IpHandbook Ch 17 Brooke Et Al PATH

7/29/2019 IpHandbook Ch 17 Brooke Et Al PATH

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ABSTRACT

PAH is an international, nonprot organization that cre-ates sustainable, culturally relevant solutions, enabling com-munities worldwide to break longstanding cycles o poor

health. By collaborating with diverse public and privatesector partners, PAH helps provide appropriate healthtechnologies and vital strategies that change the way peoplethink and act. PAH’s work improves global health and well-being. Over the past 28 years, PAH has demonstrat-ed that public–private partnerships (PPPs) can eectively address unmet public health needs, particularly when man-aged with a clear understanding o both public and privatesector objectives. Indeed, collaboration between public sec-tor and private sector partners is an especially valuable way to develop and advance appropriate health technologies oruse in developing countries. When developing and man-aging PPPs, PAH recognizes that intellectual property (IP) is an especially important component in the range o

variables that aect the economic, technical, and program-matic easibility o a new health technology intervention.Our goal, thereore, is to incorporate IP considerations asa undamental part o the PPP process. We seek to manageIP strategically to avoid or quickly overcome any IP-relatedroadblocks. Using three case studies, this chapter illustratesPAH’s strategies or private sector collaboration, as well asPAH’s approaches to managing IP.

HANDBOOK OF BEST PRACTICES | 175

CHAPTER 17.17

1. InTRoduCTIon

In many parts o the developing world, publichealth services reach less than 50% o the popula-

tion. Weak inrastructure, poor living conditions,

Brooke S, CM Harner-Jay, H Lasher and E Jacoby. 2007. How Public–Private Partnerships Handle Intellectual Property: ThePATH Experience. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices(eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHand-book.org.

© 2007. S Brooke, et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncom-mercial purposes is permitted and encouraged.

How Public–Private Partnerships HandleIntellectual Property: The PATH ExperiencesteVe BrooKe, Commercialization Advisor, Commercialization and Corporate Partnerships, PATH, U.S.A.

clAUdiA m. HArner-JAY, Commercialization Ofcer, Commercialization and Corporate Partnerships, PATH, U.S.A.Heidi lAsHer, Principal, Lasher Consulting, U.S.A.

ericA JAcoBY, Senior Program Associate, Commercialization and Corporate Partnerships, PATH, U.S.A.

limited individual and public resources, extreme

environmental conditions, population growth,

new migration patterns, violent conficts, and

a host o other conditions all pose challenges to

achieving “health or all.” While healthcare or peo-

ple in the developing world over the past quarter

century has improved enormously, recently there

have been signicant setbacks: the AIDS epidemic

and development o resistant strains o diseases, to

name a couple. Continued growth in populations

and decaying inrastructure due to lack o rein-

vestment have exacerbated the problem.

In this context, improving the eectiveness

o healthcare services requires responsive, con-

stantly evolving public health initiatives that can

harness recent advances in biotechnology to solvedicult healthcare problems in developing coun-

tries. For example, new vaccines or meningitis,

malaria, and rotavirus would greatly reduce the

impact o these deadly diseases, which kill mil-

lions o people each year in developing countries.

New, rapid diagnostic tests would detect condi-

tions at the point o care, allowing treatment and

counseling beore the client has let the clinic.

Heat stable and multivalent vaccines, prelled

injectors, and ice-ree cooling would enhance

health services and improve the eectiveness o immunization programs.



BROOKE, HARNER-jAY, LASHER & jACOBY

1756 | HANDBOOK OF BEST PRACTICES

1.1 Why are public–private partnerships so

critical for health technologies?

Our experience suggests that one o the best

ways to ensure that appropriate, aordable health

technologies are developed and made available in

developing countries is through public–privatepartnerships, or PPPs. Globally, most new health

technologies come rom the research and devel-

opment eorts o private industry. Commercial

enterprises not only have the expertise, capacity,

and resources to carry a product orward to mar-

ket, they also have strong market-driven incen-

tives to do so. Unortunately, this drive to pursue

projects with the highest potential prot means

that private companies usually do not put a high

priority on products and services or developing

countries. Markets in those countries are oten

unstable, and so perceived risks diminish project-

ed return on investment. Pharmaceutical compa-

nies, or example, would rather invest in products

that are targeted to large, lucrative therapeutic

markets than pour research dollars into malaria

or AIDS vaccines.

