The U.S. Supreme Court heard oral arguments this week in a case that could have wide-reaching implications for health care: Whether medical patents should be allowed.
At issue is the specter of doctors being sued for patent infringement based on treatment decisions derived from the scientific research underpinning the patent.
The case involves Prometheus Labs, which sued a Mayo Clinic group over a diagnostic test used to detect metabolite levels of the stomach drug thiopurine. The Prometheus patent covers a range of metabolic readings indicating a patient’s rate of uptake of the medicine, which is used to treat conditions like Crohn’s disease or inflammatory bowel disease.
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Prometheus argues that the patent covers the real-world application of scientific research, which is allowed under U.S. patent law. If the Supremes buy this, it would mean that a doctor prescribing thiopurine would infringe the patent just by being aware of the research disclosed in the patent, according to ars technica.
The Mayo Clinic – and a host of interested parties, which deluged the court with amicus briefs – counter that allowing the patent would give the Nestle subsidiary a de facto monopoly over the correlation between the metabolite levels and the drug’s effect on patients.
World Wide Medical sues J&J, Coloplast, others over brachytherapy patent
World Wide Medical Technologies and two allied businesses sued 8 medical device makers, including some of the biggest names in the business, over its patent covering brachytherapy needles.
Oxford, Conn.-based World Wide alleges that Coloplast Corp. (FRA:CBHC), Core Oncology (which bought the allegedly infringing technology from Coloplast in 2007), Johnson & Johnson’s (NYSE:JNJ) Mentor Corp. subsidiary, GE Healthcare’s (NYSE:GE) Oncura unit, C.R. Bard (NYSE:BCR), Best Medical International Inc., Theragenics Corp. (NYSE:TGX) and IsoRay Medical (NYSE:ISR) all violated the patent.
The lawsuit seeks a jury trial, a ruling of willful infringement, damages and legal costs. Read more
Invacare in talks with FDA over wheelchair consent decree
Invacare Corp. (NYSE:IVC) said it’s negotiating with the FDA over a consent decree stemming from violations the watchdog agency found at the company’s wheelchair-making plant.
"The FDA has proposed a consent decree that would require suspension of certain operations at the facilities until they are determined by the FDA to be in compliance," the Elyria, Ohio-based home health care products giant said. "Invacare has confirmed that it intends to enter into discussions with the FDA regarding the terms of the consent decree." Read more