Patent infringement in the Indian Pharmaceutical Industry

Introduction

A patent gives exclusive rights to the inventor to treat his intellectual properties well while preventing others from practicing his invention. The patent right includes making, distributing, mortgaging, or selling the design in India. Therefore, anything which interferes with such patent rights may be considered as an infringement of patent rights. It is essential to have a robust Indian Patent regime to promote innovation and also to attract new investments in India.

Indian patent law protects both the product and process patent. The drugs, agriculture, and pharmaceutical sectors are also being covered in the new patent regime. In the case of process patent infringement, the defendant will carry the burden of proofs, and in the case of product patent infringement, it is the patentee. 

Over the last 2-3 years, the number and nature of patent litigation have evolved dramatically. Innovators have not restricted themselves in merely gaining patent protection for their invention, but also aggressively protecting their patent right from being infringed upon by their competitors. Therefore, in recent years, security and enforcement of patent rights are the significant points of patent litigation. Further, patent holders are also aggressively litigating to challenge the claim of a new patent by their rivals. In this article, we will look into the pharmaceutical patent infringement cases in India.

Pharmaceuticals and The Indian patent laws – 

The Indian patent laws have complicated provisions in case of the patent of the process and final products of pharmaceutical endeavors, which take into account the fact that the pharmaceutical industry deals with the lives of the common people, and it shouldn’t be reduced to just legal rights and wrongs. It can truly be said that Indian patent laws are exemplary examples of what a balance between the interests of common people and the inventors looks like. The following two examples illustrate the balance of enforcement of patents in India.

The exceptions – The Curious Case of Nexavar

As per the World Trade Organization (WTO),

“Compulsory licensing is when a government allows someone else to produce a patented product or process without the patent owner’s consent or plans to use the patent-protected invention itself. It is one of the flexibilities in the field of patent protection included in the WTO’s agreement on intellectual property — the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.”

Bayer’s cancer drug Nexavar is critical for individual patients; however, Bayer was selling the drug at prices higher than any average person in India could afford. For the first time, the Indian Patent Office issued a compulsory license to another generic drug manufacturer Natco, to reproduce Nexavar at an affordable price for the Indian public. It led to the drug’s price to dwindle down from a massive 5,500 US dollars a month to an affordable 175 US dollars a month. The decision was hailed as a warning to drug companies for price gouging and limiting availability, while for other pharmaceutical companies, it was a  potential danger signal in the Indian market.

A general case – Novartis VS Cipla

Novartis filed a suit against Cipla for manufacturing the generic copy of Novartis’s drug “Onbrez.” The authorities issued a temporary injunction and started the investigation. Novartis was firmly able to establish their claim of ownership of the patent. The authorities rejected the counterclaim made by Cipla of an urgent need for this drug due to a public health crisis and the original drug prices being high. This case illustrates that the patents are enforced fairly, and the exemptions are not applied unless the reason is thoroughly proved.

Conclusion-

Patents are the lifeline of every research and study organization which lets them monetize their research and recoup costs of research and development. The pharmaceutical industry in India has always been embroiled in situations related to patents of medicines since a large chunk of its revenues is due to patent protection. However, patents for life-saving drugs should be enforced only after weighing morality and legality equally.

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