Without private sector collaboration many

badly needed public health products/ideas simply

ail to come to ruition. By itsel, the public sec-

tor lacks the capacity, resources, and experience

to design, develop, produce, and distribute most

new technologies. Te “technology challenge” orpublic sector health organizations, thereore, is to

shit market orces enough to attract private sec-

tor involvement in developing appropriate, cost-

eective healthcare technologies and to make

them available to resource-poor populations. o

accomplish this, the public sector must co-invest

in necessary and suitable technologies, reduce

risk, and invigorate private commercial invest-

ment through eective PPPs.

1.2 What has PATH learned about PPPs?In the past two decades, the public sector has

learned that the commercial sector can very e-

ectively produce and distribute high-quality

goods at low cost. It has also learned that beore

deciding to get involved in a project, the com-

mercial sector must perceive a reasonable re-

turn on its investment and an acceptable level

o risk. Acting as a “bridging agency,” PAH

helps to reconcile these dierences by leveraging

its technical innovation, knowledge o markets

in developing countries, understanding o com-

mercial imperatives, and experience o managing

intellectual property (IP). PAH negotiates mu-

tually benecial solutions or both the public sec-tor and private entities. Trough public–private

partnerships, the costs and risks o development

are shared—and sometimes entirely unded by

PAH with unds rom donors, private ounda-

tions, and governments—at the early stages o a

project, which helps private companies see the

potential or a reasonable return on their invest-

ment. In return, PAH can guide technology de-

velopment towards meeting the priority health

needs o resource-poor populations.

Acting as a “value-added” intermediary be-

tween industry and the public sector, PAH has

been involved in successully commercializing

and advancing over 50 new technologies or pub-

lic health in developing countries over the past

28 years.

1.2.1 Prioritizing availability, accessibility,

and affordability

ypically, a project will begin by clearly identiy-

ing a need or gap in the health system o a de-

veloping country that a new technology, at least

in part, can address. PAH identies potentialpartners, demonstrates the value o the technol-

ogy, and orms collaborations with commercial

companies to become codevelopers and/or sus-

tainable suppliers o the technology to the devel-

oping world. Alternatively, the commercial com-

pany may own a technology that can be adapted

or use in a developing country. In these cases,

PAH may approach the company to collabo-

rate or gain access to their technology. Within

these partnerships, PAH aims to meet three

objectives:1. Availability : o guarantee supply or the

developing world. Initially, PAH works

to ensure that the company has adequate

capacity to supply demonstration projects

and/or clinical trials. Later, a company

must be able to meet potential demand

in targeted countries. Over the long term,

companies must have capacity to meet



CHAPTER 17.17


wider public sector demand in relevant de-

veloping countries.

2. Accessibility : o ensure that the product is

available through distribution channels that

actually reach target populations. Although

many vulnerable populations get their ser-vices through public sector channels, they

also access healthcare through private sector

channels. PAH helps acilitate access to

both channels by working with traditional

government health services and by creating

alliances with social marketing groups that

are able to reach target populations more

broadly.

3. Afordability : o create health products that

the developing world can aord. PAH will

oten negotiate with partners to agree upon

dierent prices or dierent markets (that

is, tiered pricing by country, or between

private sector versus public sector consum-

ers). PAH also conducts cost-eectiveness

studies to help decision-makers understand

the value o the new product in relation to

other potential health products.

1.2.2 Principles for collaboration with

private sector partners

Once PAH has identied potential private sec-tor partners, it ollows a process o due diligence

to examine a potential partner’s operations and

management and to veriy material acts. Such up-

ront diligence signicantly increases the chance

o a successul partnership and assists planning.

