Personalized medicine (also known as precision medicine) is an emerging medical practice whereby medical care is tailored for a specific patient. Healthcare providers may utilize diagnostic testing, responses to prior treatments, or even modified cells from a patient’s own immune system to deliver highly targeted therapies. Improved understanding of genomics and the mechanisms underlying disease has accelerated the development of personalized medicine.
Personalized medicine is poised to deliver tremendous value to patients over the coming years. Based on classification by the Personalized Medicine Coalition, 52 of 153 New Molecular Entities approved by the FDA from 2017 to 2019 were personalized medicines. In addition, four personalized gene therapies were approved by the FDA during this period. According to Global Market Insights, the personalized medicine market is projected to achieve a compound annual growth rate of 11% and exceed $119 billion by 2026. While personalized therapies are sometimes associated with high upfront costs, they have the potential to provide significant value because they are often highly effective, thereby avoiding the inefficiencies associated with less effective treatments.
Understanding the intellectual property and economic damages issues relating to personalized medicine can be a complex endeavor that requires an in-depth understanding of the marketplace and the value of cutting-edge medical innovation. Intensity has significant experience in analyzing economic issues for a variety of cutting-edge biotechnology innovations, including personalized medicine.
One economist at Intensity working on the intellectual property issues relating to personalized medicine is Dr. Anushree Subramaniam. Dr. Subramaniam has substantial experience analyzing the economic value of personalized medicine and has a keen understanding of the underlying economic factors and considerations relating to these unique therapies. Dr. Subramaniam’s academic work at the University of Chicago focused on the economics of healthcare innovation, and at Intensity, she frequently provides economic insights on a variety of cases relating to biotechnology and pharmaceutical innovation.
Dr. Subramaniam recently worked with Intensity’s President and Founder, Dr. Ryan Sullivan, on behalf of Juno Therapeutics and Sloan Kettering in a patent infringement case involving CAR-T therapies. CAR-T therapies are a personalized form of immunotherapy that uses a patient’s own immune system to fight cancer. CAR-T therapies are made from a patient’s own T-cells. As part of a CAR-T treatment regimen, T-cells are extracted from the patient’s blood and are modified to produce structures called chimeric antigen receptors (CARs) on their surface. These CAR receptors make the cells better at detecting cancerous cells and destroying them. When these reprogrammed cells are reinfused into the patient, the CAR receptors enable the cells to kill tumor cells more effectively. Juno Therapeutics and Sloan Kettering claimed that Kite Pharma, a subsidiary of Gilead Sciences, infringed upon U.S. Patent 7,446,190, which relates to encoding chimeric T-cell receptors to facilitate a T-cell response to attack cancer cells. The product at issue was Kite Pharma’s Yescarta product.
Intensity performed an in-depth economic damages analysis and provided trial testimony relating to this matter. Intensity analyzed the economic contributions of the patented technology to Yescarta, the availability of non-infringing alternatives, available license agreements, the competitive relationship between the parties, the CAR-T innovation landscape, first-mover advantages enjoyed by Kite, and the harms to Juno from infringement.
The jury returned a verdict in favor of Juno and Sloan Kettering, with a damages amount that matched precisely the amount put forth by Dr. Ryan Sullivan. The damages award consisted of an upfront payment of $585 million and a running royalty rate of 27.6% on net sales of Kite’s Yescarta product. The resulting damages award was $752 million, which excluded potential future running royalties. A California federal judge subsequently awarded an additional $389 in enhanced damages in a final judgment, thereby resulting in a damages award of more than $1.1 billion.
Personalized Medicine Coalition, “Personalized Medicine at FDA: The Scope & Significance of Progress in 2019,” c. 2019, available at: http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PM_at_FDA_The_Scope_and_Significance_of_Progress_in_2019.pdf.
Personalized Medicine Coalition, “Personalized Medicine at FDA, “Personalized Medicine at FDA: A Progress & Outlook Report,” c. 2018, available at: http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PM_at_FDA_A_Progress_and_Outlook_Report.pdf.
Personalized Medicine Coalition, “Personalized Medicine at FDA: 2017 Progress Report,” c. 2017, available at: http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PM_at_FDA_2017_Progress_Report.pdf.
Cision PR Newswire, “Precision Medicine to Register Over 11% CAGR through 2026: Global Market Insights, Inc.,” 3/3/2020, https://www.prnewswire.com/news-releases/precision-medicine-market-to-register-over-11-cagr-through-2026-global-market-insights-inc-301014696.html.
Law 360, “Jury Says Kite Pharma Owes $752M for Infringing Patent,” 12/13/2019, https://www.law360.com/articles/1228249.
Law 360, “Juno Awarded Over $1.1B in Final Judgment for IP Case,” 4/8/2020, https://www.law360.com/articles/1261928/juno-awarded-over-1-1b-in-final-judgment-for-ip-case.