Solvay Pharma Inc. et al. v. Apotex Inc. et al., (2008) 323 F.T.R. 1 (FC)

• Judge: Gauthier, J.
• Court: Federal Court (Canada)
• Case Date: December 10, 2007
• Jurisdiction: Canada (Federal)
• Citations: (2008), 323 F.T.R. 1 (FC);2008 FC 308

Solvay Pharma Inc. v. Apotex Inc. (2008), 323 F.T.R. 1 (FC)

MLB headnote and full text

Temp. Cite: [2008] F.T.R. TBEd. MR.023

Solvay Pharma Inc. and Altana Pharma AG (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-427-06; 2008 FC 308)

Indexed As: Solvay Pharma Inc. et al. v. Apotex Inc. et al.

Federal Court

Gauthier, J.

March 6, 2008.

Summary:

Solvay Pharma Inc. (patent owner) and Altana Pharma AG (licensee) (the applicants) applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. for the production and marketing of enteric coated tablets of pantoprazole sodium in 20 mg. and 40 mg. strengths until after the expiration of Canadian Letters Patent 2,092,694 (the '694 Patent) and 2,089,748 (the '748 Patent).

The Federal Court dismissed the application, holding that the applicants failed to establish that Apotex's allegations of non-infringement were not justified.

Food and Drug Control - Topic 1104

Drugs - New drugs - Notice of compliance - General - The Federal Court reviewed the legal principles applicable on an application for a prohibition order under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) - See paragraphs 134 to 156.

Food and Drug Control - Topic 1104.1

Drugs - New drugs - Notice of compliance - Jurisdiction - Solvay Pharma Inc. (patent owner) and Altana Pharma AG (licensee) (the applicants) applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. for the production and marketing of enteric coated tablets of pantoprazole sodium in 20 mg. and 40 mg. strengths until after the expiration of Canadian Letters Patent 2,092,694 (the '694 Patent) and 2,089,748 (the '748 Patent) - In its notice of allegation, Apotex raised an issue respecting eligibility for listing on the patent register and relevance, denying that it was early working the patented inventions - The applicants argued that the court lacked jurisdiction to consider these issues on a prohibition order application (i.e., without the second persons having filed motions under s. 6(5) of the NOC Regulations) - The Federal Court held that it had no jurisdiction to consider eligibility issues (s. 4 of the NOC Regulations) or the early working issues - However, pursuant to s. 5(1)(b)(iv), the court had to consider whether the claims that were still at issue in respect of infringement were claims for the medicine itself or for the use of the medicine, because these were the only relevant claims that needed to be addressed in the notice of allegation and which could justify a prohibition order if Apotex's allegations of non-infringement were not justified - See paragraphs 41 to 68 - In the event that it was wrong on the jurisdiction issue, the court commented on the merits of the eligibility issues - See paragraphs 69 to 133.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Dismissal of application for - Solvay Pharma Inc. (patent owner) and Altana Pharma AG (licensee) (collectively Altana) applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. for the production and marketing of enteric coated tablets of pantoprazole sodium in 20 mg. and 40 mg. strengths until after the expiration of Canadian Letters Patent 2,092,694 (the '694 Patent) and 2,089,748 (the '748 Patent) - The '748 Patent generally related to novel pharmaceutical compositions combining pantoprazole (or one of its salts) as one of the medicinal ingredients, useful for the treatment and prevention of gastrointestinal diseases caused or exacerbated by H. Pylori (Hp) and secreted gastric acid - The applicants claimed that the '694 patent "discloses pantoprazole, has direct activity against Hp and describes the formulation that is best for this direct action", whereas Apotex construed the patent as relating to compositions, including those that were simultaneously resistant and not resistant to gastric juice, for combatting Hp itself and thereby treating diseases of the stomach and intestine caused by Hp - The Federal Court dismissed the application for a prohibition order, holding that the applicants failed to establish that Apotex's allegations of non-infringement were not justified - See paragraphs 1 to 230.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - [See Food and Drug Control - Topic 1104.1 ].

Cases Noticed:

Abbott Laboratories Ltd. et al. v. Canada (Minister of Health) et al. (2006), 304 F.T.R. 104; 55 C.P.R. (4th) 48; 2006 FC 1411, affd. (2007), 367 N.R. 120; 2007 FCA 251,  refd to. [para. 14].

AstraZeneca AB et al. v. Apotex Inc. et al. (2007), 314 F.T.R. 177; 60 C.P.R.(4th) 199; 2007 FC 688, refd to. [para. 14].

AB Hassle et al. v. Genpharm Inc. et al. (2003), 243 F.T.R. 6; 2003 FC 1443, affd. (2003), 329 N.R. 374; 38 C.P.R.(4th) 17 (F.C.A.), refd to. [para. 14].

Whirlpool et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 24].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 24].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 285 F.T.R. 1; 46 C.P.R.(4th) 244; 2005 FC 1725, refd to. [para. 24].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 2008 FC 142, refd to. [para. 24].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 307 F.T.R. 271; 2006 FC 1558, affd. (2007), 370 N.R. 109; 2007 FCA 187, refd to. [para. 42].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2005), 282 F.T.R. 8; 43 C.P.R.(4th) 81 (F.C.), refd to. [para. 42].

