Recent 505 (b) (2) filings and Bardy Diagnostics Vs. iRhythm : Claim construction

Contents

Recent 505 (b) (2) filings

General information

Top 10 patent cases in France

India’s pharma industry trails behind: The digital validation technology gap

Intellectual Property

Bardy Diagnostics Vs. iRhythm : Claim construction

Recent 505 (b) (2) filings

We follow 505 (b) (2) filings. Generally, 505(b)(2) NDAs relate to changes compared to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). More details 505 (b) (2) FDA approvals can be found here. The details of February 2026, 505 (b) (2) filings are as follows

General information

Top 10 patent cases in France

French courts recorded a decline in the number of cases in 2024, and recent research suggests that the downward trend continued last year. Nevertheless, French courts handed down a number of decisions in high-profile cases, particularly concerning patents from the pharmaceutical sector. One ruling has an implication for the UPC. News here

India’s pharma industry trails behind: The digital validation technology gap

India’s pharmaceutical industry will not lose its edge because it forgets how to manufacture; it will lose it because it insists on validating 2030 facilities with 1990s tools. Digital validation is the clearest window into this gap. At one extreme, some organisations still run critical GxP validation on pen, paper, and spreadsheets—impact assessments written in Word, test evidence buried in file shares, traceability held together by human memory and ad-hoc cross-checks. This feels familiar and “under control,” but it collapses under modern expectations for data integrity, real-time transparency, and network-level risk management. News here

Intellectual Property

Bardy Diagnostics Vs. iRhythm : Claim construction

In U.S. patent litigation, claim construction is the critical process of defining the meaning and scope of the specific words used in a patent’s claims. Known as the "bedrock principle" of patent law, this phase determines the legal boundaries of the invention, which in turn dictates whether a defendant has infringed the patent or if the patent itself is valid. Because the interpretation of these terms is considered a matter of law rather than a matter of fact, it is the judge—not a jury—who resolves these disputes, typically following a specialised "Markman hearing" where both parties present competing definitions based on the patent’s text and history. When interpreting these terms, courts follow a strict evidentiary hierarchy that prioritises "intrinsic evidence," which includes the claim language itself, the patent specification, and the prosecution history. Judges generally assign words their "plain and ordinary meaning" as understood by a person of ordinary skill in the art (POSA) at the time of the invention. While the specification is often described as the "single best guide" for construction, the court must carefully avoid "reading in" limitations from specific examples or embodiments into the broader claims unless the inventor clearly intended to limit the invention's scope. Extrinsic evidence, such as expert testimony or dictionaries, is generally used only as a secondary tool to help the court understand the technical context or scientific principles involved. This Memorandum and Order, issued on February 19, 2026, by Judge Joshua D. Wolson of the U.S. District Court for the District of Delaware, resolves disputed claim constructions in the patent infringement litigation between Bardy Diagnostics, Inc. and iRhythm Technologies, Inc.. Case Overview Bardy Diagnostics alleges that iRhythm infringes four of its patents, while iRhythm counters that Bardy infringes five iRhythm patents. The dispute involves 11 claim terms across 8 patents related to electrocardiographic (ECG) monitoring technology. Legal Standard The Court applied the "bedrock principle" that patent claims define the scope of the invention. Key tenets of the Court's analysis included:

• Ordinary Meaning: Words are generally given the meaning they would have to a Person of Ordinary Skill in the Art (POSA) at the time of the invention.
• Evidence Hierarchy: The Court prioritises intrinsic evidence (claim language and specification) over extrinsic evidence (expert reports or dictionaries).
• Avoiding Importation: While claims must be consistent with the specification, the Court must avoid reading limitations from specific embodiments into the broader claim language.
• Indefiniteness: A claim is only indefinite if it fails to inform a POSA about the scope of the invention with "reasonable certainty".

Bardy Patent Terms The Court resolved disputes over terms in Bardy’s '473, '562, '261, and '735 patents.

Key Findings:

• Wireless Transceiver: The Court rejected iRhythm's attempt to limit this to the transmission of "electrocardiographic signals," noting that such a limitation would render other claim language superfluous.
• Vertical Alignment: The Court determined "vertical" refers to the axis between the device face and the skin-contacting patch, rather than the patient's sternal midline.
• Removably Secured: The Court followed Federal Circuit precedent, ruling the term implies a design for separation and reuse without "doing violence" to the invention, though it declined to use the specific word "destruction".

iRhythm Patent Terms The Court resolved disputes for terms in iRhythm’s '734, '554, '277, and '859 patents .

Key Findings:

• Electrical Connection: The Court refused to limit this term to a "wire," as the specification explicitly mentioned "other suitable" connections.
• Extending From: The Court ruled that "extending" describes a spatial relationship and does not require the connection to "originate" at a specific point or exclude intervening components.
• At Least Partially: This was interpreted as a minimum requirement; the Court rejected Bardy's "negative limitation" that would prevent the adhesive from extending completely below the housing.
• Configured to Tilt: The Court clarified that the housing does not "actively" tilt itself; rather, the term describes the relative orientation that occurs when the user moves .
• Second Substrate Layer: The Court rejected a requirement that the second layer "entirely cover" the first, as "positioned over" does not inherently mean "complete coverage".

Agreed-Upon Construction During the Markman hearing, the parties reached an agreement on one additional term:

Conclusion The Court's constructions largely adhered to the plain and ordinary meaning of the terms as supported by the intrinsic record, consistently rejecting attempts by both parties to import restrictive limitations from specific embodiments or perceived purposes into the claim language. Details here This is not the pharma case, but often it is easier to understand how the court determines the meaning of terms by explicating non-pharma words.