1. Intellectual Property
&
Technology Challenges
for
Biotech Industry
in
India
Ravi Dhar, Ph.D.
(rdhar_in@yahoo.com)
(
25.4.2014
(Mobile: 987-162-0439)
Immediate Past Affiliation:
BIRAC-DBT, GoI, India
Past Affiliations:
University of Kashmir, India
University of Delhi, India
National Institute of Immunology, India
Johns Hopkins University, U.S.A.
LSU, U.S.A.
OTT, Boston University, U.S.A.
OTT, NIH, U.S.A.
4/25/2014 1RD_Vaccine Meet_2014

2. Excerpts from Interview for “Protecting the
bottom line: Tackling IP barriers in
developing generic vaccines”
Vaccine World Summit-2014, Hyderabad, India
4/25/2014 RD_Vaccine Meet_2014 2

3. 4/25/2014 RD_Vaccine Meet_2014
Acknowledgements
NIH PubMed
Scientific Community across world
DBT
NII
BIRAC
DELCON Library Services
Dr. M.K. Bhan
Various Websites
Nature Biotechnology
& other Journals
OTT, Boston University
Dr. Jerry Keusch
Dr. Ashley Stevens
OTT, NIH
3

4. Commonly Faced Challenges
(I) IP related:
•Patents though incentives to innovation, encourage investors to
provide funds for development of drugs and vaccines. However,
they also block developers or manufacturers from entering a
particular domain & hence block collaboration between entities
holding an IP e.g., type of claims on individual components of a
vaccine
•In case of patents on vaccines with multiple owners (although
these patents are related to each other), conflicts of various sorts
arise due to strength or weakness or perception of Patent Claims.
•IP leakages have been reported in several instances, these should
be blocked.
•Manufacturers should relook at use of Patent pools, as these may
be useful.
4/25/2014 4RD_Vaccine Meet_2014

5. (II) Possible Technology challenges
•Quality of early stage technologies & the science behind the
technology should be strong and should pass the validation
stage
•Enable strong technology scouting mechanisms & develop
capacity to locate a partner for transfer or upscaling
•Translational issues due to lack of skilled manpower, funding,
equipment etc.
•Need for improved cGMP practices
•Lack of basic infrastructure (cold chain and other)
•Lack of precise long-term forecasting
•Financial and logistical hurdles (country willingness and
ability to pay)
•Political choices
•Limited Capacity building effort
4/25/2014 5RD_Vaccine Meet_2014

6. (III) Industrial issues
(i) Increased regulatory review times, as well
as increasing requirements for compliance
with safety and efficacy standards
(ii) Global variations in regulatory approval
requirements
(iii) Skyrocketing R&D costs
4/25/2014 6RD_Vaccine Meet_2014

7. (IV) Art of Negotiations
•Vaccine development & production require an
art of negotiations in acquiring a license which is
related to size of companies.
•Negotiations become more complex when one
has to deal with big companies.
•This faculty needs to be enhanced by Indian
academia & industry.
4/25/2014 7RD_Vaccine Meet_2014

8. (V) Other Issues
•Long time taken for Regulatory approvals
•Dependence on Government to push volumes
•Funding for clinical trials
•Lack of institutional IP & Tech management policy &
personnel
•Limits in number of industry skilled personnel
•Non-availability of adjuvants for use in vaccine
development
•Quality assurance & maintenance
•Taxation issues
•Data exclusivity
•Lack of access to paid Patent sites for Prior art searches
•Regulatory inconveniences
•Lack of adequate Market analysis tools
4/25/2014 8RD_Vaccine Meet_2014

9. Suggestions to Players facing such Challenges?
• Develop Technology Transfer office hubs with highly trained
managers to support & handle various IP or technology
management issues
•Indulge in more active collaborations to learn from experiences
of other Manufacturers
•Serious interactions with DCGI, Health ministry, DBT, BIRAC,
ICMR, CSIR etc so as to help each other devise effective policies
to face challenges
•Workshops on Regulatory issues to highlight various issues
•More active collaborations to develop alternate vaccine
development processes free from IP regulations
•Indulge in Public Private Partnerships
4/25/2014 9RD_Vaccine Meet_2014

10. Most Common Complications Encountered by
Industry and How can these be Avoided?
• Vaccine development & manufacture is a complex and well
regulated process which needs great awareness about IP,
Technology development& art of negotiations
• Awareness about implementation & design of limited clinical
trials
• Careful framing of agreement including Royalty issues
•Press for speedy Regulatory approvals by DCGI
•Conduct carefully designed R&D to circumvent IP issues
related to vaccine or therapeutic production
•R&D related to identifying/developing new adjuvants
•Funding is essential requirement for R&D, so manufacturers
should look for Venture Funding to achieve above goals
4/25/2014 10RD_Vaccine Meet_2014

11. Three(3) most Important Factors to Consider
before Filing for a Patent?
• Market analysis to check assured market for which
one needs to use all patent information tools
•A vaccine manufacturer should conduct Freedom to
operate analysis
•Prior art searches & Valuations are essential
•One should analyse the possible Regulatory hassles
•In case a manufacturer has procured a license for
manufacturing a vaccine or a drug, it should be
ensured that patent filing & maintenance funds are
available
4/25/2014 11RD_Vaccine Meet_2014

12. Tips to Ensure Protection of Intellectual
Property:
•Ensure IP leakage does not happen, if it does, take an
appropriate legal action
• Stage at which one should discuss one’s invention
• No public disclosure of IP without legal protection
•Careful drafting of patent claims & retention of
“know-how”
•Careful monitoring of market trends
• Due diligence for possible infringement as per laws of
the land or WTO regulations
4/25/2014 12RD_Vaccine Meet_2014

13. Expectations?
“Each country has its specific health & financial issues. For
developing or under-developed countries, societal good is a
priority.
So generics are essential. I also believe that companies do not
live for charities, yet what we need is to design strategies to
develop affordable drugs (like corpus funds for R&D by
philanthropists, NGOs, Companies, common man) for
developing generic & branded vaccines.” (R.D.)
4/25/2014 13RD_Vaccine Meet_2014

14. “We also need to educate people about Health care
benefits due to drugs & vaccines. Public-private
partnerships have shown encouraging results in various
areas of governance in different parts of world. We are
hopeful that it will be beneficial for drug development in
India in the long run. Such partnerships are necessary as
they complement each others’ competencies & capacities.
(Note: I also want to point out that the viewpoints given
here do not reflect the organizational or Government
view point, but are based on my experience or research”
(Ravi Dhar_2014)
4/25/2014 14RD_Vaccine Meet_2014

15. 4/25/2014 RD_Vaccine Meet_2014 15
Thanks
(rdhar_in@yahoo.com)