New medical device regulations may affect patent filings for medical device inventions in India
The medical device sector is one of the fastest growing industries in India and has witnessed a steady double-digit growth. A study conducted by Deloitte in association with the Indian Health Care Federation revealed that the Indian medical device market is expected to reach the market size of $50 billion by 2025.
The two primary laws governing the quality and safety of medical devices in India are the Drugs and Cosmetics Act (1940) and the Medical Devices Rules (2017). The term ‘medical devices’ comes under the definition of ‘drugs’ under the Drugs and Cosmetics Act. Until very recently, the medical device sector was largely unregulated in India, with a mere 37 medical devices subject to regulation. However, in order to better monitor this sector and widen the scope of medical devices that are regulated, the definition of ‘drugs’ was amended on 11 February 2020, at the same time as the Medical Devices Rules were updated. The combined effect of these changes has been that as of 1 April 2020, all medical devices imported into or manufactured in India must be regulated under the Drugs and Cosmetics Act and the Medical Devices Rules.
The amended definition of ‘drugs’ under the Drugs and Cosmetics Act is as follows:
All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception. (Newly notified medical devices)
Further, the updated Medical Devices Rules make the registration of all the newly notified medical devices compulsory before the Drugs and Controller General of India before 1 October 2021, with the exemption of the earlier 37 notified devices. Manufacturers and importers of medical devices must now register their products on the Central Drugs Standard Control Organisation’s (CDSO) online portal, along with an ISO 13485 standard (accredited by the National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of medical devices) and a freely available sale certificate from the country of origin for importers. Appropriate licences are now compulsory under the Medical Devices Rules for newly notified devices that fall under Class A (low risk devices) and Class B (low to medium risk devices) by 11 August 2022 and for newly notified devices falling under Class C (medium to high risk devices) and Class D (high risk devices) by 11 August 2023. However, it will not be necessary to register the 37 medical devices that were notified prior to the amendments in 2020, with the CDSO.
The huge potential of the medical devices sector in India is a lucrative opportunity for innovators and they should take care to protect their inventions under the Patents Act (1970). A study by two Indian authors revealed that some of the top applicants for medical devices patents in India have been Philips, Ethicon and Sanofi. While the Act contains no blanket prohibition on the patentability of medical devices, a patent application directed at a medical device may be met with objections under Sections 3(f), 3(i), and 3(k).
Section 3(f) prohibits patenting inventions that are a mere arrangement or rearrangement of known devices, each functioning independently with their functions being already known. Thus, in order for a medical device invention to avoid an objection under Section 3(f), it is necessary to show that the medical device is more than a mere workshop improvement and the combination of the known devices must be shown to result in a better and cheaper alternative. Section 3(i) may present an obstacle where the claims in the patent application describe the invention as a method of treatment for human beings and animals rather than as a medical device. Therefore, inventions must not be directed towards monopolising any method of diagnosis or treatment of a medical condition on the human body or animals and instead be directed towards a medical device, which functions independently of a human or animal. Lastly, Section 3(k) may affect a patent for a medical device involving the use of computer software, as it prohibits patenting of computer programmes per se. However, this objection can be circumvented by demonstrating precisely how the computer software is interrelated to the working of the medical device. A few examples of medical devices employing software technologies are CT scan machines and in vitro diagnostic devices, among other things.
For patent applicants filing for medical devices in India, it is advisable that claims be drafted in such a way that they suitably circumvent aspects of Section 3. Further, the timely amendment of the Drugs and Cosmetics Act and the Medical Devices Rules is a welcome opportunity to strengthen the regulation and commercialisation of medical devices in India so as to more fully exploit the huge potential of the medical device sector.
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