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 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.
*Work performed by individuals while employed by Intensity, LLC. Intensity was acquired by Secretariat in February 2023.
References
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.
Comprehensive economic analysis finds no need to halt sales of device at center of patent dispute
Edwards Lifesciences thwarted a competitor’s bid for a significant temporary restraining order and preliminary injunction against its innovative PASCAL heart device after Secretariat and attorneys at Paul, Weiss, Rifkind, Wharton & Garrison LLP presented a comprehensive analysis refuting arguments for halting sales of the product.
Abbott sought a TRO and preliminary injunction in federal court in Delaware amid a global patent dispute over devices used to treat mitral regurgitation, where the leaflets of the mitral valve do not close tightly and allow blood to backfill into the heart. Abbott claimed PASCAL violated several of its patents and was harming sales of its competing MitraClip. Abbott sought injunctive relief and economic damages.
To evaluate the threatened TRO and preliminary injunction, Managing Director Dr. Ryan Sullivan prepared multiple expert reports for courts in the United States and Ireland, and provided live court testimony to examine the economic analysis underlying Abbott’s claim it would suffer irreparable harm and that the public interest and the balance of equities between weigh in favor of Abbott.
To assess the claim of irreparable harm, Dr. Sullivan determined not only the types of damage Abbott might suffer but whether it could be quantified and compensable. He also evaluated whether an injunction would address Abbott’s claimed harms and the extent of the economic relationship between the alleged patent infringement and the claimed harms. “The multifaceted economics issues combined with the importance of the case to both parties and patients made this an engaging project to apply our rigorous approach, “ Dr. Sullivan said. “I am very gratified that our work was a substantial basis for the court’s ruling.”
The public interest was an important consideration, since the dispute involved devices used to treat a common and dangerous heart condition. Secretariat conducted market research to determine if PASCAL benefitted patients and whether removing it from the market would cause unnecessary harm. Secretariat also weighed the relative hardships Abbott and Edwards would face if the court granted the injunction.
The firm’s economic analysis included an in-depth examination of products in the structural heart device marketplace, market definition, competition, pricing dynamics and existing licensing agreements. Secretariat also mapped out product substitution patterns at the customer level to accurately quantify Abbott’s claim of lost profits.
After considering Secretariat’s analysis and the legal arguments of Edwards’ attorneys, U.S. District Judge Maryellen Noreika denied Abbott’s motions for a TRO and a nationwide preliminary injunction. On July 13, Abbott and Edwards announced they had reached a settlement of all disputes involving the mitral regurgitation device patents. That agreement ended parallel litigation in Ireland, where Secretariat and Dr. Sullivan were prepared to present their analysis again.
*Work performed by individuals while employed by Intensity, LLC. Intensity was acquired by Secretariat in February 2023.
Intensity recognized amongst an elite group of businesses to earn this award.
Intensity joined Secretariat on February 1, 2023.
San Diego Business Journal named Intensity, LLC one of the top workplaces in San Diego, coming in at number seven in the small business category.
This annual curated list results from the corresponding award program dedicated to identifying, recognizing, and honoring the best employers in San Diego. As one of 2020’s Best Places to Work in San Diego, it is an honor to be featured on this prestigious list multiple times.
“Intensity’s selection to the list of Best Places to Work in San Diego for the fourth time reflects the commitment of the team to generating world-class work product, but moreover points to the genuine passion the team has for the company, its culture, and each other,” said Patrick Sanders, Chief Executive Officer of Intensity.
“Our success as a company stems directly from our talented and hardworking team, and the excellence they demand from each other every day.”
Companies from across the county entered the two-part survey process to determine the finalists for this list. The first part of the process consists of evaluating each nominated company’s workplace policies, practices, philosophy, systems, and demographics. The second part consists of an employee survey to measure their experiences. By combining the scores, the top companies and the final rankings are determined.
On August 27th, a virtual awards ceremony took place to honor the companies on this year’s Best Places to Work in San Diego list. A special issue of the San Diego Business Journal profiling each of the companies selected is scheduled to be published this month. For more information on the Best Places to Work in San Diego program, visit www.BestPlacestoWorkSD.com.
Intensity joined Secretariat on February 1, 2023.
Intensity was founded on the notion that combining world-class talent with recognized industry best practices produces the highest quality results possible. We proved this once again by producing a critical valuation for a client in Chapter 11 bankruptcy reorganization within a tight one-week deadline.
The case involved a major international airline with highly recognizable trademarks including logos, words, distinctive signs, and websites. When it comes to intangible assets like trademarks and intellectual property, our experts combine mathematical rigor with real-world judgment to value items that do not trade every day on the open market.
