Diabetes: J&J loses a round in glucose testing battle with Shasta

Diabetes: J&J loses a round in glucose testing battle with Shasta

Johnson & Johnson (NYSE:JNJ) and its LifeScan subsidiary took a major hit in an ongoing feud with Shasta Technologies when a court ruled this week that Shasta may develop and distribute glucose testing strips that work with LifeScan’s OneTouch blood glucose meters.

In a split decision, the panel reversed a lower court’s decision and wiped out an injunction preventing Shasta from selling its glucose testing strips. The court warned that preserving LifeScan’s test strip injunction would give the company too much monopoly power over the market.

"Rejecting a claim of exhaustion in this case would be particularly problematic because LifeScan would be permitted to eliminate competition in the sale of the strips even though the strips do not embody the claimed invention and are themselves not patentable," the majority judges wrote in the 2-to-1 ruling. "Allowing LifeScan to control sale of the strips would be akin to allowing a tying arrangement whereby the purchasers of the meters could be barred from using the meters with competing strips.

Shasta worldwide sales and regulatory agent Decision Diagnostics Corp. (OTCBB: DECN) was quick to declare victory, issuing a press release titled "DECN Wins Only Case That Matters in Federal Circuit Court" and calling the new court ruling a "seminal day" in the company’s history.

"The Circuit Court’s ruling, reversed a lower court ruling (Northern California) and has put to rest a substantial part of J&J/LifeScan’s lawsuit," Decision Diagnostics principal executive officer Keith Berman said in prepared remarks. "With this court decision, our company can move forward and complete the branding of our Genstrip."

LifeScan owns patents that cover the combined use of the meters and the strips and Shasta has tried and failed to file patents for its knock-off Genstrip products. LifeScan earlier this year won a preliminary injunction preventing Shasta from selling its strips, and the company further sued Shasta for logo infringement, saying problems with Shasta’s products are harming the Lifescan brand.

With the injunction lifted, Shasta and Decision Diagnostics are set to "fully implement its rollout strategy for GenStrip," the companies said. With a new line of credit and its legal win in hand, Decision Diagnostics estimates that it could begin bagging annual revenues of more than $250 million.

The could be a major blow to LifeScan’s business model, which relies for revenue more on sales of the strips than on the OneTouch meters themselves. LifeScan sells about 40% of its meters at below cost pricing, giving the rest out for free through healthcare providers, according to court documents. The company’s model relies on profits derived from sales of the test strips.

Decision Diagnostics says its strips cost up to 50% less than rival strips, and its management says it’s confident that it can capture market share.

RSS From Medical Design & Outsourcing

  • GlobTek presents its latest level VI AC/DC adapter and connverter
    T-43086-WWVV-X.X-Q Model is an addition to GlobTek’s Level VI compliant GT-43086 family and represents GlobTek’s 6 Watt wall plug-in series of AC/DC adapters (power supplies and chargers) with International Interchangeable blades. GlobTek’s changeable input blade system with individual field replaceable input plugs, including: North America and Japan NEMA 1-15P, Australian, UK BS 1363, European CEE […]
  • Sanmina’s familiarity with FDA gets skin treatment product to market fast
    The medical market for cosmetic devices is booming. However, quickly launching new products to meet demand is becoming more challenging because device manufactures face increased regulatory scrutiny. To help meet regulatory requirements, aesthetic and other medical-device OEMs are partnering with electronics manufacturing services (EMS) companies that also offer expertise with the FDA filings necessary to […]
  • Fluid connectors and quick disconnects for IVD equipment from CPC
    Colder Products Company (CPC) offers thousands of tubing connectors, quick disconnects and fittings for smart fluid handling in IVD and analytical equipment. Non-spill connectors speed testing throughput by eliminating drips, preventing air inclusion and increasing operator safety. Panel mount connectors can be added to existing equipment or bottle caps to provide secure, leak-free connections. Puncture […]
  • 310 Watt desktop medical power supply meets efficiency level VI requirements
    Power Partners releases a new 310 Watt medical grade desktop power supply from their PEAMD Series of AC and DC adapters. The 310 Watt unit is packed for ideal performance inside a compact case measuring 7.8 x 4 x 2 in. with a weight of only 3 lbs. The PEAMD310 Series is approved to the latest […]
  • Saelig introduces Multiple Instrument System MIS4 universal test system
    Saelig Company has introduced the ABI Electronics’ Multiple Instrument Station MIS4, an all-in-one testing tool that provides all commonly required test instruments in one compact programmable hardware module, mounted in a compact case or installed in a PC-drive bay. Controlled by ABI’s sophisticated SYSTEM 8 Ultimate PC software with a simple yet programmable operator interface, […]
  • AssurX announces document management software update for small to mid-size companies in FDA regulated industries
    AssurX, an enterprise quality management, risk and regulatory compliance solution provider, announces the release of the latest update to their AssurX document management software. The document management solution provides a cost-effective solution for small to medium sized companies faced with streamlined operations and is fully compliant for FDA regulated industries. Ideal solution for small to […]
  • Saelig presents new Amplicon Impact-R 1100F series computer
    Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]
  • Gerresheimer to acquire Centor
    Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]
  • Methods Machine Tools presents the new Nakamura-Tome NTRX-300
    Methods Machine Tools, a developer of precision machine tools and automation, has introduced the new Nakamura-Tome NTRX-300, a multitasking turning center featuring complete parts machining in one operation, with a built-in load and unload automation system and advanced operator recognition management software. The NTRX-300 features true opposing twin spindles: an 8 in. A2-6 25 HP or […]
  • MSC Apex Diamond Python and Smart Midsurface speeds modeling to validation
    MSC Software announced a new release of MSC Apex, the company’s award-winning next generation Computer Aided Engineering (CAE) platform. The MSC Apex Diamond Python release introduces: · The fourth release of MSC Apex Modeler is a CAE Specific direct modeling and meshing solution that streamlines CAD clean-up, simplification and meshing workflow. New in this release is […]
  • Quality Metrics: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications
    Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]

Leave a Reply