Publication
Government Investigations in Singapore 2025
We have contributed the Singapore chapter of Getting the Deal Through, Government Investigations 2025.
Global | Publication | June 2016
Case: Pfizer Canada Inc v Teva Canada Limited, 2016 FCA 161 (A-422-14)
Drug: EFFEXOR XR® (venlafaxine hydrochloride)
Nature of case: Appeal from action for damages pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations)
Successful party: Pfizer Canada Inc.
Date of decision: 31 May 2016
Pfizer Canada Inc. (Pfizer) markets an extended release formulation of the drug venlafaxine hydrochloride in Canada under the name EFFEXOR XR®. Pfizer (or its predecessors) listed several patents relating to venlafaxine hydrochloride on the Patent Register, including Canadian Patent Nos. 1,248,540 and 2,199,778. Teva Canada Ltd. and its predecessors (Teva) have sold venlafaxine hydrochloride in Canada since 2007 after a prohibition application commenced by Pfizer pursuant to section 6 of the Regulations was dismissed by the Court. Teva was subsequently awarded damages under section 8 of the Regulations (Trial Decision).
Pfizer appealed several aspects of the Trial Decision, including that Justice Zinn erred in: (i) relying on hearsay evidence; and (ii) his construction of the hypothetical world used to calculate Teva’s lost profits (Hypothetical World).
The Federal Court of Appeal (FCA) overturned the Trial Decision on the issue of hearsay evidence, remitting it back to the Federal Court for redetermination.
The hearsay issue arose in the context of Teva’s trial evidence that it could have manufactured and sold its generic venlafaxine hydrochloride product in the hypothetical world. Teva purchases the active pharmaceutical ingredient (API) used in its product from Alembic Inc. (Alembic), a third party manufacturer. Teva did not call a witness from Alembic to testify. Teva relied solely on the testimony of a Teva executive to establish Alembic’s capacity and willingness to supply API to Teva during the relevant period.
Despite Pfizer’s repeated hearsay objections, the Federal Court admitted this evidence, ruling that Pfizer’s objections would go to the weight to be given to the evidence rather than its admissibility.
The FCA held that the evidence constituted hearsay, and as such, could not be admitted unless it met one of the exceptions to the hearsay rule. The FCA found that the impugned evidence was neither necessary nor reliable; in particular, the FCA noted that a witness from Alembic could have been called to give direct evidence, noting that Alembic “had an incentive to say whatever needed to keep its customer pleased”.
The FCA set the Trial Decision aside and remitted the matter back to the Federal Court to be reconsidered in the absence of the hearsay evidence. No new evidence will be permitted.
The FCA reaffirmed the principles set out in Apotex Inc v Sanofi-Aventis, 2014 FCA 68, aff’d 2015 SCC 20 (reported here) regarding construction of the Hypothetical World. The Court held:
The redetermination has been set down for hearing on September 1, 2016.
FCA Decision: Pfizer Canada Inc v Teva Canada Limited, 2016 FCA 161
Trial Decision: Teva Canada Limited v Pfizer Canada Inc, 2014 FC 248, and subsequent reasons Teva Canada Limited v Pfizer Canada Inc, 2014 FC 634
Publication
We have contributed the Singapore chapter of Getting the Deal Through, Government Investigations 2025.
Publication
The private credit market and direct lending have grown and diversified immensely in the past decade, offering alternative sources and terms of debt compared to those historically provided by the syndicated leveraged loan and public issuance markets. Consequently, they are fast becoming pivotal components in the capital ecosystem, so much so that the Bank of England consider that the private credit market is currently responsible for approximately $1.8 trillion of debt issuance, which is four times its size in 2015. This growth has been particularly pronounced in Europe and the US but there has also been significant activity in Asia.
Publication
The EU’s Artificial Intelligence Regulation, commonly referred to as the AI Act, is expected to come into force during the summer of 2024 (the AI Act). The AI Act will be the first comprehensive legal framework for the use and development of artificial intelligence (AI), and is intended to ensure that AI systems developed and used in the EU are safe, transparent, traceable, non-discriminatory and environmentally friendly.
Subscribe and stay up to date with the latest legal news, information and events . . .
© Norton Rose Fulbright LLP 2023