The Indian medical device market is among the top 20 in the world and is expected to reach INR 794.29 billion by the end of 2023. Whilst highly lucrative, this market also presents a highly competitive environment. To stay ahead in the game, therefore, protecting one’s invention and ensuring its timely introduction in the market are key factors.
While the Indian Patents Act, 1970 (the Act) deals with patent protection, in the case of medical devices specifically, the import, manufacture, or sale of such devices also needs to comply with the required quality standards and regulations provided in the Drugs and Cosmetics Act, 1940 (DCA), and the Medical Device Rules, 2017 (MDR). This note provides a brief guide to the statutory and regulatory requirements governing this field, and focuses on the issues that must be considered when applying for a patent for a medical device. It also discusses the new provisions of the MDR which have introduced significant regime changes for bringing a medical device into the Indian market.
Patentability of Medical Devices
Medical devices are patentable in India with certain caveats. Section 3 of the Patents Act lists statutorily non-patentable inventions, which pose a challenge to patentability depending on the subject matter claimed. In summary, a patent application for a medical device in India is often objected to under Sections 3(i), (f), and (k). Section 3(i) is unique to this jurisdiction and precludes the patenting of methods of treatment in general. However, there is no bar in obtaining a product patent for a medical device. This section discusses these provisions in detail.
Section 3(i) is relevant with regard to medical devices as it prohibits the patenting of “any process for the medicinal, surgical, curative, prophylactic [diagnostic, therapeutic] or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products”. Therefore, claiming methods of use or the operation of a medical device for any treatment or diagnostic procedures is best avoided in patent applications. A case in point is patent application 634/MUMNP/2010, where the claims recited a method for monitoring the pressure of an inflatable cuff of an airway device, and did not mention any use of the device on the human body. The Controller in this case rejected the application on the grounds that the scope of the claims, when read with the specification, was clearly directed to the use of the device for a method of treatment of a patient during a medical procedure. In the same vein, claiming the use of a device for a method of treatment is also not advisable, as the Indian Patent Office (IPO) does not recognise ‘use’ claims per se.
Therefore, in order to avoid section 3(i) objections, it is best not to disclose any feature in which the invention is used in any way for treating the human body either externally or internally, or alternatively, include embodiments in the specification of an application where the functioning of the device is independent of the human body. An exception to this lies in methods for manufacturing prostheses or artificial limbs and taking measurements for these purposes on the human body, which are considered patentable. Claims directed towards a system for using a medical device also do not fall under the provisions of section 3(i).
The patentability of mechanical devices, in general, also falls under the purview of Section 3(f). This section prohibits patenting of inventions that are “the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way”. This was further clarified in Biswanath Prasad Radhey Shyam Vs. Hindustan Metal Industries (1979) 2 SCC 511 where the court held that “in order to be patentable, an improvement on something known before or a combination of different matters already known, should be something more than a mere workshop improvement; and must independently satisfy the test of invention or an ‘inventive step’. To be patentable, the improvement or the combination must produce a new result, or a new article or a better or cheaper article than before. A combination of old known integers may be so combined that by their working interrelation, they produce a new process or an improved result. Mere collocation of more than one integers or things, not involving the exercise of any inventive faculty, does not qualify for the grant of a patent.” In essence, one is required to show the working interrelationship between the different components of the device, and demonstrate how this contributes to the inventiveness, i.e., the technical advance of the invention.
Finally, devices that involve the use of software may be objected to under section 3(k), which bars the patenting of algorithms and computer programmes per se. In many cases, the working of a device may be closely interlinked with the use of a specialized software, for example, tele-robotic surgery, or the accurate measurement of a physiological parameter. In such cases, it is recommended to describe the precise working of the software with the hardware components to obtain a tangible result. Application 2825/CHE/2007 described a graphical user interface for a nursing station. The objection under Section 3(k) was subsequently withdrawn as the applicant demonstrated that critical hardware components were required to relay information regarding a patient’s physiological measurements to the display interface.
Bringing the invention to the market
New definition of ‘medical device’
Medical devices are included under the definition of ‘drugs’ in the DCA, and recently, the definition of ‘medical devices’ was extended to include:
“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.”
With this amendment, as of April 1, 2020, all medical devices sold in India are now regulated by the DCA and MDR.
Registration and licensing of medical devices
In addition to the new definition of medical devices, the amendments to the MDR have brought about a considerable change in the process of seeking approval to manufacture and import medical devices. Previously, there was no registration requirement, and licensing was restricted to 37 notified (or expected to be notified) categories of medical devices; however, the amendments have made both requirements compulsory.
Registration entails submitting certain details by a manufacturer or importer including:
- the name of the company or firm,
- details of the medical device (generic name, brand name (if it bears a registered trade-mark in India), model number, intended use, risk classification, construction material, dimensions (if applicable), shelf life, and sterile or non-sterile-status),
- an undertaking of the authenticity of the information by the application, and
- a certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum applicable to the device.
- For importers, an additional requirement is a free sale certificate from the country of origin.
Registration is via a registration portal set up by the Central Drugs Standard Control Organisation (CDSCO) called the ‘Online System of Medical Devices’.
The mandatory inclusion of the ISO 13485 accreditation is the clinching factor of this new regulatory regime. This ensures adherence to a quality management system that specifically regulates the safety standards of medical devices and requires periodic audits to maintain these standards. This requirement is expected to eventually phase out all un-regulated medical devices from the market, and in the long run, would benefit both consumers, as well as manufacturers or importers. For now, the government has opened the portal for voluntary registration for a period of 18 months i.e. until October 21, 2021. After this deadline, however, the registration will become compulsory, except for the 37 notified categories of medical devices that are exempt from this requirement.
Although registration has started, a notification of the risk classification of all medical devices is yet to be issued by the Drug Controller General of India (DCGI). Until then, the risk classification of a device in a Global Harmonization Task Force (GHTF) country can provide some guidance as India largely follows the GHTF system of classification of medical devices. The timelines for the registration process are unclear, but the provisions in the MDR seem to suggest that the registration number is provided instantly once all the documentation is submitted. The verification of the documents may occur at any point after the submission.
In addition to the new registration process, whereas previously only the 37 notified categories of devices required licenses, the current licensing regime will now extend to all medical devices. The government has provided deadlines to allow manufacturers and importers time to procure licenses. Low and moderate risk A and B categories, respectively, of devices, will have until August 11, 2022, to obtain a license. Medium-high and high-risk C and D categories, respectively, of devices, will need to obtain the license by August 11, 2023.
Thus, the new registration requirement and the amended all-encompassing definition of medical devices intended to extend the license requirement, the new regime is aimed at the comprehensive regulation of all medical devices in the Indian market.
India presents a growing market base for medical devices, but certain patenting and registration requirements that are specific to this jurisdiction need to kept in mind before venturing into this market. As such, medical devices are patentable in India, however, Section 3(i), which precludes methods of treatment from patentability, often poses a challenge. Claims describing the use or association of the medical device with the patient’s body are best avoided in this scenario. The recently amended Medical Device Rules, 2017, has now introduced mandatory registration of all medical devices. This entails obtaining an ISO 13485 accreditation for the device and, in the case of importers, a free sale certificate from the country of origin is also required. The license requirement has also extended to all medical devices with the introduction of the new definition of medical devices in the Drugs and Cosmetics Act, 1940. In order to ensure that transition into this new regime occurs smoothly, the government has provided deadlines to initiate registration and licensing in a phased manner depending on the risk classification of the medical device.