Sss’s Divine College of Pharmacy, Nampur Road, Satana, Nashik, Maharashtra, India 423301.
Intellectual Property Rights (IPRs) constitute a cornerstone of modern innovation systems by providing legal protection to creations of the human intellect, including inventions, literary and artistic works, confidential knowledge, and industrial innovations. These rights grant time-bound exclusivity to creators and inventors, thereby safeguarding investments, promoting recognition, and fostering economic returns. This review critically examines the significance, categories, and historical development of IPRs, with particular emphasis on their role within the pharmaceutical sector. Various forms of intellectual property patents, copyrights, trademarks, trade secrets, geographical indications, and industrial designs are analyzed in terms of their contribution to innovation, industrial competitiveness, and global trade. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, established under the World Trade Organization, is discussed as a landmark framework that harmonized international standards, particularly with respect to patent duration and enforcement. The review also outlines the patent filing process and the statutory duration of IPR protections across different categories. Within pharmaceuticals, patents, data exclusivity, and trade secrets emerge as pivotal instruments for protecting research investments, enabling commercialization, and ensuring therapeutic reliability. It is concluded that robust IPR frameworks not only stimulate innovation and public–private collaboration but also enhance global competitiveness and contribute significantly to sustainable economic and healthcare development.
Intellectual Property (IP) refers to original creations of the human intellect whether artistic, literary, scientific, or technical. These creations often result from significant investments of time, effort, skill, and resources. To safeguard such intangible assets, Intellectual Property Rights (IPRs) are granted by law, conferring exclusive rights to the creator or inventor for a specified period [1, 2, 3]. IPRs serve as a recognition of individual or institutional ingenuity, allowing innovators to benefit economically from their inventions or creative outputs [4,5]. These legal protections encourage innovation by offering a structured pathway for commercialization, branding, and the long-term preservation of intellectual assets. In today’s knowledge-based economy, the role of IPRs is pivotal. A strong IP framework is not only essential for individual recognition and reward but is also intricately linked to national development and technological progress [6]. Lack of awareness or enforcement of IPRs can lead to infringement, economic losses, and the stifling of innovation [7,8]. A patent serves as formal recognition of an invention that meets global standards of novelty, inventiveness, and industrial applicability. Intellectual Property Rights (IPRs) are essential for the effective identification, strategic planning, commercialization, and long-term preservation of innovations and creative works. Each industry should cultivate its own specialized approach to IPR, aligning it with sector-specific policies, management practices, and innovation strategies [9].
History of Intellectual Property Rights
Type of Intellectual Property Rights
Figure 1: Type of IPRs
1) Patents
Patents are granted for new inventions or discoveries, giving the inventor exclusive rights to use, make, and sell the invention for a certain period (usually 20 years). This protection is granted in exchange for disclosing the invention to the public [11].
Types of patents
Utility Patent- Utility patents protect the functional portion of the invention. Utility patents may cover new and useful machines, processes, or compounds, as well as improvements to existing machines, processes, or compounds. Depending on the invention, these patents could be classified as mechanical, software, chemical, electronic, or any other field.
Design Patent- Patents pertaining to an object's look, form, or arrangement are known as design patents. It is crucial that the thing incorporates this new design completely.
Plant Patent- As the name suggests, patents for plants are used to safeguard novel and distinctive plant varieties [11]. This is the privilege granted to farmers for the advancement, preservation, and accessibility of plant genetic resources (PGR), hence eliminating the need for farmers to constantly visit breeders. In order to facilitate the creation of an efficient system for plant variety preservation, the Indian parliament passed the Preservation of Plant Variety and Farmers Rights Act 2001 (PPV&FR act) [12].
2) Copyright
Copyright protects original literary, artistic, and musical works, granting authors or creators the exclusive right to reproduce, distribute, and adapt their works. Copyright protection typically lasts for the life of the author plus 50 to 70 years.
