Meda AB v. Canada (Health)

Meda AB v. Canada (Health)

The NOA and experts provided sufficient notice of the factual bases in Schedule B such that the affidavits need not be struck; the '725 Patent does not disclose or enable the claimed combination (in particular sublingual administration with bio/mucoadhesive function as claimed) so anticipation fails; the claimed combination was not shown to be obvious to a POSITA without hindsight; utility was demonstrated or soundly predicted; however claim 1 omits essential limitations (positioning of bio/mucoadhesive on carrier particle surfaces and being essentially water-free) and is therefore overbroad; Pharmascience's product does not practice the ordered-mixture/bioadhesive features and thus does...

Citation
2016 FC 1362
Parties
Applicants: Meda AB; Meda Pharmaceuticals Ltd.; Valeant Canada LP/ Valeant Canada S.E.C.; Respondent (proposed NOC Recipient): Pharmascience Inc.; Respondent (regulator): The Minister of Health; Respondent/patentee: Orexo AB
Court
Federal Court
Jurisdiction
Canada
Judgment Date
9 December 2016
Procedural Posture
Pm(noc) Prohibition Application Under the Patented Medicines (notice of Compliance) Regulations / Federal Court Final Judgment Dismissing Application (2016 12 09)
Outcome
Application dismissed in its entirety except that claim 1 found overbroad
Legal Topics
Patent Validity, Infringement, Anticipation, Obviousness, Utility, Overbreadth, Evidence Admissibility, NOA Sufficiency, Gillette Defence
Source Language
English
Patent Law Regulatory/administrative Law Pharmaceutical Law Civil Procedure Patent Validity Infringement Anticipation Obviousness +5 more

Case Brief

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Parties

Meda AB; Meda Pharmaceuticals Ltd.; Valeant Canada LP/ Valeant Canada S.E.C.

Applicants

Pharmascience Inc.

Respondent (proposed NOC Recipient)

The Minister of Health

Respondent (regulator)

Orexo AB

Respondent/patentee

Procedural Posture

Pm(noc) Prohibition Application Under the Patented Medicines (notice of Compliance) Regulations / Federal Court Final Judgment Dismissing Application (2016 12 09)

Legal Issues

  1. 1 Should affidavits of Pharmascience experts be struck for obstructed cross-examination?
  2. 2 Did Pharmascience rely on evidence beyond the NOA (ambush evidence)?
  3. 3 Is the '988 Patent anticipated by the '725 Patent?

Ratio Decidendi

The NOA and experts provided sufficient notice of the factual bases in Schedule B such that the affidavits need not be struck; the '725 Patent does not disclose or enable the claimed combination (in particular sublingual administration with bio/mucoadhesive function as claimed) so anticipation fails; the claimed combination was not shown to be obvious to a POSITA without hindsight; utility was demonstrated or soundly predicted; however claim 1 omits essential limitations (positioning of bio/mucoadhesive on carrier particle surfaces and being essentially water-free) and is therefore overbroad; Pharmascience's product does not practice the ordered-mixture/bioadhesive features and thus does...

Court Disposition

Application dismissed in its entirety except that claim 1 found overbroad

Orders

  • Application in respect of Canadian Patent No. 2,629,988 dismissed
  • Affidavits of Drs. Fassihi and Davé not struck