The Pharmaceutical and the Patent Law in India -By Kashish Wadhwa

Introduction

The term patent means protection of any new invention and it is an exclusive right over the invention which is given by the government to recognize such an invention. It excludes other people from making or selling or using or importing such an invention. Any person or corporation using the product will have to ask for permission beforehand from the patent holder. The Patent is like a contract between the one who came up with the invention or patent holder and the government who takes up the responsibility of protection of such an invention from any third party or corporations or companies for a limited period. Patents have territorial restrictions with them thus can be sought only in the country that it has been invented. For the protection of an invention in any other country, the patents have to be applied separately in all the countries.

The Pharmaceutical industry is one of the biggest industries any country can have, as it is never-ending and the supply for pharma will never come to an end. The pharmaceutical industry in India is governed by the Patent Laws of India.

With the coming up of the Patent’s Act, the pharma companies could patent their process of making drugs and manufacturing them. The company could keep patents for 7 years. With the introduction of general agreement on Tariffs and Trade the period for having a patent ship over a product/service now increased from 7 years to 20 years. There was a benefit to developing countries like India from such an agreement as it was a way for India to enter into the global arena of patenting. India along with having patent law and GATT also has signed the TRIPS agreement.

Earlier there was “process patent” which meant only the process of manufacturing a drug could be patented not the actual drug. Thus other companies would have to use some other technology for manufacturing the same drug. “Product Patent” was another issue that pharma companies were facing which was even the drug was patented and now other companies could not even use the same drug let alone the manufacturing.  Section 5 (1) that governed process patent was thus removed thus making the pharma industry a very expensive industry that had a monopoly of only rich money-making companies thus making medicines far away from the reach of the common man. The main factor ofthe price of any drug depends on the kind of patent over it as the sole rights of fixing the price would depend on the patent holder.

What goods/services can be patented?

The patent Act, S 2(1) (j) states that an invention would mean a new product that would be capable of industrial application. If any of the company or a person would know about of a product or service as same as their own to exist in any part of the world the patent to them shall not be granted. Some inventions will not fall under the category of the invention:

• The Invention in agriculture of horticulture

• The Invention of any information

• The Invention against public morality or order

• The Invention of a new property

• The Invention being contrary to natural law

• The Invention of medical treatment of humans and animals

All of these are mentioned in section 3 of the Patent Act.

Criteria for getting Patent-:

Patents cannot be obtained easily, certain standards have to be met for getting an invention patented.

• New product

For an invention to be patented, the invention’s subject matter shouldn’t be disclosed before the day of patent filling. It will only be considered as new when it’s not present in any of the government documents or has not been used anywhere

• Invention

The invention must be of a nature that could involve technology and evolve it in the way that makes it advanced or has any economic advancement through it or has both the features

• Usage

The invention should have an industrial nature which means it should easily be made in industry.

Compulsory Licensing-:

Compulsory licensing helps to bridge the gap between the inventor and the consumer of the patented the product so that thecommon man could use those products and not be exploited by the inventor to gain a monopoly over them. It helps the government to regulate its control over the product and give license to any of the third-party to use them without the interference of patent holder consent and the patent holder is paid in exchange for his rights.

Novartis v Union of India 2013) 6 SCC 1

This case a landmark judgment on pharmaceuticals and patent in this case Supreme Court upheld the view of pharmaceuticals companies for taking patents have to go through two tests one was the traditional test of invention and application combined with the efficiency of the drugs.

Conclusion-:

The Indian Patent Law is an exemplary Legislation of Pharmaceutical Legislation which helps to balance the interest of both the medicine makers and the medicine consumers. It doesn’t give the power in single hands which protects the monopoly and safeguards the average person from high expenses of medicines and protects the rights of inventors from copy or stealing their `ideas.