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al. (2006), 354 N.R. 88; 2006 SCC 49, refd to. [para. 43].

Ferring Inc. v. Canada (Minister of Health) et al. (2007), 310 F.T.R. 185; 55 C.P.R.(4th) 271; 2007 FC 300, affd. (2007), 370 N.R. 263; 2007 FCA 276, refd to. [para. 46].

Wyeth Canada et al. v. Ratiopharm Inc. et al. (2007), 310 F.T.R. 265 (F.C.), revd. in part (2007), 370 N.R. 89; 2007 FCA 264, refd to. [para. 53].

Apotex Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1999), 252 N.R. 72; 3 C.P.R.(4th) 1 (F.C.A.), refd to. [para. 58].

Biolyse - see Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al.

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55, refd to. [para. 72].

Bayer AG et al. v. Apotex Inc. et al. (1998), 156 F.T.R. 303 (T.D.), refd to. [para. 107, footnote 25].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 46 C.P.R.(4th) 401 (F.C.A.), refd to. [para. 108, footnote 26].

Pfizer Canada Inc. v. Canada (Minister of Health) et al. (2006), 288 F.T.R. 235; 55 C.P.R.(4th) 161 (F.C.), affd. (2006), 354 N.R. 294; 55 C.P.R.(4th) 187 (F.C.A.), refd to. [para. 115].

Abbott Laboratories et al. v. Canada (Attorney General) et al. (2007), 312 F.T.R. 91; 58 C.P.R.(4th) 30 (F.C.), refd to. [para. 115].

Hoffmann-La Roche Ltd. et al. v. Canada (Minister of National Health and Welfare) et al. (1996), 205 N.R. 331; 70 C.P.R.(3d) 206 (F.C.A.), refd to. [para. 134].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1994), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 134].

Pharmascience v. Sanofi-Aventis Pharma Inc. - see Aventis Pharma Inc. et al. v. Pharmascience Inc. et al.

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al. (2006), 352 N.R. 99; 53 C.P.R.(4th) 453 (F.C.A.), refd to. [para. 135].

Sanofi-Aventis Pharma Inc. v. Apotex Inc. - see Aventis Pharma Inc. et al. v. Pharmascience Inc. et al.

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al. (2006), 354 N.R. 383; 55 C.P.R.(4th) 388 (F.C.A.), refd to. [para. 135].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2001), 213 F.T.R. 161; 16 C.P.R.(4th) 21 (T.D.), affd. (2002), 298 N.R. 323; 22 C.P.R.(4th) 1; 2002 FCA 421, refd to. [paras. 136, 137].

Dableh v. Ontario Hydro (1996), 199 N.R. 57; 63 C.P.R.(3d) 129 (F.C.A.), refd to. [para. 136].

Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 283 F.T.R. 1; 45 C.P.R.(4th) 449; 2005 FC 1461, refd to. [para. 137].

Sanofi-Aventis Canada Inc. et al. v. Novopharm Ltd. et al. (2007), 366 N.R. 231; 59 C.P.R.(4th) 24 (F.C.A.), refd to. [para. 137].

AB Hassle et al. v. Apotex Inc. et al. (2003), 249 F.T.R. 1; 34 C.P.R.(4th) 65 (F.C.), refd to. [para. 145, footnote 31].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2002), 291 N.R. 339 (F.C.A.), refd to. [para. 139].

Lundbeck (H.) A/S et al. v. Canada (Minister of Health) et al. (2003), 240 F.T.R. 57; 30 C.P.R.(4th) 97 (F.C.), refd to. [para. 160].

AB Hassle et al. v. Apotex Inc. et al. (2002), 223 F.T.R. 43; 21 C.P.R.(4th) 173 (T.D.), affd. (2003), 312 N.R. 288; 29 C.P.R.(4th) 23 (F.C.A.), refd to. [para. 209].

Eli Lilly & Co. et al. v. Nu-Pharm Inc. et al. (1996), 199 N.R. 185; 69 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 209].

AstraZeneca AB et al. v. Apotex Inc. et al. (2004), 245 F.T.R. 196 (F.C.), affd. (2005), 335 N.R. 1 (F.C.A.), refd to. [para. 219].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330; 42 C.P.R.(4th) 97 (F.C.A.), refd to. [para. 219].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al. (2007), 364 N.R. 325; 2007 FCA 163, refd to. [para. 228].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 5(1) [para. 46]; sect. 6(5) [para. 42].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Authors and Works Noticed:

Dipiro, Joseph T., et al., Pharmacotherapy - A Pathophysiologic Approach (6th Ed. 2005), generally [para. 18, footnote 4]; pp. 710, 711 [para. 91, footnote 21].

Counsel:

Neil Belmore and Lindsday Neidrauer, for the applicants;

H.B. Radomski, Andrew R. Brodkin and Belle Van, for the respondents.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Toronto, Ontario, for the applicants;

Goodmans LLP, Toronto, Ontario, for the respondents.

This application was heard in Toronto, Ontario, on December 10, 2007 (5 days), by Gauthier, J., of the Federal Court, who delivered the following decision on March 6, 2008.