Protection of medical devices in India
Patents are the inseparable attendant of innovation and innovative products. Numerous patent applications on medical devices are filed every year, reflecting the scale of innovation in this field and value of the healthcare sector. The Indian Patents Act, 1970 and the Patents Rule, 2003 govern the protection of patents in India. The act provides protection for both products and processes.
Medical devices, as instruments or apparatus, are protectable under the act. However, innovations arising in the medical device field may experience challenges from some exclusions such as sections 3(d), 3(f) and 3(i) of the act, particularly the provision of section 3(d), which is unique to India. This imposes an obligatory requirement on the applicant to make an assessment of the aforesaid sections at an early stage, probably at the drafting stage, to ensure a secure protection of medical devices.
The exceptions under the act can make the prosecution of medical devices challenging. Institutions, whether domestic or international, that are making innovations in the field and filing patent applications in India need to take note of these exclusions to ensure smoother prosecution and grant of patents.
In addition to pharmaceutical products and processes, which are often challenged under section 3(d), innovations relating to medical devices can also be challenged through section 3(d).
Section 3(f) of the act requires a medical device innovation to demonstrate that the said device is not a mere arrangement or re-arrangement of known devices. This section creates patentability issues for medical devices with incremental improvements. For incremental innovations, it is essential for the innovators to demonstrate that such incremental improvement shows a unique combination of components and results in a better medical device in terms of expeditious process in a more economical manner. More specifically, if such incremental inventions can be shown to have more affordable and economic value then they are likely to fall outside the scope of the said section.
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