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Fintiv 2.0: USPTO Director Issues Guidance Softening Risk of Discretionary Denial

Newly appointed USPTO Director Kathi Vidal issued a set of interim procedures clarifying how the Patent Trial and Appeal Board (PTAB or Board) should apply its Fintiv decision going forward. Vidal’s guidance, which will...more

Sandoz’s High Concentration Adalimumab Biosimilar Application Accepted by EMA

Sandoz recently announced that the EMA (European Medicines Agency) has accepted its application for a 100 mg/ml citrate-free formulation of its biosimilar HYRIMOZ® (adalimumab). The indications covered in the application...more

Expanding Operations in Biologics

Catalent and Abzena both recently announced substantial investments into new biologics facilities. Catalent is spending up to $160 million to build a new manufacturing facility near Oxford, UK....more

International Trade Commission Institutes Investigation of Alvotech’s Adalimumab Biosimilar

As noted in our December 21, 2021 post, Complainants AbbVie Inc., AbbVie Biotechnology Ltd. and AbbVie Operations Singapore Pte. Ltd. filed a complaint at the International Trade Commission against Respondents Alvotech hf.,...more

USPTO Issues New Guidance “Clarifying” its 2013 Policy Statement on Availability of Injunction Relief and Exclusion Orders for...

For those who attended our October webinar on standard essential patent (SEP) issues at the International Trade Commission (ITC), you may recall that, in 2013, the U.S. Patent and Trademark Office (PTO) and Department of...more

2019 Trends at the International Trade Commission

The U.S. International Trade Commission (ITC) just closed the books on fiscal year 2019. We summarize some notable trends below....more

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