Subject Matter Jurisdiction Remains in Hatch-Waxman Patent Infringement Action after ANDA Filer Changes from Paragraph IV to Paragraph III Certification

The Ninth Circuit recently reversed a district court’s decision to strike a plaintiff’s trade secret claims under the Defend Trade Secrets Act (DTSA) at the discovery stage. In doing so, the Ninth Circuit made clear that under the DTSA, whether a party defined their trade secret with sufficient particularity is a question of fact that generally does not lend itself to resolution in the absence of at least some discovery. This ruling contrasts with the California Uniform Trade Secrets Act (CUTSA), which requires a party to define their trade secrets with reasonable particularity before commencing discovery.

The Federal Circuit recently vacated a summary judgment ruling of invalidity, holding that the district court erred in applying preclusive effect to the Patent Trial and Appeal Board’s unpatentability findings regarding other claims in the same patent. In doing so, the Federal Circuit reiterated that issue preclusion does not apply where the prior factual determinations were made under a lower standard of proof.

The Federal Circuit recently clarified the requirement for work disclosed in a reference to qualify as “by another” under pre-AIA Sections 102(a) and (e), holding that there must be complete inventive identity between the information disclosed in the asserted reference and the inventors named on the relevant patent. 

The District Court for the Northern District of California recently granted a defendant’s motion to bifurcate, ordering that issues related to PGR estoppel should be decided in a bench trial, while the remaining issues in the case should proceed to a jury trial.

The Northern District of Iowa recently held that a defendant’s motion for partial summary judgment of invalidity was barred after the PTAB issued final written decisions, regardless of when the motion was filed. The defendant filed its motion before the final written decisions were issued, but the court rejected the defendant’s argument that the timing of the motion insulated it from estoppel.

In a recent final written decision, the PTAB determined that a reference patent was not prior art, despite the petitioner’s post‑filing attempt to correct its petition. While the petitioner argued that it intended to rely on the patent application’s earlier date of publication, both the corrected petition and the expert declaration continued to reference the issued patent rather than the published application.

The USPTO Director recently granted a petitioner’s request for rehearing of the decision discretionarily denying institution of inter partes review, ultimately vacating the original decision, and referring the petition to the board for an institution decision.

In considering claims to a method of reducing cardiovascular events, the Federal Circuit held that the term a “clinically proven effective” amount did not render the claims patentable over the prior art. Specifically, the Federal Circuit held that the “clinically proven effective” amount, whether limiting or not, could not be used to distinguish the prior art because the claims also specified the exact amount of the drugs to be administered in the method. The Federal Circuit also rejected patentee’s evidence of unexpected results because that evidence was tied solely to the “clinically proven effective” limitation.