News & Analysis as of

Patents Drug Approvals

Smart & Biggar

Update on biosimilars in Canada - October 2021

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Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more

American Conference Institute (ACI)

[Virtual Event] FDA Boot Camp - September 23rd - 24th, 8:15 am - 12:45 pm EDT

For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more

Smart & Biggar

Biosimilars: Comparison chart between Canada, US and Europe

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As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more

Smart & Biggar

PMPRB releases draft Guidelines operationalizing amended Patented Medicines Regulations

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On November 21, 2019, the Patented Medicines Prices Review Board (“PMPRB”) released draft new Guidelines for consultation, together with a backgrounder. The new Guidelines are intended to operationalize the amended Patented...more

Robins Kaplan LLP

ANDA Approvals - Winter 2018

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Please see Chart below for more information....more

Smart & Biggar

Certificate of Supplementary Protection Regime: First Anniversary Update

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September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more

Smart & Biggar

Rx IP Update - July 2018

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IN THIS ISSUE: - Shire’s VYVANSE patent valid, prohibition order issued - First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data - PMPRB News - Patented Medicine...more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Smart & Biggar

Rx IP Update - December 2017

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PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Smart & Biggar

Rx IP Update - November 2017

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Canada’s new linkage litigation scheme: A comparison to Hatch-Waxman - The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for...more

Smart & Biggar

Rx IP Update - July 2017

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Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Smart & Biggar

Rx IP Update - May 2017

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Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

Smart & Biggar

Rx IP Update - April 2017

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Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Morrison & Foerster LLP

No Patent for You

Patent eligibility restrictions hit life sciences and tech - After years of issuing rulings limiting what can be patented, the Supreme Court turned its attention squarely toward patent eligibility in the life sciences...more

McDonnell Boehnen Hulbert & Berghoff LLP

Galderma Laboratories, L.P. v. Tolmar, Inc. (Fed. Cir. 2013)

When does a prior art disclosure of a concentration range of a medicament render obvious the use of a species that falls within that range, when that same use was also known in the prior art? After all, common sense should...more

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