India is counted among the top 20 global medical devices markets, and is the fourth largest market in Asia after Japan, China and South Korea. Presently, the Indian medical devices industry is valued at USD 5.2 billion, having approximately 750–800 medical devices manufacturers with an average investment of INR 170–200 million, and an average turnover of INR 450–500 million. Approximately, 65% of the manufacturers are major domestic players, who operate in the consumable segment and cater to the local market with limited export. As per reports, this industry has the potential to grow at 28% per annum to reach $50 billion by 2025, especially since India permits up to 100% foreign direct investment in medical devices through the "automatic route" i.e. foreign investments do not require the prior approval of the government or Reserve Bank of India. Accordingly, the focus on IPR protection specifically patent rights, as also regulatory requirements related to the medical device industry has increased in India.
Before we discuss the regulatory requirements, and how to protect inventions related to medical devices, it is important to understand what is meant by the term medical device.
Definition of medical device and regulations
The Indian Patents Act 1970 does not contain any definition expanding upon the term medical device. However, the term is defined under the Medical Device Rules 2017:
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;
Further, WHO (World Health Organization) defines medical device as,
"medical device means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices
- providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
Note: Products which may be considered to be medical devices in some jurisdictions but not in others include:
- disinfection substances,
- aids for persons with disabilities,
- devices incorporating animal and/or human tissues,
- devices for in-vitro fertilization or assisted reproduction technologies."
Thus, as per the Medical Devices Rules 2017, the term 'medical device' includes devices and substances alike under its ambit. In general, the Medical Device Rules 2017 seek to regularise medical devices in the following ways:
1) Medical devices have been classified as per global harmonization task force (GHTF) practice into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk).
2) A third-party Conformity Assessment and Certification system has been introduced through notified bodies. Further, these notified bodies were brought into an accreditation system under the National Accreditation Board for Certification Bodies (NABCB).
3) A certain degree of freedom has been given to manufacturers by way of self-compliance whereby manufacturing licences for Class A medical devices will be granted without prior audit of manufacturing site.
4) Manufacture of Class A and Class B medical devices will be licensed by state licensing authorities after quality management system audit by an accredited notified body.
5) Manufacture of Class C and Class D medical devices will be regulated by the Central Licensing Authority and, where required, the assistance of experts or notified bodies will be taken.
6) Separate provisions for regulation of clinical investigation (clinical trials) of investigational medical devices (i.e. new devices) have also been made in-keeping with international practices and, like clinical trials, these will be regulated by the Central Drugs Standard Control Organization (CDSCO).
7) Product standard of medical devices will have to comply with the Bureau of Indian Standards (BIS). In case the BIS standard has not been laid down, the specifications of the International Organization for Standardization (ISO) or the International Electro Technical Commission (IEC) shall be adhered to.
8) Licence and loan licence under the rules are granted in perpetuity and periodical renewals are not required.
9) The process from submission of application to grant of permission is made electronic under various provisions of the rules.
While the industry in general has reacted positively to the Medical Devices Rules 2017, and regards them as being progressive, effective implementation continues to remain an area of concern.
Intellectual property and medical devices
Along with regulatory issues, protection of IPR, specifically patent rights has also emerged at the forefront in respect of medical devices. This is in tune with the global trend of the rise in number of patent applications filed to protect medical devices in India and abroad. In fact, the healthcare and medical devices domain was the area with the largest number of Indian patent applications filed in the US during 2015-2018. India is a signatory to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, and has made appropriate amendments to the Patents Act 1970 to bring it in line with TRIPS requirements including grant of product patents for all fields, including pharmaceuticals and medical devices.
Under Clause 3(a) of Article 27 of the TRIPS agreement, a member state may exclude diagnostic, therapeutic and surgical methods for the treatment of humans or animals from the scope of patentable subject matter. The historical reason for exclusion of method of treatment from patentability is twofold. First, the process of removal of a pathological condition from the body through a treatment was not considered as something which was "industrial applicable". Secondly, and an often cited reason, is to keep the medical practitioner free from fear of patent infringement so that the best possible treatment is available to patients. It is, however, important to mention here that the exclusion under Article 27(3)(a) is discretionary and not directory and therefore, a member may choose to retain the patentability of method of treatment in its jurisdiction.
One example of a member state which has retained patentability of method of treatment is the United States. In the USA, both medical devices and methods of medical treatment are patentable subject matter. Further US patent law, unlike European law, does not differentiate between diagnostic and other methods of medical treatments when it comes to patentability or enforceability. All medical methods are considered patentable. However, to retain the historical reason for exclusion of method of treatment, a patent for method of treatment cannot be enforced against licensed medical practitioners or a medical entity under 35 USC 287. It is, however, important to mention that this immunity is not extended to technicians or companies involved in mere diagnostics during medical treatment. Accordingly, a medical device cannot be manufactured or sold in the absence of the patentee's consent in a free market. However, mere performance of medical activity by a medical practitioner does not amount to infringement. Unlike the USA, the European Patent Convention under Article 53 Clause 3 excludes surgical, therapeutic and diagnostic methods from patentability.
In India, the Patents Act, under Section 3, provides certain exclusions from patentability. Section 3(i) of the Patents Act is relevant for the discussion and reproduced herein:
3. The following are not inventions within the meaning of this Act:
….
(i) 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.
Section 3(i) of the Patents Act is often cited as an objection to patentability against a patent application concerning medical devices along with their method/process of operation. The jurisprudence related to Section 3(i), and its interpretation is at a nascent stage in India, as very limited case law exists on the subject. Courts and patent offices have granted relief/protection/ interim directions to patentee's in cases related to diagnostic devices, inhalers, syringes etc. on the basis that the same does not relate to a 'process for medical treatment'. However, in view of an increased number of patent applications in the field of medical devices, as well as aspects of use of AI/robotics towards performing functions related to medical treatment, this area is likely to emerge as extremely contentious in patent litigation in the near future, with parties questioning the patentability of such inventions.
The regulation of medical devices in India is transitioning to a mature stage by way of the Medical Devices Rules 2017, which is backed by TRIPS compliant patent protection. With the advent of a new regulatory regime, the emphasis has also shifted to the quality of medical devices and ease of doing business by having an Indian Standard on a par with international standards. By bringing the standard setting institutions like BIS to an equal level to ISO and IEC with the help of notified bodies, the government has substantially reduced the cost of procuring the certification for products.
The strengthened regulation of medical devices in India is also backed by a robust IPR system wherein after introduction of the Commercial Courts Act 2015, cases related to IPR are regarded as commercial disputes which are then governed by strict timelines and procedures that have been introduced by the legislature. While India still has to witness an evolution of jurisprudence on patentability of all aspects of medical devices, Indian laws are substantially aligned with TRIPS and other major jurisdiction like the USA and Europe with sufficient legal recourses available to an inventor.
Authors
Saya Choudhary Kapur
Saya Choudhary Kapur heads one of the patent teams which primarily deals with patent litigation pertaining to multiple fields including pharmaceuticals and medical devices. She actively advises clients on issues relating to procurement, licensing and enforcement of patents. She has been involved in various landmark cases including Novartis v Union of India, Bayer Corporation & Anr v UOI & Ors.
Vivek Ranjan
Vivek Ranjan is a part of the litigation team and is also a registered patent agent. His area of practice is patent law, drugs regulatory and pricing issues, and service matters. He is currently involved in handling disputes related to standard essential patents.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, any other of its practitioners, its clients, or any of its or their respective affiliates. This article is for general information purposes only and is not intended to be and should not be taken as legal advice.