Eli Lilly Canada Inc. v. Apotex Inc

Eli Lilly Canada Inc. v. Apotex Inc

Claims construed purposively show the 377 Patent claims tadalafil as a PDE V inhibitor but do not claim treatment of erectile dysfunction; the 784 Patent claims that novel therapeutic use (oral treatment of ED) and is therefore not coterminous with the 377 Patent; assessment of obviousness-type double patenting does not justify invalidation because the prior art available at relevant date(s) did not make the 784 claims obvious; the patent specification together with the common general knowledge enabled a skilled person to produce solvates/hydrates so the 784 Patent is not insufficient; the 1997 Amendment and supporting evidence establish assignment to ICOS and a proper chain of title so...

Citation
2015 FC 875
Parties
Applicant; Respondent Patentee: Eli Lilly Canada Inc.; Respondent: Apotex Inc.; Respondent: Minister of Health; Respondent Patentee (licensor): ICOS Corporation
Court
Federal Court
Jurisdiction
Canada
Judgment Date
20 July 2015
Procedural Posture
Patented Medicines (notice of Compliance) Regulations Prohibition Application Under S.6 (pmnoc) / Final Judgment on Merits (hearing and Reasons Issued)
Outcome
Application allowed
Legal Topics
Double Patenting, Insufficiency (sufficiency of Disclosure), Standing/chain of Title, PMNOC Regulations Compliance, Claim Construction, Judicial Comity
Source Language
English
Patent Law Pharmaceutical Regulatory Law Intellectual Property Administrative Law Double Patenting Insufficiency (sufficiency of Disclosure) Standing/chain of Title PMNOC Regulations Compliance +2 more

Case Brief

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Parties

Eli Lilly Canada Inc.

Applicant; Respondent Patentee

Apotex Inc.

Respondent

Minister of Health

Respondent

ICOS Corporation

Respondent Patentee (licensor)

Procedural Posture

Patented Medicines (notice of Compliance) Regulations Prohibition Application Under S.6 (pmnoc) / Final Judgment on Merits (hearing and Reasons Issued)

Legal Issues

  1. 1 Is Canadian Patent No. 2,226,784 invalid for double patenting over Canadian Patent No. 2,181,377?
  2. 2 Is the 784 Patent invalid for insufficiency for failure to teach how to make hydrates (solvates)?
  3. 3 Does Eli Lilly have standing under the PMNOC Regulations given alleged defects in the chain of title and non-compliance with s.6(4) and para 4(4)(d)?

Ratio Decidendi

Claims construed purposively show the 377 Patent claims tadalafil as a PDE V inhibitor but do not claim treatment of erectile dysfunction; the 784 Patent claims that novel therapeutic use (oral treatment of ED) and is therefore not coterminous with the 377 Patent; assessment of obviousness-type double patenting does not justify invalidation because the prior art available at relevant date(s) did not make the 784 claims obvious; the patent specification together with the common general knowledge enabled a skilled person to produce solvates/hydrates so the 784 Patent is not insufficient; the 1997 Amendment and supporting evidence establish assignment to ICOS and a proper chain of title so...

Court Disposition

Application allowed

Orders

  • Application allowed
  • Minister of Health is prohibited from issuing a Notice of Compliance to Apotex Inc. for APO-Tadalafil until the expiry of Canadian Patent No. 2,226,784 (expiry July 11, 2016)