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Medical process patents are government-granted monopolies on conceptual methods for taking care of patients. Since the early 1990s, medical process patents have proliferated as a result of changes in the patent review process. Medical process patents now complicate medical practice, increase medical costs, restrict access to therapeutic and diagnostic procedures, and discourage innovation. Medical process patents are uniformly opposed by the American Medical Association, the Association for Molecular Pathology, the American College of Obstetrics and Gynecology, the American College of Medical Genetics, and many others.
Since 1999, I have maintained the free publicly available online HIV Drug Resistance Database, which contains several programs that enable clinicians and researchers and laboratories to obtain HIV-related information to help manage their patients’ treatment. In 2007, a company named Advanced Biological Laboratories (ABL), which had recently purchased two patents on the concept of using computers to help physicians make treatment decisions, approached Stanford University claiming that my work infringed their patents. In 2008, without my knowledge, a member of Stanford University’s general counsel together with the Dean of Medicine and Dean of Research negotiated a confidential agreement with ABL. According to the Stanford-ABL agreement, Stanford obtained immunity from ABL for the use of the HIV Drug Resistance Database at Stanford University Hospital and in return ABL licensed a family of contentious Stanford patents.
In 1996, Roche Molecular System (RMS) developed and obtained FDA-approval for a laboratory test for measuring the amount of HIV in a patient’s blood sample. In 2005, Stanford University’s general counsel sued RMS for $200 million dollars claiming that by offering “virus load” testing, RMS was inducing physicians to infringe a family of Stanford University patents that claimed ownership of the concepts of using virus load and drug resistance test results in patient management. The Stanford-ABL agreement required ABL to license Stanford University’s patents on both concepts in exchange for attempting to limit the use of the freely available HIV Drug Resistance Database. Several months after signing the ABL agreement, the Stanford University general counsel lost its case versus RMS in the district of Northern California. In 2009, the case versus RMS was lost in the Court of Appeals of the Federal Circuit. In 2011, the case was lost in the Supreme Court.
In June 2010, the Provost of Stanford University informed Stanford’s Faculty Senate that Stanford-ABL cross-licensing agreement was a serious mistake and indicated that the university would establish a process to ensure that faculty members are consulted on legal settlements that directly impact their research.
During the past three years, I have learnt much about the U.S. patent system, intellectual property law, abuses of the patent system, university licensing practices, and medical process patents. This website contains a summary of my experience and my ongoing three-year effort to invalidate the ABL patents through the United States Patent & Trademark Office (USPTO) reexamination process. The website also contains all of the legal documents pertaining to my experience as well as to the Stanford University patents that were cross-licensed in the Stanford-ABL agreement.
