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INTELLECTUAL PROPERTY & ABS
: WHAT CAN THE EMBRIC COMMUNITY DO?
Dr Arul George Scaria
Co-Director, Centre for Innovation,
IP and Competition (CIIPC)
National Law University, DelhiEMBRIC General Assembly, Heraklion, September 19, 2018
DILEMMA OF AN OPEN SCIENCE ADVOCATE FROM THE
Open Access v. ABS Regulations
(LEGAL) CONTEXT OF THE DISCUSSION
Convention on Biological Diversity
Nagoya Protocol on Access and Benefit Sharing
Negotiations for a new international, legally binding instrument to the United Nations
Convention on the Law of the Sea (UNCLOS) – biodiversity beyond national
WHY DO WE NEED A NEW INSTRUMENT/ APPROACH?
Image source: https://www.flickr.com/photos/unitedwaylowermainland/8771398278
THE OPTIMAL ABS SYSTEM
Promotes research and innovation
Provides legal certainty to all stake-holders
Ensures fair, equitable, and sustainable sharing
sharing of monetary and non-monetary benefits
TWO POTENTIAL APPROACHES
Lessons from India?
IP AND ABS
TRIPS Agreement – harmonization of IP laws
Patent laws – harmonization in terms of minimum duration of protection, scope of protection,
Most jurisdictions allow patents relating to GR – considerable differences in practice
ASSOCIATION FOR MOLECULAR PATHOLOGY V. MYRIAD
GENETICS, INC. (2013, US SUPREME COURT)
“We hold that a naturally occurring DNA segment is a product of nature and not patent
eligible merely because it has been isolated.”
“Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent
eligible “new . . . composition[s] of matter,” §101. Myriad’s patent descriptions highlight
the problem with its claims: They detail the extensive process of discovery, but extensive
effort alone is insufficient to satisfy §101’s demands”
Complementary DNA (cDNA) - an artificial product that mirrors the coding parts of genes
- is patent-eligible as it is not naturally occurring
EPO - DISAPPOINTING APPROACH
Biological material which is isolated from its natural environment or produced by means
of a technical process even if it previously occurred in nature
Examination of a patent application or a patent for gene sequences or partial sequences
- subject to the same criteria of patentability as in all other areas of technology
(EU Dir. 98/44/EC, rec. 22)
Industrial application of a sequence or partial sequence must be disclosed in the patent
Balsiak et. al (2018), ‘Corporate control and global governance of marine genetic
Methodology: 38 million records of genetic sequences associated with patents, from
records of the patent division of GenBank from the National Center for Biotechnology
Information - created a database of12,998 sequences extracted from 862 marine species
>1600 sequences from 91 species associated with deep sea and hydrothermal vent
systems - commercial interest in MGR from areas BNJ?
47% of all marine sequences - registered by one company - BASF
Combined share of 220 other companies - 37%
Universities and commercialization partners - 12%
Actors located or headquartered in 10 countries - 98% of all patent sequences
NEED FOR PATENT REFORMS- SOME IMPORTANT
Are patents incentivising innovations in the area?
Extent of exclusivity created on genetic resources?
Are public databases enabling more patenting?
Commercialization of patents
Patenting for promoting openness?
Important: Need to link the notification system with the current patent system
IP AND ABS
Other relevant IP regimes -
Impact of copyright regime
Access to scientific literature
Access to databases
Impact of database protection rights
Impact of trade secrets regime
POTENTIAL ROLE(S) OF EMBRICS COMMUNITY
Should EMBRICS community get involved in the discussions on ABS & IP?
How could the EMBRIC cluster foster open innovation? How could the EMBRIC cluster
address ABS and IP?
How could EMBRIC regional centres influence benefit-sharing for MGRs territories of
POTENTIAL ROLE(S) OF EMBRICS COMMUNITY
UNCLOS ILBI - Advocate for a notification system that enables track and trace - ex
situ and in silico
Advocate linking of IP system with the notification system
Promote open access
Avoiding embargos to the maximum extent possible
Reducing fears about open access
Promoting data citations
Benefit sharing in the event of commercialisaiton
Promote open (and collaborative) innovation with the global south
Facilitating collaborations among researchers – need for policy changes in the global south also