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FDA: The Effects of Loper on the Regulatory Agenda

The Supreme Court’s decision in June 2024 in Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce to overrule the Chevron doctrine has major implications for every administrative agency,...more

USPTO Publishes Drug Patent and Exclusivity Study Report

The U.S. Patent and Trademark Office (USPTO), in conjunction with the Food and Drug Administration (FDA) and in response to January 2022 and April 2022 letters from Senator Thom Tillis (R-NC), has published a report examining...more

USPTO Issues Updated Guidance on Obviousness

For the first time in nearly 15 years, the U.S. Patent and Trademark Office (USPTO) has issued “Updated Guidance for Making a Proper Determination of Obviousness” under the U.S. Supreme Court’s ruling in KSR Int’l Co. v....more

USPTO Releases Guidance on Rule 132 Declarations

The U.S. Patent and Trademark Office (USPTO) has released new training materials on “Declaration practice under 37 CFR 1.132 (Rule 132).” The materials were developed under a collaboration initiative with the U.S. Food and...more

Time Has Run Out for China’s 15-Day Mailing Rule

As of January 20, 2024, applicants are no longer able to enjoy a 15-day grace period for most response deadlines pertaining to patent applications being pursued in the Chinese National Intellectual Property Administration...more

A Look at FDA’s Proposed Changes to Labeling for Biosimilars and Interchangeable Biosimilars

The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more

Time Is Running Out For The EPO’s 10-Day Rule

Stakeholders accustomed to having “ten more days” to respond to a communication from the European Patent Office will have to update their calendaring systems for documents dated on or after November 1, 2023. This is because...more

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