The preservation of intellectual property rights (IPRs) is becoming increasingly crucial as the world's economies grow more knowledge-based. IPRs are exclusive rights that encourage investment in knowledge-based assets, entrepreneurship, and innovation. One of these important rights is the law of patents. When an exclusive privilege is awarded to an innovation, it is called a patent. This helps the inventors gain from their innovation by providing their creations with legal protection. Additionally, it provides the general public with access to the technical details of these ideas, which ultimately promotes innovation in society. The pharmaceutical patents are the industry’s core of IPR and are essential for encouraging pharmaceutical research. In contrast to the other sectors where they could be used as safeguards, patents are critical to innovation in the pharmaceutical sector. This patent provides creators with the sole right to use their inventions, acting as barriers to copying and offering to spend money on R&D. They provided the effect of the 20-year patent period once the application is filed. Because of the significance of Trade-Related Aspects of Intellectual Property Rights (TRIPS) contracts, the benefits of patentability, and the explanations of the several kinds of pharmaceutical patents, this research offers a succinct summary of Indian patent law on pharmaceuticals.

Keywords: intellectual property, pharmaceutical industry, Trade-Related Aspects of Intellectual Property Rights.

TYPES OF PHARMACEUTICAL PATENTS

• Process patents:

Process patents cover specific production methods rather than the final product. These are widely used in developing countries such as India and Argentina. Process modifications made possible by these patents help governments safeguard the interests of underserved groups and curtail the monopoly of large firms. The reduced profit margins, however, may deter investments in the pharmaceutical sector, which frequently results in compulsory licensing for the general public's benefit.

• Product patents:

Product patents prevent others from selling or manufacturing ideas by granting inventors the only right to do so. The US, UK, France, Germany, Canada, and the countries that have ratified the TRIPS agreement are among the many industrialized countries that have product patent systems. These patents can result in monopolies, which can be especially harmful in developing regions where people struggle to satisfy their fundamental necessities, even while they do protect innovators.

• Product-by-process patents:

Product-by-process patents define a product according to its production process. They are provided when the only method to differentiate a product from previous ones is through its manufacturing process. But in order to get a patent, the product—not the production method—is what matters. Even if the prior version was produced in a different manner, a product from a product-by-process claim will not be awarded a patent if it is not unique or original.

• Formulation patents:

Formulation patents cover particular therapeutic forms or compositions, including generic formulations used in a range of treatments and certain pharmacological classifications. Transdermal patches and slow-release technologies are two examples. Knowing the type of patent is essential for focusing the search while performing a thorough patent search.

ROLE OF TRIPS IN THE PHARMACEUTICAL INDUSTRY

India had to eliminate its process patent regulations under TRIPS Agreement causing major changes in its pharmaceutical industry because inventors obtained exclusive rights that negatively affected generic drug production for affordable medications. The global IP standards gained momentum because of this shift thus requiring India to modify its Patent Act with Section 3(d) to prevent undeserving patents for therapeutic-efficacy-deficient innovative products. Section 3(d) of the Indian Patent Act, introduced in 2005 as per the TRIPS guidelines, enabled India to face “evergreening” while safeguarding low-cost medication production. The need for TRIPS flexibilities allowed India to preserve its role as "pharmacy for the Global South" by continued generic medication exports worldwide despite initial worries that product patent implementation would hurt generic availability. These reforms developed an equilibrium between drug patents designed to foster innovation and fair access to medicines making India keep its market leadership in generic drug production as it joins the standardized patent system.

CHANGE IN THE INDIAN PATENT ACT

Under Section 3(d) of the Indian Patent Act, pharmaceutical patents cannot be granted for known substances that only receive minor changes unless these modifications provide superior therapeutic results. After TRIPS, India enacted Section 3(d) (2005) to block attempts at monopoly extension through derivative drug development that lacks meaningful therapeutic advantages for known medications. Section 3(d) of public health laws requires therapeutic efficacy improvements in patent applications to directly correspond with how the substance functions clinically, according to Novartis v. A beta-crystalline form of imatinib failed to win patent protection from the Supreme Court of India in Novartis v. Union of India (2013) because it lacked effective clinical benefits. Section 3(d) achieves a patent balance between innovation rewards and accessible generic pricing because it forces substantial improvement beyond previous scientific knowledge to prove inventions provide transformative medical solutions instead of minor adjustments. As India maintains its position as a global supplier of low-cost medicines through this framework, it retains TRIPS flexibilities.

CURRENT CHALLENGES IN THE INDIAN PATENT REGIME

The pre-grant opposition mechanism receives a direct threat from recent Patent Rule changes (2023–2024) which protect against frivolous patents and evergreening. Above regulations place fees ranging from ₹4,000 to ₹20,000 on petitioners while bestowing unrestricted dismissal authority upon patent controllers which discourages civil society groups together with generic manufacturers from challenging dubious patents thereby enabling drug companies to create monopolies on medicine prices. The new changes introduce mechanisms that respond to Western pharmaceutical companies' demands based on trade agreements including the EFTA-India TEPA so they can enforce strict IP regulations while limiting public health measures. The new provisions weaken Section 3(d) of the Indian Patent Act by introducing measures that decrease the level of investigation for therapeutic patentability. The extension of patent “working” disclosure requirements to occur every three years instead of annually allows companies to mask their failure to meet local manufacturing obligations thus reducing compulsory licensing potential. All of these regulatory changes restrict generic drug competition while raising medication costs which threatens India's status as the "Global South's pharmaceutical provider and endangers low-income patients who depend on inexpensive generics.

Affordable medication costs are needed for public health along with universal healthcare to succeed. The Updated Indian Patent Rules threaten to reverse affordable drug objectives by permitting weak protection against pharmaceutical extensions and reducing opportunities for generic pharmaceutical growth. Government authorities should review and adjust the current patent rule revisions to strike a balance between market competition and patient care protection for preserving health services availability at affordable prices. 

Author :-Ananya Jha, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.

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