Freedom to Operate Search
Medical device companies generally opt for product clearance studies for one or more markets wherein freedom to operate patent search is required to ensure the medical devices do not infringe upon the existing patents in such markets. To conduct freedom to operate patent search, or a FTO search, patent attorneys give equal consideration to granted patents and published patent applications, which may be granted at later date. Such FTO studies can help medical device companies in evaluating possible patent infringement scenarios by performing patent claim mapping.
Medical Devices in India
Medical devices regulations in India are about to undergo a radical transformation with effect from January 1, 2018. This is the date on which Medical Devices Rules 2017 will be notified, wherein various crucial provisions are stated, including definition of medical devices. This is a major change as compared to earlier regulations, wherein medical devices were covered under the pharmaceutical regulations, i.e. Drugs and Cosmetics Act. With the proposed notification of the new Medical Devices Rules 2017, the government has attempted to distinguish medical devices from pharmaceuticals.
As per the proposed medical devices regulations in India, the definition of medical devices includes any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software, intended by its manufacturer to be used specially for human beings or animals 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;
(vi) control of conception;
which does not achieve the primary intended action in or on the human body or animals by any pharmacological or immunological or metabolic means, but which may be assisted in its intended function by such means, and covered under the Drugs and Cosmetics Act, 1940 (“D&C Act”).
Medical Devices Approval in India
In accordance with the proposed medical devices rules, the government of India has proposed single window clearance for approval of medical devices in India, including, medical device applications for import, manufacture, sale or distribution and clinical investigation, whether to be assessed by the DCGI or State licensing authority. It has been proposed that all such regulatory applications for medical devices will have to be made through a single online portal of the central government, wherein the details of the portal are yet to be notified.
Medical Device Patents
Medical devices and processes can be covered under medical device IP (intellectual property) law, whereby inventors, medical device companies, medical device startups, medical device incubators and venture capitalists protect the innovations by way of patents. Such innovations cover medical devices and corresponding processes across a diverse range of categories, including, cardiovascular, dental, diabetes, neurovascular, ENT, gastrointestinal, imaging, ophthalmic, prosthetics, orthopedics, diagnostics, dermatology, infusion pumps, embolic protection, dialysis, nephrology, robotics, oncology, ventilators, surgical equipment and medical technology applications capable of being executed via smartphone and handheld devices.
Medical Device Patent Services
Patent attorneys in the field of medical devices assist clients with multiple services, including patent prior art searches, patent landscape reports, state of art patent search, patent due diligence, patent licensing agreements, FTO (freedom to operate) patent search, patent assignment agreements, patent drafting, patent prosecution, PCT patent filings (national phase and international phase), patent audit and technology licensing (in-licensing and out-licensing).
Medical Device Patents – Drafting Patent Claims and Writing Patent Applications
Patent attorneys with expertise in writing medical device patents tend to draft patent claims covering both the medical devices and methods of medical treatment. However, such patent drafting practice varies for each jurisdiction as in US and Australia, medical treatment methods can be patented whereas in China, Europe and Japan, such medical treatment patent claims are not allowed.
Medical Device Patent Attorney
Law office of Rahul Dev is a niche technology and research based law firm focusing on next generation business and legal issues faced in India and outside India during international business and cross-border technology transactions.
We assist our clients in close collaboration with our associates and counsels within India and outside by providing custom engagement models to address our client’s needs.
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Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter
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