[1]<\/strong><\/a><\/sup>.\nSince medical devices can be monopolised through various intellectual property\nrights, the protection of these rights is highly critical.<\/p>\n\n\n\nThe development of medical devices and\ndeployment in the market requires meeting requisite regulatory compliance and\nobtaining IP protection and clearance. Medical device development often\nrequires the development and protection of IPR simultaneously at various stages\nof development. This is important to understand the many legal challenges which\nmay eventually arise during the commercialisation or protection of the\ninventions. The key factors which need to be considered include outlining competition\nand conducting prior art searches to avoid any litigations in the future. It is\nhighly imperative to analyse these IP matters during various stages of the life\ncycle of medical devices and how to maintain a strategic edge over multiple\nmanufacturers in the market.<\/p>\n\n\n\n
Along with adhering to regulatory\nrequirements, the protection of intellectual property rights, especially patent\nrights, is increasingly becoming an essential aspect of the development of\nmedical devices. This is in sync with the global trend of increasing the number\nof patent applications which are filed in order to protect the IP associated\nwith medical devices. For the years from 2015 to 2018, the most significant\nnumber of patent applications was filed in the domain of medical devices and\nhealthcare from India in the US. India, being a signature to the Trade related\naspects of Intellectual Property Rights or the TRIPS agreement, has made\nnecessary amendments to the Patent Act of 1970 to have it conform with the\nobligations of the TRIPS Agreement, including granting of product patents for\nvarious fields, including medical devices and pharmaceuticals.<\/p>\n\n\n\n
Article 27, Clause 3(a) of the TRIPS\nagreement says that a member state is allowed to exclude therapeutic, surgical\nand diagnostic methods of treating animals or humans from the school subject\nmatters which can be patented. There is a twofold reason for excluding\ntreatment methods from patentability. Firstly, the whole process of removing\nthe pathological condition from the body was not considered something which can\nbe said to have an “industrial application\u201d. The second and the most\nprevalent reason just keep a medical professional can provide the best\ntreatment available to an individual without the constant fear of infringing\nanother\u2019s patent. However, it is of vital importance to mention that the above\nmentioned exclusion is not directory but discretionary, and members can choose\nto keep treatment methods as a subject matter for patentability in their\njurisdiction.<\/p>\n\n\n\n
The United States is an example offer a\nmember state which chooses to retain treatment methods as patentable. Medical\ndevices, as well as medical treatment methods, are patentable in the United States.\nFurthermore, unlike the European patent law, the US law does not differentiate\nbetween diagnostic and various other treatment methods when it comes to\nenforceability or patentability. Every medical method of treatment is\nconsidered patentable. However, in order to keep the reason for the exclusion\nof the treatment method, patents for the treatment method shall not be enforced\nagainst licensed medical professionals or any medical entity. It is also\nimportant to note that this immunity shall not be extended to companies and\ntechnicians who are involved in the domain of diagnostics during medical\ntreatment. When a medical device is granted a patent, neither can it be\nmanufactured nor can it be sold without the consent of the patentee in a free\nmarket. However, the performance of a medical activity by a medical professional\nshall not amount to infringement. Article 53 Clause 3 of the European Patent Convention\nexcludes diagnostic, surgical therapeutic methods of treatment from\npatentability.<\/p>\n\n\n\n
Section 3(i) of the Patents Act of 1970 is\noften considered an objection against the patentability of medical devices\nalong with the process or method of operation of such devices. The jurisprudence\nand interpretation pertaining to this particular provision in India are at a\nnascent stage, with there being limited case laws on the subject. Patent\noffices and courts have often granted protection or any other relief to a\npatent in cases pertaining to diagnostic devices, syringes, inhalers and other\nsimilar medical devices on the reasoning that it does not pertain to the\nprocess for medical treatment. However, this particular area may soon become\nextremely contentious in the future in patent litigations because of the rising\nnumber of patent applications in relation to medical devices and the increased\nuse of artificial intelligence or robotics and performing varied functions in\nthe field of medical treatment.<\/p>\n\n\n\n
The regulations in relation to medical devices in India have\ntransitioned to a mature stage after the introduction of the Medical Devices\nRules of 2017, which is further backed by pattern protection which is TRIPS\ncompliant. After the introduction of the new regulatory regime, the focus is\nmore on the ease of doing business and the quality of medical devices by\ndeveloping an Indian standard which is at par with many global counterparts. Institutions\nlike the Bureau of Indian Standards set standards which are at an equal level to\nthe International Organization of Standardization and IEC. By introducing\norganisations like these, the government has significantly reduced the cost of\nobtaining certification for products.<\/p>\n\n\n\n
A robust system of regulations pertaining to medical devices in India is\nalso backed by a strong IPR system where cases related to IPR are now regarded\nas commercial disputes and thus have strict procedures and timelines what\nhappened put in place by the legislature. This was brought about after the Commercial\nCourts Act of 2015 was enacted. While there is still a dearth of solid\njurisprudence and precedents in relation to the patentability of medical\ndevices, most of the Indian laws are essentially compliant with the TRIPS\nagreement and with other jurisdictions like Europe and the USA along with\nrequisite legal remedies which are available to an inventor.<\/p>\n\n\n\n
<\/span>Intellectual Property at\nVarious Stages of Medical Device Development – IP Strategies for Medical\nDevices<\/span><\/h2>\n\n\n\nThe life cycle of the medical device\ncomprises of the following stages:<\/p>\n\n\n\n