May 2025

Clinical Trials Get a Legal Shield: Federal Circuit Reverses Pharma Patent Injunction

Patent

by Dennis Crouch

The Federal Circuit’s May 6, 2025 decision in Jazz Pharmaceuticals v. Avadel focuses on the scope of injunctive relief for infringement under 271(e).  The appellate court held that a district court may not enjoin a pharmaceutical company from initiating new clinical trials or offering open-label extensions where such activities are protected by the Hatch-Waxman Act’s safe harbor provision, even when the company’s commercial product has been found to infringe a valid patent. The court reversed the portions of the injunction that would have prohibited these activities, and vacated and remanded the portion that barred seeking FDA approval for new indications.

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 24-2274, slip op. (Fed. Cir. May 6, 2025).

(more…)

The Federal Circuit’s Rigid Approach to Secondary Considerations

Patent

by Dennis Crouch

Purdue Pharma has filed a petition for certiorari asking the Supreme Court to review what it characterizes as the Federal Circuit’s overly rigid application of the “nexus” requirement for objective indicia of non-obviousness. I agree with the petition that the Federal Circuit’s approach contradicts the Supreme Court’s longstanding precedent requiring a flexible and expansive analysis of obviousness factors, exemplified both by the court’s 2007 KSR decision as well as older cases, such as Minerals Separation v. Hyde, 242 U.S. 261 (1916).

(more…)

Legacy of In re Rijckaert: Inherency’s Limited Role in Obviousness Analysis

Patent

by Dennis Crouch

The Federal Circuit’s 1993 decision in In re Rijckaert, 9 F.3d 1531 (Fed. Cir. 1993), set an important boundary on the use of inherency in obviousness determinations. I recently reread the case and wanted to reintroduce the case that continues to be regularly cited in both patent prosecution and litigation.

Rijckaert involved a patent application for a magnetic recording apparatus that established a precise mathematical relationship between time expansion/compression and three variables: α (the wrapping angle of tape around the drum), n (the number of head pairs), and M (non-recording intervals). This relationship—expressed as α*n/(180*(M+1))—allowed for optimal track filling on the magnetic tape.  The approach was designed to allow reduction of acoustic noise by positioning heads close together with rigid mechanical coupling, while maintaining proper signal timing and track alignment regardless of drum wobble or other mechanical imperfections.  The PTO rejected the application as obvious two prior art references, despite neither reference teaching the claimed relationship or even discussing all three variables in combination.

The Board of Patent Appeals upheld the rejection by assuming that the relationship would be inherently satisfied if one assumed specific values for the variables. The Federal Circuit, however, reversed, emphasizing that the prior art failed to establish a prima facie case of obviousness because it neither disclosed nor suggested the claimed relationship. (more…)

AI and Cognitive Laziness for Lawyers

Patent

by Dennis Crouch

I enjoyed reading Professor S.I. Strong’s new article on AI-lawyering and her proposed solution that inspired by the English legal profession’s structure. Although I think this is all still early stage, emerging empirical research is showing how generative AI usage often triggers “metacognitive laziness” and “cognitive offloading” in users. Studies particularly with law students show reduced motivation to learn, diminished ability to self-regulate, and less deep engagement with material—gaining only improved short-term performance on individual tasks.  Routine reliance on AI usage is also showing an atrophy of other critical skills. Namely, when professionals have confidence in GenAI’s ability to perform a task, those folks spend much less effort thinking critically about the issues.

Artificial Intelligence in Civil Justice Systems: An Empirical and Interdisciplinary Analysis and Proposal for Moving Forward by S.I. Strong :: SSRN (more…)

By all Means: When Software Functions Lack Correspnding Structure

Patent

by Dennis Crouch

In a case highlighting the ongoing challenge of claim construction in software patents, the Federal Circuit has affirmed the district court’s determination that Fintiv’s asserted claims are invalid as indefinite. Fintiv, Inc. v. PayPal Holdings, Inc., No. 2023-2312 (Fed. Cir. Apr. 30, 2025).  In the software-element two-step, the court first held that the claim terms “payment handler” and “payment handler service” should be treated as “mean-plus-function” limitations under 35 U.S.C. § 112(f) because the claim terms used lacked inherent structural meaning; and then as a result found the claims invalid as indefinite because the specification lacked sufficient structural support.   U.S. Patent Nos. 9,892,386, 11,120,413, 9,208,488, and 10,438,196.

The Statutes at Issues:

  • 35 U.S.C. 112(b) Conclusion. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
  • 35 U.S.C. 112(f) Element in Claim for a Combination.
    An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

(more…)