Latest Federal Court Cases: Actelion Pharms. Ltd. V. Mylan Pharms. Inc.

Why It Matters

The decisions tighten how patent claim language is interpreted in pharma cases, curb excessive fee sanctions, and broaden admissible expert evidence, reshaping litigation strategy across IP sectors.

Key Takeaways

• Fed. Cir. upheld 25 ± 2 °C pH measurement for patent claims
• Mylan cleared of literal infringement and doctrine of equivalents
• Prosecution‑history estoppel blocked Actelion from broader pH range
• Court limited fee awards in mCom case, requiring bad‑faith proof
• Expert can cite undisclosed source code under Fed. R. Evid. 703

Pulse Analysis

The Federal Circuit’s ruling on Actelion v. Mylan underscores the critical role of claim construction in pharmaceutical patent disputes. By anchoring the “pH of 13 or higher” requirement to a standard laboratory temperature, the court reinforced that specifications and expert testimony must consistently reflect that condition. Generic manufacturers can now cite this precedent to argue that temperature‑dependent pH measurements fall outside the literal scope of older patents, potentially accelerating market entry for high‑pH formulations while prompting patentees to draft broader, temperature‑agnostic claims.

In the mCom IP case, the appellate panel sent a clear message to litigants about the standards for “exceptional” fee awards. While the district court deemed the suit frivolous, the Federal Circuit required concrete proof of bad‑faith conduct before imposing sanctions under 35 U.S.C. § 285 and 28 U.S.C. § 1927. This decision will likely temper aggressive fee‑seeking tactics and encourage parties to focus on substantive validity arguments rather than relying on procedural penalties to deter competitors.

The Bissell decision expands the evidentiary landscape for IP cases involving software. By confirming that experts may base opinions on source code not formally entered into evidence, the court aligned patent practice with Federal Rule of Evidence 703, which permits reliance on data the expert is aware of. This flexibility benefits companies defending complex technology patents, as it reduces the burden of admitting voluminous code while still allowing robust expert analysis. Collectively, these rulings shape a more nuanced balance between protecting patent rights and ensuring fair, evidence‑based litigation.