Inventive step under the Patents Act

Patent is a license that is conferred by the respective authority of the Government to a medicine company, granting an exclusive right to manufacture and market a specific medicine. It is the intellectual property right granted to individuals or companies for an invention that is unique in nature.

How are the inventions treated under the Indian Patents Act?

As per the Indian Patent Act, any invention of a new product or process (mainly medicine) is an absolutely new invention and is capable of industrial application. In other words, a patent application is applicable only when there is novelty (absolutely new) and can be applied for industrial use.

As per Sec. 2 (1) (ja) of the Indian Patent Act, an invention that is an advancement to the technical part, in comparison to the knowledge and matter already in existence, is bringing a new econo0mic significance, or both are eligible for the patent registration.

India as one of the signatories to Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), strictly follows these criteria for patenting an invention:

1. Novelty: The invention must be an absolutely new product or a new process. By definition, novelty includes anything that has been not done or seen before.

2. Inventive Step: The term 'inventive step' has not been clearly defined by the provision under the Act, but 'invention' was defined as anything new or useful process, art, method or manner of manufacture, the machine, apparatus, and other articles that is useful and includes any new improvement.

3. Industrial Applicability: Industrial applicability requires that the invention is capable of being made or used in the industry. A patent can only be awarded for an invention that is sensitive to industrial application, i.e. for an invention that can be made or used in some kind of industry.

Why Patenting Is necessary?

The World Trade Organization (WTO) has established its guidelines regarding patenting the inventions have certain advantages, they are as follows:

● The patent registration enables the patent-owner to prevent others from copying, manufacturing, selling or importing without antecedent permission from the owner. This is useful to protect the persons from any unauthorized products or medicines, that may cause a contradictory effect on their health. This is a preventive measure to obtain the good health of people.

For example, recently;y the discussion on patenting the Covid vaccine is going on, which the US and EU countries are in favour of patenting, whereas, India and South Africa are not. The US has pointed out some logical reasons in favour of patenting the vaccines. Moreover, if a person takes two or more vaccines from different drug developers, and face any health risk later, it'll be challenging to diagnose the source of the health hazard.

● The patent permits the owner to provide a license to others to use, produce, develop or sell it. This not only gets authority but also controls the development and selling of the same. If not patented, any fraudulent drug developer, through marketing strategies may influence people that the vaccine promoted by them is more robust and cost-effective, the government cannot do much in this case, until they are caught violating any existing law.

What is the recent development concerning the inventive step for patenting?

In the meeting of all the members of the World Trade Organization in December 2020, at Geneva, a conference was carried over the proposal made by India and South Africa to abandon the part of the rules concerning the intellectual property of WTO, with not to patent the covid vaccine to work for more population and open the ways to be manufactured as a generic medicine.

Unfortunately, the meeting ended in an undesirable situation for the developing countries who backed the proposal made by India and South Africa. South Africa argued that the WTO's Trade-Related Aspects of Intellectual Property (TRIPS) is not much help and in comfort, quoted the incident of HIV/AIDS pandemic in South Africa, costing almost 11 million lives due to negligence to secure life-saving medicines.

In opposition, to the recommendation to waive off the patent protection, is debated by Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations that excluding patents can be deadly, as it assumes the risk of causing harm to the whole medical-industrial structure.