Third-Party Generic Strip Litigation

The diabetic test strip market is defined by a "razor-and-blades" model, leading to aggressive litigation between Original Equipment Manufacturers (OEMs) (LifeScan, Roche, Abbott) and Third-Party Generic Manufacturers (UniStrip, Decision Diagnostics).

Key aspects of this legal landscape include:

• Patent Infringement: OEMs defend the electrochemical architecture and signal processing methods of their strips to block generics.
• Technological Lock-Outs: OEMs implement proprietary "handshakes" and firmware updates to reject non-branded strips. When generics bypass these, they face anti-circumvention lawsuits.
• Antitrust Counterclaims: Generic manufacturers argue that OEMs engage in "predatory innovation" by modifying meters solely to exclude competition, rather than to improve patient care.
• Regulatory Status: Third-party strips often hold FDA 510(k) clearance for safety, but this does not protect them from patent litigation, creating a scenario where products are medically approved but legally restricted.

While the Medicare Competitive Bidding Program reduced the price incentives for generics, and the rise of CGM is shifting focus away from strips, this litigation history established critical precedents regarding medical device interoperability and the limits of proprietary consumables.