Sections 3 and 4 of the Indian Patent Act define innovations and discoveries that are not patentable. Understanding the breadth of exclusions from patentability is critical for inventors and businesses seeking intellectual property rights in India. This article examines the primary types of innovations that have been determined to be non-patentable under the requirements of the Indian Patent Act.
It focuses on the exclusions of mathematical approaches, computer programs, incremental medicinal advancements, and conventional knowledge. Relevant case laws that have questioned the meaning and bounds of these legislative exclusions are examined. The study tries to clarify the subject matter that is not patentable in light of the balanced goals of the Indian Patent Act.
On the one hand, the legislation strives to foster real innovation. At the same time, it seeks to prevent monopolies and patent abuse in fields such as computational techniques, traditional knowledge, and small medicinal adjustments.
Statutory Exclusions from Patentability
Sections 3 and 4 of the Indian Patent Act define innovations and discoveries that are expressly not patentable. Section 3 is named ‘What are not innovations,’ and Section 4 is titled ‘What are not inventions within the meaning of this Act,’ respectively. These provisions attempt to avoid monopolies in areas regarded as non-patentable by India’s policy goals by identifying the subject matter ineligible for patents.
The Section 3 excludes from patent protection the following general categories:
- An innovation whose primary or intended use or economic exploitation may be detrimental to public order or morals or which causes substantial harm to human, animal, or plant life, health, or the environment.
- A simple finding of a new property or application for an existing material.
- The simple arrangement, re-arrangement, or repetition of known devices does not result in a new product or employs at least one new element.
- A substance produced by a simple mixing that results merely in the aggregation of the qualities of its constituents or a procedure for making such a substance.
- Simply discovering a scientific principle.
- Surgical, curative, or therapeutic procedures for people or animals. This exclusion does not apply to any gadgets or apparatus employed in such a manner.
- Plants and animals, in whole or in part, other than microorganisms, including seeds, varieties, and species, as well as fundamentally biological processes for plant and animal production or propagation.
- A mathematical or business approach, as opposed to a computer program or algorithms.
- A literary, theatrical, musical, or artistic work, as well as any other aesthetic endeavor, including films and television programs.
- A simple strategy, rule, or way of executing a mental task or of playing a game.
Section 4 of the Indian Patent Act addresses atomic energy innovations. It declares that any discovery linked to atomic energy is not patentable. The significant features include:
- Section 20 of the Atomic Energy Act of 1962 applies to any innovation relevant to atomic energy. Section 20 addresses the ownership and utilization of inventions in the realm of atomic energy.
- The Central Government owns all atomic energy innovations, according to Section 20 of the Atomic Energy Act. Such inventions are not eligible for private patents.
- The Act broadly defines atomic energy as any reference to fissionable material, atomic piles, nuclear reactors, and ways for creating, managing, or utilizing atomic energy.
- This area covers any invention that pertains to or employs fissionable material or atomic energy for industrial or commercial reasons.
- Under this clause, processes, devices, products, or matter compositions employing fissionable material or atomic energy are also not patentable. The goal is to ensure that any inventions related to atomic energy are freely available for use by the Central Government and the general public.
- No patents may be issued for any innovations that fall under the concept of atomic energy as defined by this Act. The government owns such innovations.
Thus, Sections 3 and 4 define subject matter and technological sectors ineligible for patent protection under the Indian Patent Act. This comprises abstract ideas, natural things, computer programs in and of themselves, mental processes, creative works, instructional techniques, biological processes, mathematical procedures, and other similar items that do not fit the requirements of novelty, innovative steps, and industrial application. However, court judgments and policy recommendations continue to shape the limitations of patent eligibility under these legislative exclusions.
Exclusion of Mathematical Methods and Computer Programs
According to Section 3(k) of the Indian Patent Act, mathematical processes and computer programs per se are explicitly excluded from being eligible for patent protection. The section above has undergone modifications and has been shaped by amendments and court rulings about the patentability of software-related innovations.
The 2002 Amendment
The inclusion of the word ‘per se’ in Section 3(k) of the Patents (Amendment) Act, 2002 was intended to clarify the patentability requirements for computer programs. Previously, the Act did not allow for the patenting of computer programs without any restrictions.
The change made in 2002 included the term ‘per se’ to indicate that while computer programs are not eligible for patent protection, software innovations may be eligible for patents if they exhibit a ‘technical application’ or a ‘technical impact.’ Consequently, the amendment implemented the technical effect test as a criterion for determining the eligibility of software for patent protection.
Interpretation in Ferid Allani Case
The case of Ferid Allani v. Controller General of Patents & Designs served as a means to examine and evaluate the understanding and application of Section 3(k). The present invention pertains to a technique for retrieving data contained in a database using Boolean search queries.