3) Trademarks
Trademarks protect distinctive symbols, logos, names, and slogans that distinguish products or services. Trademark holders have exclusive rights to use these identifiers in connection with their goods or services.
4) Trade Secrets
Trade secrets encompass confidential business information, such as manufacturing processes, formulas, and customer lists. Protection of trade secrets relies on maintaining their secrecy within a business.
5) Industrial Designs
Industrial designs refer to the ornamental or formal appearance of a product. The TRIPS Agreement establishes minimum standards for the protection of industrial designs, which are integral to intellectual property rights [13].
6) Geographical Indication
Geographical indications (GIs) are a form of intellectual property that protect the distinct quality and reputation of products linked to a specific region or country. Commonly applied to goods such as wines, cheeses, and textiles, GIs ensure product authenticity. As IPR laws vary across jurisdictions, recognition is not always universal; thus, stakeholders must be aware of local regulations to effectively protect their intellectual assets [14].
The Patent Filing Steps
Step 1: Filing of Patent Application or Priority Application
There are four patent offices at Chennai, Mumbai, New Delhi, and Kolkata (head office). The applicant has to file a patent application in the appropriate form with all relevant information concerning the invention, such as a description, claims, drawings, an abstract, etc. The applicant has the option to file a provisional specification to establish priority of the invention when the disclosed invention is only at a conceptual stage. Thereafter, within 12 months, the applicant has to file a complete specification in the prescribed format.
Step 2: Publication of Application
The patent application is published in the office journal after expiry of 18 months. The applicant can also put up a request for early publication by paying an additional prescribed fee.
Step 3: Opposition of Patent
The pre-grant patent opposition, if any, may be filed within three months of patent publication. This type of opposition representation is entertained by the controller of the patent office if patent filing applicant has put up a request for patent examination. There are also provisions for post-grant patent opposition [14].
Step 4: Request for Examination.
A request for examination is a formal application made by the patent applicant to the patent office, asking for the start of the examination process of a published patent application. Without this request, the patent will not be examined and will be considered withdrawn after the deadline. It must be filed within a specific time period (e.g., 48 months from the filing/priority date in India [15].
Step 5: Examine and Clarify the Raised Objections.
After submitting the Request for Examination (RFE), the patent office reviews the application and issues a First Examination Report (FER). This report may contain technical and legal objections to novelty, inventive step, clarity, and patentable subject matter. The applicant must respond to the objections within a specified time frame (for example, 6 months in India [16].
Step 6: Grant of Patent.
The grant of a patent is the patent office's official decision to approve the application after the applicant has successfully addressed all objections raised during the examination. Once granted, the applicant becomes the patent holder, with exclusive rights to manufacture, use, sell, or license the invention for a set period of time (usually 20 years from the filing) Each patent's validity period is 20 years from the date of filing, regardless of whether a provisional or complete specification is included with the patent application. The patent's date is determined when the application is filed. A trademark registration is considered to have taken effect 10 years after the application filing date, which is used as the registration date [17].
Duration of Intellectual Property Rights
Application of IPRs
Figure 2: Importance of IPR
1. Patents and Drug Development
One of the key forms of IPR in the pharmaceutical industry is patents. Patents provide exclusive rights to the inventor of a new drug or treatment, preventing others from manufacturing, selling, or using the invention without permission for some time. This exclusivity period is usually 20 years from the date of filing of the patent application. Patents incentivize drug development by providing a mechanism for recovering the costs of research and development and the time spent in bringing the drug to market and by allowing drug companies to earn profits from the sale of their products. However, the patent system has also been subject to criticism, particularly when it comes to access to medicines in developing countries. Critics argue that the high prices of patented drugs may prevent people in developing countries from accessing life-saving treatments and that the patent system may be used to extend monopolies and prevent the development of generic drugs.
