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Imports Pharmaceutical Patents

WilmerHale

Federal Circuit Addresses Scope of Medical Device and Drug Infringement Safe Harbor

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On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more

K&L Gates LLP

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

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In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more

Fish & Richardson

Federal Circuit to Consider the Relevance of an Alleged Infringer’s “Intent” in a Hatch-Waxman Safe Harbor Analysis

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The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more

Goodwin

ITC Trial Wraps Up on Botox Trade Secret Case

Goodwin on

Last week a trial was held before the International Trade Commission (ITC) in the trade secret case brought by Allergan and Medytox against Daewoong and Evolus.  Allergan and Medytox filed a complaint with the ITC on January...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

Dechert LLP

U.S. and China Sign Phase 1 Trade Deal – A Large Purchase Agreement, While Tariffs Remain in Place

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On January 15, 2020, U.S. President Trump and Chinese Vice Premier Liu He signed a Phase 1 trade deal between the countries. The agreement includes a pledge from China to increase its imports of U.S. goods and services by...more

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

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Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

BakerHostetler

The Weekly Hill Update

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Below is the Federal Policy team’s weekly preview, published when Congress is in session. HEADLINES - • Chinese Vice Premier Liu He is scheduled to visit Washington, but President Donald Trump’s Twitter threats to raise...more

Jones Day

ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval

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Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission (“ITC”) might be able to enter the fray too. On April 18, 2018, the ITC issued a notice...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

WilmerHale

Federal Circuit Patent Updates - August 2015

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The Dow Chemical Company v. Nova Chemicals Corporation (No. 2014-1431, -1462, 8/28/15) (Prost, Dyk, Wallach). Dyk, J. Reversing award of supplemental damages. "We hold that the intervening change in the law of...more

Dorsey & Whitney LLP

US China Trade War — Stock Market Crash, Presidential Trade Politics, Trade Policy, Customs, Antitrust and Securities

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The Chinese stock market crash and world- wide effect on stock markets around the World has created a crisis with day to day developments. The World Stock market crash stated on August 24, 2015 and went through to August...more

McDonnell Boehnen Hulbert & Berghoff LLP

How the Kirtsaeng Decision Could Ruin the U.S. Branded Drug Industry

The Constitution gives Congress the power to grant copyright and patent protection in the same part of Article I, specifically in Section 8, Clause 8...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: Court of Appeal Refers Questions on Specific Mechanism to Court of Justice of European Union

Merck Canada Inc and Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals plc - Prior to their accession to the European Patent Convention, several states did not allow patent protection for pharmaceutical products. To...more

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