The patent application was deemed ineligible for approval under Section 3(k) due to the determination that the invention was a mathematical approach implemented on computer systems without demonstrating any significant technological progress. According to the ruling, computational methods that rely purely on mathematical formulas or business regulations, without any technological innovation, are not eligible for patent protection under Indian legislation.
Section 3(k) is intended to mitigate the formation of monopolies about abstract mathematical techniques and algorithms. Nevertheless, software that employs technical methods and produces a technical outcome may still be eligible for patent protection by the modified regulation.
Exclusion of Incremental Pharmaceutical Innovations
Section 3(d) of the Indian Patent Act seeks to limit the patenting of evergreening and incremental medicinal inventions. Novel versions of existing compounds are only patentable if they significantly enhance the effectiveness of the known drug.
Objective of Section 3(d)
The Patent Act amendment of 2005 added this provision. It inhibits pharmaceutical firms from prolonging medication monopolies by making small changes and applying for new patents. This ‘evergreening’ approach efficiently extends the patent life of proven drugs that give no further therapeutic value.
According to Section 3(d), salts, esters, polymorphs, isomers, formulations, or derivatives of known compounds are not patentable unless they show a considerable improvement in effectiveness over the original chemical. As a result, only substantial inventions that significantly increase therapeutic benefit are patentable under this exclusion.
Interpretation in the Novartis Case
Section 3(d) ‘s reach was tested in the landmark Novartis AG v. Union of India case involving the medicine Glivec. Novartis filed a patent application for the beta crystalline form of Imatinib Mesylate, a salt version of the well-known anti-cancer medication Imatinib.
The patent claim was denied under Section 3(d) because the beta version did not significantly improve therapeutic effectiveness over Imatinib, the original patented chemical. After a legal battle that reached the Supreme Court, the court ruled that the salt form did not qualify for a new patent under Section 3(d) as it only had a minor alteration without any improved effectiveness.
Thus, Section 3(d) effectively prohibited evergreening efforts by prohibiting patents for incremental pharmaceutical innovation based on minor alterations to existing medications. The Novartis case established its use in analyzing drug patents structurally similar to recognized chemicals.
Safeguarding India’s Traditional Knowledge from Biopiracy
Section 3(p) of the Indian Patent Act excludes fundamentally biological methods for generating or multiplying plants and animals from patent eligibility. The drafters created this clause expressly to prevent the immoral biopiracy patenting of India’s traditional medical knowledge.
India has a rich tradition of indigenous treatments that use biological or botanical resources, such as Ayurveda and Unani. Indian plants have been providing therapeutic benefits for millennia, and people commonly use them to heal ailments. However, international corporations sought patents on such Native bioresources by portraying their advantages in contemporary scientific jargon. This commits flagrant theft of traditional knowledge.
Righting Historical Wrongs – Revocation of Controversial Neem and Turmeric Patents
Turmeric and neem are two major examples of such biopiracy. The University of Mississippi Medical Centre received two US patents in 1995. One for “using turmeric in wound healing” and the other for “turmeric for treatment of peptic ulcers.” In India, people have well-documented the wound-healing benefits of turmeric for ages. After a lengthy legal struggle, India persuaded the USPTO to withdraw these contentious turmeric patents.
India pointed out previous art showing neem’s use. This led to the rejection of US and Japanese patents on neem extraction processes and pesticidal applications. India has once again successfully defended its traditional knowledge from patent monopolies.
The 2002 Patent Act amendment introduced Section 3(p) prohibiting such biopiracy. It fundamentally removes biological techniques from patentability for propagating or growing plants and animals. This protects India’s traditional medical knowledge from sudden patent monopolies. India can prevent biopiracy by codifying the exclusion of patents on indigenous bioresources.
Section 3(p) establishes a compromise between India’s international patent law commitments and its commitment to protecting indigenous traditional knowledge. Copyright laws still allow for the protection of creative discoveries involving biological resources. The public domain prohibits granting exclusive rights on traditional therapeutic use. Thus keeping such information open to everyone. This affirms India’s commitment to its rich history of medicinal systems, such as Ayurveda, which belong in the public domain. This prevents it from falling under private ownership via biopiracy.
Sections 3 and 4 of the Indian Patent Act carve out certain limitations from patent eligibility to maintain the country’s policy goals. These exclusions prohibit patents on abstract ideas, algorithms, natural substances, traditional knowledge, and other concepts.
The constraints seek to avoid patent abuse and unnecessary monopolies in software, incremental pharmaceutical discoveries, and old medical knowledge. Simultaneously, Indian patent law promotes real ideas using technology, human creativity, and natural resources.
Cases such as Novartis, and Ferid Allani, have aided in interpreting the exclusions and setting precedents against patent infringement. India hopes to strike the correct balance between promoting research-driven innovation and restricting the exploitation of specific subject matter. The evolving exclusions strive to achieve this difficult balance while remaining consistent with the country’s public policy goals.