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An Overview of Patent for Medical Devices in India

calendar28 Nov, 2022
timeReading Time: 6 Minutes
An Overview of Patent for Medical Devices in India

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 Billion by 2023. The growth of the medical device industry can be attributed to multiple factors, such as improved healthcare infrastructure, increased healthcare spending, increased medical tourism, growing healthcare insurance and increased penetration of the private sector. In this blog, we will discuss the Patent for Medical Devices in India.

Patentability of Medical Devices in India  

In the United States, patent protection is granted for both products and procedures, whereas in India, patent law is more like the European Patent Law[1], which says that the procedure of treatment of the human/animal body by surgery/therapy and diagnostic methods is not patentable. It is clearly mentioned under Section 3(i) of the Patents Act, 1970, which says that any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic/other treatment of human beings/any process for an identical treatment of animals to give them free of disease/to increase their economic value or that of their products is non-patentable.

Current Indian Scenario 

The Indian healthcare sector is growing rapidly, and there is huge potential for growth in the coming years. With the increase of hospitals and healthcare facilities in India, there is a need for sophisticated devices and equipment to provide better treatment facilities to patients. The demand and the growth of medical devices have led the Indian Government to allow 100% foreign direct investment into this sector. There is a huge dependency on the import of medical devices, which in turn has allowed many foreign manufacturers to enter in medical device market in India and hence requires Intellectual right protection.

The Indian Healthcare industry has shown huge growth in recent years. The Medical Device  Industry is evaluated at around US$ 5 billion, according to figures and is growing at a good pace. There has been a tremendous spike in the number of Hospitals and healthcare facilities which has, in turn, created a need for good devices so that they can provide accurate treatment to individuals. In order to know the ever-growing requirement for medical devices in the healthcare sector, the Government of India allowed 100% foreign direct investment in the medical device sector. It has also come up with a Draft Regulation to oversee the country’s huge medical device industry.

Key Highlights of the Medical Device Market in India

  1. It forms most part of the Healthcare industry
  2. It is Asia’s fourth-largest market
  3. It is expected to grow at a compound annual growth of around 15% annually
  4.  Huge dependency on Imports
  5. It is estimated that around 70 % of the medical device market is catered to by import.
  6. More of the aged population and changes in lifestyle leading to chronic diseases have enhanced the demand for medical devices.

Provision of law pertaining to Patent for Medical Devices in India

The provision of Patents for medical devices in India is applicable with certain limitations. Provision of section 3 of the patent act lists out the non – patentable invention, which poses a challenge to patentability depending on the subject matter claimed.to summarize, the application for Patent for Medical Devices is as per Sections 3 (i),(f) and (k).

  • Product Patent

The patented medical device gives the owner the right and monopoly and also helps to enhance profit. It protects the right of the patent holder. Product patent also bars manufacturers from using a similar process as yours to manufacture the same product.

  • Process Patent

Process patent is typically given to the manufacturing process of the medical device than the device itself. Product patent gives you limited protection as they cannot prevent others from using a different process for manufacturing similar device.

When someone goes to get a product patent, the patent authority will typically guide one through all the steps, but the product owner needs to evaluate certain points carefully.

  1. Whether the idea of the device is completely new and unique? As per the patent law, the products or devices only get a patent when they are new, unique and useful.
  2. Whether the product is distinct from what is already there in the market? There are many medical devices on the market; before looking for a patent, one needs to ascertain that the device differs from what is in the market.
  3. What type of Product or Process patent do you want to acquire? As an innovator, one knows his /her product better than anyone else. Before getting a patent, the applicant must explain his / her product. You need to explain it to the attorney if you seek their Guidance.
  4. Whether the applicant has the required resources for the patent application? As this process is quite time-consuming and also involves high costs. The applicant is required to be prepared for patent application by clarifying such matters before the process starts.

Important Sections to refer to before applying for a Patent for Medical Devices

As discussed above, section 3 deals with the Patent for Medical Devices. It lists out the invention that is not patentable. Following is the list of such invention

  • An invention which does not make sense or which, on the face of it, is contrary to well-established natural laws [Section 3(a)]
  • An invention whose primary use could be contrary to public morality and health or which may, in turn, cause harm to human, animal or plant life/health or to the environment. [Section 3 (b)]
  • When the mere arrangement or re-arrangement or duplication of known devices, each is functioning independently of one other in a known way. [Section 3 (f)]
  • Any process for the medicinal, curative, surgical, curative, or other treatment of human beings/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. [Section 3 (i)]
  • Any mathematical or computer program or business method. [Section 3 (k)]

Advantages of getting a Patent for Medical Devices

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:

  1. The patent holder gets the exclusive right to have commercial benefits out of his invention. No one makes a duplicate product or can copy the idea of the patentee. Such a right helps the patentee to boost their business.
  2. The patent holder gets right over his invention for 20 long years, and hence this helps the patentee to earn profits from the invention for that period of time.
  3. The patent holder gets the right to grant a license or transfer the rights of the Patent.
  4. The patent holder also gets the right to prevent any person from selling, using, importing, offering or exporting the patented product in the Indian Territory.
  5. The patent holder has the full right to sue the Patent for infringement.

Important note: – Right comes with the obligation that is required to be fulfilled by the person who is applying for a Patent for Medical Devices.

Process of getting Patent for Medical Devices in India

Following is the procedure for Patent for Medical Devices:

  • Check the patentability of an invention by conducting a search of the Patent: 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.
  • Drafting of Application: 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.

Following are the forms for a patent application in India.

  1. Application for grant of Patent (Form 1)
  2. Provisional/complete specification (Form 2)
  3. Undertaking under section 8 this is required in the case where a patent application is already filed in a country other than India) (Form 3)
  4. Declaration as to inventorship (Form 5)
  5. Forms are submitted only by start-ups and small entities. (Form 28)
  • Publication of patent application– The Patent is required to be published in the patent journal once it is filed. This is usually done after passing of 18 months from the date of application. If the applicant wants to get it published, then he/she can make a frequent filing in form 9.  
  • Examining Patent Application in Form 18: The applicant is required to make an application for examination. The Patent is granted only after a full examination. A complete search is done by the officer where they evaluate the required technology in depth and in case there are any objections, they raise the same, and hence it’s communicated to the applicant. The report which is issued is called as FER i.e. the First Examination Report
  • Grant of Patent: In case when all the objections are resolved, the Patent is granted.

Conclusion

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.

Read Our Article:A Step by Step guide for Registration Process for Medical Devices in India

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