Goutam Bhattacharyya Shweta Khurana January 11 2023 Medical devices and diagnostic inventions in India: patenting trends K&S Partners | Healthcare & Life Sciences - India Goutam Bhattacharyya, Shweta Khurana Healthcare & Life Sciences IntroductionTop applicantsYearly number of patent filingsCPCs with most patenting activityGlobal patenting activityCommentIntroductionThe Indian medical devices market is the fourth largest in Asia, after Japan, China and South Korea, and it is among the top 20 globally. As of 2020, the Indian medical devices market was estimated to be worth $12 billion, with an expected compound annual growth rate (CAGR) of 15% – two-and-a-half times the global growth rate. Between 2020 and 2025, the diagnostic imaging market is expected to expand at a CAGR of 13.5%.IP laws – primarily those concerning patents – play a crucial role in promoting innovation relating to medical devices. This article, the second in a series on medical devices in India,(1) focuses on the patenting trends for inventions relating to medical devices.Top applicantsFigure 1 shows the top 10 applicants that filed patent applications in India pertaining to this area in the past 10 years.Figure 1: top 10 applicants that filed patent applications in India pertaining to medical devicesThese patenting trends are based on a broad search on "www.lens.org" in the past 10 years in the Indian jurisdiction using the following string:((MEDICAL OR HEALTH OR BIOMEDICAL OR BIO-MEDICAL) AND (DEVICE OR APPARATUS OR SYSTEM OR MACHINE))Figure 1 shows that Koninklijke Philips NV is the top player in terms of patenting activity in the field of medical devices in India, followed by Fresenius Medical Care and Dentsply.Yearly number of patent filingsA year-by-year analysis of patent applications filed over the past decade shows that the period between 2013-2016 saw the highest degree of patent filings (Figure 2). Between 2017 and 2020, there were almost no patent filings in this area.Figure 2: number of patents filed per yearCPCs with most patenting activityThe cooperative patent classifications (CPCs) in which there was most patenting activity include:G16H (healthcare informatics);A61B (diagnosis; surgery; identification);A61L (methods or apparatus for sterilising materials or objects in general; disinfection, sterilisation, or deodorisation of air; chemical aspects of bandages, dressings, absorbent pads, or surgical articles; materials for bandages, dressings, absorbent pads or surgical articles); andA61K (preparations for medical, dental or toilet purposes).Figure 3 below shows the top 20 CPCs in the area of medical device patenting.Figure 3: top 20 CPCs in the area of medical patentingGlobal patenting activityA global analysis shows that India remains among the top 20 jurisdictions in terms of the number of patent applications pertaining to medical device inventions.Figure 4: top 20 jurisdictions in terms of the number of patent applications relating to medical devicesThis shows that, despite regulatory issues, India provides a favourable ecosystem for innovation in the medical device sector, although it seems to be dominated by foreign players.CommentIn the era of multi-disciplinary research, the health tech ecosystem is undergoing significant evolution and expansion. Examples include:medical devices that use artificial intelligence;connected devices;the internet of things;healthcare innovations with augmented reality (AR) – by wearing an AR-enabled head-mounted device, surgeons can now view patients' vitals during a procedure without the need to look away and gather data from multiple displays;machine learning;robotics for surgical precision;and tissue engineering using 3D printing.Recent advancements in molecular biotechnology such as the following have also opened new vistas in the healthcare ecosystem:micro ribonucleic acid as a next-generation therapeutic and diagnostic agent;applications of clustered regularly interspaced short palindromic repeats-Cas-based diagnostics and genome-editing tools (for further details, see "Untapped potential of CRISPR in India: IP perspective");engineered gut microbiomes for treating diseases; andstem cell technology and regenerative medicine.It is evident from these examples that India's health tech ecosystem is growing at a rapid pace. According to a report by Inc42,(2) healthcare software-as-a-service is set to become a $3.5 billion market opportunity, growing at a three-year CAGR of 45%.To continue this growth spurt, the IP system must evolve to embrace the medical field's advancement. Futuristic technologies require fundamentally new encouragement mechanisms and pose new issues for intellectual property. There is a clear need to re-examine the relevant provisions in the Patent Act to provide opportunities for patenting inventions in this area so as to incentivise innovators.For further information on this topic please contact Goutam Bhattacharyya or Shweta Khurana at K&S Partners by telephone (+91 80 4042 7900) or email ([email protected] or [email protected]). The K&S Partners website can be accessed at www.knspartners.com.Endnotes(1) For the first article in the series, see "Medical devices and diagnostic inventions in India: patentability requirements".(2) The State of Indian Start-up Ecosystem Report, 2022.