PAH needs to decide, or example, whether a

company has enough resources to dedicate to a

project, whether the company is stable and nan-

cially viable, whether the collaboration is appro-

priate given its current situation, and whether the

company represents the best choice or a PAHpartnership. Due diligence is an accepted—and

oten required—practice in the private sector,

and it helps ensure the sustainability and impact

o PAH’s PPPs.

In addition, PAH proessionals have a re-

sponsibility to preserve PAH’s integrity and sta-

tus as a publicly unded nonprot, nongovern-

mental organization and ulll this responsibility

by evaluating partnerships with respect to nine

principles or private sector collaboration.1 From

the perspective o IP management, the ollowing

two principles are most important:

1. Clear link to mission. PAH’s collabora-

tions with private sector companies mustpositively aect the availability, accessibil-

ity, and aordability o important health

products or public health programs in de-

veloping countries.

2. Recognition o private sector needs.

PAH recognizes the company’s need to

benet commercially, which ensures a sus-

tainable commitment to the collaboration.

PAH’s goals or availablity, accessibility,

and aordability o products or develop-

ing country public health programs will

likely be met i PAH’s expectations o

the private sector collaboration are realis-

tic and take into account the ull range o

costs necessary rom product development

to commercialization.

2. HoW do pATH’S pppS HAndle Ip?

Given its mission, PAH has an inherent inter-

est in managing IP to achieve maximum public

health benets. PAH’s approach to IP manage-

ment has common themes or all projects. PAHproessionals review the existing and competing

IP rights o all partners, negotiate with partners

over the exact terms o ownership or all IP gener-

ated over the course o the project, agree on what

happens i the partnership terminates beore the

project’s completion, and speciy responsibilities

or protecting project IP generated by partners

and PAH. Ater a technology is developed, IP

is managed in the context o a commercialization

strategy and a licensing plan.

Within each o these activities are myriadcomplexities that infuence the specic strategies

and tactics PAH adopts to negotiate IP. Perhaps

the best way to understand PAH’s approach to

handling IP, then, is through case studies. wo o

the ollowing case studies, the rst involving cer-

vical-cancer screening diagnostics and the second

involving a meningitis vaccine, are well along the

product development pipeline. In these projects,





IP is managed to advance specic products through

subsequent stages o development and commer-

cialization leading to use in developing countries.

A third case study, involving vaccine stabilization,

describes technologies in an earlier stage o R&D

that will become components o nal productsrather than complete products themselves. In

this case, PAH is pursuing the development o

a portolio o technologies simultaneously in or-

der to distribute risk and ensure progress toward

a successul outcome. IP is managed to advance

the technology portolio, with the understanding

that technologies developed over the course o

the project will become important components

o uture nal vaccine products.

2.1 Cervical-cancer-screening tests: two is

better than one

Although cervical cancer is preventable, about

200,000 women die each year rom it—oten in

their most productive years. Pap-smear screen-

ing programs help keep cervical cancer rates

relatively low in wealthier countries; however,

the success o these screening programs rely on

regular visits to healthcare acilities, expensive

pathology laboratories, and ollow-up visits. Due

to the cost, implementation challenges, and the

complexity o properly screening and treating

women in developing countries, the Pap-smearmethod has had only a limited impact in these

areas. Not surprisingly, more than 80% o new

cervical cancer cases occur among women living

in developing countries.

2.1.1 How the public and private sectors

came together

Because cervical cancer aects women in devel-

oped countries and developing countries, private

industry had already invested in research to im-

prove diagnostic screening tools or human pap-illomavirus (HPV), the virus is associated with

over 99% o cervical-cancer cases. However, these

commercial enterprises had not taken an inter-

est in adapting their technology to make it more

aordable and appropriate or developing-coun-

try health settings. Tis would have required a

large investment in both product development

and clinical studies—or a market that can aord

prices that are only a raction o those in devel-

oped countries. Hence, investing in HPV diag-

nostic technology or public sector markets in de-

veloping countries would never be a top priority

or a commercial entity.

