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The Access RegimePatent Law Reforms for Affordable Medicines$
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Feroz Ali

Print publication date: 2016

Print ISBN-13: 9780199463480

Published to Oxford Scholarship Online: April 2016

DOI: 10.1093/acprof:oso/9780199463480.001.0001

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Heightened Standards of Patentability

Heightened Standards of Patentability

Raising the Bar on Inventions

Chapter:
(p.89) 4 Heightened Standards of Patentability
Source:
The Access Regime
Author(s):

Feroz Ali

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780199463480.003.0004

Patents are not granted uniformly across nations as the standards for patentability varies across nations. This chapter analyses standards of patentability, specifically nonobviousness and the enhancement of efficacy, for pharmaceutical patents. The new definition of nonobviousness laid down by the Patents Act has serious ramifications in terms of raising the bar on inventions that can be patented. A further significance of the new definition is that it places the burden of disclosure squarely on the patent applicant. This chapter then examines the threshold requirement of enhancement of efficacy. The provision itself has been introduced to curb any initiative to patent bioequivalents. The judicial determination of the meaning of the term ‘efficacy’ and the legislative intent behind the provision are explained herein.

Keywords:   patentability, nonobviousness, inventive step, technical advance, disclosure, section 3(d), Novartis case, Supreme Court

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