{"id":50965,"date":"2022-11-28T12:05:14","date_gmt":"2022-11-28T06:35:14","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=50965"},"modified":"2022-11-28T12:05:16","modified_gmt":"2022-11-28T06:35:16","slug":"patent-for-medical-devices-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/patent-for-medical-devices-in-india\/","title":{"rendered":"An Overview of Patent for Medical Devices in India"},"content":{"rendered":"\n<p>In\nIndia, the medical device sector is growing rapidly; it has also been\nrecognized as the sunrise sector by the Government. In recent times, this\nsector has shown tremendous growth and has the potential to grow further in the\nupcoming years. This sector has shown double-digit growth and is expected to be\nan industry US$50 Billion by 2023. The growth of the medical device industry\ncan be attributed to multiple factors, such as improved healthcare infrastructure, increased healthcare spending,\nincreased medical tourism, growing healthcare insurance and increased\npenetration of the private sector. In this blog, we will discuss the Patent for\nMedical Devices in India.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/patent-for-medical-devices-in-india\/#Patentability_of_Medical_Devices_in_India\" >Patentability of Medical Devices in India &nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/patent-for-medical-devices-in-india\/#Provision_of_law_pertaining_to_Patent_for_Medical_Devices_in_India\" >Provision of law pertaining to Patent for Medical\nDevices in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/patent-for-medical-devices-in-india\/#Important_Sections_to_refer_to_before_applying_for_a_Patent_for_Medical_Devices\" >Important Sections to refer to before applying for\na Patent for Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/patent-for-medical-devices-in-india\/#Advantages_of_getting_a_Patent_for_Medical_Devices\" >Advantages of getting a Patent for Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/patent-for-medical-devices-in-india\/#Process_of_getting_Patent_for_Medical_Devices_in_India\" >Process of getting Patent for Medical Devices in\nIndia<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/patent-for-medical-devices-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Patentability_of_Medical_Devices_in_India\"><\/span>Patentability of Medical Devices in India &nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In the United States, patent protection is granted for both\nproducts and procedures, whereas in India, patent law is more like the <strong><em>European Patent Law<\/em><\/strong><sup><a class=\"text-primary\" href=\"https:\/\/en.wikipedia.org\/wiki\/European_patent_law\"><strong>[1]<\/strong><\/a><\/sup>, which says that the\nprocedure of treatment of the human\/animal body by surgery\/therapy and\ndiagnostic methods is not patentable. It is clearly mentioned under <strong><em>Section\n3(i) of the Patents Act, 1970<\/em><\/strong>, which says that any process for the medicinal,\nsurgical, curative, prophylactic diagnostic, therapeutic\/other treatment of\nhuman beings\/any process for an identical treatment of animals to give them\nfree of disease\/to increase their economic value or that of their products is\nnon-patentable. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Current\nIndian Scenario&nbsp;<\/strong><\/h3>\n\n\n\n<p>The Indian healthcare sector is growing\nrapidly, and there is huge potential for growth in the coming years. With the\nincrease of hospitals and healthcare facilities in India, there is a need for\nsophisticated devices and equipment to provide better treatment facilities to\npatients. The demand and the growth of medical devices have led the Indian\nGovernment to allow 100% foreign direct investment into this sector. There is a\nhuge dependency on the import of medical devices, which in turn has allowed\nmany foreign manufacturers to enter in medical device market in India and hence\nrequires Intellectual right protection. <\/p>\n\n\n\n<p>The Indian Healthcare industry has shown huge growth in recent\nyears. The Medical Device&nbsp; Industry is\nevaluated at around US$ 5 billion, according to figures and is growing at a\ngood pace. There has been a tremendous spike in the number of Hospitals and\nhealthcare facilities which has, in turn, created a need for good devices so\nthat they can provide accurate treatment to individuals. In order to know the\never-growing requirement for medical devices in the healthcare sector, the\nGovernment of India allowed 100% foreign direct investment in the medical\ndevice sector. It has also come up with a Draft Regulation to oversee the\ncountry&#8217;s huge medical device industry. