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European Union › Intellectual Property Protection › Prescription Drugs

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Goodwin

Dr. Reddy’s Secures License from Henlius to Market Daratumumab Biosimilar in the U.S. and Europe

Goodwin on

On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s...more

Proskauer - The Patent Playbook

Preparing for Europe’s Unified Patent Court

Proskauer - The Patent Playbook on

After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Hogan Lovells

EU SPC Manufacturing Waiver Now in Force

Hogan Lovells on

The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469).  The Waiver has been introduced with the stated aim of putting EU generic and...more

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

Jones Day on

The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

Hogan Lovells on

On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

Hogan Lovells

Patent law in Europe: What pharmaceutical companies need to know

Hogan Lovells on

Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more

Ladas & Parry LLP

UK Supreme Court Decision In Actavis V. Eli Lilly – Doctrine Of Equivalents Recognized

Ladas & Parry LLP on

In its decision of July 12, 2017 in Actavis v. Eli Lilly, the Supreme Court of the United Kingdom for the first time formally adopted the concept of a doctrine of equivalents when considering what constituted an infringement...more

Hogan Lovells

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Hogan Lovells on

Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more

Hogan Lovells

UK Supreme Court hands down landmark ruling in favour of Eli Lilly

Hogan Lovells on

Following last Friday’s (7 July 2017) unusual move of advance publication of the outcome of the case, the UK Supreme Court now published the reasons for its decision in the long-running Actavis v Eli Lilly case. The reasons...more

Hogan Lovells

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

Hogan Lovells on

The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more

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