The Cancer Immunotherapy Pilot Program and Chimeric Antigen Receptor-T Cell Treatments
Ellen Shamansky The Cancer Immunotherapy Pilot Program (also known as Patents 4 Patients) provides fast-track review to patent applications describing methods of treating cancer with immunotherapy, such as chimeric antigen receptor (“CAR”)- T cell treatments. This article explores considerations for claiming CAR-T cell treatments, including court rulings and examiner guidelines on patentable subject matter in the life sciences, the Federal Circuit’s decision in NantKwest, Inc. v. Lee in 2017, and pending applications and current litigation over CAR-T cell treatments. Read Full Text Here
Interoperability’s Role in Striving for Precision Medicine
Martha Koroshetz President Obama announced the Precision Medicine Initiative in his 2015 State of the Union address, a research effort to find treatments that are tailored to specific genetic profiles and characteristics. This personalized and context-specific treatment approach will require big data analysis of patient outcomes and their genetic sequence, which must then be accessible and comprehensible to caregivers. The initiative must therefore be able to reconcile genetic data, demographic information, and health information, in the electronic health record. To achieve data interoperability, the organizations engaged in the initiative must confront questions of data privacy, standardize data exchange, and incentivize...
Data Exclusivity for Biologic Drugs: The TPP’s Potential Poison Pill?
Tina Cheung On October 5, 2015, after many years of secretive negotiations, the US government with 11 other countries across the Asia Pacific and Latin America reached an agreement on the largest free-trade deal in history, the Trans-Pacific Partnership (TPP). Addressing everything from wildlife conservation and tax reductions for agriculture, to the free flow of information on the Internet and intellectual-property rights for movies and pharmaceutical drugs, this far-reaching agreement has the potential to impact up to one-third of world trade. One of the most contentious parts of the agreement involves intellectual property rights of pharma companies to data exclusivity...
Telemedicine & the Courts: Teladoc v. Texas Medical Board as a Case Study
Mary Delsener Today, health insurance companies such as Aetna and United Healthcare have partnered with telemedicine companies in order to provide the service for its members. Teladoc, Inc., which markets itself as the first and largest telehealth provider in the United States, is one such company. Of all of business generated by Teladoc’s 11.5 million members, one quarter comes from Texas. Over the course of the past year, however, Teladoc’s ability to continue its services in the state has been on legally tenuous ground due to repeated steps taken by the Texas Medical Board to oust the company from its...
Telemedicine’s Opportunities and Risks; A Balancing Act
Robert Park Obstacles that can complicate successful implementation of telemedicine are the legal ramifications. Legal complications can include fraud and abuse, patient confidentiality, and compliance with state requirements. Violation of patient care can result in heavy fines, and in telemedicine, a recent case involving the Texas Medical Board and a Telemedicine company could heat up within the coming months. Because of these obstacles, healthcare organizations face an arduous journey to getting reimbursed for implementing telemedicine. Read Full Text Here
The Daraprim and the Pharmaceutical Pricing Paradox: A Broken System?
Franklin Liu In a recent study by the American Association of Retired Persons (AARP), the average prices for brand-name prescription drugs were found to have increased by an average of 13 percent in 2013, compared to the inflation rate the year of just 1.5 percent. The Daraprim and Cycloserine cases, while extreme illustrations, depict a broader trend of increasing U.S. drug and health care costs to patients. The two manufacturers’ pricing decisions illustrate a longstanding tension in the pharmaceutical industry between the need for firms to recoup the high costs associated with bringing drugs to market and keeping drugs affordable...