CAR-T Innovative Technology with Surge in IP
A process to manufacture or develop a therapeutic drug is a highly complex matter that requires deep involvement of numerous elements such as drug discovery, clinical trials, FDA approval, and IP feasibility. The use of CAR-T cell (Chimeric antigen receptor T cell) therapy in medicine embodies the essence of the future therefore healthcare companies are working more eagerly towards it. The CAR-T cell therapy has already shown a great potential to sideline the traditional therapy system because of its targeted action with no or minimal side effects. Many leading research firms are filing patents across the globe thereby creating a massive impact on advancement in CAR-T cell therapy.
The business landscape and scientific research strategy of the pharmaceutical industry have undergone a far-reaching change from the last two decades. While a drug candidate is going through the drug discovering pipeline, clinical trials and patent filing aspects for new drug production should be thoroughly considered, wherein patent protection and intellectual property plays a significant role in supporting a successful pharmaceutical business. In other words, it is the real backbone of cushioning the innovation. Intellectual property rights and patentability frameworks have metamorphosed into formally adopting the innovative CAR-T cell therapy. In the drug development process, the new drug approved by FDA rings the doorbell of patent valuation.
Overall, the CAR-T cell therapy market is predicted to jump up to more than $13.5 billion by 2026. The well-known two promising products approved by the US Food and Drug Administration (FDA) are Gilead’s YESCARTA and Novartis’s KYMRIAH, wherein Gilead’s YESCARTA claimed an overall response rates of 72% in aggressive B-cell non-Hodgkin lymphoma whereas Novartis’s KYMRIAH demonstrated 83% in B-cell acute lymphoblastic leukemia. The CAR-T cell therapy has been constantly climbing up the worth, as proof having had a sight on $456 million sales that Yescarta had in 2019, and is expected to reach $1 billion by 2021. Following that Kymriah reported $278 million sales in 2019, and $1 billion in annual sales within a few years is projected by Novartis.
CAR-T cell therapy has become a valuable asset in medicine, therefore the expansion in research and development has been increasing year after year. The patent filing trend is conclusive proof of therapy showing the upward spike. Approx. 1700 patent families had been filed worldwide on CAR-T cell therapy applications over the period between 1998 to 2017 – only three patents were published in the US in 2010, and approx. 700 patents were filed until 2019 in the US. Similar growth was observed in the EPO and the Patent Cooperation Treaty (more than 450 PCT applications had been published in 2018). The top assignees in the domain are The University of Pennsylvania holding the first place with approx. 144 patent families, followed by the National Institute of Health-US with approx. 83 patent families, and Novartis and Memorial Sloan Kettering Cancer Center in the third place with 74 patents each.
It can be concluded from the patent trends that there are several reasons responsible for the IP surge and success in CAR-T cell therapy. The primary reason for high patent filing is due to the role of CAR-T cell therapy in various disease conditions, such as the therapy is prominent in the treatment of cancer, autoimmune diseases, and orphan diseases. Another reason is the use of CAR-T cell therapy for various disease conditions offers no or minimal side effects because the therapy molecules work at a specific cell level.
As per clinical data statistics, the CAR-T cell therapy emerges as the most promising and concrete technique for treating cancer, wherein CARs natural proteins are manipulated in such a way that the T-cells specifically bind to cancer cells. The researchers genetically modify the T-cells and further express CARs on their surface. After re-programing, these cells are incorporated into the body where CAR-T cells kill tumor cells. Such clinical data points and a variety of benefits of CAR-T cell therapy have built confidence for research and development, and thereby a rise in IP filing activity has been observed.
Pharmaceutical companies are considering CAR-T cell therapy as a better option, thus they are collaborating with biotechnological companies to boost the role of CAR-T cells in the therapeutic market and flourish their businesses. For example, Kite Pharma has recently been acquired by Gilead Science, that holds a leading-edge cell therapy technology and a new oncology drug (Kymriah), Immune sequencing method developed by Abvitro is taken up by Juno therapeutics for development. Such collaborative works, pharmaceutical-biotechnological collaboration, benefits of CAR-T cell therapy, role in various disease conditions, and other various factors contribute to the surge of the CAR-T cell therapy.