A patent is the intellectual property that gives its owner the legal right to exclude others from making, selling, using and fabricating an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention , According to World Intellectual Property organisation "A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem".[1]

Patent Law in India:

Patent rights were introduced in India for the first time in 1856 and in 1970, the Patent Act 1970 was passed, and this act repealed all previous legislations related to patent. Again, the patents Act, 1970 was amended by the Patents (Amendment) Act, 2005 regarding extending product patents in all areas of technology including food, medicine, chemicals, and microorganisms.

India is also a signatory to the Paris Convention for the protection of industrial property,1883, Trade—Related (Aspects of) Intellectual Property Rights (TRIPS), General Agreement on Tariffs and Trade (GATT) and the Patent Cooperation Treaty,1970.

The Patents Act, 1970 provides that any inventions that satisfies the criteria of newness, non-obviousness and usefulness can be subject matter of a patent.

Sections 3 and 4 of the Indian Patents Act, 1970 provides the certain criteria which have to be fulfilled to obtain a patent in India. They are:

• Patent Subject Matter,
• Novelty or new invention, ^[2]
• Inventive steps or non-clarity, ^[3]
• Capable of industrial application. ^[4]

Patent Law in USA:

In the United States, a patent is a limited-time monopoly for a new invention or discovery. It is a contract between government and an inventor that gives the inventor the right to exclude others from making, selling, or using the invention for a set period of time.

The Patent Act governs the granting of patents and the workings of the United States Patent and Trademark Office (USPTO). The USPTO issues three types of patents: Utility Patents, Design Patents, and Plant Patents.

To be issued a patent, an invention must meet four conditions:

• Be able to be used,
• Have a clear description of how to make and use it,
• Be new or novel,
• Be "not obvious," as related to a change to something already invented.

The impact of the world trade organization on pharmaceutical patents (Indian overview):

Before the establishment of World Trade Organization, India had a product patent regime for all inventions under the Patents and Designs Act, 1911. However, in 1970, the government introduced the new patents act which excludes pharmaceuticals and agrochemicals products from eligibility for patents.

The establishment of the World Trade Organization has led to rapid shift in world trade. The agreement on Trade-Related (Aspects of) Intellectual Property Rights (TRIPS) was negotiated during the Uruguay round trade negotiations of the General Agreements on Tariffs and Trade (GATT) and "one of the primary reasons for incorporating intellectual property issues into the GATT framework was the Pharmaceutical Industry".[5] India signed the GATT on 15 April 1994.

India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India's patent legislation includes provisions for availability of patents for both pharmaceutical products and process inventions. Patents are to be granted for a minimum term 20 years to any invention of a pharmaceutical product or process that fulfils established criteria.

India has decided to avail itself of the full transition period for developing countries and has until 1 January 2005 to extend patent protection to pharmaceutical products. In keeping with the TRIPS commitments[6], India has started on a process of amending the patents act by providing exclusive marketing rights (EMRs) and creating a mailbox system for patent applications for a period of five years or until the patent is granted or rejected, whichever is earlier.

How patents are used in the pharmaceutical industry in India:

Patents plays a crucial and important role in the pharmaceutical industry in India, especially in the realm of medical patents.

India's pharmaceutical industry has undergone significant changes and transformation over the years evolving from a predominantly generic drug manufacturing hub to a centre for innovation. The granting of patents is a fundamental aspect of fostering innovation by providing inventors with exclusive right to their innovations for a limited period. In the context of medical patents, these innovations often relate to novel drugs, formulations, or medical devices that address unmet medical needs.

Patents are used in the pharmaceutical industry in India because of the critical factors influencing the use of patents in the pharmaceutical sector is the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, administrated by the World Trade Organisation (WTO). India being a signatory to TRIPS, had to make amendments to its patent laws.

In 2005, India transitioned from a process patent regime to a product patent regime, allowing for the patenting of specific drugs and medical innovations.

The Indian patent laws includes provisions for compulsory licensing, allowing the government to grant licenses to third parties to produce patented drugs in certain situations. This mechanism aims to balance the interests of patent holders and the need for widespread access to critical medications, especially in public health emergencies.

Indian patent law constrained the Issue of Evergreening, evergreening refers to the practise of making minor modifications to an existing drug, often with the little therapeutic improvement, to extend the patent protection period. Indian patent law contains provisions to prevent evergreening, ensuring the genuine innovations receive patent protection while preventing the undue extension of monopolies.

India's approach to medical patents also aligns with its commitment to public health. Initiatives like the National Pharmaceutical Pricing Authority (NPPA) regulate the prices of essential medicines to ensure affordability for the general population.

How patents are used in the pharmaceutical industry in united states:

In United States, patents provide inventors and pharmaceutical companies with exclusive rights to their inventions for a limited period, typically 20 years from the filing date. This exclusivity allows the patent holder to prevent others from making, using, selling, or importing the patented invention without permission. In the context of medical realm these inventions are often relate to novel drugs, formulations, methods of treatment, and medical devices.

In the United States, the use pf patents system is encourage research and development (R&D) by offering inventors temporary monopoly on their inventions. This exclusivity enables pharmaceutical companies to recoup the substantial investments required for drug discovery, clinical trials, and regulatory approval.

The Hatch-Waxman Act, 1984 officially known as the Drug Price Competition and Patent Term Restoration Act, represents a notable aspect of the pharmaceutical patent landscape in the USA. This legislation aimed to encourage both innovation and generic competition by establishing a framework for the approval of generic drugs. Under the Act, generic manufacturers can challenge the validity of certain patents held by the originator drug company, leading to patent litigation and the potential entry of more affordable generic alternative into the market.

In the USA the Food and Drug Administration (FDA) considers patent information provided by the originator drug company when reviewing generic drug application. This process helps to prevent premature entry of generic versions into the market and ensures that generic manufactures address patent concerns before marketing their products.

The U.S. Patent and Trademark Office (USPTO) reviews and approves all patent applications. In the USA patents area form of contract between the inventor and the government. The inventor agrees to disclose the entire invention, and in return, the government grants the inventor the exclusive right to stop others from using or making that invention.

Conclusion:
In conclusions, patents are integral to the functioning of the pharmaceutical industry in both India and the USA particularly in the context of medical patents, is a developing, dynamic, and evolving landscape. The transition to a product patent regime has spurred innovations, with a greater focus on Research and Development (R&D). In both country's laws challenges such as Evergreening are supress via balancing innovation, compulsory licensing, and regulations.

The interplay between patents, public health, and affordability continues to shape the pharmaceutical landscape in India, reflecting the delicate equilibrium between fostering innovation and ensuring the availability of essential medicines to the masses.

References:

• https://www.wipo.int/patents/en
• https://blog.ipleaders.in/what-is-a-patent-law-in-india/
• https://www.justia.com/intellectual-property/patents/
• https://www.lexology.com/library/detail.aspx?g=09cc3860-e1f5-4463-afb9-f881528f0578

End-Notes:

1. https://www.wipo.int/patents/en/
2. Section 2(1)(l) of the Patent Act, 1970
3. Section 2(ja) of the Patents Act, 1970
4. Section 2 (ac) of the Patents Act, 1970
5. Zafar Mirza, WTO/TRIPs, Pharmaceuticals and Health: Impacts and Strategies, The Society for International Development, SAGE publications.
6. Article 70(8), read with Article 65(2) and (4) of TRIPS, obligates developing countries to provide for a mailbox mechanism for depositing applications and an exclusive marketing rights regime.