Patentability Standards and Subject Matter Exclusions Explained

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Introduction

A patent is a limited exclusive monopoly right granted by the Government of India to an inventor or assignee for an invention, in exchange for the public disclosure of that invention. In simple terms, a patent protects an inventor’s creation for a limited period, safeguarding their commercial interests while eventually contributing knowledge to the public domain.

India’s patent regime, governed by the Patents Act, 1970, maintains standards comparable to leading jurisdictions globally. A patent confers a negative right, allowing the patent holder to exclude others from making, using, selling, or importing the invention without authorization through licensing or assignment.

However, this protection is time-bound and remains valid for 20 years from the filing date of the application, after which the invention becomes part of the public domain and can be freely used.

Conditions of Patentability

Invention

Section 2(j) defines an “invention” as a new product or process involving an inventive step and capable of industrial application.

Accordingly, patents may be granted for products or processes that satisfy three essential requirements:

Novelty

Inventive step (non-obviousness)

Industrial applicability

Novelty

An invention is considered new if it has not been anticipated by prior publication, public use, or prior knowledge anywhere in the world before the filing date.

Non-Obviousness

The invention must involve an inventive step and should not be obvious to a person skilled in the relevant field of technology.

Industrial Applicability [Section 2(ac)]

The invention must possess commercial viability and utility, meaning it should be capable of being manufactured or used in an industry.

New Invention

Section 2(l) defines a “new invention” as an invention or technology not anticipated by prior publication or use anywhere in the world before the filing of the patent application with complete specification. In other words, it must not form part of the public domain or the existing state of the art.

Inventive Step

Section 2(ja) defines “inventive step” as a feature of an invention involving technical advancement over existing knowledge or possessing economic significance, or both, making the invention non-obvious to a person skilled in the art.

However, some critics argue that granting patents based solely on economic significance without sufficient technical advancement may dilute the threshold of innovation required for patent protection.

Non-Patentable Subject Matter

Section 3 of the Patents Act, 1970 lists subject matter exclusions under the heading “What are not inventions.” It includes multiple clauses specifying categories that cannot qualify as inventions, even if they satisfy novelty, inventive step, and industrial applicability.

Thus, an invention falling within any exclusion under Section 3 cannot be patented.

TRIPS Compliance and Evolution of Patent Law

The TRIPS Agreement acts as a global framework for intellectual property protection, requiring member states to align their national laws with international standards.

India became a member of the TRIPS Agreement in 1995 and was granted a ten-year transition period to bring domestic IP laws into compliance. Consequently, amendments were introduced to the Patents Act in 1999, 2002, and 2005, with the 2005 amendment being particularly significant in aligning Indian patent law with TRIPS obligations.

Most subject matter exclusions under Section 3 remained unaffected, except for certain provisions clarified to meet global standards.

Key Exclusions under Section 3

a) Inventions Contrary to Public Order or Morality [Section 3(b)]

This clause excludes inventions whose commercial exploitation would be contrary to public order or morality or which cause serious harm to human, animal, plant life, health, or the environment.

Because environmental and public welfare considerations are broad, this provision can significantly limit patentability in sensitive sectors.

b) Mere Discovery [Section 3(c)]

The Act excludes mere discoveries of scientific principles, abstract theories, or naturally occurring living or non-living substances.

Thus, substances directly isolated from nature, such as microorganisms, proteins, enzymes, or natural compounds, are not patentable. However, processes involving human intervention to isolate or modify such substances may qualify as inventions if they satisfy patentability criteria.

c) New Form of Known Substance [Section 3(d)]

This provision prohibits patenting a new form of a known substance unless it results in enhanced efficacy. It also excludes mere discovery of new uses or properties of known substances.

The 2005 amendment strengthened this clause to prevent pharmaceutical companies from extending patent life through minor modifications—a practice commonly referred to as patent evergreening. The law therefore restricts protection for incremental changes unless genuine therapeutic efficacy improvements are demonstrated.

Conclusion

This discussion provides a comprehensive overview of Indian patent law, covering the meaning of patents, conditions for patentability, and statutory exclusions.

Patent protection plays a crucial role in encouraging innovation while ensuring that, after a reasonable period, technological knowledge becomes publicly accessible. The patentability standards—novelty, inventive step, and industrial applicability—serve as essential filters to ensure only deserving inventions receive protection.

At the same time, exclusions relating to morality, mere discovery, and new forms of known substances demonstrate legislative caution against misuse of patent rights. These safeguards are particularly important in sectors like pharmaceuticals, where patent extensions could restrict public access to essential medicines.

Overall, Indian patent law reflects an effort to balance innovation incentives with public interest while aligning domestic law with international commitments under the TRIPS framework.

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