Merck & Co. et al. v. Canada (Minister of Health) et al., 2010 FC 1043

• Judge: O'Reilly, J.
• Court: Federal Court (Canada)
• Case Date: October 22, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FC 1043;(2010), 375 F.T.R. 135 (FC)

Merck & Co. v. Can. (2010), 375 F.T.R. 135 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. OC.019

Merck & Co. Inc. and Merck Frosst Canada Ltd. (applicants) v. The Minister of Health and Apotex Inc. (respondents)

(T-1545-08; 2010 FC 1043)

Indexed As: Merck & Co. et al. v. Canada (Minister of Health) et al.

Federal Court

O'Reilly, J.

October 22, 2010.

Summary:

The applicants (Merck) sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex Inc. The NOC would allow Apotex to market a generic version of the drug dorzolamide, used in the treatment of glaucoma. Merck currently had a monopoly on sales of dorzolamide in Canada by virtue of its '211 patent. Apotex alleged that the '211 patent was invalid for double-patenting, because before Merck obtained the '211 patent, it already had a patent for a family of compounds that included dorzolamide, namely the '262 patent. Merck maintained that it had voluntarily relinquished its rights under the '262 patent by having dedicated it to the public in 2007. The parties agreed that if the '211 patent was valid, Apotex's generic version of dorzolamide would infringe it.

The Federal Court dismissed Merck's application. The court found that Merck had not met its burden of proof. In particular, the court found that Merck's dedication of the '262 patent did not defeat Apotex's allegation of double-patenting.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Apotex served Merck with its first notice of allegation (NOA) regarding Merck's '211 patent in 2007 - In 2008, Apotex withdrew that NOA and served a second one that specifically alleged that the '211 patent contained the same invention as Merck's '262 patent and, therefore, was invalid for double-patenting - Between the service of those two NOAs, Merck dedicated the '262 patent to the public - The issue was whether the allegations set out in Apotex's NOA should be evaluated on the date the NOA was filed, or the date of the hearing - The Federal Court stated that there was support in the court's jurisprudence both for the former approach and for the latter - However, the Federal Court of Appeal made it clear that the correct approach was to determine whether the allegations contained in the NOA were justified as of the date of the hearing - This meant that the court had to consider the effect of any dedication that was made prior to the hearing - Accordingly, the court took account of Merck's dedication of the '262 patent in determining whether Apotex's allegation of double-patenting was justified - See paragraph 15.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - [See Patents of Invention - Topic 1674 ].

Patents of Invention - Topic 1508

Grounds of invalidity - General - Re divisional applications - [See Patents of Invention - Topic 1674 ].

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - Merck sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex - The NOC would allow Apotex to market a generic version of the drug dorzolamide - Merck currently had a monopoly on sales of dorzolamide in Canada by virtue of its '211 patent, which was a divisional patent - Apotex alleged that the '211 patent was invalid for double-patenting, because before Merck obtained the patent, it already had a patent for a family of compounds that included dorzolamide, namely the '262 patent - Merck maintained that it had voluntarily relinquished its rights under the '262 patent by having dedicated it to the public - The Federal Court found that Apotex's allegation of invalidity was justified - Merck had not discharged its burden of proof to establish the contrary - Therefore, its application for a prohibition order was dismissed - "Where a patentee obtains a divisional patent that does not conform to the Patent Act, the remedy is provided by the prohibition against double-patenting ... Merck's dedication of the '262 patent should not immunize the '211 patent from an allegation of double-patenting" - As to Merck's argument that the '211 patent issued in accordance with the practices of the Patent Office at the time and that the '211 patent's life-span did not exceed the 17-year statutory time-frame, the court stated that practices adopted by the Patent Office could not expand a patentee's rights under the Patent Act - Further, while the '211 patent itself would provide a monopoly to Merck for no more than 17 years, overall, if the court were to give the dedication of the '262 patent the effect Merck desired, its monopoly on sales of dorzolamide would exceed 17 years - See paragraphs 33 to 37.

Patents of Invention - Topic 1748

Grounds of invalidity - Public dedication of patent - Effect of - A patentee purported to defeat a double-patenting allegation against a second patent by dedicating the first - The Federal Court considered the legal effect of dedications - "The Patent Act contains two mechanisms for correcting faulty patents - reissue (s. 47) and disclaimer (s. 48). These devices permit patentees to rectify inadvertent errors. Unlike reissues and disclaimers, dedications are a creature of common law. Case law recognizes that a patentee can publicly declare, through a dedication of the patent's claims, that it will not enforce its monopoly. The Federal Court of Appeal has stated that 'the dedication of a patent to public use is analogous to a gift, in the sense that it is a unilateral act that results in a patent holder voluntarily depriving itself of patent rights' ... Obviously, being a creature of common law, dedications are not circumscribed by statutory requirements or conditions. At the same time, the Court must ensure that the use of a dedication would not be inconsistent with the Patent Act" - See paragraphs 16 to 19.

