See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/340816282

Case Comment: Divya Pharmacy v. Union of India

Article in Biotechnology Law Report · April 2020

DOI: 10.1089/blr.2020.29161.zmn

CITATIONS READS
3 2,017

1 author:

M. Z.M. Nomani
Aligarh Muslim University
187 PUBLICATIONS 857 CITATIONS

SEE PROFILE

All content following this page was uploaded by M. Z.M. Nomani on 11 July 2020.

The user has requested enhancement of the downloaded file.

Biotechnology Law Report | Vol 39, No https://www.liebertpub.com/toc/blr/39/
2 2

Biotechnology Law
Report
Executive Editor: Christopher M.
Holman, PhD, JD
ISSN: 0730-031X Online ISSN: 1557-8704
Published Bimonthly Current Volume: 39

Delivering critical, authoritative analysis of

biotech patents and litigation, regulatory
and legislative activity, and trade-related
aspects of biotechnology.

VOLUME 39, ISSUE 2 / APRIL 2020

News Briefs
Selected Developments in Biotechnology Law and the Biotechnology Industry
By Steven J. Zweig Pages: 77—78 https://doi.org/10.1089/bIr.2020.29164.sjz

The Holman Report

Inherency in the Patenting of Biotechnology and Pharmaceutical Innovation
By Christopher M. Holman

1 of 2 14-Apr-20, 7:16 PM
Biotechnology Law Report | Vol 39, No https://www.liebertpub.com/toc/blr/39/
2 2

Original Articles

Reconsidering Conflicts over Gene Patents in View of Taiwan Patent Law

By Lung-Sheng Chen Pages: 100—112 https://doi.org/10.1089/bIr.2020.29162.Isc

Arbitrability of Disputes Arising from Patents: A Comparative Study

By Tariq Kameel and Ramzi Madi Pages: 113—121
https://doi.org/10.1089/bIr.2020.29163.rm

Case Comment

Divya Pharmacy v. Union of India, High Court of Uttarakhand, India; 2018 SCC Online Utt. 1035
By Dr. Zafar Mahfooz Nomani Pages: 122—128 https://doi.org/10.1089/bIr.2020.29161.zmn

Case in Point
Amgen Inc. v. Amneal Pharm. LLC United States Court of Appeals of the Federal Circuit, 2020
945 F.3d 1368
Pages: 129—138 https://doi.org/10.1089/bIr.2020.29166.cmh

Genentech, Inc. v. Hospira, Inc. United States Court of Appeals of the Federal Circuit, 2020 946
F.3d 1333
Pages: 139—147 https://doi.org/10.1089/bIr.2020.29167.cmh

Hospira, Inc. v. Fresenius Kabi USA, LLC United States Court of Appeals of the Federal Circuit,
2020 946 F.3d 1322
Pages: 148—154
https://doi.org/10.1089/bIr.2020.29168.cmh

Pension Pharm. LLC v. Alvogen Malta Operations Ltd. United States Court of Appeals of the
Federal Circuit, 2019 945 F.3d 1184

Pages: 155—162 https://doi.org/10.1089/bIr.2020.29169.cmh

2 of 2 14-Apr-20, 7:16 PM
 39 Biotechnology Law Report 122
Number 2, 2020 Case Comment
Mary Ann Liebert, Inc.
DOI: 10.1089/blr.2020.29161.zmn

Divya Pharmacy v. Union of India

High Court of Uttarakhand, India; 2018 SCC Online Utt. 1035

Writ Petition (M/S) No. 3437 of 2016; Judgment Reserved on September 7, 2018;
Judgment Delivered on December 21, 2018

Edited for Biotechnology Law Report by DR. ZAFAR MAHFOOZ NOMANI*

Downloaded by 106.223.199.100 from www.liebertpub.com at 04/14/20. For personal use only.

