Janssen-Ortho Inc. et al. v. Canada (Minister of Health) et al., (2010) 361 F.T.R. 268 (FC)

• Judge: Zinn, J.
• Court: Federal Court (Canada)
• Case Date: January 18, 2010
• Jurisdiction: Canada (Federal)
• Citations: (2010), 361 F.T.R. 268 (FC);2010 FC 42

Janssen-Ortho Inc. v. Can. (2010), 361 F.T.R. 268 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. JA.056

Janssen-Ortho Inc. and Alza Corporation (applicants) v. The Minister of Health and Novopharm Limited (respondents)

(T-780-08; 2010 FC 42)

Indexed As: Janssen-Ortho Inc. et al. v. Canada (Minister of Health) et al.

Federal Court

Zinn, J.

January 29, 2010.

Summary:

The applicants applied under s. 6 of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Novopharm Ltd. with respect to its methylphenidate product until the expiry of Canada Patent No. 2,264,852 (the '852 patent). Methylphenidate was a drug used to treat Attention Deficit Hyperactivity Disorder. Novopharm asserted that its product did not infringe the '852 patent.

The Federal Court dismissed the application. Novopharm's product did not infringe the '852 patent.

Patents of Invention - Topic 1033

The specification and claims - Construction of a patent - By reference to disclosure - The applicants applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Novopharm Ltd. with respect to its methylphenidate product until the expiry of Canada Patent No. 2,264,852 (the '852 patent) - Methylphenidate was a drug used to treat Attention Deficit Hyperactivity Disorder - Novopharm asserted that its product did not infringe the '852 patent - With respect to patent construction, at issue was whether one should consider the disclosure when construing the patent's claims - The Federal Court held that an interpreter should examine disclosure, but with caution - "Recourse may be had to the disclosure for the purpose of confirming the interpretation arrived at from examining the claims alone or to disclose an ambiguity in the language of the claims that was not otherwise evident. However, the patentee cannot expand the monopoly specifically expressed in the claims by borrowing phrases from the disclosure and placing them into the language of the claims. ... If one considers the disclosure before considering the dependent claims, one runs a risk of forming an opinion as to the proper construction of the independent claims based on the content of the disclosure when that interpretation is not supported by or may, in fact, be contrary to the dependent claims. ... In short, one should not take an unescorted and unchaperoned romp through the disclosure; one must have a guide or compass which one obtains from first examining all of the claims of the patent." - See paragraphs 111 to 135.

Patents of Invention - Topic 2926

Infringement of patent - Acts not constituting an infringement - Of particular patents - The applicants applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Novopharm Ltd. with respect to its methylphenidate product until the expiry of Canada Patent No. 2,264,852 (the '852 patent) - Methylphenidate was a drug used to treat Attention Deficit Hyperactivity Disorder (ADHD) - Novopharm asserted that its product did not infringe the '852 patent - Methylphenidate was known and had been in widespread use since at least the 1950s - Prior to the '852 patent, methylphenidate, marketed as Ritalin, was the standard treatment for ADHD - The first Ritalin dosage form was an immediate release dosage form and as such it would release all of the active drug in the tablet within minutes after being ingested - The amount of methylphenidate in the blood plasma of the patient taking immediate release Ritalin quickly increased after ingestion of the tablet and then decreased as the drug was expelled from the body - The Ritalin would control the ADHD symptoms of the patient for three to five hours with the peak effectiveness being over the first one to two hours - The patient would then have to take another tablet of Ritalin in order to control the symptoms - Most patients took between two and three tablets a day - A graph of the concentration levels of methylphenidate in the patient's blood plasma would show a series of peaks and valleys, with a peak following the ingestion of each tablet - A sustained release Ritalin, Ritalin SR, was developed later as a once-a-day alternative to the multiple dose regime of the immediate release Ritalin formulation - A sustained release formulation was designed to slow the release of the drug such that the release process rather than being immediate took place over several hours - Ritalin SR released methylphenidate over several hours and did so with a descending or decreasing rate of drug release over time; however, it resulted in a relatively constant or flat line level of concentration of methylphenidate in the blood plasma - Ritalin SR was found to be less successful than immediate release Ritalin in treating ADHD - The Federal Court held that with the background of the prior art and looking at the independent claims alone, a person skilled in the art would interpret them to mean that methylphenidate was being released from the composition in a sustained-ascending amount over time - Because Novopharm's product did not release methylphenidate from its dosage form in a sustained-ascending dose over time, it did not infringe the '852 patent - See paragraphs 136 to 159.

Cases Noticed:

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 90].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2005), 281 F.T.R. 74; 2005 FC 1332, affd. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 90].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168; 2000 SCC 66, refd to. [para. 91].

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. 94].

Lister v. Norton Brothers and Co. (1886), 3 R.P.C. 199 (Ch. D.), refd to. [para. 98].

White v. Dunbar (1886), 119 U.S. 47 (Sup. Ct.), refd to. [para. 98].

Dableh v. Ontario Hydro, [1996] 3 F.C. 751; 199 N.R. 57 (F.C.A.), refd to. [para. 113].

Martinray Industries Ltd. et al. v. Fabricants National Dagendor Manufacturing Ltd. et al. (1991), 49 F.T.R. 81; 41 C.P.R.(3d) 1 (T.D.), refd to. [para. 114].

Halford et al. v. Seed Hawk Inc. et al. (2004), 246 F.T.R. 1; 2004 FC 88, refd to. [para. 117].

Metalliflex Ltd. v. Wienenberger Aktiengesellschaft, [1961] S.C.R. 117, refd to. [para. 119].

Merck & Co. et al. v. Apotex Inc. et al. (2004), 253 F.T.R. 178; 2004 FC 567, refd to. [para. 123].

Lunbeck Canada Inc. v. Genpharm ULC - see Lundbeck Canada Inc. v. Canada (Minister of Health) et al.

Lundbeck Canada Inc. v. Canada (Minister of Health) et al. (2009), 343 F.T.R. 53; 2009 FC 146, refd to. [para. 123].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2007), 311 F.T.R. 21; 2007 FC 455, refd to. [para. 123].

Green v. Canada (Treasury Board) (2000), 254 N.R. 48 (F.C.A.), refd to. [para. 125].

Browne v. Dunn (1893), 6 R. 67 (H.L.), refd to. [para. 125].

Catnic Components Ltd. v. Hill & Smith Ltd., [1982] R.P.C. 183 (H.L.), refd to. [Appendix A].

Procter & Gamble Co. v. Beecham Canada Ltd. and Calgon Interamerican Corp. (1982), 40 N.R. 313; 61 C.P.R.(2d) 1 (F.C.A.), refd to. [Appendix A].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 56 C.P.R.(2d) 145, refd to. [Appendix A].

Biovail Corp. v. Canada (Minister of National Health and Welfare) (2006), 348 N.R. 120; 2006 FCA 105, refd to. [Appendix A].

Counsel:

Neil R. Belmore, Lindsay Neidrauer, Greg Beach and Marian Wolanski, for the applicants;

Jonathan Stainsby, Andrew Skodyn and Julian Worsley, for the respondent, Novopharm;

Not represented, for the respondent, Minister of Health.

Solicitors of Record:

Belmore McIntosh Neidrauer, LLP, Toronto, Ontario, for the applicants;

Heenan Blaikie, LLP, Toronto, Ontario, for the respondent, Novopharm;

John H. Sims, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health.

This application was heard at Toronto, Ontario, on November 16-19, 2009, by Zinn, J., of the Federal Court, who delivered confidential reasons for judgment on January 18, 2010, and the following public reasons for judgment on January 29, 2010.