In 2003, PAH received unding rom theBill & Melinda Gates Foundation or its Screening

echnologies to Advance Rapid esting (SAR)

project. Tis project includes support or clinical

studies involving over 22,000 women in China

and India, as well as support or developing low-

cost, easy-to-use, culturally acceptable tests or

cervical cancer screening. Since the private sec-

tor had already developed relevant technologies,

and since PAH possessed useul data, a PPP was

a logical choice. wo testing ormats appeared

promising, so PAH orchestrated partnerships

with two companies to develop the test ormats

to detect HPV (one using DNA, and the other

using a biomarker protein).

Both companies in the PPP are working

to create a test that is sae, accurate, aord-

able, simple to use, and acceptable to women

and healthcare providers. ests will be based on

a cervical swab provided by a healthcare pro-

vider or a vaginal swab obtained by the woman

hersel. Health workers with minimal training

and equipment should be able to process either

test in one day. Both tests are expected to havea higher than 90% accuracy rate in detecting

cervical precancer or cancer (the Pap-smear test

has a 55%–65% accuracy rate). Tis means that

women who get tested only once in their lie-

time, using one o the new methods, will still

have a high probability o avoiding cervical can-

cer disease.

2.1.2 PATH’s management of IP

When negotiating with partners, PAH oten

nds it helpul to articulate the dierent rolesand responsibilities and the expected durations o

the various phases involved in the project. For the

SAR project agreements, there was the R&D

phase, which would last approximately ve years,

and the commercial sales phase, which would last

10 years rom the date o rst sale. In the R&D

phase, PAH assumed responsibility or seven

primary activities:



CHAPTER 17.17


• unding a portion o each industry partners’

direct R&D costs

• providing biological samples during

research

• conducting market and industry assessments

• conducting some key product developmenttasks, specically with lateral fow technology

• conducting program and product cost-e-

ectiveness studies

• developing or the new tests an evaluation

ramework or public health program use

• conducting multicenter, multicountry

(India and China) clinical evaluations o the

perormance o the new test that would be

suitable or the compilation o data required

or product registration in those countries

In turn, PAH’s industry partners agreed to:

• conduct product development activities as

outlined in their agreements

• assemble and protect any needed IP

• manuacture and supply the products or

clinical evaluations

• nalize the products or registration and

commercial supply

Each o PAH’s private sector partners in

this project already controlled key IP or the

technologies included in its respective diagnos-tic test. Tis eliminated the need to broker IP

or reagents rom multiple parties. However,

the two partnerships are more complex when

it comes to creating PAH’s backup IP rights

i either industry partner were to decide not to

go orward. In one agreement, PAH obtained,

under certain backup conditions, a long-term

supply agreement to the partner’s key reagent, as

well as the ability to sublicense others to produce

a nal diagnostic test incorporating this reagent.

In the other agreement, the industry partneragreed to appoint a third party to manuacture

and supply the diagnostic test i it does not want

to continue commercialization. Te latter part-

ner would never be comortable allowing its core

background IP to move out o its direct con-

trol, so rather than asking the company to grant

PAH rights to background IP, PAH ocused

on ensuring continued supply. Both agreements

set pricing targets that are signicantly lower

than anything currently available.

Following the successul completion o re-

search, development, and validation, PAH’s

industry partners will be responsible or obtain-

ing the necessary regulatory approvals and ormanuacturing and selling the test at an aord-

able price in India, China, and other developing

countries. By the end o 2008, two easy-to-use,

inexpensive, and appropriately designed diagnos-

tic products to detect cervical precancer and can-

cer should be available in developing countries.

2.1.3 Key insights

All projects come with their own unique chal-

lenges, particularly when multiple partnerships

are involved. In the case o the SAR project,

PAH was able to avoid some common pitalls

by careully selecting its partners. For example,

because PAH came orward with links to

clinical researchers and policy-makers, and be-

cause it had a solid understanding o the speci-

cations that any new cervical-cancer-screening

test would need, PAH was able to attract two

top-tier industry partners that had the expertise

and capacity to move product development or-

ward. Tese partners were attractive to PAH

because they owned proprietary control o the

key reagents needed or their specic technolo-gies. Tis allowed the project to avoid the even

more uncertain, complex, and lengthy negotia-

tions necessary to bring multiple IP holders into

a workable product development project.

