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.

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Excerpts from Interview for “Protecting the bottom line: Tackling IP barriers in

developing generic vaccines”

Vaccine World Summit-2014, Hyderabad, India

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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

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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.

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(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

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(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

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(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.

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(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

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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

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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

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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

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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

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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.)

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“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)

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Thanks (rdhar_in@yahoo.com)