A medical device is any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination intended by the manufacturer to be used for human beings. Use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Typically used for diagnostic, monitorial and preventive purposes and can be used to treat and ease a variety of problems. Fair examples for medical device could be a medical thermometer, x-ray machine, anesthesia breathing circuit or even a hearing aid. Used for various diagnostic activities.
In India, the Department of Health under India's Ministry of Health and Family Welfare is responsible for the jurisdiction over the regulation of medical devices. The Central Drug Standard Control Organization (CDSCO) in the Ministry of Health is primarily responsible for regulation of drugs but also medical devices, diagnostic devices and cosmetics2.
The Ministry of Health classifies the medical devices in two types.
i. Life saving medical equipment
ii. Non life saving medical equipment
Manufacturers of medical devices defined as drugs must apply Good Manufacturing Practices (GMP) and conduct suitable tests to prove the product quality. The quality systems shall concern design, development and manufacture. This kind of devices also requires risk management in form of ISO 14971. The registration shall be done according to Rule 24A of the Drugs and Cosmetic Act and Form 40 shall be filed. The applicant can be the manufacturer, the importer or the responsible agent in India3.
IMPORTANCE OF PATENTS IN MEDICAL DEVICES IN INDIA
A patent is a monopoly right for an invention, which is used to carve out market exclusivity for a product. Patent protection is time-limited and in India, this limit is for 20 years from the date of filing the patent application. In many countries, there are restrictions on patenting of methods of therapy, diagnosis and surgery. Section 3(i) of the Patents Act, 1970, excludes the following:
"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."
The Indian Patents Act, 1970 interprets the concept of exclusion from patentability in a more or less strict manner. The literal rule of interpretation applied in this regard has always had a human rights perspective to it. The ideals of public health and social welfare in consonance with advancement in technology, enshrined under the Indian Constitution is given due importance and relevance in the interpretation of the exclusion clause of the Patents Act, 19704. However, it is important to patent the devices and instrumentation in the medical device industry in order to protect their inventions. It is to be noted that usually there is no issue with obtaining patent protection for a product invention, assuming that the product meets the patentability requirements of being new, non-obvious and capable of industrial application.
A patent in medical devices helps the company in generating income from its innovative products and acts as an asset which can be sold or licensed for an agreed sum or royalty rate. A company that files patents that gives a serious impression to the competitors and gets a bargaining chip in negotiations with third parties. For instance, Medical devices rely on electronic components, alone or in combination with other technologies, and include miniaturization, microelectronics, and nano-electronics and among others.
However, the use of electronic components significantly increases the technical complexity of the resultant device. There may be problems related to safety, power sources, protection of the device in the environment of the body and other factors. Such technical complexity may also provide significant IP advantages however, as solutions to these problems may be patentable.
Furthermore, software can also be a medical device, or can form a component within a medical device. Software is frequently operated by a computer or other device in communication with a medical device to receive input for analysis, direct the functioning of the medical device and so forth. As a medical device, or as part of a medical device, software may be patentable as a stand alone invention or as part of a larger system with multiple components.
Medic-Aid was a small UK-based company that developed and manufactured medical devices for the healthcare profession. Its clients included hospitals, clinics and NHS trusts. The company has since been acquired and subsumed into a large multi-national corporation5. A German company threatened Medic- Aid to sue for infringement of one of their patents and of unregistered design right following the launch of an important new product. The product, a drug delivery device, was fundamentally important to Medic-Aid's business, so it was crucial that they were able to continue selling it. Medic-Aid, through negotiations and by making minor modification in their product and adjusting the design, settled both the suits in its favor6.
It is evident from Section 3(i) of the Patents Act, 1970, that processes cannot be patented. However, there is no expressed exclusion of the patents for medical devices. Hence, they are patentable in India in light of the illustrations so mentioned above. Moreover, it is important for a patent holder to get its devices registered in order to generate income from its innovative products.
1. Legal Intern, 5th year ITM Law School, Gurgaon
4. JIPR Article vol 18
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