Indian Patent Law Case Study

Indian Patent Laws on pharmaceutical products:

History:

India’s first patent law was passed in 1856 during British colonial rule however the patentability of pharmaceutical products was provided by 1911 Act .During the absence of patent laws , the Indian pharmaceutical industry grew at remarkable pace but patents laws inherited from Great Britain restricted the manufacturing and industry remained stagnant till 1940’s. There was a growing consensus just after independence in 1947 that to boost manufacturing restrictive patents must be temporarily removed. Amendments were made in 1970 to the Indian Patents Act abolished product patents but retained process patents with a reduced span of protection. For this, the government of India appointed

Developing countries rebelled against strict imposition of this stand from developed countries as they sought compromise whereby the Article 27:1 states as follows:

“Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced” Amendments in the Act and

Further clarifications have been made in obtaining compulsory licence to facilitate export of patented pharmaceutical products by Indian companies to countries that do not have adequate production capacities. TRIPS gave this instrument of compulsory licensing to governments so that they can allow domestic manufacturers to manufacture patented products within 3 years of their introduction. This would open an opportunity for manufacturers to export the medicines to other countries which are not in manufacturing of drugs. India has the opportunity to emerge as world leader in the field of export of drugs as India is rich in cost effective and intellectually competitive manpower and other resources.

Pharmaceutical substance:

The amendment currently describes Pharmaceutical substance as any new entity involving one or more inventive steps.

As it stands, the provision is too broad as it allows all types of pharmaceutical substances. The term chemical ought to have been inserted so as to read any new chemical entity.

Immunity for generic production:

This act enables the manufacturers (Generic drugs) to continue production of generic version of new drugs. For doing so, the generic companies are required to pay the patent holder a reasonable royalty. With respect to the reasonable royalty it creates the problem of excessive demands from the patent holder and litigation. The reasonable royalty rate should have