PAH also provided access to well-character-

ized, highly sought-ater clinical specimens rom

countries outside the industry partner’s normal

research networks. In addition, PAH oered

the opportunity or major eld-based clinical

assessments o nal products, assessments that

would be sucient or product registration inthose countries. As a result, the two industry

partners realized that working with PAH would

provide a unique opportunity to reengineer their

product (in the case o one partner) or develop

a new product (in the case o the other partner)

to address lower-price market segments, thus

gaining valuable inroads into the challenging but

attractive markets o India and China. Without





the PAH program incentives, it is unlikely that

either company would have undertaken these

major eorts to adapt and develop their tech-

nologies or use in developing countries.

2.2 Meningitis vaccine: a new model for vaccine development

Meningitis, also reerred to as spinal meningitis,

is an inection in the fuid that surrounds the

brain and spinal cord. When caused by a bacte-

rial inection, the disease can be quite severe and

may result in brain damage, hearing loss, learning

disabilities, and death. Epidemic meningitis has

been present on the Arican continent or about

100 years.

Over the last 20 years, countries located in

Arica’s “meningitis belt,” roughly located be-

tween Senegal and Ethiopia, have depended on

a disease control strategy involving surveillance

and, once outbreaks are detected, reactive mass

immunization campaigns using meningococcal

polysaccharide vaccines. Tese interventions are

massive, expensive, and disruptive, and they de-

fect scarce resources rom public health eorts to

control other diseases. Moreover, recent studies

have shown that ater an epidemic has begun, ol-

low-up mass vaccinations are ineective at pre-

venting meningitis.

Unortunately, while the public health needor a meningitis vaccine in Arica is great, no

manuacturers have been willing to develop an

aordable, eective group A meningococcal vac-

cine. In the 1990s, when more than 100,000

people died in Arica rom a group A meningi-

tis outbreak, there was also a group C meningitis

outbreak in the United Kingdom, which resulted

in 1,000 deaths. By 2001, three vaccine manu-

acturers had developed group C meningococcal

vaccine or the United Kingdom. No vaccine or

group A, however, had been developed.2


came together

Te disease-specic components or a highly e-

ective group A meningococcal conjugate vac-

cine existed beore the PAH/World Health

Organization (WHO) Meningitis Vaccine

Project began. Te conjugation technology also

existed, which was a key production process

step—it chemically links the two components,

which makes the vaccine highly immunogenic

and eective in young children, provides long-

lasting protection, and decreases carriage and

transmission rates. Yet no one was bringing thesecomponents together to develop and produce a

meningococcal A vaccine. Te challenge was to

develop a program capable o motivating a vac-

cine producer to take a risk on an indigent mar-

ket unable to pay high prices or the meningo-

coccal A vaccine.

o address this challenge, in 2000 WHO com-

missioned an independent assessment o existing

IP on conjugation technology and o the costs or

project development and production or a group

A or group A/C meningococcal conjugate vac-

cine intended or Arica.3 Te assessment showed

that development was easible and that a vaccine

costing around US$0.40 per dose was possible—a

price that health managers in sub-Saharan Arican

countries were willing to pay. Soon ater, the Bill

& Melinda Gates Foundation awarded PAH a

ten-year grant to establish, in partnership with

WHO, the Meningitis Vaccine Project, which will

advance the development, production scale-up,

testing, licensure, and introduction o conjugate

meningococcal A vaccines or Arica.


Te Meningitis Vaccine Project brought three crit-

ical partners to the table: SynCo Bio Partners B.V.,

which supplied meningococcal polysaccharide A

(one o the two main components o the vaccine);

the Serum Institute o India Limited (SIIL) to sup-

ply tetanus toxoid (the second main component

o the vaccine) and to scale-up the manuactur-

ing processes or the nal vaccine; and the U.S.

Food and Drug Administration’s (FDA) Center

or Biologics Evaluation and Research to transertheir conjugation technology. Tis consortium was

a new model or vaccine development: a key raw

material came rom one source, the technology

rom another, and the nal scale-up or produc-

tion rom another. Moreover, it included a north-

to-south transer o technology and capacity.

