Technology Transfer With The - WHO · Award Recognition: 2014 LES “Deals of Distinction™” • One of the top national awards given for technology transfer activities by Licensing

NIAID TTIPO/NIH OTT Science. Ideas. Breakthroughs.

Peter Soukas, J.D., Technology Licensing Specialist NIAID/Technology Transfer and Intellectual Property

Office February 22, 2016 (MenAfriVac Closure Conference)

Technology Transfer With The Human Element:

Vaccine Technologies with Global Health Significance: Traditional

Approach •  IP filings in US, EPO, Canada, Australia & Japan •  Exclusive licensing of single large company •  Focus on large market indications •  Other indications often still focused only on

Western markets – e.g. traveler’s vaccines. Ø Didn’t always meet public health needs

Ø Difficult regulatory strategy (combo product)

Vaccine Technologies with Global Health Significance: Alternate

Strategy •  Regional approach taking into consideration the needs

of OECD and Emerging and LDC markets

•  Outside OECD Countries, preference for local/regional vaccine manufacturing organizations •  More rapid market entry and uptake in developing countries

•  Driven by local public health and business needs

•  Consider filing for patent protection in countries where vaccines will be produced and licensing unpatented biological materials

Licensing of Vaccines with Global Health Significance: Alternate Strategy

•  Possible support by NIH/FDA during development period •  Consultation •  Biological materials •  Clinical trial collaboration •  Collaborative R&D Agreements (CRADAs)

•  Licensing technologies to global NGOs (PATH, IVI, IAVI, AERAS) to partner with regional vaccine producers

•  US and European Licensees •  Mechanisms for distribution in developing countries: directly,

requirements for sublicensing, or by limiting the geographic scope of each license

The Lee / Frasch Patented Conjugation Method

MenAfriVac Patent Rights •  Original provisional application filed

August 6, 2003 •  US, EP, IN, BR, CN, AU, CA, ZA •  Cover three variations of new conjugation

method •  Many patent rights issued; some pending •  US Patents: 8,048,432; 8,465,749;

8,753,649

MenAfriVac License Agreement •  Nonexclusive to PATH

•  Sublicense to SII

•  Concurrent with CRADA for co-development with FDA/CBER

•  Limited Territory (meningitis belt + developing world)

•  Territory has a twist (i.e. sales to WHO or other NGO)

•  Agreement incorporates vaccine cost considerations

•  Development timeline did not need to be amended (PATH’s projections were accurate for development of vaccine)

More Licensees/Technology Complications

•  Technology is licensed to South African private entity and Chinese private entity

•  One application pending from Asian manufacturer

•  Aware of use by at least one other party without license agreement (Indonesian manufacturer)

•  Proven technology available for licensing from FDA (NIH no longer handles FDA technology transfer)

•  FDA has further improvements/methods available for licensing (contacts can be provided at FDA)

Carl Frasch (top photo far left) and Robert Lee (bottom photo, second from left) hosted SIIL scientists to teach them the critical laboratory techniques for making the new meningitis A conjugate vaccine.

Personal Side of Tech Transfer: Teaching and Training

Serum Institute of India Ltd. (SIIL) §  Largest “emerging supplier” §  World’s largest producer of measles and DTP §  Two-thirds of the world’s immunized children are vaccinated by a vaccine

manufactured by SIIL Partnered with the Meningitis Vaccine Project to develop an

affordable (< $US 0.50 per dose) vaccine designed specifically for Africa to protect against meningococcal meningitis under sublicense of the FDA technology by NIH.

Successful Model With NGO Partnerships

•  MenAfriVac® license model for other NGO agreements

•  Successful product specific for African market

•  Incidence to zero in vaccinated areas

•  250 million doses provided •  Cold chain not required •  Introduced into 26 African

countries

Award Recognition: 2014 LES “Deals of Distinction™”

•  One of the top national awards given for technology transfer activities by Licensing Executives Society •  The “return on investment" goal for the NIH / FDA is not financial, but rather maximizing the public health impact of license agreement

•  Showcases "intriguing model" of vaccine development for developing countries

Acknowledgements/Contact •  NIH/OTT: S. Ferguson, U. Reichman, S. Ano •  NIAID/TTIPO: M. Mowatt, R. Williams •  FDA: A. Welch, B. Ronnenberg, B. Droke •  FDA/CBER: R. Lee, D. Murphy •  SII: M. LaForce, M. Karkare •  PATH: M. LaForce, C. Ottoson, S. Haralson,

C. Hennings •  Contact Information: Email: [email protected],

Phone: 301-496-2644