As new biomarkers are identified to classify disease and customize treatments to individual needs, Supreme Court legal battles are in process to determine whether a private company can own the rights to a particular biomarker.
In an article published recently in the New England Journal of Medicine (NEJM), Jason Karlawish, MD, professor of Medicine, Medical Ethics and Health Policy in the Perelman School of Medicine at the University of Pennsylvania, and coauthor Aaron S. Kesselheim, MD, JD, MPH, from Brigham and Women’s Hospital and Harvard Medical School, explore a series of high-profile court cases in which the limits of patent protection are tested.
Since a US Supreme Court ruling unanimously “rendered invalid 2 patents covering a method for determining proper drug dosage,” as Nature reports, discussions have escalated about how to pay for personalized medicine. The NEJM coauthors report that, “a patentable process now needs to involve an inventive and novel application of a law of nature beyond well-understood, routine, conventional activity, previously engaged in by those in the field.”
Some argue that there is no way to recover biomarker innovation costs without patents protecting the medical discoveries. In response, Supreme Court Justice Breyer questioned whether special market-exclusivity protection was necessary.
Rather, Karlawish and Kesselheim propose that enhanced public funding, public-private partnerships, and open-source consortia may improve biomarker discovery and development over a private model. According to the NEJM piece, “the Supreme Court’s move to free the fundamental processes of medical diagnosis from private ownership…could ultimately enhance the public health.”
In any case, as biomarkers become more and more predominant, solutions will be necessary for guaranteeing access to and paying for personalized medicine.
Source: Penn Medicine.