PATENTS BIOMEDICAL HEALTHCARE

PATENTS IN BIOMEDICAL AND HEALTHCARE INDUSTRY IN INDIA

Biomedical Engineering and Healthcare Industry in India – An Introduction:

Biomedical engineering is the application of engineering and technology applicable to the domain of living or biological systems, with an emphasis on human health and diseases¹. It also involves the designing of medical devices and its use for treatment of various diseases. The healthcare sector includes biomedical technology, medical devices, clinical trials, telemedicine, medical equipment. The healthcare sector is a booming at a brisk pace that have helped Indian economy to grow².

Biomedical Engineering and Healthcare Industry in India:

The Biomedical Engineering and Healthcare market is expected to increase three-fold to INR 8.6 trillion (US$ 133.44 billion) by 2022. The medical tourism is increasing at the rate of 18% per year and is expected to reach US$ 9 billion by 2020³. With the rise in Gross Domestic Product (GDP), the scope of healthcare services is expected to strengthen in the coming future. In the past few years, the expenditure of government have increased from 1.2% in FY14 to 1.4% in FY18. The rise in market share of health insurance has reached to US$ 6.06 billion in FY20 (upto January 2020)³.

The medical device industry in India is the 4^th largest market for medical devices in Asia. It is estimated to be worth around $50 billion by 2025. The medical device industry consists of Multinational Companies, Small and Medium Enterprises (SMEs) and several Start-Up Companies ⁴. Medical devices industry in India has the potential to grow at 28% p.a. and with recent government initiatives such as Startup India, Make in India, 100% Foreign Direct Investment (FDI), the Indian medical device industry is expected to witness aggressive IP filing and innovation trends and is poised to grow exponentially targeting US$50 billion industry by 2025⁴. The key market shares out of the total medical devices industry (2016) includes – Diagnostic imaging-36%; Consumables – 19%; Patient aids – 9%; orthopedic prosthetics – 8%; Dental products- 4⁵.

Text Box: 2020F — Figure 1 Healthcare Sector Growth trend (US$ billions)

Medical Devices and Patent Filing Trends:

The Indian Patents Act, 1970 does not include any definition for the term medical device. However, the term is defined under the Medical Device Rules 2017 in section 2(zb) as :

2. In these rules, unless the context otherwise requires,-

…..

(zb) “medical device” means,-

(A) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i),

(B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii),

(C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act;⁶

The emerging trends in the Biomedical and Healthcare field like introducing robotics in medical devices, wearable health devices, brain research, introducing artificial intelligence, other applications of technologies like cloud computing and big data analytics are major patentable subjects in the medical and healthcare industry. The trend of patent filings in the medical device sector has only 3.6% contribution during the last 5 years (2013–2017).

However, one major obstacle for players in the diagnostic sector is that diagnostic methods not patentable under section 3 (i) of the Indian Patents Act, 1970.

Major players in the medical device industry as per the Patent Filings:

With the permission of 100% Foreign Direct Investment in medical devices through the automatic route, an increasing number of MNCs for example Johnson & Johnson, General Electric Co., Medtronic Inc. Siemens, Baxter International Inc. and Koninklijke Philips Electronics N.V. (Philips), Ethicon Endo-Surgery (Ethicon), Baush & Lomb and Sanofi-Aventis Deutschland GmbH (Sanofi) are setting up their manufacturing bases in India. These MNCs are the top 10 applicants in terms of patent filings who are dominant in Indian market.

The domestic players in the highly import dominated field of medical device players include Zimmer India, BPL healthcare India, Sushrut Surgicals, Forus Health, HD medical services (India), WIPRO technology, HCL Technologies, Nidhi Meditech system. With the increase in trend of filing the patents on medical devices by start-ups, SMEs and commencement of Patent Prosecution Highway pilot program between India and Japan starting from November 21, 2019; it will be advantageous for the medical device market to flourish.

Government Initiatives and Policies in Biomedical Engineering and Healthcare Industry in India:

Some of the major initiatives taken by the Government of India to promote Indian healthcare industry are as follows³:

In Union Budget 2020-21, Rs 35,600 crore (US$ 5.09 billion) has been allocated for nutrition-related programmes.
The government has announced Rs 69,000 crore (US$ 9.87 billion) outlay for the health sector that is inclusive of Rs 6,400 crore (US$ 915.72 million) for PMJAY in Union Budget 2020-21.
The Government of India aims to increase healthcare spending to three percent of the Gross Domestic Product (GDP) by 2022.
On September 23, 2018, Government of India launched Pradhan Mantri Jan Arogya Yojana (PMJAY), to provide health insurance worth Rs 500,000 (US$ 7,124.54) to over 100 million families every year.
The Government of India has launched Mission Indradhanush with the aim of improving coverage of immunisation in the country. It aims to achieve atleast 90 per cent immunisation coverage by December 2018 which will cover unvaccinated and partially vaccinated children in rural and urban areas of India.

Future Prospects in Biomedical Engineering and Healthcare Industry in India:

India being the fourth largest market for medical devices in Asia have lots of of opportunities for players in the medical devices industry. India’s healthcare industry is expected to reach $280 billion by 2020³. The medical and hospital industry in India is estimated to rise to Rs 8.6 trillion (US$ 132.84 billion) by FY22 from Rs 4 trillion (US$ 61.79 billion) in FY17 at a CAGR of 16-17 per cent. In future, Government of India is planning to increase the public health share to 2.5 per cent of the country’s GDP by 2025³. Further, by giving special importance on the subject of several initiatives started by government like Make-in-India, that opens new direction to a flourishing future of biomedical health technologies and new inventions for providing affordable healthcare to India’s billion-plus population⁷.

REFERENCES:

For more information on Patent Rights, Biomedical Engineering & Healthcare industry in India please contact us at info@ssrana.com or submit a query.

Patent Filing in India

Patent Application Drafting in India