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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

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

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

A&O Shearman on

The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...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

Proskauer - The Patent Playbook

Preparing for Europe’s Unified Patent Court

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

[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

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Bolar Exemption in Europe and Asia

Bolar exemption in Europe - The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or...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

Hogan Lovells

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

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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

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

Skadden, Arps, Slate, Meagher & Flom LLP

"Antitrust and Competition: Nonmerger Enforcement Activity Heats Up on Both Sides of the Atlantic"

U.S. and European antitrust agencies had similar enforcement priorities last year, a trend we expect to continue in 2014. Nonmerger enforcement will continue to focus on intellectual property, financial services and...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: UK Court of Appeal Rules on Interim Injunctions

The Court of Appeal recently issued a decision concerning the issues that should be considered when granting an interim injunction. The proceedings related to Novartis' product zoledronic acid, which was used to treat...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: UK Court of Appeal Upholds Invalidity of Enantiomer Patent

Originally published in WP Thompson & Co. on April 1, 2013. The "Obvious to Try" Test Is Overused in Assessing Obviousness - The UK Court of Appeal Decision in Novartis AG vs Generics (UK) Ltd (trading as United...more

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