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Healthcare & Life Sciences

February 07 2018
Nancy Pei Life sciences intellectual property: 2017 highlights

Canada - Smart & Biggar/Fetherstonhaugh

With major developments regarding patent linkage, patent term and other substantive patent issues, 2017 was one of the most significant years in history for Canadian life sciences IP and regulatory law. Highlights included the Supreme Court's striking down of the promise doctrine, the Canada-EU Comprehensive Economic and Trade Agreement amendments and the laying of the foundations to overhaul the Patented Medicine Prices Review Board regulations and guidance.

Author: Nancy Pei
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Brandon Heard Proposed amendments to Food and Drug Regulations and Medical Devices Regulations

Canada - Smart & Biggar/Fetherstonhaugh

Among other changes, Health Canada recently released proposed amendments to the Food and Drug Regulations. Under the amendments, "clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission" would cease to be treated as confidential and would be released to the public following a final regulatory decision, with no requirement to notify the affected party of the release.

Author: Brandon Heard
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Recent updates

Urszula Wojtyra Supreme Court dismisses Apotex's leave application

Canada - Smart & Biggar/Fetherstonhaugh

Author: Urszula Wojtyra
Scott D Stein Second Circuit finds government's continued payment in face of fraud allegations undercuts materiality

USA - Sidley Austin LLP

Authors: Scott D Stein, Brenna E Jenny

Upcoming event

2nd Pharma and Biotech IP Summit

February 8 2018 - London

IAM’s second annual Pharma and Biotech IP Summit will once again bring together leading IP experts from across life sciences. Last year’s Brexit vote added further uncertainty to an already precarious life sciences IP market and with the Unified Patent Court now thrown into confusion, the political and legislative landscape is one to navigate with caution. Against this backdrop, attendees will hear the latest IP strategies for thriving at a time when regulatory and legislative changes are significantly impacting business models.

For more details go to: