Federal Court declares invalid a patent for a medical device measuring osmolarity of tear film

By Brandon R. Heard

On February 12, 2018, Justice Manson of the Federal Court found certain claims of Canadian Patent No. 2,494,540 (“540 patent”) invalid on the basis of obviousness and anticipation: Regents of the University of California v I-MED Pharma Inc, 2018 FC 164. The 540 patent relates to a chip for measuring the osmolarity of a sample of bodily fluid, including tear film. The plaintiff Tearlab Corporation and the defendant I-Med Pharma market competing medical devices for measuring tear film osmolarity. The Court agreed with the claim construction urged by the plaintiffs, finding that the claims encompassed both in vivo and ex vivo applications of the invention. As a result, I-Med Pharma’s medical device—which measured osmolarity in vivo—fell within the scope of the claims. However, as a result of this construction, the Court also found that the claims were anticipated by prior art that disclosed in vivo devices for measuring osmolarity, including of tear film. Further, the Court found that it was obvious to combine prior art to “create a device that can be used both in vivo and ex vivo, and includes a separate or onboard processing unit, to measure osmolarity of tear fluid”. The Court dismissed the attacks of inutility and insufficiency. The plaintiffs have appealed.

Federal Court grants motion to strike plaintiff’s quia timet pleading in oxycodone infringement action

By Abigail Smith

On February 21, 2018, Justice O’Reilly granted Collegium’s motion to strike Purdue’s statement of claim for infringement of a patent relating to oxycodone salt (Purdue’s OXYNEO): Purdue Pharma v Collegium Pharmaceutical, 2018 FC 199. The Court overturned the Prothonotary’s dismissal of the motion, finding that the facts did not allege anything beyond the regulatory use exemption and that the imminence branch for the test for a quia timet action was not met: Purdue’s allegations merely suggested that Collegium was attempting to meet Canadian regulatory requirements, and did not contemplate when Collegium might obtain a Notice of Compliance (NOC). Purdue’s action was brought in parallel with an application under the pre-amended (PMNOC) Regulations. The amended PMNOC Regulations (previously reported) will now effectively allow for quia timet actions by permitting a patent owner who receives a notice of allegation (NOA) to bring an action for infringement of patents not covered by the NOA, but which could be infringed by the generic drug.

Costco pharmacy directors fined for professional misconduct for acceptance of over $1.2M in rebates

By Abigail Smith

On March 14, 2018, the Discipline Committee of the Ontario College of Pharmacists found that two directors of Costco pharmacies committed acts of professional misconduct by soliciting $1,266,000 in payments related to advertising which would reasonably be regarded as rebates for purchase of interchangeable drug products, contrary to provisions of the Drug Interchangeability and Dispensing Fee Act and the Ontario Drug Benefit Act. The pharmacists were each fined $20,000.

New Court Proceedings

For complete details about these pharmaceutical proceedings, click here.

PM(NOC) Proceedings

mesalamine (ASACOL 800): Allergan v Tillotts

Other Proceedings

trastuzumab (HERCEPTIN, TRAZIMERA); pertuzumab (PERJETA): Hoffmann-La Roche and Genentech v Pfizer

gatifloxacin (ZYMAR, Apo-Gatifloxacin): Apotex v Allergan

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