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Merck Frosst Canada Inc. v. Canada ( Minister of Health and Welfare )

T-304-96 / T-306-96 / T-386-96

MacKay J.

7/2/97

11 pp.

Patents-Applications for order adding Novopharm and Apotex, generic drug manufacturers, as parties respondent to, or granting leave to intervene in, three applications for judicial review-Applications brought in relation to patent lists for drug simvastatin, ivermectin, acyclovir and interferon alpha-n1-Issue in each application for judicial review whether Minister has power to remove process patents from patent lists submitted by patentees under Regulations in view of decision in Deprenyl Research v. Apotex Inc. (1995), 60 C.P.R. (3d) 501 (F.C.A.)-Court of Appeal therein upheld Trial Division decision ((1994), 55 C.P.R. (3d) 171) Regulations, s. 2, in defining "claim for the medicine itself", words used in s. 4 to describe patents to be included on patent list, not including claim for particular process used in production of medicine-Following decision, Minister of National Health and Welfare caused audit to be made of patent lists filed under Regulations-Following audit, some, but not all, process patents removed from lists before proceedings commenced by applications for judicial review, and for interim injunctions-Key factors considered in dealing with applications by Apotex and Novopharm to participate in proceedings: interests of two generic companies possibly affected by outcome of applications for judicial review, divergence from, or similarity between interests as generic companies and those of Minister, and whether would be prejudice to applicants if applications to participate granted-Application of RR. 1602, 1611 and 1716(2)-Principles applicable to R. 1716(2) cases applied in adding party respondent to judicial review since 1992 and introduction of procedure for judicial review in Federal Court Rules, RR. 1600 et seq.-Applicants herein do not have particular interest such as that recognized by McGillis J. in Apotex Inc. v. Canada (Attorney General) (1993), 48 C.P.R. (3d) 54 (F.C.T.D.)-Acyclovir excepted, neither Apotex nor Novopharm has made application for NOC for any drug products concerned in proceedings-Cannot be considered as parties who "ought to have been joined" or whose presence before Court necessary to ensure all matters will be determined within meaning of R. 1716(2)-Issue narrower than in Apotex case referred to supra, and no affidavit making allegations warranting full opportunity for proposed respondents to address-Nevertheless, Apotex and Novopharm have legal interests, transcending mere commercial interests, which will be affected by decision of Minister raised by proceedings for judicial review: rights to make application for NOC and to have it considered on merits without application of processes established by Regulations, unless patent claims, listed under Regulations by patent holders, within those described by regulations to be protected-Although interests of proposed intervenors no different in essence from interests of other generic drug marketers, others have not made application to participate in proceedings-Moreover, companies active in numerous proceedings in Court under Regulations-In addition, interests of proposed participants different from those of Minister and Attorney General, and they can bring to hearing evidence of effects upon their interests of one or another interpretation of Regulations in way respondent Minister cannot-No prejudice to position of applicants for judicial review, or that of Minister, if Apotex and Novopharm permitted to intervene in hearing of applications-Novopharm and Apotex admitted as intervenors-Federal Court Rules, C.R.C., c. 663, RR. 1602 (as enacted by SOR/92-43, s. 19), 1611 (as enacted idem), 1716(2).

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