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Medicinal preparations obtain limited patentability due to the various exclusions found in Section 3 of the Indian Patents Act. To ensure success in the pharmaceutical industry stakeholders must understand which patents are excluded under Section 3 of the Indian Patents Act.

Section 3(d): Addressing Incremental Innovation

Section 3(d) is a pivotal provision that restricts the patenting of:

“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant“

The law exists to eliminate evergreening practices by preventing medications from gaining patents for insignificant therapeutic improvements of original drugs. The applicants need definitive proof showing substantial treatment improvements to satisfy this condition.

The section contains provisions which bar patent applications for:

• The acceptance of known substance variations such as polymorphs, salts, esters, ethers, metabolites, prodrugs, particles, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of known substances into patents is restricted to cases which prove substantial therapeutic effectiveness improvements. This is a high bar to clear.
• New uses of known substances. The patenting of new medical applications involving existing drugs is usually excluded under this section.
• A known process, machine or apparatus itself cannot result in new patentability unless it produces new products or utilizes fresh reactants during the operation.

Demystifying Section 3(d):

The Indian patent law under Section 3(d) acts as a blockade against pharmaceutical companies making trivial modifications to drugs that fail to provide essential therapeutic benefits. For applicants to overcome this challenge they must provide substantiated proof that demonstrates how their new form surpasses known substances in therapeutic activity. This could include:

• Better bioavailability boosts the performance of therapeutic treatment.
• The drug maintains its therapeutic power by causing minimal health-related adverse effects on patients.
• The product longevity together with its stable properties helps patients achieve enhanced therapeutic outcomes.

Medical standards cannot be met by solubility-enhanced drug formulations or stand-alone formulation designs unless they prove improved therapeutic results.

For Example, the Supreme Court of India ruled on Novartis AG vs. Union of India & Others (2013) as the most famous case tied to Section 3(d). The Supreme Court of India validated the Novartis patent application denial for beta-crystalline form Imatinib Mesylate (Glivec) as this chemical represented only a different presentation of an already existing substance with minimal efficacy enhancement. The overturned Novartis patent established vital guidelines for interpreting Section 3(d) whereas it functions to counter “evergreening” in pharmaceutical patents.

Section 3(e): Barring Simple Admixtures

Section 3(e) states that:

“substances obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance” are not patentable.  

The particular provision prevents patent issuance for fundamental substance mixtures when the combined output reflects only independent component influences without emerging novel combined actions. Standard patent regulations state that combination patent eligibility requires synergistic effects between components.

Demystifying Section 3(e):

A prohibition exists for patent applications on drug combinations when such formulations fail to show better results than basic additive interactions. Drug formulas require synergy evidence between their components to qualify for a patent for superior outcomes than individual components. The official patent agencies refuse to grant patent protection for medications producing only basic combined effects.

For Example, a corporate patent of paracetamol and ibuprofen combination requires evidence demonstrating superior pain relief capabilities than the individual drugs at equivalent doses. Such demonstrated synergy between components becomes necessary to survive challenges based on Section 3(e) of the patent.

The patentability of formulations and combinations receives limited consideration through legal proceedings such as Ajantha Pharma Limited vs. Allergan Inc even though the main points relate to inventive step and Section 3(d) regulations.

Section 3(i): Excluding Methods of Treatment

Section 3(i) explicitly excludes from patentability:

“any process for the medicinal, surgical, curative, prophylactic [preventive], diagnostic, therapeutic or other treatment of human beings or 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.”  

Both human and animal drug treatment methods receive no patent protection according to Indian patent law. The exclusion of drug usage methods does not extend to drug substances if these substances fulfil all required patent eligibility criteria. Patents exist for drug formulations alongside delivery systems when these systems deliver advantages that extend past medication delivery functions.

Demystifying Section 3(i):

Medical treatment techniques are excluded from patenting under this section (medicinal, surgical, therapeutic processes on humans/animals). It becomes impossible to obtain patent protection for a medical procedure which entails administering existing pharmaceutical substances to treat diseases. Two main conditions define when drugs or formulations along with medical devices can receive patents for treatment purposes. Free availability of medical treatment methods takes center stage as the main objective of this section.

For Example, some patent applications by Stempeutic Research Pvt. Ltd. move from treatment method claims to product claims by framing them as “(e.g., ‘a composition for use in treating…’)” in order to pass Section 3(i) standards. The patentability of stem cell therapies and their application methods results in evaluations about the influence of this section.

Section 3(p): Traditional Knowledge 

The fundamental criterion regarding medicinal preparations in India excludes inventions which exclusively contain traditional knowledge or duplicate established properties of well-known components. Under Section 3(p) of the Patents Act the law stipulates that:

“an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components” is not patentable.

Section 3(p) stands out as an essential provision for India since the nation maintains an abundant traditional medical heritage that includes practices like Ayurveda, Unani, Siddha and Yoga. Section 3(p) exists to block knowledge misappropriation through patents which contains already known information handed down through generations.

Demystifying Section 3(p):

According to this part legal protection cannot be obtained when a compound is merely isolated from traditional plants yet it’s already known medical properties remain unchanged. The main goal in this context aims to stop anyone from obtaining patents for materials that traditional communities have long practiced.

Traditional knowledge cannot completely stop the granting of patents for derived inventions. Specifically the patent can be approved if significant inventive steps occur.

• A new method for extract and purify known compounds from traditional sources leads to create improved products with better functionality or unique features.
• Creating a new application for an established material when this functional drawback remained unknown to traditional knowledge systems.
• The method needs to pass through Section 3(d) efficacy guidelines unless the material being enhanced is considered unknown in the traditional knowledge framework.
• A traditional remedy derived from knowledge integration has been developed into a new dosage form which proves to enhance stability and bioavailability levels.

The patentability assessment becomes possible when innovation goes beyond basic recognition or duplicating existing traditional knowledge. A genuine inventive contribution above existing traditional knowledge standards serves as the essential criterion for patentability to be considered. The Traditional Knowledge Digital Library (TKDL) serves as a central tool to stop patent grants involving traditional knowledge through its worldwide distribution of previous knowledge to patent authorities.

For Example, the patent dispute between CSIR and USA focused on turmeric’s healing capabilities for wounds which proved successful for Indian authorities in their challenge against U.S. patent rights. The US case regarding traditional knowledge patenting directly supports Section 3(p) in the Indian Patents Act which blocks the patenting of such heritage knowledge. The US patent on turmeric wound healing was revoked by the CSIR who presented proof of traditional Indian medical use of the natural product. The case established major ground breaking status when it comes to protecting traditional knowledge from biopiracy principles.  

The fungicidal properties of neem went under EPO patenting attempts as a biopesticide. Many organizations together with India contested this patent because they believed the practice of pesticide usage with neem roots originated from Indian traditional knowledge. This extensive case illustrates the strong efforts to stop anybody from patenting traditional knowledge while its legal process lasted multiple years.