Impact of the Amended Indian Patent Act on the Indian pharmaceutical industry

• Published in: Journal of generic medicines 2008-01, Vol.5 (2), p.111-119
• Main Authors: Vijayaraghavan, Bakthavathsalan, Raghuvanshi, Poonam
• Format: Article
• Language: English
• Subjects: Contracts; Drugs; Innovations; Intellectual property; Laws, regulations and rules; Licensing agreements; Licensing, certification and accreditation; Marketing; Pharmaceutical industry; Prescription pricing; R&D; Research & development
• ISSN: 1741-1343; 1741-7090
• DOI: 10.1057/palgrave.jgm.4950102

It has been more than two years since the Indian Patent Act of 1970 (the Act) was amended to make it compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The amendments were made amidst much expectation, protest and confusion. Despite having had ten years to put the amendments together, the Indian Government had to resort to a hurried Presidential Ordinance in December 2004 to amend the Patent Act. In March 2005, after an invigorating public debate involving all stakeholders, legislators were able to come out with amendments that attempted to strike a balance between promoting innovation and ensuring that Indians had continued access to affordable medicines and so that India remained the ‘pharmacy’ of the developing world. The amendments changed the paradigm under which most, if not all, Indian pharmaceutical companies built their businesses. Now that the first product patent in the pharmaceutical sector has been granted (Patent No. 198952 granted on 21st February, 2006 to Roche, on pegylated interferon-α conjugates) and a challenge to a key amendment has come to an unsuccessful end at the Madras High Court, this paper takes a look at what the impact of the amendments have been so far and what they could be in the future.