The legal basis for patent protection in India is governed by the Patents Act, 1970, which establishes the definition of patentable subject matter. The Act has some exclusions to stop ever-greening and frivolous patents, even if it offers broad standards for patentability. Section 3(d), which particularly emphasizes incremental innovations in medicines and other sectors, is one such clause.

In order to restrict the extension of monopoly rights on known compounds without a notable improvement in efficacy, Section 3(d) of the Patents Act of 1970 was created. Following the historic Novartis AG v. Union of India case in 2013, this clause became crucial to India's intellectual property laws. India's resolve to guarantee that patents are only awarded for true breakthroughs rather than slight alterations of already-approved medications was reaffirmed by the Supreme Court's interpretation of Section 3(d). This strategy supports India's public health policy by maintaining the affordability and accessibility of necessary medications.

Section 3(d) aims to combine innovation with preventing "ever-greening," a process in which pharmaceutical corporations attempt to prolong patent protection by making minor modifications to already-approved medications. India's rigorous approach necessitates evidence of improved medicinal efficacy, in contrast to many Western jurisdictions that give patents for minor adjustments. As a result, India is becoming a major participant in international discussions over public health and intellectual property rights.

The clause has important ramifications for patients around the world, generic medicine producers, and the pharmaceutical business. Public health supporters see Section 3(d) as an essential safeguard against monopolistic activities, while multinational corporations contend that it hinders research and development. The clause has been crucial in enabling the manufacturing of reasonably priced generic medications, increasing access to life-saving therapies, particularly in underdeveloped countries.

The purpose of this project is to examine Section 3(d)'s reach and effects in relation to India's larger patentable subject matter framework. To determine whether the provision successfully strikes a balance between innovation and the public interest, it will look at significant court rulings, policy concerns, and global viewpoints.

Patentable Subject Matter

The term "patentable subject matter," which was taken from the US Patent Code, is not used anywhere in the Patents Act. The term "Patentable Subject Matter" is used in the TRIPS Agreement. Subjects that are deemed patentable and those that are not are referred to as patentable subject matter. The legal foundation for patent protection is established by the Indian Patents Act, 1970, which also defines what qualifies as patentable subject matter[1].

Section 2(j) of Patent Act 1970 defines invention as "invention means a new product or process involving an inventive step and capable of industrial application"[2]. The concept of innovation, which stipulates that an invention under the Act must be either a product or a process, gives broad guidelines for what constitutes a patentable subject. In other words, an innovation needs to be a process or a product in order to qualify for patent protection. Therefore, items and processes that are eligible for patents are not restricted by field, technology, or any other factor.

The three main criteria that an invention must meet are industrial applicability, inventive step (non-obviousness), and originality. Even though they fit these requirements, not all inventions can be patented.

Patentability Criteria and Exclusion under the Patent Act 1970

Patents Act's Sections 3 and 4 define what is and is not patentable, guaranteeing that some discoveries, abstract concepts, and natural processes are not covered by patents. These exclusions are meant to prevent monopolies over basic scientific information while striking a balance between innovation and the public interest.

In addition to the three basic prerequisites, Section 3 of the Patents Act expressly forbids the patenting of specific subject topics. Natural rules, mathematical techniques, traditional wisdom, plants and animals, and business practices are all included in this[3]. Because it forbids the creation of new forms of well-known compounds unless they exhibit improved therapeutic efficacy, Section 3(d) is essential in preventing the ever-greening of pharmaceutical patents.

In a similar vein, Section 3(k) only permits software innovations that exhibit technological breakthroughs, excluding computer programs in general from patentability. These exclusions make ensuring that the patent system doesn't give monopolies for non-inventive improvements or unjustly limit access to knowledge.

Section 3(d) of Patent Act 1970

One of the most important clauses in Indian patent law is Section 3(d) of the Patents Act, 1970. Its goal is to stop patents from being granted for minor changes made to already-approved drugs unless they significantly increase their effectiveness. This clause is essential to India's intellectual property laws, particularly for the pharmaceutical sector, because it forbids "ever-greening," the practice of pharmaceutical corporations extending their patent monopoly by making slight modifications to already-approved medications. Section 3. What are not inventions?
The following are not inventions within the meaning of this Act:

• 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.

Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. This clause guarantees that patents are only awarded for true inventions and not for small enhancements that don't make a substantial contribution to innovation. New forms, new uses, and new attributes are not covered by the patentability clause. An illustrative list of forms that are regarded as the same substance as the known material is provided in the explanation for novel forms. The effectiveness clause contains an exception that must be met for a new form to be patented. The new form will be eligible for patent protection if it is more effective than the known form of the chemical. Despite being a limited exception to the exclusion from patentability, this is a crucial opportunity to meet the criterion for patentable subject matter. Analysis of whether a new form is patentable involves the following steps:

1. Identifying the known substance.
2. Determining its purpose and efficacy.
3. Determining whether the invention being claimed is a new form of the known substance.
4. Determining the new form's efficacy.
5. Comparing the new form's efficacy with the known substance's efficacy with regard to the purpose.

