News & Analysis as of

United States-Mexico-Canada Agreement (USMCA) Pharmaceutical Industry

Smart & Biggar

Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision

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On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data protection. As...more

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

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Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more

White & Case LLP

House Republicans Introduce Bill to Renew 2015 Trade Promotion Authority Law and Establish New Negotiating Objectives for...

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On July 27, Reps. John Joyce (R-PA) and Jim Banks (R-IN) introduced legislation that would establish new US trade negotiating objectives for the pharmaceutical sector, in the context of a broader renewal of the trade...more

King & Spalding

Update on the Proposed TRIPS Waiver at the WTO: Where is it Headed, and What to Expect?

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On June 8-9, 2021, the World Trade Organization’s (WTO) TRIPS Council will hold their first meeting in the wake of the U.S. Trade Representative (USTR) announcing “the Biden-Harris Administration’s support for waiving...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

Smart & Biggar

Update on biosimilars in Canada – August 2020

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The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in October...more

White & Case LLP

Ahead of the pack: US M&A 2019: US dealmakers steer a steady path through global headwinds

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As the rest of the world backed away from the deal table, confident US corporates continued buying businesses—especially in the life sciences and TMT sectors, and particularly in the domestic market. US dealmakers had a...more

Kramer Levin Naftalis & Frankel LLP

USMCA: Implications for Biologics and Innovation

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more

Tarter Krinsky & Drogin LLP

Biosimilar And Generic Drug Companies Benefit From Patent Related Amendments To The USMCA

It is very likely the U.S. President will soon sign the newly amended United States-Mexico-Canada Agreement (USMCA), which is intended to replace NAFTA. Mexico has already ratified the amended USMCA and Canada is expected to...more

McGuireWoods Consulting

Washington Healthcare Update - January 2020 #3

This week in Washington: The House is not in session. The Senate will resume the impeachment trial on Tuesday....more

Clark Hill PLC

Window On Washington - Vol. 4, Issue 3

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Outlook for This Week in the Nation’s Capital - Congress. The House is in recess this week and the Senate will begin the impeachment trial later this afternoon. ...more

Robins Kaplan LLP

Financial Daily Dose 1.17.2020 | Top Story: Senate Passes USMCA by Wide Margin to Update NAFTA

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While there’s plenty of other business afoot in D.C. these days, it also happens to have been a pretty big week for trade deals. A day after Phase One with China was inked, the Senate overwhelmingly approved a revised...more

BakerHostetler

Capitol Hill Healthcare Update

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NEW SENATOR JOINS HEALTH COMMITTEE - Newly sworn-in Sen. Kelly Loeffler, R-Ga., is the newest member of the Senate Health, Education, Labor and Pensions Committee....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

Clark Hill PLC

Window On Washington - Vol. 3, Issue 48

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Outlook for This Week in the Nation’s Capital - The Window on Washington will not publish while Congress is in recess and will return to your inbox in the new year on January 6. ...more

Smart & Biggar

Amendments to USMCA remove 10-year data protection requirement for biologics

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On December 10, 2019, the parties to the Canada-United States-Mexico Agreement (commonly referred to as USMCA, or the new NAFTA) signed amendments (see summary of revised outcomes) to the Agreement. The original USMCA was...more

Mintz - Intellectual Property Viewpoints

New revised USMCA trade deal affects intellectual property rights, but not exclusivity period for biologics

On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”). The USMCA, if ratified by each respective country, would replace the...more

Clark Hill PLC

Window On Washington - Vol. 3, Issue 47

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Outlook for This Week in the Nation’s Capital - Appropriations. All signs are currently positive that the appropriations process will wrap up in time to meet the December 20 deadline....more

Goodwin

10-Year Data Exclusivity for Biologics Removed from Final USMCA Agreement

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On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994....more

Robins Kaplan LLP

Financial Daily Dose 12.10.2019 | Top Story: Remembering Influential Former Fed Chair Paul Volcker

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Some remembrances upon the passing of influential former Fed Chair Paul Volcker, a force in American economic policy for nearly 60 years who led “the Federal Reserve’s brute-force campaign to subdue inflation in the late...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - November 2019

Congress returns to Washington this week after the Thanksgiving recess to find a feast of leftover legislative items still on the table. Congress has a limited number of days remaining on the 2019 legislative calendar to...more

McDonnell Boehnen Hulbert & Berghoff LLP

Trump Administration Considering Reduction in Biologics Exclusivity Period

On Monday, December 2, 2019, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and...more

Clark Hill PLC

Window On Washington - Vol. 3, Issue 42

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Outlook for This Week in the Nation’s Capital - Thank you to all who have served. Happy Veterans Day from Clark Hill....more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2019

Congress returns to D.C. this week for a short three-week sprint to a series of important deadlines on September 30. Chief among them is funding the federal government for Fiscal Year (FY) 2020 which begins on October 1,...more

Hogan Lovells

AFTA NAFTA: USMCA and the path forward

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On 30 September, after an intensive, last-minute flurry of negotiations, Canada joined the United States and Mexico in a new trilateral agreement to replace the original North American Free Trade Agreement (NAFTA 1.0). ...more

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