To be or not to be exclusive: the sutezolid story

Johns Hopkins University is deeply committed to providing access to essential medicines, and has been working for years to advance the goal of ensuring that promising therapies for tuberculosis reach the market in an expeditious and accessible way. As with other promising drugs in the early stages of development, sutezolid is not yet ready for patients, and will require costly development and approval steps before it can help to address tuberculosis. At this stage, there are scant data on sutezolid's safety or efficacy in patients with tuberculosis. A series of clinical trials, which typically cost more than US$50 million, will be required to understand these issues and inform potential benefits versus potential risks to patients. Sutezolid's early stage of clinical development sets it apart from the in-market or late-stage clinical development HIV medicines targeted by the Medicines Patent Pool.1UNITAIDA review of the sutezolid (PNU-100480) patent landscape. World Health Organization, Geneva2014: 4http://www.unitaid.eu/images/marketdynamics/publications/PNU-10048_Patent_Landscape.pdfGoogle Scholar In this case, the story is further complicated by the fact that Johns Hopkins University does not own patent rights for the sutezolid compound; thus, our intellectual property is not necessary for the clinical development and commercialisation of sutezolid itself. Johns Hopkins is part of a jointly assigned patent application with Pfizer Inc entitled “Combination therapy for tuberculosis” (WO2010026526A1), and is limited to the use of sutezolid in combination with other compounds to treat tuberculosis. The development of sutezolid requires a strong outside partner who can take on the costs and risks of the next steps: but such a partner is unlikely to be found without an appropriate set of assurances around their ability to recover their investment. Our challenge is to ensure that we provide the incentives to invest in the development of this compound, while also promoting our interest in the widespread distribution of medicines at an affordable price. As researchers and clinicians devoted to human health, Johns Hopkins University aims to ensure the best use of its intellectual property. Indeed, we seek to partner with those organisations who are most willing to pursue development, obtain regulatory approval, and bring this promising combination technology to patients. Furthermore, we aim to respond to the great unmet global need around tuberculosis and the dearth of companies investing in this area. I declare no competing interests. To be or not to be exclusive: the sutezolid storyI arrived at the Johns Hopkins University campus with a sense of déjà vu; it was my first visit to my alma mater in years. I had travelled to Baltimore for a meeting about the licensing of sutezolid, a much-awaited drug candidate for treatment of Mycobacterium tuberculosis. The research faculty, technology transfer officers, university administration, and advocates at the meeting felt the weight of the responsibility. We knew that licensing a tuberculosis drug candidate could be a historic event. Full-Text PDF Open Access