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Biosimilars 2020 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

For the first time since FDA licensed the first biosimilar, Sandoz’s Zarxio ® (filgrastim-sndz), in 2015, the United States saw a decrease in annual biosimilar approvals in 2020. Legislation Relating to Biologics and Biosimilars. BPCIA Litigation. Antitrust Litigation. Post-Grant Challenges at the PTAB. Conclusion.

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The US’ Review of March-in Rights, and Some Questions on an Indian Counterpart

SpicyIP

According to the NIST, the US govt invests approximately $115 billion in R&D through various universities, non-profits, and businesses. March-in rights are provisions that allow the government to require a license for inventions stemming from this investment, upon the fulfilment of certain conditions.