• Author: Suma B.- Patent Agent - RKD Bangalore Office

Biomedical engineering is a unique combination of medicine, biology and engineering or rather the application of engineering principles to medicine and biology. The specialization is not widely publicized, but the booming healthcare sector in the Indian economy has paved the way for many multinationals to set up shop in India in this specialty. This in turn is raising the awareness of the field on the educational front.

With the liberalizing of Government Policies, even 100% Foreign Direct Investment is permitted in Medical devices through the automatic route. Taking advantage of this lucrative opportunity, an increasing number of MNCs are setting up their manufacturing bases in India. Examples being Johnson & Johnson, General Electric Co., Medtronic Inc. Siemens, Baxter International Inc. and Koninklijke Philips.

Year 2017 has seen emerging trends like robotics, wearable device and brain research and it is expected to be revamped in the upcoming years. The year 2018 is said to witness how technology will contribute in uplifting the healthcare sector with application of technologies like cloud computing and big data analytics in medical image processing also knowledge of material science in developing low cost instrumentation.

Startups are expected to bring innovation while refurbishing the sector by combining technologies like AI (Artificial Intelligence) and machine learning with traditional practices in the healthcare.

Patenting activity is a definitive indicator of the innovation happening in the healthcare sector. On the basis of subject matter, patents in biomedical engineering can be broadly classified into diagnostic and therapeutic.

Patent application filings in the medical device sector during the last 5 years (2013–2017) contributed only 3.6% of the total patent applications filed, which may be attributed to a nascent medical device sector and lack of Intellectual Property (IP) awareness or funding support for IP filings. The analysis shows increasing trends in medical device patent applications in India, with a major share of the patent applications being filed from the USA. Although foreign players dominate the medical device sector, studies indicate that as, at a small scale, Indian applicants are actively filing patents in all key domains this sector.

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

Another hurdle faced by the IP departments in healthcare MNCs is getting clearance from the atomic energy department under section 4 of the Indian Patents Act, 1970 for particle emission imaging system (including X-ray and PET).

About seven hundred patent applications have been made till now at the IPO for the diagnostic sector and about 34 have been granted and in the therapeutic sector the number of applications stand at four hundred fifty and about 38 have been granted.

Major players in this patent field are, Johnson & Johnson (400 applications, 40 granted), General Electric Co (500 applications, 40 granted)., Medtronic Inc (600 applications 50 granted). Siemens (470 applications, 40 granted) Baxter International Inc. (470 applications, 40 granted) and Koninklijke Philips (470 applications, 40 granted).

Patenting activity is only expected to increase in the coming years with the enabling environment being provided by the Government of India as a result of recent policy initiatives such as Startup India, Make in India, 100% Foreign Direct Investment (FDI) and so on and support to start-ups for IP filings, the Indian medical device industry is expected to witness aggressive IP filing and innovation trends and is poised to grow exponentially.

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