Impact of New Patent Law on Drugs in India

The Indian Parliament passed the 3rd Patent (Amendment) Bill in March 2005 in order to conform to the requirements of the World Trade Organization Agreement on Trade Related Aspects of IP Rights. One of the major changes that the third amendment brought about was India’s recognition of product patents for foods, drugs and pharmaceuticals. Following changes have been made in the amended Patent Act:

Inventive Step:- The amended Act redefines the patent as a “patent for any invention granted under this Act”. The inventive step which was earlier made an invention not obvious to a person skilled in the art, the new definition states that an invention must involve an inventive step and technical advances as compared to existing knowledge which must have economic significance. The new Act defines a “pharmaceutical substance” as ‘any new entity involving one or more inventive steps’.
Section 5 of the Patents (Amendment) Act 2005, which provided for only a limited term process patent protection for inventions relating to food, drugs and medicines, has been scrapped. The amendment now provides for 20 years of protection for all categories of inventions.
Exceptions to Patentability:- The Act dropped the earlier provision that created the possibility for granting of a Patent on a second medical use of a known drug under section 3(d) relating to enhancement of known efficacy.
Compulsory Licensing:- Grounds for compulsory licensing has been expanded as defined by the World Health Organisation. A compulsory license can be requested within three years of the date of granting a patent under Section 84(1) of the Act. The party interested in working the invention in India may negotiate with the patentee within six months after the grant of a patent on the invention.
Merely Paper Patents(The Mail Box):- Section 11A of the act made a new provision under which generic drug manufacturers can continue marketing the product granting them immunity from infringement suits from patent holders and requiring them to pay only a reasonable royalty to patentee.
Opposition to Patent:- Chapter V concerning opposing a patent was given a new chapter heading “Opposition Proceedings to the Grant of Patents”. In this respect Section 25(1) was deleted in order to strengthening pre-grant opposition which can be filed at any time after publication of the patent application, but before grant of a patent.
Publication:- The requirement of initial publication under Section 11A of the Patents Act was amended. Under the amendments, the publication of a patent application will not prevent research on the subject matter of the invention as disclosed in the published specifications under Section 47(3) of the act.
Data Exclusivity:- Although there no law has been passed in India in this regard, but there is a widely held view that a data protection law is required to comply with the requirement of TRIPS on data exclusivity which could help a patent owner prevent a manufacturer from marketing a generic version of a product for an additional period even after the 20 year term of the patent expires. The US and European Union grant Data Exclusivity for 5 and 11 years, respectively.
Bolar Provision:- This would allow a generic drug manufacturer to produce or patent drugs for the purpose of development. This provision is made under Section 107A of the TRIPS’ Article 30.
Parallel Imports:- The provision has further been streamlined to avoid unnecessary delays.

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