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Key\nHighlights of the Medical Device Market in India <\/strong><strong><\/strong><\/h3>\n\n\n\n<ol><li>It forms most part of the\nHealthcare industry <\/li><li>It is Asia&#8217;s fourth-largest\nmarket <\/li><li>It is expected to grow at a\ncompound annual growth of around 15% annually <\/li><li>&nbsp;Huge dependency on\nImports <\/li><li>It is estimated that around\n70 % of the medical device market is catered to by import. <\/li><li>More of the aged population\nand changes in lifestyle leading to chronic diseases have enhanced the demand\nfor medical devices. <\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Provision_of_law_pertaining_to_Patent_for_Medical_Devices_in_India\"><\/span>Provision of law pertaining to Patent for Medical\nDevices in India <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The provision of Patents for <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/medical-device-registration\">medical devices<\/a><\/strong>\nin India is applicable with certain limitations. Provision of section 3 of the\npatent act lists out the non \u2013 patentable invention, which poses a challenge to\npatentability depending on the subject matter claimed.to summarize, the\napplication for Patent for Medical Devices is as per <strong>Sections 3 (i),(f) and (k)<\/strong>. <\/p>\n\n\n\n<ul><li><strong>Product\nPatent <\/strong><\/li><\/ul>\n\n\n\n<p>The patented medical device gives the\nowner the right and monopoly and also helps to enhance profit. It protects the\nright of the patent holder. Product patent also bars manufacturers from using a\nsimilar process as yours to manufacture the same product. <\/p>\n\n\n\n<ul><li><strong>Process Patent<\/strong><\/li><\/ul>\n\n\n\n<p>Process patent is typically given to the\nmanufacturing process of the medical device than the device itself. Product\npatent gives you limited protection as they cannot prevent others from using a\ndifferent process for manufacturing similar device. <\/p>\n\n\n\n<p>When someone goes to get a product patent,\nthe patent authority will typically guide one through all the steps, but the\nproduct owner needs to evaluate certain points carefully. <\/p>\n\n\n\n<ol><li>Whether\nthe idea of the device is completely new and unique? As per the patent law, the\nproducts or devices only get a patent when they are new, unique and useful. <\/li><li>Whether\nthe product is distinct from what is already there in the market? There are\nmany medical devices on the market; before looking for a patent, one needs to ascertain\nthat the device differs from what is in the market. <\/li><li>What type\nof Product or Process patent do you want to acquire? As an innovator, one knows\nhis \/her product better than anyone else. Before getting a patent, the\napplicant must explain his \/ her product. You need to explain it to the\nattorney if you seek their Guidance.<\/li><li>Whether\nthe applicant has the required resources for the patent application? As this\nprocess is quite time-consuming and also involves high costs. The applicant is required\nto be prepared for patent application by clarifying such matters before the process\nstarts.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Important_Sections_to_refer_to_before_applying_for_a_Patent_for_Medical_Devices\"><\/span>Important Sections to refer to before applying for\na Patent for Medical Devices <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>As\ndiscussed above, section 3 deals with the Patent for Medical Devices. It lists\nout the invention that is not patentable. Following is the list of such\ninvention <\/p>\n\n\n\n<ul><li>An invention which does not make sense or which, on the\nface of it, is contrary to well-established natural laws [<strong><em>Section 3(a)]<\/em><\/strong><\/li><li>An invention whose primary use could be contrary to\npublic morality and health or which may, in turn, cause harm to human, animal\nor plant life\/health or to the environment. [<strong><em>Section 3 (b)]<\/em><\/strong><\/li><li>When the mere arrangement or re-arrangement or\nduplication of known devices, each is functioning independently of one other in\na known way. [<strong><em>Section 3 (f)]<\/em><\/strong><\/li><li>Any process for the medicinal, curative, surgical,\ncurative, or other treatment of human beings\/any process for a similar\ntreatment of animals to render them free of disease or to increase their\neconomic value or that of their products. [<strong><em>Section 3 (i)]<\/em><\/strong><\/li><li>Any mathematical or computer program or business method.\n[<strong><em>Section\n3 (k)<\/em><\/strong>]<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Advantages_of_getting_a_Patent_for_Medical_Devices\"><\/span>Advantages of getting a Patent for Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>A patent holder gets to enjoy multiple rights as per the Indian Patents act when his \/her medical device is patented. The following are some advantages of getting a Patent for Medical Devices in India: <\/strong><\/p>\n\n\n\n<ol><li>The\npatent holder gets the exclusive right to have commercial benefits out of his\ninvention. No one makes a duplicate product or can copy the idea of the\npatentee. Such a right helps the patentee to boost their business. <\/li><li>The\npatent holder gets right over his invention for 20 long years, and hence this\nhelps the patentee to earn profits from the invention for that period of time.<\/li><li>The\npatent holder gets the right to grant a license or transfer the rights of the\nPatent. <\/li><li>The\npatent holder also gets the right to prevent any person from selling, using, importing,\noffering or exporting the patented product in the Indian Territory.<\/li><li>The\npatent holder has the full right to sue the Patent for infringement.