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A&O Shearman

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

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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

Goodwin

EMA Issues Positive CHMP Opinions for Biocon’s Denosumab Biosimilars

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Last week, Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Biocon’s two denosumab biosimilar candidates....more

Goodwin

Accord Receives Positive EMA Opinion for Two Denosumab Biosimilars

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On April 2, 2025, Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for two denosumab biosimilars: OSVYRTI and JUBEREQ. OSVYRTI is indicated for the...more

Goodwin

European Commission Approves Celltrion’s AVTOZMA (CT-P47)

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​​​​​​​On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®....more

Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated January 13, 2025

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more

Goodwin

Update on Recent International Biosimilar Approvals - September 2024

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Approval of Celltrion’s Ustekinumab Biosimilar in the EU:  On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA...more

Goodwin

Biosimilar Approval Updates in Europe and China

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On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab),...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

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As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Hogan Lovells

[Webinar] Antitrust today: Emerging issues affecting the life sciences industry - March 12th, 9:00 am - 10:00 am PST

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Join the Hogan Lovells Antitrust and Competition team on Friday, March 12, 2021 to discuss hot antitrust topics in the life sciences industry, including: - What life sciences companies should expect with respect to...more

White & Case LLP

Court of Justice ruling in Paroxetine

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The European Court of Justice's ruling in Paroxetine, handed down in record time just before Brexit, confirms the narrow interpretation of restrictions by object given in other recent cases. It also clarified certain issues...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

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On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

Hogan Lovells

EU SPC Manufacturing Waiver Now in Force

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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

Goodwin

Year in Review: Top 5 Foreign Market Developments in 2018

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Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market - As a result of litigation and resulting global settlements, several...more

Jones Day

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

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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

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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

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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

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Ladas & Parry LLP

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

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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

Mintz - Intellectual Property Viewpoints

Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize...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

Hogan Lovells

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

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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

Jones Day

European Commission Sets its Sights on Allegedly Excessive Drug Prices

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In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Patterson Belknap Webb & Tyler LLP

Update on Biosimilar Approvals and Pending Applications in Europe and the U.S.

Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six...more

Smart & Biggar

Rx IP Update - February 2017

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Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a...more

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