Merck Sharp & Dohme Corp. v. Pharmascience Inc.

Merck Sharp & Dohme Corp. v. Pharmascience Inc.

The Court found the Asserted Claims valid: the PSA (multi-disciplinary team including chemist(s), formulator and clinician) would not have been motivated from WO498 and the prior art to select sitagliptin DHP monohydrate; salt and polymorph screening outcomes were unpredictable and the inventors’ extensive, atypical experimental investment culminating in a serendipitous but reproducible monohydrate established non-obviousness; the patent disclosure (detailed method and methods A–G) enabled the skilled person to make the monohydrate by the filing date and did not require undue experimentation, so the sufficiency challenge failed; accordingly claims 4–7, 19, 20, 22, 24 and 26 are not...

Citation
2022 FC 417
Parties
Plaintiff: Merck Sharp & Dohme Corp.; Plaintiff: Merck Canada Inc.; Defendant: Pharmascience Inc.
Court
Federal Court
Jurisdiction
Canada
Judgment Date
11 April 2022
Procedural Posture
PMNOC Regulations Patent Infringement / Trial — Judgment on Validity
Outcome
Judgment for Plaintiffs. Defendant’s invalidity allegations dismissed; Asserted Claims (4-7, 19, 20, 22, 24, 26) found valid and infringement declared under the parties’ stipulation.
Legal Topics
Obviousness, Insufficiency, Selection Patent, Claim Construction, Inventive Concept, Infringement Declaration
Source Language
English
Patent Law Pharmaceutical Regulation (pmnoc) Intellectual Property Litigation Evidence (hearsay) Obviousness Insufficiency Selection Patent Claim Construction +2 more

Case Brief

Summary, issues, holding and outcome

More case intelligence is available

Unlock the full research layer for this judgment.

Full judgment text Legal principles 5 Authorities cited 14 Party arguments 2 Amounts and remedies 2
Sign in to unlock

Parties

Merck Sharp & Dohme Corp.

Plaintiff

Merck Canada Inc.

Plaintiff

Pharmascience Inc.

Defendant

Procedural Posture

PMNOC Regulations Patent Infringement / Trial — Judgment on Validity

Legal Issues

  1. 1 Was the 400 Patent (Canadian Patent No. 2,529,400) obvious or obvious-to-try as of June 24, 2003?
  2. 2 Does the 400 Patent meet the Patent Act s.27(3) sufficiency requirements?
  3. 3 How should the Asserted Claims be construed and who is the person skilled in the art (PSA)?

Ratio Decidendi

The Court found the Asserted Claims valid: the PSA (multi-disciplinary team including chemist(s), formulator and clinician) would not have been motivated from WO498 and the prior art to select sitagliptin DHP monohydrate; salt and polymorph screening outcomes were unpredictable and the inventors’ extensive, atypical experimental investment culminating in a serendipitous but reproducible monohydrate established non-obviousness; the patent disclosure (detailed method and methods A–G) enabled the skilled person to make the monohydrate by the filing date and did not require undue experimentation, so the sufficiency challenge failed; accordingly claims 4–7, 19, 20, 22, 24 and 26 are not...

Court Disposition

Judgment for Plaintiffs. Defendant’s invalidity allegations dismissed; Asserted Claims (4-7, 19, 20, 22, 24, 26) found valid and infringement declared under the parties’ stipulation.

Orders

  • The Defendant’s allegation that claims 4-7, 19, 20, 22, 24 and 26 of Canadian Patent No. 2,529,400 are invalid for obviousness and/or insufficiency is dismissed and such claims are found valid.
  • Declaration that making, constructing, using or selling by Pharmascience Inc. of sitagliptin phosphate tablets (25 mg, 50 mg, 100 mg) in accordance with ANDS No. 233922 will directly or indirectly infringe at least one of claims 4-7, 19, 20, 22, 24 or 26 of Canadian Patent No. 2,529,400.