Merck & Co. et al. v. Canada (Minister of Health) et al., 2010 FC 1042

• Judge: O'Reilly, J.
• Court: Federal Court (Canada)
• Case Date: October 22, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FC 1042;(2010), 375 F.T.R. 121 (FC)

Merck & Co. v. Can. (2010), 375 F.T.R. 121 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. OC.018

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

(T-1544-08; 2010 FC 1042)

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

Federal Court

O'Reilly, J.

October 22, 2010.

Summary:

The applicant (Merck) sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex based on Merck's '211 and '965 patents. The NOC would permit Apotex to market a drug which combined two active ingredients, dorzolamide and timolol, used in the treatment of glaucoma. Merck currently marketed a product containing those agents under the name "Cosopt".

The Federal Court, in a companion case reported at (2010), 375 F.T.R. 135; 2010 FC 1043, found that Merck had not established that Apotex's allegation of invalidity with respect to the '211 patent was unjustified, and therefore denied Merck's request for an order prohibiting the Minister from issuing Apotex an NOC based on that patent.

The Federal Court denied Merck's request for an order of prohibition based on the '965 patent. The court found that part of the '965 patent was anticipated and that the remainder was obvious. Apotex's allegation of misrepresentation was unjustified.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - The applicant (Merck) sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex based on Merck's '965 patent - Apotex suggested that the putative invention in the '965 patent was anticipated in three earlier publications - In the alternative, Apotex argued that what Merck maintained was the real invention of the '965 patent, the co-formulation of dorzolamide and timolol, was obvious - Finally, Apotex submitted that Merck acquired the '965 patent by virtue of a material misrepresentation to the patent office and, therefore, that the patent is invalid - The Federal Court denied Merck's request for an order of prohibition - Part of the '965 patent was anticipated and the remainder was obvious.

Patents of Invention - Topic 1507

Grounds of invalidity - General - Untrue material allegations in petition, specification or drawings - Merck sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex based on Merck's '965 patent - Apotex submitted that Merck acquired the '965 patent by virtue of a material misrepresentation to the patent office and therefore the patent was invalid; specifically, that Merck caused the patent examiner to believe that the principal named inventor of the '965 patent discovered the co-formulation of dorzolamide and timolol, when Merck knew that it was Nardin who had made the discovery - The Federal Court stated that Apotex's argument "would have had considerable force" had it not already concluded that the co-formulation was not anticipated by Nardin - Given the court's construction of the patent, the allegation of invalidity based on s. 53 of the Patent Act was not justified - Merck's communication with the patent examiner was not untruthful in respect of a material issue - Further, the court had no basis on which to conclude that it was made wilfully for the purpose of misleading the examiner - See paragraphs 53 to 57.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Merck sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex based on Merck's '965 patent - The NOC would permit Apotex to market a drug which combined two active ingredients, dorzolamide and timolol, used in the treatment of glaucoma - Merck currently marketed a product containing those agents - Apotex argued that what Merck maintained was the real invention of the '965 patent, namely the co-formulation of dorzolamide and timolol, was obvious - Merck argued that a co-formulation was not a predictable or obvious product of the prior art, and also pointed out that the prior art references were all disclosed to the patent examiner, yet the patent issued - With respect to the conclusion in a U.K. case that a co-formulation was obvious, Merck said that the "obvious to consider" test applied in that case had been rejected in Canada - The Federal Court held that Merck's submissions did not prove that the allegation of obviousness was unjustified - It was more or less self-evident that a co-formulation would work as well as co-administration - No evidence of difficult or prolonged experimentation to achieve a co-formulation was tendered and no evidence about the course of conduct leading to a co-formulation was provided - The prior art and the general common knowledge in the field would have motivated a skilled person to attempt to co-formulate dorzolamide and timolol - Nor was the court satisfied that the patent examiner was directed to the most significant piece of prior art - See paragraphs 35 to 52.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - [See Patents of Invention - Topic 1589 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - Merck sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex based on Merck's '965 patent - The NOC would permit Apotex to market a drug which combined two active ingredients, dorzolamide and timolol, used in the treatment of glaucoma - Merck currently marketed a product containing those agents - Apotex alleged that the '965 patent was anticipated by an abstract published in the journal "International Ophthalmology" - Merck submitted that the publication did not anticipate the '965 patent because it said nothing about co-formulation and it did not explicitly identify dorzolamide - Expert evidence submitted by the parties confirmed that the abstract did not disclose a co-formulation of dorzolamide and timolol - Further, no particulars were given as to the concentration of the two medicaments, the dosing schedule, or the degree to which intra-ocular pressure was reduced - The Federal Court held that the abstract did not meet the test for disclosure - It did not contain enough information to lead a skilled person to the subject matter of the '965 patent - See paragraphs 25 to 27.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - Merck sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex based on Merck's '965 patent - The NOC would permit Apotex to market a drug which combined two active ingredients, dorzolamide and timolol, used in the treatment of glaucoma - Merck currently marketed a product containing those agents - Apotex alleged that the '965 patent was anticipated by a European patent (the '879 patent) - Merck argued that the '879 patent contained no information about dosing, concentrations, or the effect of combining the two active ingredients, and submitted that the '879 patent did not teach a co-formulation - The Federal Court stated that, although the possibility of co-formulation was alluded to in the '879 patent in the phrase "the two active agents are present in approximately equal amounts", there was too little information in the '879 patent to lead a skilled person to the subject matter of the '965 patent - Therefore, the disclosure requirement was not met - See paragraphs 28 and 29.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - Merck sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex based on Merck's '965 patent - The NOC would permit Apotex to market a drug which combined two active ingredients, dorzolamide and timolol, used in the treatment of glaucoma - Merck currently marketed a product containing those agents - MK-507 was Merck's internal designation for dorzolamide - Apotex alleged that the '965 patent was anticipated by an abstract authored by Nardin and others - Three of Nardin's co-authors were Merck employees - Nardin did not identify MK-507 - Merck maintained that the abstract did not identify dorzolamide and did not involve a co-formulation of dorzolamide and timolol - The Federal Court agreed - However, the use claims of the '965 were clearly anticipated by Nardin - Nardin disclosed the concentrations of the two ingredients and data on the additive effect of the two agents in reducing intra-ocular pressure - Merck provided no evidence that a skilled person would have been unable to determine the identity of MK-507, which was published well before the relevant date - It was not a secret - See paragraphs 30 to 34.

Cases Noticed:

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 18].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 24].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 337 F.T.R. 17; 71 C.P.R.(4th) 237; 2008 FC 1359, refd to. [para. 24].

Teva UK Ltd. v. Merck & Co., [2009] EWHC 2952; [2009] All E.R.(D.) 136 (Pat.), refd to. [para. 33].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 41].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161; 2005 FC 1283, affd. (2006), 349 N.R. 183; 265 D.L.R.(4th) 308; 46 C.P.R.(4th) 401; 2006 FCA 64, refd to. [para. 51].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 67 C.P.R.(4th) 94; 2008 FC 538, refd to. [para. 52].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 53 [Annex "A"].

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.