[Ip-health] NIH grant for "Development of an Intellectual Property (IP) Strategy for the Commercial Advancement of a Direct Phase II SBIR-Funded technology

Michael H Davis m.davis at csuohio.edu
Tue Jan 3 09:16:50 PST 2017


They won't march in because they don't know anything about prices but they know all about intellectual property? Is this agency out of its mind?



Sent from my T-Mobile 4G LTE Device


-------- Original message --------
From: Jamie Love <james.love at keionline.org>
Date: 1/3/17 12:03 PM (GMT-05:00)
To: Ip-health <ip-health at lists.keionline.org>
Subject: [Ip-health] NIH grant for "Development of an Intellectual Property (IP) Strategy for the Commercial Advancement of a Direct Phase II SBIR-Funded technology

https://projectreporter.nih.gov/project_info_description.cfm?aid=9253581&icde=32443948

Apparently the NIH will give you a grant to help you patent the heck out of
a technology where they are also funding the research.


Project Number: 1SB1HL137591-01
Former Number: 2SB1HL131050-03
Contact PI / Project Leader: KARLSSON, SVEN M

Title: DEVELOPMENT OF AN INTELLECTUAL PROPERTY (IP) STRATEGY FOR THE
COMMERCIAL ADVANCEMENT OF A DIRECT PHASE II SBIR-FUNDED HUMAN PLATELET
BIOREACTOR Awardee Organization: PLATELET BIOGENESIS, INC.



PROJECT SUMMARY/ABSTRACT

Platelet BioGenesis is developing a microfluidic bioreactor to produce
human platelets at clinical scale. Platelets are the 'band-aids' of the
bloodstream, responsible for clot formation and blood vessel repair. Low
platelet count is a significant consequence of cancer treatment,
transplant, and surgery, for which plate- lets are a critical first-line
therapy to prevent mortality due to uncontrolled bleeding. Platelets are
de- rived exclusively from volunteer donors. Risk of bacterial growth
during room temperature storage limits plate- let shelf life to 5 days, 2
of which are expended by bacterial screening, and 1 during transport to
hospitals. As a result blood centers typically do not have more than a
1.5-day platelet inventory available for transfu- sion, making platelet
unit inventory especially vulnerable to routine depletion[1, 2]. To address
this ma- jor unmet need we are developing a platelet bioreactor that
reproduces key features of adult bone marrow (physiological
microenvironment) to trigger platelet production from human induced
pluripotent stem cells (hiP- SCs, a replenishable source of progenitor
cells which can be stored frozen for years) at clinical/commercial scale.
This SBIR CRP Program proposal for Technical Assistance (SB1) outlines a
comprehensive intellectual property strategy for Platelet BioGenesis to
develop a proprietary, patent protected technology to produce
cGMP-compliant human bioreactor-derived platelets at commercial scale for
clinical use in 3 specific aims: Aim 1. Understanding the Patent Landscape.
We will work with IP counsel to: (1) identify and assess licens- ing
various third party patents and patent applications related to
megakaryocyte differentiation protocols and the platelet bioreactor, (2)
perform further patent searches (landscape and/or freedom to operate) to
ensure that we are able to commercialize our technology without
infringement, and/or (3) identify any additional third party patents that
may be licensed by us to further improve our competitive commercial
position. Aim 2. Protecting Proprietary Technology to Enable
Commercialization. We will work with IP counsel to identify intellectual
property generated by us and will formulate a strategy for protecting such
intellectual prop- erty, either by filing patent applications or ensuring
that the technology is maintained as a trade secret. Aim 3. IP Agreements.
We will work with the IP counsel to: (1) review our non-disclosure
agreements, em- ployment or consultant agreements to ensure the ownership
and protection of our intellectual property, and (2) negotiate and enter
into license agreements with cGMP-compliant hiPSC suppliers for access to
relevant cell lines. cGMP-hiPSC line master banks will be maintained and
differentiated into megakaryocytes under estab- lished supply agreements
using proprietary cell culture protocols.

Public Health Relevance Statement:

PROJECT NARRATIVE Human platelets are presently derived exclusively from
volunteer donors and have a shelf life of 5 days, mak- ing platelet unit
inventory sensitive to depletion and putting platelet recipients at risk of
sepsis and viruses dur- ing surgery, pregnancy and birth,
cancer/HIV/burn-treatment, and transplant. There are currently no licensed
therapeutics that immediately increase platelet counts, and insufficient
platelet supply to meet projected US demand (~2.3M platelet units/year in
2013). Platelet BioGenesis has: identified cGMP-compliant hiPSC lines,
validated megakaryocyte differentiation protocol and platelet
storage-permissive media, and established a mi- crofluidic bioreactor to
rapidly trigger functional platelet production at clinical/commercial
scale. We now seek to develop a comprehensive IP strategy for linking these
key technologies, which is necessary to advance bio- reactor-derived
platelets (bdPLTs) for clinical use.

--
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love
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