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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

USPTO Issues “Reasonable” Guidance on Enablement Under Amgen v. Sanofi

The USPTO has issued “Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.” The Guidelines set forth the U.S. Patent and Trademark...more

USPTO Says Prior Art Date of AIA Patents is Not Limited By Dynamic Drinkware

When Dynamic Drinkware was decided in 2015, commentators debated whether differences in the language of the American Invents Act (AIA) version of 35 USC § 102 would shield AIA patents from its restrictions. Now, U.S. Patent...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

USPTO Report On COVID-19 Diagnostic Patent Filings

The U.S. Patent and Trademark Office (USPTO) released a report on innovations in COVID-19-related diagnostics as a case study of how innovation and intellectual property operate during times of crisis. The study utilized...more

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