The Skinny Line Between Possible and Plausible
By now most people have heard that Hikma v. Amarin, No. 24–889 (June 4, 2026), was an overall favorable decision for skinny labeling....
Turning Up the Heat: Federal Circuit Sets the Temperature for pH Measurements in Precedential Opinion
The Federal Circuit recently affirmed a Northern District of West Virginia decision finding no literal or doctrine of equivalents...
Let's Talk "About". . . That Bird?
Much ink has been spilled over the meaning of “about” when used to characterize an amount or a range recited in a patent claim. Sometimes...
Squires Again Broadens Discretion for Post-Grant Proceedings
On Wednesday, March 11, 2026, United States Patent and Trademark Office (USPTO) Director John Squires issued a memorandum[1] announcing...
Back to the Well: FDA’s Draft Guidance on New Clinical Investigation Exclusivity
- Introduction
FDA recently published a new draft Guidance for Industry titled “New Clinical Investigation Exclusivity (3-Year Exclusivity)...
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