Drug Patenting Under IPR

INTRODUCTION

This specific blog discusses how a drug patent may be secured under Indian patent law. In this context, Novartis v. Union of India, a significant Supreme Court decision, has been discussed.

To fully inform the reader on the process of obtaining a drug patent, the many aspects of getting a drug patent have been discussed in this blog.

The different aspects of obtaining a drug patent are discussed in this blog, including what the Indian patent idea is and the seminal Novartis v. Union of India decision, which outlines the requirements for obtaining an Indian drug patent.

The end of this blog mentions and explains my results with regard to obtaining a drug patent in India as well as with regard to this important ruling.

Introduction to a Patent

A patent is a legal privilege given to a certain person in relation to his creation, allowing him to prevent others from using, selling, manufacturing, or importing the invention without his or her previous consent.

Consequently, we may conclude that the patent concept is very beneficial to inventors since without it, their ideas might be readily stolen and exploited by others to their detriment as competitors.

Criteria of patentability in India

1. The following requirements for obtaining a patent in India must be met by the inventor's invention:
2.  The invention must be innovative, which simply means that it cannot have been utilised or published anywhere in the world prior to the date the application for the relevant patent was filed.
3.  The invention must include an innovative step; that is, one or more of its features must represent a technological improvement over existing knowledge, have economic value, or both.
4.  The innovation in issue must be capable of being utilised in an industry and should have industrial application capacity.
5. It must not belong to the class of innovations that are not eligible for patent protection in the relevant jurisdiction.

Landmark case law on patentability of a drug in India is that of-

Novartis v. Union of India

It is a significant decision on Indian IPR laws. It concerns the denial of a medicine patent application that lacked both "invention" and "superior effectiveness."

Facts: In this instance, the Novartis business registered a patent application for the medicine Gleevec.

In order to cover the medicament within the definition of "innovation" as stated in Section 3 of the Patent Act of 1970, the business submitted this patent application.

Judgment by the Supreme Court: After a seven-year legal struggle, the Supreme Court denied Novartis' plea, and the top court cited two key justifications:

1. According to the court, there was not an invention of a new drug, and the Patents Act of 1970 does not consider the finding of an already-existing medicine to be an invention.

2. According to the Patent Act of 1970, which governs the granting of patents for pharmaceuticals, a new test—improved therapeutic efficacy—is taken into account in addition to the traditional requirements of novelty, inventive step, and application for claims that cover small modifications to an existing drug

And in this case the Gleevec drug also failed to prove this test.

Therefore, based on this body of case law, it is abundantly clear that in order for a drug to be patentable, it must also pass the tests of novelty, inventive step, and application. Additionally, where a claim pertains to minor adjustments to an already-approved drug, the test of improved therapeutic efficacy also plays a significant role.

CONCLUSION

The topic of obtaining a drug patent in India is covered in length in this blog with the aid of a significant ruling on the subject, Novartis v. Union of India. What is the definition of a patent in India? This blog post also addresses the historic Novartis v. Union of India ruling, which outlines the requirements for a medication to be granted an Indian patent.

As all the many components of obtaining a medicine patent in India have been covered in-depth in this article, it will be easier for readers to assess the topic.

Findings-

To be eligible for a patent in India, an invention must meet the following requirements:

 1. It must be new;

 2. It must involve an inventive step;

3. It must be capable of being used in industry; and

4. It must not fall into a class of inventions that are not eligible for patents in the relevant jurisdiction.

 After doing extensive research on the subject, I learned that the landmark decision in Novartis v. Union of India established a new principle in addition to these, stating that the test of improved therapeutic efficacy also plays a crucial role in cases where there are claims that cover incremental changes to an existing drug. The invention in question should offer some sort of improvement in the therapeutic efficacy when compared to the pre-existing drug.