INTELLECTUAL PROPERTY RIGHTS (IPR)

2. What are Intellectual Property Rights (IPR)?

Intellectual Property Rights (IPR) refer to legal rights granted to creators and owners of intellectual property, which are intangible assets resulting from human creativity and innovation. These rights provide creators and owners with exclusive control over the use and distribution of their intellectual creations, allowing them to benefit financially and protect their works from unauthorized use by others.

The main types of intellectual property rights include

• Patents protect inventions and technological innovations, granting the inventor exclusive rights to manufacture, use, and sell their invention for a limited period, typically 20 years from the date of filing the patent application.
• Copyrights protect original works of authorship, such as literary, artistic, musical, and dramatic works, as well as software, films, and other creative expressions. Copyright holders have exclusive rights to reproduce, distribute, perform, and display their works for a specified period, usually the lifetime of the author plus 50 to 70 years.
• Trademarks protect distinctive signs, symbols, logos, names, or slogans used to distinguish the goods or services of one business from those of others. Trademark owners have the exclusive right to use their mark in commerce and prevent others from using similar marks that may confuse consumers.
• Trade secrets protect confidential business information, such as formulas, processes, techniques, or customer lists, which provide a competitive advantage to a business. Unlike patents, trade secrets do not require registration and can potentially last indefinitely as long as they remain secret.
• Industrial designs protect the visual appearance or aesthetic aspects of a product, such as its shape, configuration, pattern, or ornamentation. Design rights grant exclusive rights to the owner to use and prevent others from using their design for a limited period.
• Geographical indications identify goods as originating from a specific geographical location, where a particular quality, reputation, or other characteristic of the product is essentially attributable to its geographical origin. GI rights protect the unique identity and reputation of products associated with specific regions.

3. About generic medicines

Generic medicines are pharmaceutical products that contain the same active ingredients, dosage form, strength, and route of administration as brand-name drugs. However, they are typically sold under their chemical or non-proprietary name instead of a brand name. Generic medicines are bioequivalent to their brand-name counterparts, meaning they have the same therapeutic effect and safety profile when administered to patients under the same conditions.

The key characteristics of generic medicines

• Generic medicines contain the same active pharmaceutical ingredients (APIs) as brand-name drugs. These active ingredients are responsible for the therapeutic effects of the medication.
• Generic medicines have the same dosage form (e.g., tablet, capsule, injection) and strength as the corresponding brand-name drug, ensuring consistency in dosing.
• Generic medicines are required to demonstrate bioequivalence to the brand-name drug through rigorous testing. This means that the rate and extent of absorption of the active ingredient into the bloodstream are similar to that of the brand-name drug when administered at the same dose.
• Generic medicines must meet the same quality, safety, and efficacy standards as brand-name drugs. Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe, review and approve generic medicines before they can be marketed.
• One of the primary advantages of generic medicines is their lower cost compared to brand-name drugs. Generic manufacturers do not incur the same research and development expenses as brand-name companies, allowing them to offer their products at a lower price.
• In many countries, including the United States, generic medicines are considered interchangeable with their brand-name counterparts. This means that pharmacists can substitute a generic version for the brand-name drug if it is available, as long as it meets certain regulatory requirements.

4. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement?

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is an international treaty administered by the World Trade Organization (WTO). It sets out minimum standards for the protection and enforcement of intellectual property rights (IPRs) among WTO member countries. The TRIPS Agreement was negotiated during the Uruguay Round of multilateral trade negotiations and came into effect on January 1, 1995.

Key features of the TRIPS Agreement include

• The TRIPS Agreement covers various forms of intellectual property, including patents, copyrights, trademarks, geographical indications, industrial designs, and trade secrets.
• The agreement establishes minimum standards of protection and enforcement for each type of intellectual property. These standards require member countries to provide adequate and effective protection for intellectual property rights, ensuring that they are enforceable through civil and criminal procedures.
• The TRIPS Agreement requires WTO member countries to treat foreign intellectual property rights holders no less favourably than domestic rights holders. This principle, known as national treatment, prevents discrimination against foreign intellectual property rights holders in terms of protection and enforcement.
• Member countries are also required to grant the most favoured nation treatment to intellectual property rights holders from other WTO member countries. This means that any advantages, privileges, or exemptions granted to the intellectual property rights holders of one WTO member country must be extended to the rights holders of all other WTO member countries.
• The TRIPS Agreement allows member countries to adopt certain flexibilities and exceptions to intellectual property rules to promote public health, access to medicines, and other public policy objectives. These flexibilities include compulsory licensing, parallel importation, and limitations and exceptions to copyright and patent rights.
• The TRIPS Agreement provides for a dispute settlement mechanism to address disputes between WTO member countries regarding the interpretation and application of the agreement's provisions. This mechanism allows countries to bring complaints against each other and seek resolution through WTO adjudication procedures.

5. The patent criteria in India

In India, the criteria for granting a patent are outlined in the Patents Act, 1970, and its subsequent amendments. To qualify for a patent, an invention must meet the following criteria.

• The invention must be new and not disclosed to the public anywhere in the world before the date of filing the patent application. Any prior publication, use, or disclosure of the invention would jeopardize its novelty.
• The invention must involve an inventive step or non-obvious advancement over existing knowledge or technology for a person skilled in the relevant field. In other words, it must not be obvious to someone with ordinary skills in the field.
• The invention must be capable of being made or used in an industry. It should have practical utility or industrial application and be capable of being manufactured or used in some kind of business or industrial activity.
• Certain subject matters are excluded from patentability under Indian patent law. These include inventions that are frivolous, contrary to public order or morality, mere discoveries of a scientific principle or method, schemes, rules, or methods of performing mental acts or doing business, computer programs per se, and methods of agriculture or horticulture.
• The patent application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the relevant field. The application must include a description of the invention, claims defining the scope of protection sought, and any necessary drawings or diagrams.
• The invention must not have been disclosed to the public in any manner, including through publication, before the filing date of the patent application. Public disclosure before filing can undermine the novelty and patentability of the invention.

Applicants seeking a patent in India must ensure that their invention satisfies these criteria and file a patent application with the Indian Patent Office. The patent application will undergo examination to determine whether the invention meets the statutory requirements for patentability. If the application meets all criteria, a patent will be granted, providing the inventor with exclusive rights to the invention for a specified period, typically 20 years from the date of applying.

6. The theme of the World Intellectual Property Day, 2024

• World Intellectual Property Day was established by the World Intellectual Property Organization (WIPO) in 2000 to promote awareness about intellectual property rights and their importance in fostering innovation, creativity, and economic development.
• The date of April 26th was chosen for World Intellectual Property Day because it marks the anniversary of the entry into force of the Convention establishing the World Intellectual Property Organization in 1970.
•  2024 Theme: "IP and the SDGs: Building our common future with innovation and creativity." This year's theme focuses on how IP rights can be used to advance the UN's Sustainable Development Goals (SDGs), which aim to address global challenges like poverty, inequality, and climate change.

7. The Way Forward

Addressing concerns related to intellectual property rights and access to medicines requires a comprehensive and collaborative approach involving multiple stakeholders and policy domains. By engaging in dialogue, advocacy, and policy reform efforts, stakeholders can work towards ensuring that intellectual property rights support innovation while also promoting access to essential medicines for all.