SYNOPSIS

Whether an Indian company having no foreign participation in terms of shareholding

and management is mandated to Access and Benefit Sharing (ABS) of biological re-
sources or fair and equitable benefit sharing (FEBS) with local communities under
the Biological Diversity Act, 2002 was the question in Divya Pharmacy v. Union of
India.1 This issue has been considered in the Nagpur Bench of the Bombay High
Court and the Central Bench of the National Green Tribunal (NGT), but the Uttarak-
hand High Court has dwelt on the subject with far greater specificity and clarity. The
Indian Biological Diversity Act, 2002 requires ABS of plants, animals, and micro-
organisms for commercial use by foreign and Indian entities by prior informed consent
(PIC) and approval by the National Biodiversity Authority (NBA) and State Biodiversity
Boards (SBB). Under the Indian biodiversity law, it is mandatory for all foreign and In-
dian companies, institutions, individuals to seek prior consent and approval for ABS
with the local community for nurturing their intellectual capital and property under
FEBS. This principle is underpinned in the Biological Diversity Act, 2002, the Biolog-
ical Diversity Rule, 2003, and the Access and Benefit Sharing Guidelines, 2014 in con-
formity with the Convention on Biological Diversity, 1992, Bonn Guideline, and the
Nagoya Protocol, 2010. Despite the clarity of biodiversity normative jurisprudence,
there is a popular perception among Indian companies that it is applicable only to for-
eign companies. In other words, Indian companies are mandated to seek consent and
approval from SBB but absolved from the responsibility of the ABS or FEBS provisions.
One such case in point is Divya Pharmacy under the Patanjali brand claiming exemp-
tion from ABS in the garb of nationalistic and indigenous company.
The Uttarakhand High Court in the Divya Pharmacy v. Union of India held that all
Indian companies which are extracting biological resources are liable to seek prior ap-
proval as well as share part of their revenue with indigenous and local communities
having traditional knowledge. The decision has adopted a pragmatic approach to bio-
diversity conservation and commercial exploitation of biological resources within the
ambit of fair and equitable sharing of benefits with indigenous and local communities

1
2018 SCC Online Utt. 1035.

E-mail for Dr. Zafar Mahfooz Nomani: zafarnomani@rediffmail.com.

*The synopsis is original content and the decision itself has been condensed for ease of readability.