2. Data Exclusivity
Data exclusivity is another form of IPR that is important in the pharmaceutical industry. Data exclusivity protects the data generated during the clinical trials of a new drug, preventing competitors from using the data to gain regulatory approval for a generic version of the drug. Data exclusivity periods are usually shorter than patent terms and can range from five to ten years. Data exclusivity is important because it allows drug companies to recover the costs of clinical trials, which can be extremely expensive. Without data exclusivity, generic drug manufacturers could simply use the data generated by the innovator company to obtain regulatory approval for their products, without incurring the high costs of clinical trials.
3. Trademarks
Trademarks are another form of IPR that is important in the pharmaceutical industry. Trademarks are used to protect the brand names of drugs, as well as their packaging and other identifying features. Trademarks help to prevent confusion among consumers and ensure that the quality of the product is maintained. Trademarks are particularly important in the pharmaceutical industry because they help to build brand loyalty and trust among patients. Patients are often more likely to choose a drug that they are familiar with and trust, and trademarks help to build that familiarity and trust.
4. Trade Secrets
Trade secrets are another type of IPR that is significant in the pharmaceutical industry. Trade secrets are confidential information used by a business to gain a competitive advantage over its rivals. In the pharmaceutical industry, trade secrets can include information about a drug's manufacturing process or formulation. Trade secrets are important because they allow drug companies to maintain a competitive advantage over their competitors without disclosing sensitive information to the public. However, trade secrets can be abused and used to prevent the development of competing products.
5. Regulatory Exclusivity
Regulatory exclusivity is another form of IPR that is important in the pharmaceutical industry. Regulatory exclusivity protects drugs that have been granted regulatory approval, preventing competitors from gaining approval for generic versions of the drug for some time. Regulatory exclusivity periods are usually shorter than patent terms and can range from six months to three years. Regulatory exclusivity is important because it allows drug companies to recover the costs of obtaining regulatory approval for their products, which can be a long and expensive process. Without regulatory exclusivity, generic drug manufacturers could simply rely on the regulatory approval of the innovator company to gain approval for their products, without incurring the high costs of obtaining regulatory approval [20,21,22,23].
Role of Intellectual Property Rights in Innovation and Economic Growth
1. Promoting Innovation
Intellectual property rights, such as patents, copyrights, and trademarks, provide creators and inventors with exclusive rights, encouraging investment in R&D.
2. Economic Growth
IPRs have a significant impact on national GDP, foreign direct investment, and employment. Countries with strong IPR systems frequently see increased technology transfer, venture capital, and startup ecosystem development. Industries that rely heavily on intellectual property rights are known to produce higher-value products and increase export opportunities.
3. Encouraging Public Private Collaboration
IPRs foster collaboration between academic institutions and industry, allowing university research to be commercialized, particularly in pharmaceuticals, biotechnology, and medical devices.
4. Increasing Competitiveness
Strong intellectual property rights allow domestic companies to compete globally by protecting product uniqueness, ensuring market exclusivity, and fostering brand loyalty [24].
CONCLUSION
Intellectual Property Rights are integral to modern innovation systems, particularly in the pharmaceutical sector, where they incentivize research and development, protect intellectual investments, and support economic growth. By granting time-bound exclusive rights, IPRs facilitate the transformation of scientific discoveries into marketable products and enhance industrial competitiveness. Key forms of IPR such as patents, data exclusivity, trademarks, and trade secrets serve as essential tools for safeguarding proprietary technologies and fostering sustained innovation. The TRIPS Agreement has played a pivotal role in harmonizing IP standards globally; however, its effective and equitable implementation remains critical to balancing innovation incentives with public health needs. Ultimately, a robust and well enforced IPR framework is vital for promoting pharmaceutical advancement and contributing to broader socio-economic development.
REFERENCES
Vishvaja A. Kapadnis*, Shivraj P. Jadhav, Mayur S. Bhamare, Sunil K. Mahajan, Intellectual Property Rights in Pharmaceutical Sector: Driving Innovation, Protection, And Economic Growth, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 8, 2629-2636 https://doi.org/10.5281/zenodo.16939173
10.5281/zenodo.16939173
