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Patents Amended Regulation

Sheppard Mullin Richter & Hampton LLP

Highlights of Revised Regulations for Implementing Patent Law of China

On December 11, 2023, the State Council of the People’s Republic of China announced its decision to amend the Implementing Regulations of the Patent Law of the People’s Republic of China (the “2023 Regulations”), marking the...more

Stikeman Elliott LLP

Patent Rules Amendments In Force as of October 3, 2022, Reflecting Canada’s Commitments Under CUSMA

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On October 3, 2022, the majority of the amendments introduced by the Rules Amending the Patent Rules on June 2, 2022, came into force and effect. The amendments aim to streamline the patent examination process and bring...more

Smart & Biggar

PM(NOC) Regulations: Five-year anniversary of major amendments

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September 21, 2022, marked the fifth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fifth year...more

Smart & Biggar

New PMPRB regulations registered, in force July 1, 2022, interim approach to pricing announced

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As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more

Smart & Biggar

PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more

Smart & Biggar

PMPRB Update: Jurisdiction extends to CSPs effective June 30; coming into force of Patented Medicines Regulations and Guidelines...

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The coming into force of the amended Patented Medicines Regulations has been delayed a third time, now until January 1, 2022. The amendments, once in force, will add new price regulatory factors, revise the list of...more

Quarles & Brady LLP

A Quick Dive Into the Upcoming Changes to Chinese Design Patent Law

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On October 17, 2020, the Chinese Legislature passed the Fourth Amendment to the Chinese Patent Law, which will come into effect on June 1, 2021. As discussed in our previous post, the Fourth Amendment included several updates...more

Smart & Biggar

PMPRB proposes to modify Guidelines definition of "gap medicine" to include medicines sold by July 1, 2021

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Update: See our March 30, 2021 article, which reports the outcome of the consultation, and our April 29, 2021 article reporting an update to compliance timelines for Grandfathered and Gap medicines. Further updates, including...more

Smart & Biggar

2020 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more

Smart & Biggar

New Federal Court Guidelines for Complex Proceedings consolidate and update previous guidelines

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Update: The Federal Court updated the Guidelines on May 18, 2021, which can be found here. The Federal Court has released a new consolidated practice direction, Case and Trial Management Guidelines for Complex...more

Smart & Biggar

Federal Court of Appeal dismisses appeal of first trial decision under the amended PMNOC Regulations

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UPDATE: On July 9, 2021, the Supreme Court of Canada denied Amgen’s leave to appeal (see article here). On November 3, 2020, the Federal Court of Appeal heard and dismissed the appeal of the first trial decision under the...more

Smart & Biggar

Amended PM(NOC) Regulations: Third Anniversary Update

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September 21, 2020 marked the third anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations), which heralded significant changes to the litigation landscape for...more

Smart & Biggar

Federal Court releases decision on validity of the Amending Regulations of the Patented Medicines Regulations

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UPDATE: See July 15, 2020 article here describing the decision in more detail. On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On...more

Smart & Biggar

PMPRB releases revised draft Guidelines

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UPDATE: See June 23, 2020 article here describing the notable changes. See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of research-based...more

Smart & Biggar

New amendments to PMPRB pricing regulations push back deadlines by six months

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Update: See December 30, 2020 and January 26, 2021 articles discussing the further amendments which defer the coming into force date of the Amended Regulations until July 1, 2021. Further to our June 1, 2020 update,...more

Smart & Biggar

Amendments to PMPRB Regulations will now be in force January 1, 2021

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Update: See our June 10, 2020 article here describing the amendments extending the deadline, and our articles here and here regarding the amendments further deferring the coming into force date until July 1, 2021, and our...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...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

Smart & Biggar

Canada releases final amendments to Patented Medicines Pricing Regulations; in force July 1, 2020

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On August 9, 2019, Health Canada announced the final amendments to the Patented Medicines Regulations (see news release here and RIAS here). These amendments represent the first substantive revision to the Regulations since...more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Smart & Biggar

Rx IP Update - May 2019

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IN THIS ISSUE: - Federal Court dismisses Servier's application for order of prohibition regarding salt patent for perindopril arginine - FCA upholds issuance of NON-W letter and cancellation of reconsideration process...more

Wilson Sonsini Goodrich & Rosati

Important Legislative and Regulatory Changes Impacting the Commercialization of Cannabis, Hemp, and CBD

A number of important changes have occurred in the cannabis, hemp, and cannabidiol (CBD) spaces. This alert presents a snapshot of significant developments and selected future predictions....more

Smart & Biggar

Amended PMNOC Regulations: First Anniversary Update

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As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more

Knobbe Martens

Proposed Legislation: The Hatch-Waxman Integrity Act

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Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Updated Bayh-Dole Regulations Increase Certain Risks of Losing Title to Federally Funded Inventions

Businesses and nonprofits that receive funding under a federal government agreement (e.g., contract, cooperative agreement, or grant) executed after May 14, 2018, are subject to the updated regulatory provisions that...more

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