Remove topics food-and-drug-administration-fda
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FDA Announces Biosimilar Funding Opportunity

LexBlog IP

On March 7, 2022, the US Food and Drug Administration (FDA) issued a Funding Opportunity Announcement (FOA) to commit up to $5 million in fiscal year 2022 toward several research proposals. Specifically, the FDA anticipates awarding as many as five proposals up to $1 million in funding.

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Executive Order for Advancing Biotechnology and Biomanufacturing Innovation Signed by President Biden

LexBlog IP

The objective of the Executive Order is to “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.” ” Data Initiative.

Privacy 52
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Seeing Clearly: Article III Standing of IPR Judicial Review

Patently-O

He has an extensive background in chemistry, food science, and viticulture. Article III standing remains a hot topic at all levels of federal litigation and across many different areas of law. Guest Post by Jordan Duenckel. Jordan is a third-year law student at the University of Missouri and a registered patent agent.

Art 49
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Battle of the experts: court deals with surveys, damages, other Lanham Act experts

43(B)log

Plaintiff ChromaDex sought to exclude defendant Elysium’s survey expert and damages rebuttal expert, while Elysium moved to exclude ChromaDex’s survey, damages, FDA regulation, and clinical studies experts. Those who ultimately said yes and that the FDA had reviewed it were asked “What do you believe effectiveness means in this context?”

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Key Trends in PTAB’s 2021 Orange Book and Biologic Patent Study

LexBlog IP

The first study covering these topics was released on March 13, 2018, and the second on July 18, 2019. Food and Drug Administration’s (FDA’s) electronic Orange Book database. Food and Drug Administration’s (FDA’s) electronic Orange Book database. Trends Over Time.

Patent 52
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Duty of Disclosure Before USPTO Highlighted in Federal Register

LexBlog IP

Director Vidal highlights four different topics as they relate to the duty of disclosure standard: 1. DUTY OF DISCLOSURE BEFORE USPTO HIGHLIGHTED IN FEDERAL REGISTER. The notice begins by discussing to whom the duty of disclosure applies. The notice begins by discussing to whom the duty of disclosure applies. Who Has a Duty to Disclose.

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Biosimilars 2021 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. Yet, given fewer FDA approvals in 2020 and 2021, this year saw the lowest number of commercial launches since 2017. Introduction. Conclusion.