The new form is deemed to have enhanced efficacy, making it patentable subject matter, if its effectiveness for the alleged patent purpose is greater than that of the known substance for the same purpose. Benefits offered by the new form that are unrelated to the substance's intended use will not be useful in demonstrating increased efficacy[5].

Objectives of Section 3(d)

1. Preventing Ever-Greening of Patents
   Preventing the extension of patent monopolies by little alterations to already-approved medications is one of Section 3(d)'s primary goals. In order to secure a new patent and prolong their market exclusivity, pharmaceutical corporations employ a tactic known as "ever-greening," in which they make minor modifications to their current medications, such as changing their crystalline forms, dosages, or combinations.
   
   A pharmaceutical corporation with a 20-year patent on a medicine, for instance, can try to change the formulation or add a new salt form and apply for a new patent. In the absence of Section 3(d), this might postpone the release of generic equivalents, maintaining high drug costs and restricting patient access. Section 3(d) guarantees that generic medication producers can create affordable substitutes when the original patent expires by limiting patents on such minor alterations^[6].
    
2. Ensuring Affordable Access to Medicine
   As the "pharmacy of the world," India supplies generic medications to millions of patients worldwide, particularly in developing nations. If patents were granted on minor modifications without proof of enhanced efficacy, affordable generic alternatives would be delayed, making treatment unaffordable for many. This goal is in line with India's international obligations under the Doha Declaration on TRIPS and Public Health (2001), which permits countries to prioritize public health over patent protection. By implementing Section 3(d), India has ensured that essential drugs remain accessible, especially for diseases like cancer, HIV/AIDS, and tuberculosis^[7].
    
3. Encouraging Genuine Innovations
   Promoting actual scientific and technological breakthroughs as opposed to pointless changes is another important goal of Section 3(d). The clause guarantees that patents are exclusively awarded for significant advancements that advance technology. For instance, a pharmaceutical company would be eligible for a patent if it created a genuinely novel and more potent medication. But according to Section 3(d), merely creating a novel derivative of an already-approved medication without enhancing its efficacy does not satisfy the patentability requirement. This guarantees that research and development efforts are focused on real discoveries rather than small adjustments for profit. Instead of letting businesses make money off of flimsy tweaks, this policy encourages the creation of truly novel medications that provide genuine therapeutic advantages.
    
4. Maintaining a Balanced Patent System
   In order to balance innovation and the general welfare, Section 3(d) is essential^[8]. Patent laws are intended to incentivize investment in research and development (R&D) by providing innovators with exclusive rights for a restricted time. Unrestricted patent protection, however, can result in monopolistic behavior, in which businesses stifle competition and inflate prices. Section 3(d) raises the standard for patentability by:
   • Promoting competition: keeps medication costs reasonable by permitting generic drug producers to join the market when the original patent expires.
   • Encouraging corporations to invest in creating truly original drugs rather than depending on modest tweaks by promoting research in new drug discovery.
   • Preventing monopolization: keeps the market open for competition by preventing large pharmaceutical companies from unfairly prolonging their patents^[9].

Judicial Interpretation Of Section 3(D)

Novartis AG (Appellant) Vs. Union Of India & Others (Respondents)

In 1998, Novartis AG, the case's appellant, submitted a patent application for imatinib in the form of crystalline salt for use in the treatment of cancer. The methanesulfonic acid addition salt form of the compound Imatinib, known as Imatinib Mesylate (also known as Glivac or Glivec), was specifically claimed to be better storable than its needle-shaped, alpha crystalline form due to differences in melting points and X-ray diffraction diagrams. Its beta crystalline form is non-needle shaped, has better flow properties, making it better processible, and is less hygroscopic and more thermodynamically stable.

Additionally, it asserted that the beta crystalline form of imatinib mesylate has a 30% greater bioavailability than the free base version of the drug. Because the compound did not satisfy the requirements of Section 3(d), which excludes new forms of a known substance with known efficacy from the scope of patentability unless enhanced efficacy is shown, the application was denied by the patent office and then by the Intellectual Property Appellate Board.

The Appellate Board cited the Madras High Court's ruling, which concluded that improved efficacy translates into improved therapeutic effect and that the substance in question was ineffective, falling under Section 3(d). Nonetheless, it concurred that the molecule met the other standards for patentability, including inventive step, novelty, and industrial usefulness. This result was reached after Novartis appealed the Appellate Board's ruling to the Supreme Court of India.

When discussing the background of Section 3(d), the Court noted that the section primarily deals with pharmaceutical and chemical inventions and that its goal was to prevent the abuse of product patents in medicines. The Court stated that the amended section of Section 3(d) clearly establishes a second tier of qualifying standards for chemical substances and pharmaceutical products to allow for genuine and true inventions while also preventing attempts to repeatedly patent or extend the patent term on spurious grounds.

