The August 2025 edition of our Texas Round-Up focuses on developments in cases involving pharmaceutical and medical device products.
Nivagen v. Sun Pharmaceuticals, 2:24-cv-00036-RWS, ECF 71 (E.D. Tex.)
On August 8, 2025, Judge Payne granted Sun’s request to transfer Nivagen’s case against it from the Eastern District of Texas to the District of New Jersey. Nivagen’s complaint alleges infringement by Sun’s product, SEZABY™ (phenobarbital sodium), indicated for the treatment of neonatal seizures in term and preterm infants. Venue allegations in the complaint centered on Sun’s two sales employees residing in the Eastern District, job postings, sales of SEZABY™ in the Eastern District, and participation in Texas’s Medicare Rebate Program. On June 27, 2024, Sun filed its motion to dismiss Nivagen’s complaint for improper venue or, in the alternative, transfer.
Judge Payne found Nivagen’s allegations insufficient to support venue based on Celgene Corp. v. Mylan Pharms., Inc., 17 F.4th 1111 (Fed. Cir. 2021). The Federal Circuit in Celgene held that locations of employees are not per se a regular and established place of business under § 1400(b). As in Celgene, Judge Payne found no evidence that any Sun employee residing in the Eastern District stored “literature, documents and products,” which can qualify an employee’s home as a regular and established place of business. Nivagen, 2:24-cv-00036-RWS, ECF 71 at 4. The parties did not conduct venue discovery — Nivagen argued that the two employees “possibly have business-related materials at their homes.” Id.
As a result of the transfer order, Judge Payne cancelled the Markman hearing scheduled for August 14, 2025. Sun recently filed a motion asking Judge Payne to cancel all pending case deadlines, which the parties are briefing. The New Jersey matter is 2:25-cv-15210 (D.N.J.).
Auto Injection Technologies v. Ypsomed, 2:25-cv-00377-JRG (E.D. Tex.)
In April 2025, Auto Injection Technologies filed complaints in the Eastern District against Novo Nordisk, GSK, Bayer, Medtronic, and Ypsomed. The complaints allege infringement of drug delivery patents that Auto Injection acquired from Sanofi-Aventis. Last month, Judge Gilstrap set the GSK case for a scheduling conference on September 30, 2025. He also consolidated the Ypsomed and Novo Nordisk matters. Auto Injection recently filed a notice of settlement in the Ypsomed case on September 2, 2025. The Bayer and Medtronic cases have had no substantive activity to date.
Medshape v. Arthrex, 6:24-cv-00151-DTG, ECF 114 (W.D. Tex.)
This complaint was filed in March 2024 by Medshape, Inc., Trilliant Surgical LLC, and Encore Medical, L.P. (d/b/a Enovis Foot and Ankle) (collectively, “Enovis”). Enovis markets the DynaNail® system used for surgeries involving ankle and foot fusion, such as tibiotalocalcaneal fusion surgery. Enovis alleges that Arthrex’s Hindfoot Fusion Nail system competes with DynaNail® and infringes Enovis’ patents covering its product.
Judge Gilliland issued a claim construction order on August 29, 2025, deciding three issues:
- “Bone fragment” is different than “bone.” The parties disputed whether “bone” could include fully formed bone (as Enovis argued) or is limited to portions of a bone (as Arthrex argued). Relying on different uses of “bone” and “bone fragment” in the specification and during prosecution, Judge Gilliland sided with Arthrex and construed “bone fragment” as “a piece of bone broken from a larger bone.”
- “Substantially in an austenitic phase” is not indefinite. Arthrex argued that the asserted patent failed to provide a boundary for this term of degree or provide guidance on how to measure the amount of bone device material in an austenitic phase. (According to the patent’s specification, this phase is more rigid than the earlier malleable phase.) Judge Gilliland noted that he did not find either party’s experts persuasive on this issue because both were well-qualified. Ultimately, Judge Gilliland agreed with Enovis’ expert that the claims did not require a precise percentage of austinite.
- No order of claim steps where none specified. Finally, Judge Gilliland resolved an issue that arose after the original claim construction hearing. Rather than hold a second hearing, Judge Gilliland decided the issue on the papers. Enovis argued that claim step (a) must be completed before a claim step (c). Arthrex argued the two steps could be completed at any time. Primarily based on the claim’s requirement that a third step, (d), occur after (c), Judge Gilliland sided with Arthrex that steps (a) and (c) need not occur in a particular order relative to each other.
This case is currently set for trial in April 2026.
