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Pharmaceutical Industry › Imports › Pharmaceutical Patents

A&O Shearman

UK will permanently retain its UK+ exhaustion regime to allow continued supply of medicines into the UK

A&O Shearman on

The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more

Morgan Lewis

Key Considerations for Foreign Clinical Trials When Looking Abroad for Product Development

Morgan Lewis on

With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more

WilmerHale

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

WilmerHale on

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)

K&L Gates LLP on

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

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

Herbert Smith Freehills Kramer

USMCA: Implications for Biologics and Innovation

Herbert Smith Freehills Kramer on

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

McDermott Will & Schulte

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Schulte on

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

BakerHostetler on

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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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