Our team huddled at the outset to develop a strategy for fulfilling the assignment within the deadline. We considered the relevance and feasibility of several methods commonly used to value intellectual property, including the cost, market and income approaches. Our analysis quickly revealed that the income approach was best in this specific case because it provides the most reasonable and accurate estimate of the true value of the airline’s distinctive brand markers.
The income approach measures the net present value of expected cash flows from an asset over its useful life. To derive that value for the trademarks in this case, our experts calculated the expected after-tax cash flows attributable to the brand and discounted them to the present at an appropriate interest rate. Given the particular facts of this case, we used the avoided royalty method, calculating the amount the airline would have to pay to license the trademarks and estimating the present value of “savings” the airline enjoyed by owning the brand outright instead of paying someone else to use it.
Pulling together the data, deciding on a valuation approach, and delivering a highly defensible estimate to the court within one week was yet another example of Intensity’s ability to assemble the right resources in a tight timeframe to deliver a world-class result.
Temporary insolvency is just one of many complications in fraudulent conveyance claims presented by COVID-19. Secretariat’s Paul Marcus, Sangjoon Lee and Brendan Porter examine the potential ramifications on determining companies’ value and solvency in fraudulent conveyance claims brought on by the global coronavirus pandemic.
Force majeure provisions in construction contracts have attained a spotlight perhaps never seen before as a result of the COVID-19 pandemic and the impact is it having on the US$10 trillion-dollar global industry. In this article from Secretariat’s Mike Allen, Conrad Bromley and Paul Roberts, we consider in more detail how tendering contractors and employers might seek to manage this risk in the ongoing waves of COVID-19, which are a feature of the “new normal.”
Intensity* was retained on behalf of a company that engages in the development and licensing of a significant patent portfolio pertaining to digital video receiver and interactive guide technology and provides consumer electronics hardware and software pertaining to the same. At the International Trade Commission, the company accused a large national cable provider of unlawful importation of certain digital video receivers and broadband gateways accused of infringing some of the company’s patents. Intensity was asked to perform both an economic domestic industry analysis pertaining to certain of the company’s products claimed to practice the patents as well as to provide an evaluation of the significance of the large national cable provider’s domestic inventory of accused products.
As part of its domestic industry analysis, Intensity researched the significance of the relevant products in the marketplace, quantified the relevant domestic investments, and demonstrated the significance and substantiality of the investments to the company and the marketplace in general. Intensity also provided an evaluation of the domestic industry of one of the company’s licensees for certain digital video receiver products claimed to utilize the asserted patents. Intensity’s domestic industry quantification and results were accepted in terms of accuracy and methodology, and Intensity’s client was able to secure a summary judgment order for economic domestic industry.
Intensity also demonstrated the commercial significance of the large national cable provider’s domestic inventory of accused products by assessing its commercial value and its sufficiency to meet forecasted demand. Based on Intensity’s analysis, the Administrative Law Judge recommended a cease and desist order in the Initial Determination.
*Work performed by individuals while employed by Intensity, LLC. Intensity was acquired by Secretariat in February 2023.
Secretariat is proud to welcome Manus Bradley and Conrad Bromley as the newest Managing Directors in the firm’s Dubai office. Together, they add significant depth to our already impressive construction team in the region, and for the first time, expand our services to include quantum capabilities.
Climate change is an existential threat to the planet. Increasingly, litigation and arbitration are being pursued as a means of forcing governments and companies to take responsibility for their actions and impacts on climate change. In this article, Secretariat Managing Director Andrew Maclay takes a look at some prominent cases in climate change litigation and arbitration and discusses their implications for the quantifications of damages.
Secretariat is proud to announce it has earned the second-place ranking in Global Arbitration Review’s prestigious GAR 100 Expert Witness Firms’ Power Index. According to Managing Director Don Harvey, “GAR’s Expert Witness Power Index is the definitive global ranking of expert firms across the international arbitration industry. Having the Secretariat name included in this class is an honor in its own right.” Mr. Harvey added “This achievement validates the hard work, commitment and sterling reputation our people are dedicated to earning every day and shows how we make ‘Experience Above All’ come to life.”
A full copy of the press release is available by clicking the link below
https://lnkd.in/dhGfnvg
A full copy of the rankings is available on the GAR website
https://lnkd.in/drzJY8n
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COVID-19’s impact on construction projects is immense in numerous ways, but we are only starting to learn what the long-term consequences will be. While some projects came to an abrupt halt, some continued, but with significant delays. Presented as part of Global Arbitration Review Live Construction Disputes at Paris Arbitration Week, Secretariat Managing Director Don Harvey will join an esteemed panel to discuss the effects COVID-19 is having on construction project progress and how delays can be viewed for the purposes of claiming extension of time.