Patents of Invention - Topic 1748

Grounds of invalidity - Public dedication of patent - Effect of - A patentee purported to defeat a double-patenting allegation against a second patent by dedicating the first - The Federal Court derived the following from the case law: a dedication was an effective means by which a patentee could relinquish its patent rights; dedication of some claims did not affect the patentee's rights under other undedicated claims; and in circumstances where there was no suggestion that the patentee had extended its monopoly, dedication of claims under one patent might protect another patent with overlapping claims from an allegation of double-patenting - The court noted that those propositions did not dictate what should happen in circumstances like those of the case at bar, where the patentee would secure an advantage through a dedication - See paragraphs 30 and 31.

Patents of Invention - Topic 1748

Grounds of invalidity - Public dedication of patent - Effect of - Merck sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex - The NOC would allow Apotex to market a generic version of the drug dorzolamide - Merck currently had a monopoly on sales of dorzolamide in Canada by virtue of its '211 patent, which was a divisional patent - Apotex alleged that the '211 patent was invalid for double-patenting, because before Merck obtained the patent, it already had a patent for a family of compounds that included dorzolamide, namely the '262 patent - Merck submitted that its dedication of the '262 patent was a complete answer to the allegation - If the dedication were to have the effect Merck desired, Merck would achieve a monopoly over its invention 28 days beyond the statutory 17-year period - The Federal Court stated that the court should not permit a dedication to have the effect that Merck suggested - While an extra monopoly of 28 days "is not a lengthy extension, neither is it de minimus" - If Merck made a good faith mistake when it acquired the '211 patent as a divisional, it had available to it the statutory remedies of reissuance or disclaimer - It was unnecessary for the court to conclude that the '211 patent was void from the beginning given its overlapping claims with the '262 patent, as the court had to evaluate Apotex's NOA as of the date of the hearing, not some prior date - See paragraphs 31 and 32.

Patents of Invention - Topic 1748

Grounds of invalidity - Public dedication of patent - Effect of - [See Patents of Invention - Topic 1674 ].

Cases Noticed:

Bristol-Myers Squibb Canada Co. et al. v. Apotex Inc. et al. (2009), 342 F.T.R. 161; 74 C.P.R.(4th) 85; 2009 FC 137, refd to. [para. 15].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2009), 347 F.T.R. 159; 2009 FC 648, refd to. [para. 15].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2010), 404 N.R. 356; 85 C.P.R. (4th) 279; 2010 FCA 168, refd to. [para. 15].

Sandoz Canada Inc. v. Abbott Laboratories et al. - see Abbott Laboratories et al. v. Canada (Minister of Health) et al.

Warner-Lambert Canada Inc. et al. v. Canada (Minister of Health) et al., [2003] 2 F.C. 514; 296 N.R. 279; 22 C.P.R.(4th) 417; 2002 FCA 454, refd to. [para. 18].

Parke-Davis Division v. Canada (Minister of Health) - see Warner-Lambert Canada Inc. et al. v. Canada (Minister of Health) et al.

Searle (G.D.) & Co. et al. v. Merck & Co. et al. (2002), 219 F.T.R. 64; 20 C.P.R.(4th) 103; 2002 FCT 540, refd to. [para. 22].

Merck & Co. et al. v. Apotex Inc., [2007] 3 F.C.R. 588; 354 N.R. 51; 55 C.P.R.(4th) 1; 2006 FCA 323, refd to. [para. 34].

Bayer Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1998), 154 F.T.R. 192; 82 C.P.R.(3d) 359 (T.D.), affd. (2000), 258 N.R. 238; 6 C.P.R.(4th) 285 (F.C.A.), refd to. [para. 36].

Counsel:

Brian Daley, Judith Robinson and Kativa Ramamoorthy, for the applicants;

Andrew Brodkin and Richard Naiberg, for the respondents.

Solicitors of Record:

Ogilvy Renault, LLP, Montreal, Quebec, for the applicants;

Goodmans, LLP, Toronto, Ontario, for the respondents.

This application was heard in Montreal, Quebec, on December 14-17, 2009, before O'Reilly, J., of the Federal Court, who delivered the following reasons for judgment and judgment, at Ottawa, Ontario, dated October 22, 2010.