After determining that imatinib mesylate was covered by prior disclosure, the Supreme Court evaluated its effectiveness in relation to that of its polymorph, the beta crystalline form of imatinib mesylate, for the purposes of Section 3(d). The Court examined the information provided by the Appellant regarding improved flow characteristics, increased thermodynamic stability, decreased hygroscopicity, and enhanced bioavailability and came to the conclusion that the beta crystalline form of imatinib mesylate lacked enhanced efficacy. The Court stated that efficacy under Section 3(d) for pharmaceutical substances meant therapeutic efficacy. When compared to the free base imatinib or its mesylate salt, the court found that the aforementioned features did not improve the effectiveness of cancer treatment.

Regarding the definition of efficacy, the Court declared that a medicine's therapeutic efficacy must be evaluated rigorously and precisely. The 2005 amendment's addition of language to section 3(d) that established the requirement of "enhancement of the known efficacy" and the explanation's requirement that the derivative "differ significantly in properties with regard to efficacy" led to this determination.

The Court argues that only those qualities that are directly related to efficacy—in the instance of a pharmaceutical, its therapeutic efficacy—are important, rather than all helpful or beneficial qualities. According to the Court, a simple form modification with inherent qualities would not constitute "enhancement of efficacy" of a recognized substance[10].

Conclusion And Suggestions
The Patents Act, 1970, governs patentability in India and guarantees that only new, non-obvious, and industrially useful innovations are granted patent protection. Nonetheless, Section 3's exclusions, particularly Section 3(d), are essential for avoiding pointless patents and guaranteeing that only true innovations are safeguarded.

This has been especially important in the pharmaceutical industry, where stringent patentability standards keep necessary medications reasonably priced and stop patents from ever-greening. Indian courts have reaffirmed the significance of improved medicinal efficacy as a need for patentability through judicial interpretations, most notably in Novartis AG v. Union of India (2013). This ensures that the public interest is protected while allowing for innovation[11].

Even if India's patent system has been beneficial, there are still a number of issues. Pharmaceutical and technology businesses commonly argue that the stringent interpretation of patent rules hinders investment in research and development (R&D). There is also concern that the Indian Patent Office makes inconsistent decisions because there are no clear rules on what constitutes increased efficacy.

Furthermore, even while industrialized countries and multinational pharmaceutical companies have successfully resisted attempts to weaken Section 3(d), India is still subject to examination under international trade agreements, especially from organizations like the United States Trade Representative (USTR).[12]

India should endeavor to provide more precise rules on patent eligibility, especially with relation to Section 3(d), in order to allay these worries. A clearer definition of "enhanced efficacy" will guarantee uniformity in patent review and make the requirements easier for innovators to comprehend. The effectiveness and dependability of the patent granting process can also be improved by fortifying patent examination protocols through updated training for patent officers and the use of AI-based patent examination tools.

Additionally, India needs to find a balance between promoting innovation and preserving affordability in vital areas like technology and healthcare. To ensure that Indian enterprises are encouraged to create innovative innovations rather than depending on small adjustments, the government should provide incentives and funding schemes for local pharmaceutical and technical R&D.

Without sacrificing accessibility, partnerships between academic institutions, research groups, and the commercial sector can potentially promote significant innovation.
In summary, India has a well-organized framework for patentable subject matter that places equal emphasis on public health and innovation. To meet changing domestic issues and global trends, however, ongoing changes are required.

India can further solidify its position as a leader in technical developments and reasonably priced medications while preserving a robust and well-balanced patent system by enacting more transparent legislative frameworks, bolstering its capacity to examine patents, and encouraging local innovation[13].

End Notes:

1. Dr. Elizabeth Verkey, Law of Patents, Eastern Book Company, Lucknow, 1st edition (2005)
2. Section 2(j) of Patent Act 1970
3. N.S. Gopala Krishnan & T.G. Agitha, Principles of Intellectual Property, Eastern Book Company, 1st edition, 2004
4. Section 3(d) of Patent Act 1970
5. Dr. Elizabeth Verkey, Law of Patents, Eastern Book Company, Lucknow, 1st edition (2005)
6. Substantive requirements of patentability in India by Monica Raje
7. Patentable Subject Matter and the Necessity of Limitations on It by Prof. (Dr.) Tabrez Ahmad and Debmita Mondal
8. An Attempt at Quantification of 'Efficacy' Factors under Section 3(d) of the Indian Patents Act by Aditya Kant
9. N.S. Gopala Krishnan & T.G. Agitha, Principles of Intellectual Property, Eastern Book Company, 1st edition, 2004
10. Novartis AG v. Union of India (2013) 6 SCC 1
11. Novartis AG v. Union of India (2013) 6 SCC 1
12. Dr. Elizabeth Verkey, Law of Patents, Eastern Book Company, Lucknow, 1st edition (2005)
13. N.S. Gopala Krishnan & T.G. Agitha, Principles of Intellectual Property, Eastern Book Company, 1st edition, 2004