Patentability of Medical Devices & Diagnostic Inventions in India

The Patents Act, 1970 encapsulates the laws associated with patentability of all kinds of inventions. Patents are a type of intellectual property (IP) that grant exclusive rights to the owner of the item/process patented and prevent anyone else from manufacturing, copying, using or selling the item/process for a specific period of time.

Under Section 53 of the Patents Act, a patent is valid for 20 years from the date of application to grant the patent.

A patent is only applicable for one invention, irrespective of whether it’s a product or service. When it comes to determining exactly what shall account for an invention, its definition can be found under Section 2(1)(j) of the Patents Act, wherein it notes an invention to be ‘a new product or process that consists of an inventive step and can be used for industrial applications.’ The ‘inventive step’ mentioned therein refers to the invention containing any technological advancement that did not exist before.

The idea of limiting diagnostic processes and medical devices basically originates from morality, as it is believed that limiting the availability of life-saving treatments and preventing patients from receiving the best treatments available is not the right thing to do. As such, it also prevents individuals from making financial gains by leveraging inventions, be it a diagnostic process or medical device, that would prove to be highly beneficial for the general public.

Medical Devices Sector in India

The medical devices sector of India is the 4th largest medical devices sector in Asia and one of the top 20 in the world. This sector played a major role during the COVID-19 pandemic and came up with solutions that were beneficial not only for India but other countries around the globe as well.

In 2020, the size of the medical devices sector of India was estimated to be USD 11 billion, while it was found to hold 1.5% of the global medical devices sector. Furthermore, it is expected to grow at a compound annual growth rate (CAGR) of 15%, which is more than twice the global growth rate.

As per the National Medical Devices Policy, 2023, medical devices can majorly be categorized as:

• Implants
• Consumables & Disposables
• Electronic equipment
• Surgical equipment
• In-vitro Diagnostic Reagents

Considering the incredible value of this sector in India, the protection offered by regulations in regard to the patentability of medical devices is also quite significant.

What Can’t be Patented?

There are some products and services that are considered ‘inventions’ as per the interpretation of Section 2(1)(j) of the Patents Act but cannot be patented.

As per Section 3(f), any product/process that is simply an arrangement, rearrangement or duplication of existing devices, each of which function freely of one another is a way known to the public, shall not fall under the definition of an ‘invention’ under the Patents Act and, thus, would not be patentable.

According to Section 3(i) of the Act, any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or any other treatment of humans or any process that offers similar treatment for animals to free them from some disease, boost their economic value or that of their products shall not be considered an ‘invention’ and, thus, would not be patentable.

Section 3(p) of the Act states that any invention that in effect, is a traditional method or a compilation or duplication of the known aspects of traditionally known components shall not be considered an ‘invention’ and, thus, would not be patentable.
An example of Section 3(p) of the Act is mentioned in the ‘Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals’ by the Office of the Controller General of Patents, Designs and Trademarks as follows:

• The claim was related to an inflammatory bowel disease (IBD) treatment that involved giving an adequate quantity of Andrographis paniculate extract. The extract was said to contain andrographolide, neoandrographolide, 12-didehydrogenandrographolide, 14-deoxy-11, and 14-deoxyandrographolide.
• However, when this claim was analyzed, it was found the method being referred to did not fall under the scope patentable inventions under Section 3(p) of the Patents Act as it consisted of some traditional knowledge.

Diagnosis is defined in the ‘Manual of Patent Office Practice and Procedure’ as the identification of medical illness’ nature, generally by conducting an investigation of its history and symptoms and through different tests. Asserting the overall physical condition of a person is known as ‘diagnostic’. The manual excluded the below mentioned processes to guide the Patent Officers with respect to patentability of processes:

• Medicinal methods, for example, process to give medicine orally, via injectables, topically, or via a dermal patch.
• Surgical methods, for example, a no-stitch incision method for cataract surgery.
• Diagnostic methods.
• Curative methods, for example, a new method to clear plaque from teeth.
• Prophylactic methods, for example, methods for vaccination.
• Therapeutic methods, for example, a new process for therapy.
• Any operation on the body that needs the surgeon’s knowledge and expertise and consists of treatments like abortion, cosmetic treatment, embryo transplants, etc.

Following is an illustrative example of the above, which can be found in the ‘Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals’:

• The claim was related to a cancer-treating method, which involved simultaneously or sequentially giving the patient a blend of Gemcitabine and P276-00 or a blend of Gemcitabine and P1446A. However, the said cancer should be one from the group that consists of lung cancer, colorectal carcinoma, pancreatic cancer, and head and neck cancer.
• The subject of this claim is not within the ambit of patentable inventions under Section 3(i) of the Act, as being directed to a method of treatment of human beings or animal.

After studying the above-mentioned provisions, especially Section 3(i), it can be said that any process used to diagnose a disease shall not be patentable. However, it must be noted that this provision is only applicable to the treatment of humans and animals. Plants were removed from the ambit of this provisions through a 2002 amendment and as such, process to diagnose diseases in plants are patentable.

Furthermore, it was found that the definition under Section 3(i) is only limited to the living body and as such, processes performed on tissues or fluids that have been permanently removed from a body are considered patentable.

Although it states that diagnostic processes are not patentable, Section 3(i) does not make any reference with regards to the patentability of medical devices.

Conclusion

Patents aim to protect genuine inventions and help the inventor gain significant benefits for their efforts. However, it does not aim to allow individuals to patent certain medical devices and diagnostic processes that can actually prove to be highly beneficial for the general public. Besides, while treatment of humans and animals is not patentable, after the exclusion of ‘plants’ from the definition, diagnostic processes for treatment in plants can be patented.