WHAT IS A PATENT?

A patent is defined as an exclusive right to the owner for their invention which is unique and new, involves inventive step and is capable of industrial applications. The primary objective of granting of a patent is to protect the owner from others in practices of making, using, license etc. of patented invention through a patent license.

WHAT CAN BE PATENTABLE?

As discussed, patent protection is given to the owner’s invention which is unique and new in nature. Thus the invention must be novel, useful and non-obvious. In order to be patentable an invention must not be disclosed publicly at any point of time i.e. not contacted with public. In case where the owner does not patent his invention, the risk of getting copied or used is always there.  

DRUG PATENTS

With the new inventions day by day, better quality drugs are getting introduced each year. With the drugs and its connection with the patents, wide path for commercial benefits has found its way.

PATENT AND PHARMACEUTICAL INDUSTRY

Patents are granted for inventions and not primarily for medicines. Thus, patents may be granted for:

1. A chemical compound or molecule
2. A medical indication or therapeutic effect of the molecule;
3. The combination of products;
4. The manufacturing process

Thus there can be more patent for a single medicine i.e. one for the chemicals involved and the other for the production process for an example. Just like many countries, in India the Patents Act of 1970 also allows the Indian Companies to develop and market generic versions of the patented drugs.

COMPULSORY LICENSING

Compulsory licensing is defined as a process whereby a government can allow any company, agency or designated person the right to make a patented product or use a patented process under license without the consent of the real owner.

Even recently to make vaccine for corona virus available within a small period of time, the governments of many countries used compulsory licensing.

WHY DRUG PATENT IS IMPORTANT

Patents contribute a major part in the pharmaceutical sectors and companies. Also patent protection ensures and helps to protect their innovative ideas. Drug Patents are important in the way that through this investments and costs incurred during research and other stages can be compensated. Also with the increasing competition, drug patent will ensure to provide protection of duplicacy against competitors in the market. At the most drug patents will help to increase and strengthen the economic growth of the companies in the market.

CRITERIA TO BE FOLLOWED FOR THE DRUG PROTECTION

It needs to be notice that each and every drug cannot be given protection. Thus all drugs cannot be patented. A certain order and criteria needs to be followed in order to gain protection for patents. One of the primary criteria is that the inventions must be new and useful. Other criteria, is the non-obvious nature of the drug i.e. the new drug when compared with the previous inventions must not provide the same type of support or information as in other inventions. This criteria remains as one of the most important criteria while considering patentability of a drug.

One question arises that whether those drugs who are not registered will counter the patentability of a new drug with similarities in it? The answer to this question is that if a drug is not patented it still owes the common law protection. However if one applies for the patentability for the same drug, he will get it as the original owner must have patented for its own drug. But since he failed, he will be having no rights in relation with it.

Lastly, the patent must have a purpose. It must be formed or made to serve the benefit of needy people.  

NOVARTIS CASE

Novartis is the main producer of Glivec[i], a drug used for the treatment of blood cancer. The company sought a patent that would give exclusive rights to produce Glivec, on the other stopping production by the Generic Drugs Industry in India.

In the year of 1997, India did not allowed for the protection for pharmaceutical products, therefore Novartis filed a patent application for the same in the Chennai Patent Controller’s Office. The cause of application was in connection with Novartis who kept on hold until 2005 when India amended its system. In the early 2006, the Patent Controller rejected the patent application on the ground that the Patents Act does not allow protection for the modified version of the existing drug. Further In May 2006, Novartis challenged the decision of Chennai High Court.

In August 2007, this case got transferred to the Patent Office of the Intellectual Property Appellate Board by the High Court. In June 2009, the Board disagreed with the Patent Controller’s decision and found out that the Glivec was new as it involved an inventive step in it. However, patent protection was denied on the ground that Novartis did not demonstrate that the new product was more effective in comparison than the previous one as under the Patents Act.

Novartis finally moved to the Supreme Court to review the decision of the Board. The company stood strong on the point that since Glivec satisfied key criteria including novelty, it should be considered on “invention” under the Patents Act. Thus on April 2013, the Supreme Court upheld the Board’s decision and found that Novartis failed to prove improved therapeutic efficacy of the new version.

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CONCLUSION

Patents are created to encourage innovators and maximise the good to help people and to make healthcare affordable. It becomes very important and necessary for big pharma companies to obtain patent protection for their products in order to secure their investments. The year 2005 marks a very important year in drastic change with the access to medicines in developing countries like India and in compliance with the World Trade Organization (WTO) and Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. However India has continued in maintaining a balance between the TRIPS and public health by providing of the drugs at lower costs.

Therefore it is important that patents needs to be safeguarded as they are a fundamental incentive for the innovative activities in pharmaceuticals industry.

BY- MUNIS NASIR