716-98 STYLE OF CAUSE: APOTEX INC. Appellant (Respondent) - and - BAYER AG AND BAYER INC. Respondents (Applicants) -and- THE MINISTER OF NATIONAL HEALTH AND WELFARE Respondent (Respondent) DATE OF HEARING: WEDNESDAY, SEPTEMBER 12, 2001 PLACE OF HEARING: TORONTO, ONTARIO REASONS FOR JUDGMENT OF THE COURT BY: EVANS J.A. DATED: THURSDAY, SEPTEMBER 13, 2001 DELIVERED FROM THE BENCH AT TORONTO, ONTARIO ON WEDNESDAY, SEPTEMBER 12, 2001. APPEARANCES BY: Mr. H. B. Radomski, and Mr. A. Brodkin For the Appellant Mr. R. S. Jolliffe, and Mr. N. R. Belmore, and Mr. J. Buchan For the Respondents, Bayer AG and Bayer Inc. SOLICITORS OF RECORD: Goodman Phillips & Vineberg Barristers & Solicitors Suite 2400, Box 24 250 Yonge Street Toronto, Ontario M5B 2M6 For the Appellant Gowling, Strathy & Henderson Barristers & Solicitors Suite 4900 Commerce Court West Toronto, Ontario M5J 1J3 For the Respondents, Bayer AG and Bayer Inc. FEDERAL COURT OF APPEAL Date: 20010913 Docket: A-715-98 A-716-98 BETWEEN: APOTEX INC. Appellant (Respondent) - and - BAYER AG AND BAYER INC. Respondents (Applicants) -and- THE MINISTER OF NATIONAL HEALTH AND WELFARE Respondent (Respondent) REASONS FOR JUDGMENT OF THE COURT