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Life Sciences Licensing and M&A Update: Catching Up on Recent Decisions Affecting Commercially Reasonable Efforts Definitions and...

Recently, the Delaware Chancery Court and the Third Circuit issued three significant decisions on key issues affecting licensing and M&A transactions in the life sciences industry....more

MetaBirkins Post-Trial Ruling Clarifies Line Between Trademark Infringement and Free Expression and Grants Broad Injunctive Relief

On Friday, June 23, 2023, Judge Jed Rakoff issued a highly anticipated decision, permanently enjoining artist Mason Rothschild from selling “MetaBirkin” NFTs, which depict furry, digital versions of the Hermès signature...more

EMA Adopts Positive Opinion for Amgen’s Eculizumab Biosimilar Candidate BEKEMV®

On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®. BEKEMV® is a biosimilar candidate referencing Alexion’s biological product SOLIRIS® (eculizumab), which is a recombinant...more

3 Reasons Beauty Cos. Should Consider Pursuing Patents

​​​​​​​Intellectual property protection is more important than ever in the beauty industry as the market for cosmetics becomes more crowded and competitive. Some cosmetic companies have used patents as a key tool to...more

Deal Watch: Henlius Licenses Rituximab and Trastuzumab Products to Abbott in Brazil

Earlier this week, Shanghai Henlius Biotech, Inc. announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay S.R.L. for the commercialization of HANLIKANG (rituximab) and HANQUYOU...more

Purple Book Updates

In 2021, the FDA’s Purple Book went live, providing a searchable database of licensed biological products, including the patent information provided to biosimilar applicants during the patent dance. Pursuant to a law enacted...more

Health Canada Approves Celltrion’s Adalimumab Biosimilar, YUFLYMA

According to various reports, Celltrion has received approval from Health Canada for YUFLYMA, a biosimilar of AbbVie’s HUMIRA product.  YUFLYMA was previously approved in Europe, and is a high-concentration, low-volume,...more

Year in Review: Top Legal Developments of 2021 Impacting Biosimilars

As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more

Tanvex and Biocad announce Phase III results at ESMO Congress

Last week, results of Tanvex’s phase III study on its trastuzumab biosimilar candidate (TX05) were published in connection with the European Society for Medical Oncology’s (ESMO’s) Congress 2021. The study compared the...more

Enzene Biosciences Announced Romiplostim Approval in India

Last week, Enzene Biosciences announced that it has received marketing authorization from the Drug Controller General of India (DCGI) for its biosimilar product romiplostim. The product will be offered in three dosage...more

The ITC’s Evolving Economic Prong of the Domestic Industry Requirement

The domestic industry requirement at the U.S. International Trade Commission (ITC or Commission) continued to evolve in three significant opinions in 2014. In one opinion, the Commission set forth a nexus requirement for...more

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