Pharmaceutical drugs and patent protection

Throughout history, nothing has killed more humans than the bacteria, viruses and parasites that causes diseases. Not the natural disasters like earthquakes, volcanoes or tsunami nor the war, not even close . And now one of such virus, known as COVID-19 (hereinafter referred to as “the virus”) caused by the virus SARS-CoV-2, originated from Wuhan, China, has caused a global pandemic as declared by the World Health Organisation (or WHO) on 30^th January 2020. There are as of now 2,99,16,191 cases and 9,42,478 deaths caused worldwide because of which there is need of vaccines and medicines to immunize against the virus and cure the same respectively, because of which it becomes appropriate to understand the patent protection as regard to medicines in Indian legal framework.

Development of patent protection in India

Pre-TRIPS agreement

The principal law for patenting system in India is the Patents Act, 1970. According to the statute initially introduced, no product patents but only process patents could be granted for inventions relating to food, drugs and chemicals, this implied for drugs that a pharmaceutical company only could protect the process used by it to manufacture it and not the drug itself, thereby giving another party a chance to reverse-engineer the product and manufacture the same drug but following a different process. The patents were valid for seven years from the grant of protection.

Post-TRIPS agreement

In 1994, the World Trade Organization (or WTO) was setup and India being the party to it became the signatory to General Agreement on Tariffs and Trade, 1994 (or GATT, 1994) as well as to the Trade Related Aspect of Intellectual Property Right Agreement (or TRIPS Agreement) in 1995 because of which India was under a contractual obligation to amend its Patents law to bring them in compliance with the provisions of the agreement.

Patents (Amendment) Act, 1999

This was the very first amendment in this statute of the series of amendment yet to come which brought the following changes:

A pipeline protection till authorities initiated granting product patents;
Provisions for filing of applications for product patents in the field of drugs and agrochemicals w.e.f. 1st January 1995 were added; and
Introduction of Exclusive Marketing Rights (EMRs) on above-mentioned patents.

Patents (Amendment) Act, 2002

To comply with the second set of obligations under TRIPS further amended were introduced in the Patents Act, 1970. This amendment introduced provisions of:

20 years uniform term of patent for all categories of invention;
Definition of “invention” was made compliant with TRIPS agreement; and
Reversal of burden of proof in case of process patent infringement suit, among other changes.

Patents (Amendment) Act, 2005

Through this amendment:

Finally the product patent regime was introduced.
It made patentable, subject to certain prescribed conditions, mere discovery of new form, property or use of a known substance.
Modification were made to the provisions related to pre grant and post grant oppositions.
provision were introduced for the grant of compulsory license for export of patented pharmaceutical products in certain conditions

Criteria of patentability

Sec 2(1)(m) of the Act defines “patent” as “means a patent for any invention granted under this Act” thus implying that patent is granted for the protection of a “invention”, which is defined as “means a new product or process involving an inventive step and capable of industrial application”. Therefore, there can be carved out 3 essentials requirements for an invention to be patentable:

Newness or new invention: to be patentable the subject matter of the invention must not be in the public domain, that is it should not be published in any document or used anywhere in the world or be known in any other way before the date of patent filing.

In F. Hoffmann-La Roche Ltd. v. Cipla Ltd. the court stated that “the relevance of the provision of “new invention” lies in the fact that it gives a flavour of the invention of the Legislature. Section 2(1)(l) when read in conjunction with sec 2(1)(j) also clarifies as to what is considered to be not new in the terms of the Act”.