<\/li><\/ol>\n\n\n\n<p><strong><em>Important note: &#8211; Right comes with the\nobligation that is required to be fulfilled by the person who is applying for a\nPatent for Medical Devices<\/em><\/strong><strong><em>.<\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Process_of_getting_Patent_for_Medical_Devices_in_India\"><\/span>Process of getting Patent for Medical Devices in\nIndia <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the\nprocedure for Patent for Medical Devices:<\/p>\n\n\n\n<ul><li><strong>Check the patentability of an invention by conducting a search of the Patent<\/strong>: First, you need to identify the patentability of the device and whether a patent for it is available or not. This step is not mandatory, but it is advisable that one should follow this step. <\/li><li><strong>Drafting of Application<\/strong>: After completing the search, another step is to complete the application form in Form 1. Application for Patent for Medical Devices is to be accompanied by a patent specification. One has to prepare this in Form 2, where an applicant needs to specify completion depending upon the state of the invention, even if it is not completed yet or partially completed. If the applicant files a provisional application, a time gap of 12 months is provided to finalize the invention and file the complete application. The draft is required to be submitted with the application. The draft of the Patent for Medical Devices is very important as it helps the patent office to decide whether or not a patent should be granted. <\/li><\/ul>\n\n\n\n<p><strong>Following\nare the forms for a patent application in India.<\/strong><\/p>\n\n\n\n<ol><li>Application\nfor grant of Patent (Form 1)<\/li><li>Provisional\/complete\nspecification (Form 2)<\/li><li>Undertaking\nunder section 8 this is required in the case where a patent application is\nalready filed in a country other than India) (Form 3)<\/li><li>Declaration\nas to inventorship (Form 5)<\/li><li>Forms are\nsubmitted only by start-ups and small entities. (Form 28)<\/li><\/ol>\n\n\n\n<ul><li><strong>Publication of patent application<\/strong>&#8211; The Patent is required to be published in\nthe patent journal once it is filed. This is usually done after passing of 18\nmonths from the date of application. If the applicant wants to get it published,\nthen he\/she can make a frequent filing in form 9. &nbsp;<\/li><\/ul>\n\n\n\n<ul><li><strong>Examining Patent Application in Form 18<\/strong>: The applicant is required to make an\napplication for examination. The Patent is granted only after a full\nexamination. A complete search is done by the officer where they evaluate the\nrequired technology in depth and in case there are any objections, they raise\nthe same, and hence it\u2019s communicated to the applicant. The report which is issued\nis called as FER i.e. the First Examination Report<\/li><li><strong>Grant of Patent<\/strong>: In case when all the objections are\nresolved, the Patent is granted. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Patenting a medical device is a time taking process, but it is worth all time and effort. With the increasing demand and foreign manufacturers coming into India for the sale, distribution and manufacturing of medical devices, it is advisable to get the Patent done. It truly makes sense to protect your novel idea and have complete rights over it. <\/p>\n\n\n\n<p class=\"text-left\"><b>Read Our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/registration-process-for-medical-devices-in-india\/\">A Step by Step guide for Registration Process for Medical Devices in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In India, the medical device sector is growing rapidly; it has also been recognized as the sunrise sector by the Government. In recent times, this sector has shown tremendous growth and has the potential to grow further in the upcoming years. This sector has shown double-digit growth and is expected to be an industry US$50 [&hellip;]<\/p>\n","protected":false},"author":38,"featured_media":50966,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2903],"acf":{"service_id":"385"},"authorName":"Srishti Pandey","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/05\/MicrosoftTeams-image-13.jpg","authorDescription":"She holds degree in B.COM, LLB (Delhi University), LLM (NLU, Delhi) and is also NET Qualified. She has previously worked as an Assistant Professor of Law in renowned university. She has a keen interest in writing on legal topics using academic and professional acumen.","postViews":4683,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50965"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/38"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=50965"}],"version-history":[{"count":2,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50965\/revisions"}],"predecessor-version":[{"id":50968,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50965\/revisions\/50968"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50966"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=50965"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=50965"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=50965"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}