News & Analysis as of

Reporting Requirements Patents

Smart & Biggar

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

Smart & Biggar on

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

PMPRB update: New regulations now coming into force July 1, 2022

Smart & Biggar on

The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred for the fourth time, now until July 1, 2022. The news was announced on...more

Smart & Biggar

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

Smart & Biggar on

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

Smart & Biggar on

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 amendments to PMPRB pricing regulations push back deadlines by six months

Smart & Biggar on

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

Smart & Biggar on

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

Mintz - Intellectual Property Viewpoints

ITC Domestic Industry Products Do Not Need to Be Commercially Available

In a recent initial determination, Administrative Law Judge (“ALJ”) Cheney of the U.S. International Trade Commission (“ITC”) held that domestic industry products do not need to be commercially available to satisfy section...more

Smart & Biggar

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

Smart & Biggar on

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

American Conference Institute (ACI)

[Event] FDA BOOT CAMP - March 25 - 27, 2019, New York, NY

Obtain the guidance you need to master the difficult area of FDA regulatory law - 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...more

Hogan Lovells

IPunkt | IP auf den Punkt gebracht - Oktober 2018

Hogan Lovells on

Datenschutzgrundverordnung stark im Zeichen des Datenschutzes. Viele Unternehmen hatten die Mammut-Aufgabe, die relevanten Anforderungen des Datenschutzes an die Verarbeitung personenbezogener Daten umzusetzen. ...more

Davis Wright Tremaine LLP

Mandatory Report re: IP, Services Obtained from or Provided to Foreign Persons Due July 30

The BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons is conducted every five years by the Bureau of Economic Analysis of the U.S. Department of Commerce....more

Smart & Biggar

The Pricing of Patented Drugs in Canada: Stakeholder Consultation Period Open Until June 28, 2017

Smart & Biggar on

The Patented Medicine Prices Review Board (PMPRB) regulates the price of patented medicines in Canada by determining whether a price is excessive. The Board is revisiting its approach to pricing, and has now released a...more

Foley & Lardner LLP

District Court Upholds FTC Hart-Scott-Rodino Rules for Pharmaceutical Patent Transfers

Foley & Lardner LLP on

A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We...more

McDermott Will & Emery

FTC’s Reporting Rule for Pharmaceutical Patent Transfers Upheld

On May 30, 2014, the U.S. District Court for the District of Columbia ruled in favor of the Federal Trade Commission (FTC) in a dispute with the Pharmaceutical Research and Manufacturers of America (PhRMA) regarding the...more

Dechert LLP

FTC Orders Greater HSR Reporting of Patent Licenses in the Pharmaceutical Sector

Dechert LLP on

Background. One item on the negotiation checklist for patent licenses in the pharmaceutical sector is compliance with the U.S. Hart-Scott-Rodino (“HSR”) Premerger Notification Rules. The HSR rules require that certain patent...more

Ballard Spahr LLP

FTC Issues Premerger Notification Review Changes for Pharmaceutical Patent License Transfers

Ballard Spahr LLP on

The Federal Trade Commission (FTC) issued final changes to the premerger notification rules to expand the circumstances that require pharmaceutical industry companies to report proposed acquisitions of exclusive patent rights...more

16 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide