Healthcare & Life Sciences updates

Canada

Contributed by Smart & Biggar/Fetherstonhaugh
Amendments to Patented Medicines Regulations expected to come into force no earlier than Spring 2020
  • Canada
  • 22 May 2019

Health Canada recently released its Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief document provides a high-level overview of the anticipated amendments released in draft form on 2 December 2017, the expected impact of these amendments and the consultation process.

On the (Quebec health) record: Quebec government liable for patent infringement
  • Canada
  • 22 May 2019

In a digital-age David versus Goliath case, the Federal Court recently held that the Quebec government had infringed two patents owned by Dr Luc Bessette relating to a shared medical records system that he had invented 20 years ago. This is the first time that the Quebec government has been held liable for patent infringement and the decision provides important guidance to institutions, enterprises and inventors alike.


USA

Contributed by Sidley Austin LLP
Rule 9(b)'s particularity requirement and constitutionality of False Claims Act qui tam provisions
  • USA
  • 22 May 2019

In a recent decision, the Tenth Circuit reversed a district court's dismissal of qui tam claims, reasoning that the relator's allegations had satisfied Rule 9(b) of the Federal Rules of Civil Procedure. Among other things, the defendant contended that the court's intervention is necessary to resolve a deep circuit split on whether Rule 9(b)'s particularity requirement can be relaxed where a defendant exclusively holds the information necessary to state a claim.


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