122
 Biotechnology Law Report  Volume 39, Number 2
CONCLUSION
Drawing inspiration from meticulously drafted
biodiversity jurisprudence over the last two decades,
the Biological Diversity Act, 2002 was promulgated
to regulate traditional knowledge, innovations, and
practices and sustainable use in India. The Uttarak-
hand High Court seized this opportunity in the
Divya Pharmacy case and ruled on legal questions
concerning difficulties and practicalities of enforc-
ing ABS with local communities. It clarified that
SBBs are empowered to demand FEBS while har-
nessing biological resources for commercial use. It
emphasized the need to create deterrence against
avoidance of FEBS by user companies in the
name of nationalistic policies. The judgment has
touched on the seminal dimensions of biocultural
rights and establishing community property rights
Downloaded by 106.223.199.100 from www.liebertpub.com at 04/14/20. For personal use only.
for traditional knowledge of biological resources.
It has the potential to develop a communitarian
and diversity-related intellectual property system
juxtaposed to trade-related aspects of intellectual
property rights underpinned in the TRIPs Agree-
ment, 1995.20 The novelty of this jurisprudence for-
tifies the powers, functions, and role of NBA and
the SSBs in establishing standard-setting param-
eters in ABS negotiations and bargaining to the
benefit of the local communities under the Indian
biodiversity laws.
ACKNOWLEDGEMENT
The author would like to acknowledge the Indian
Council of Social Science Research, New Delhi for
its funding of Minor Research Projects on Role of
International Biodiversity Law in Developing
Legal Framework for Access and Benefit Sharing
(ABS) Regime in India, 2019–2020.
SUGGESTED READINGS
Amirmahmoudi, M. and Nomani, M.Z.M. ‘‘Access
and Benefit Sharing Provisions Under Biodiversity
Conservation Law in Australia and Its Implications
for India,’’ 4(2) Legal Research Development, 35–
46 (2018).
Amirmahmoudi, M. and Nomani, M.Z.M. ‘‘South Af-
rican Model of Access and Benefit Sharing and Its
Implications for India,’’ 5(2) International Journal
of Law, 60–64 (2019).
127
Bhutani, Shalini and Kanchi Kohli, ‘‘Ten Years of The
Biological Diversity Act,’’ Economic and Political
Weekly, 15–18 (2012).
Department of Biotechnology, National Biotechnol-
ogy Development Strategy 2007, Ministry of Sci-
ence and Technology, Government of India, New
Delhi (2007).
Ghatate, Utkarsh, ‘‘People’s Biodiversity Register for
Access and Benefit Sharing,’’ National Biodiver-
sity Strategy and Action Plan. Kalpavriksh, Pune
and Ministry of Environment and Forests, Govern-
ment of India, New Delhi. (2001).
Kohli, Kanchi and Shalini Bhutani, Chasing Benefits:
A Post-Nagoya Protocol View on Access and Ben-
efit Sharing, Briefing Paper, Kalpavriksh and
World Wide Fund for Nature, Pune (2011).
Kohli, Kanchi and Shalini Bhutani, ‘‘Access to India’s
Biodiversity and Sharing Its Benefits,’’ 50 Eco-
nomic and Political Weekly, 1 (2015).
Kohli, Kanchi and Shalini Bhutani, ‘‘Biodiversity and
the Processes of Law,’’ in Bioresources and Bio-
process in Biotechnology: Status and Strategies
for Exploration, Vol. 1, 49–71, Sabu Abdul-
hameed, N.S. Pradeep, and Shiburaj Sugathan
(eds.), Singapore: Springer (2017).
Nomani, M.Z.M., ‘‘Environment Agriculture and
Challenges of Bio-Piracy: A Blue Print of Indian
Sui Generis Legal Order,’’ 1(2) Indian Journal of
Environmental Law, 3–22 (2000).
Nomani, M.Z.M., Laws and Flaws Relating to Biolog-
ical Diversity in India: A Kaleidoscopic View,
(2000) 2 Company Law Journal, 17–22 (2000).
Nomani, M.Z.M., ‘‘Access and Benefit Sharing Mod-
els of Intellectual Property Rights Under Biologi-
cal Diversity Convention and Bonn Guidelines: A
Critical Appraisal Under India Perspective,’’ 2
Journal of the Faculty of Juridical Sciences,
Mody Institute of Technology and Science, 91–
106 (2010).
20
M.Z.M. Nomani, WTO, TIRIPS Agreement and Protection
of Plant Variety: Imperatives and Implication for Indian
Intellectual Property Regime, in Law Relating to Intel-
lectual Property Rights: Retrospect and Prospect
117–133 (A.K. Kaul and V.K. Ahuja eds., University of
Delhi, 2001).
 128
Nomani, M.Z.M. ‘‘Biological Diversity, IPR and Sus-
tainable Development: A Critical Appraisal of
Access and Benefit Sharing Models of U.S., Aus-
tralia and India,’’ 6(11&12) International Journal
of Environmental Consumerism, 40–55 (2010).
Nomani, M.Z.M., ‘‘People’s Participation Through
Public Hearing and Environment Impact Assess-
ment (EIA) Law,’’ 18 Guru Nanak Dev University
Journal, 121–136 (2010).
Nomani, M.Z.M., ‘‘Application of Trade Secret Law in
Plant Variety Protection in India,’’ 2(1) Manupatra
Intellectual Property Reports (MIPR), F/1-
14(141–156) (May 2018).
Nomani, M.Z.M. and F. Rahman, ‘‘Intellection of
Trade Secret and Innovation Laws in India,’’
Downloaded by 106.223.199.100 from www.liebertpub.com at 04/14/20. For personal use only.
View publication stats
Biotechnology Law Report  Volume 39, Number 2
16(4) Journal of Intellectual Property Right,
341–350 (2011).
Nomani, M.Z.M. and F. Rahman, ‘‘Bio Piracy of Tra-
ditional Knowledge Related Geographical Indica-
tions: A Select Study of Some Indian Cases,’’
3(3) Manupatra Intellectual Property Reports
(MIPR), 135–152 (2016).
Nomani, M.Z.M. and M. Rauf, ‘‘Legal Policies for
Bio-Prospecting of Natural Resources in India,’’
39(11) Indian Journal of Environmental Protec-
tion, 1009–1015 (November 2019).