Janssen Inc. et al. v. Mylan Pharmaceuticals ULC et al., (2010) 376 F.T.R. 311 (FC)
Judge | Barnes, J. |
Court | Federal Court (Canada) |
Case Date | November 10, 2010 |
Jurisdiction | Canada (Federal) |
Citations | (2010), 376 F.T.R. 311 (FC);2010 FC 1123 |
Janssen Inc. v. Mylan Pharmaceuticals (2010), 376 F.T.R. 311 (FC)
MLB headnote and full text
Temp. Cite: [2010] F.T.R. TBEd. NO.009
Janssen Inc. and Janssen Pharmaceutica N.V. (applicants) v. Mylan Pharmaceuticals ULC and The Minister of Health (respondents)
(T-175-09; 2010 FC 1123)
Indexed As: Janssen Inc. et al. v. Mylan Pharmaceuticals ULC et al.
Federal Court
Barnes, J.
November 10, 2010.
Summary:
The applicants applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to the respondent until the expiry of their patent ('950 patent) in respect of the applicants' galantamine product, Reminyl, used to treat Alzheimer's disease. The inventive concept of the '950 patent was limited to the applicants' claimed discovery that the slow titration of galantamine improved patient tolerability for the drug, by reducing side-effects, and resulted in the ability to use a lower maintenance dose than had previously been shown effective.
The Federal Court dismissed the application.
Patents of Invention - Topic 1532
Grounds of invalidity - Want of subject matter - Method of medical treatment - The applicants applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to the respondent until the expiry of their patent ('950 patent) in respect of the applicants' galantamine product, Reminyl, used to treat Alzheimer's disease - The inventive concept of the '950 patent was limited to the applicants' claimed discovery that the slow titration of galantamine improved patient tolerability for the drug, by reducing side-effects, and resulted in the ability to use a lower maintenance dose than had previously been shown effective - The Federal Court dismissed the application - The patent was invalid - The '950 patent's relevant claims covered a method of medical treatment and were, on that basis, unpatentable - A patent claim over a method of medical treatment that, by its nature, covered an area for which a physician's skill or judgment was expected to be exercised was not patentable in Canada - This would include the administration of a drug whereby the physician, while relying upon the dosage advice of the patentee, would still be expected to be alert and responsive to a patient's profile and to the patient's reaction to the compound - By attempting to monopolize an effective titration regimen for galantamine, the '950 patent interfered with the ability of physicians to exercise their judgment in the administration of generic versions of the drug - See paragraphs 20 to 52.
Cases Noticed:
Tennessee Eastman Co. et al. v. Commissioner of Patents, [1974] S.C.R. 111; 8 C.P.R.(2d) 202, consd. [para. 21].
Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 21 C.P.R.(4th) 499; 2002 SCC 77, refd to. [para. 22].
Visx Inc. v. Nidek Co. et al. (1999), 181 F.T.R. 22; 3 C.P.R.(4th) 417 (T.D.), affd. (2001), 273 N.R. 268; 16 C.P.R.(4th) 251; 2001 FCA 215, refd to. [para. 23].
Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 85 C.P.R.(4th) 321; 2010 FC 510, refd to. [para. 23].
Axcan Pharma Inc. v. Pharmascience Inc. et al. (2006), 291 F.T.R. 160; 50 C.P.R.(4th) 321; 2006 FC 527, refd to. [para. 24].
'318 Patent Infringement Litigation, Re (2008), 578 F. Supp.2d 711 (D. Del.), refd to. [para. 44, footnote 3].
Amazon.com Inc. v. Canada (Attorney General) (2010), 376 F.T.R. 288; 2010 FC 1011, refd to. [para. 53].
King Pharmaceuticals Inc. v. Eon Labs Inc., 2010 Fed. Cir. 09-1437 (U.S. Ct. App.), refd to. [para. 54].
Authors and Works Noticed:
Sadavoy, Joel, Psychotropic Drugs and the Elderly: Fast Facts (2004), generally [para. 27].
Counsel:
Jason Markwell and David Badurina, for the applicants;
Tim Gilbert, Nathaniel Lipkus and Matthew Dugas, for the respondent, Mylan Pharmaceuticals ULC.
Solicitors of Record:
Ogilvy Renault, LLP, Toronto, Ontario, for the applicants;
Gilbert's, LLP, Toronto, Ontario, for the respondent, Mylan Pharmaceuticals ULC.
This application was heard on September 7 and 8, 2010, at Toronto, Ontario, by Barnes, J., of the Federal Court, who delivered the following judgment at Ottawa, Ontario, on November 10, 2010.
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