PAH rst negotiated a nonexclusive li-

cense or the FDA conjugation technology rom



CHAPTER 17.17


the U.S. National Institutes o Health Oce o

echnology ranser (on behal o the FDA),

which PAH then sublicensed to SIIL. o pro-

tect the charitable mission o the project, PAH

and SIIL agreed that i SIIL were to cease de-

veloping or producing the vaccine, SIIL wouldtranser to PAH the manuacturing know-

how developed during their collaboration to

enable another manuacturer to make the vaccine.

SIIL also granted back to PAH a nonexclusive,

sublicensable license to SIIL-owned technology

necessary to make the vaccine. In addition, the

PAH-SIIL agreement set out an explicit initial

pricing o US$0.40 per dose or sales to the public

sector. PAH’s agreement with SIIL also includes

explicit procedures and remedies should SIIL not

meet public sector demand or charge the public

sector more or the vaccine than the maximum

agreed-upon price.

2.2.3 Key insights

It is somewhat unusual or vaccine manuacturers

to accept a nonexclusive sublicense or a key pro-

duction process such as a conjugation technol-

ogy. However, the PPP and technology transer

gave SIIL incentive to accept this. First, since no

manuacturer had been willing to make this vac-

cine, SIIL considered the risk that a competing

manuacturer would step orward to use nonex-clusively available FDA technology or a group A

meningococcal conjugate vaccine was very small.

Second, although SIIL is one o the world’s lead-

ing vaccine manuacturers and had prior research

experience working with conjugation technology,

both SIIL and PAH knew they would be acing

complex development challenges and an aggres-

sive timetable. o help address these challenges

and make the project more attractive to SIIL,

PAH ormed a technical team composed o

the FDA inventors and other industry and gov-ernment experts, who creatively and eciently

helped the Meningitis Vaccine Project surmount

the inevitable technology scale-up and standard-

ization hurdles. Tird, the U.S. National Institutes

o Health Oce o echnology ranser (NIH

O) would have likely required higher up ront

ees, milestone payments, and higher royalty rates

i PAH and/or SIIL had demanded an exclusive

license to the conjugation technology. By nonex-

clusively in-licensing the conjugation technology

under lower-cost terms and bundling it with ur-

ther technology transer support, pharmaceutical

development, and clinical trials unding, PAH

provided a package that would allow SIIL to keepthe nished vaccine price at the targeted US$0.40

per dose, even ater paying royalties to the NIH

O. At this price, the new vaccine would cost

less than current expenditures in hyperendemic

areas, even beore adding lost livelihood income

and disability savings.

2.3 Creativity and flexibility accelerate vaccine

stabilization technologies

Te global health community is trying to make

vaccines available to all the world’s children, but

this commitment is stressing an already ragile

cold chain: the distribution network o equip-

ment and procedures used to maintain vaccine

quality rom the vaccine manuacturer to the

recipient. While strengthening and expanding

existing cold-chain capacity is one option or

reducing these stresses, improving vaccine ther-

mostability—the inherent ability or vaccines

to withstand extreme temperatures—is likely to

be the more eective and sustainable approach.

In recent years, stabilization technology has ad-

vanced so ar that it could reduce the relianceo vaccines on the cold chain and acilitate ex-

panded delivery options. Tese products could

reduce the logistical burden o vaccine delivery,

reduce vaccine waste, improve saety, and acili-

tate extended coverage.


came together

Vaccine producers typically seek to obtain su-

cient product stability to meet the standards o

developed countries. Tis means that vaccinestypically require storage at rozen (−20º C) or

rerigerated (2–8º C) temperatures. Some heat-

sensitive vaccines (such as measles, BCG, and yel-

low ever vaccines) must be lyophilized (reeze-

dried) in order to achieve this level o stability.

Vaccine producers have been reluctant to urther

improve thermostability to reduce reliance on

the cold chain or two main reasons. First, there





is no perceived need or such products in devel-

oped countries where cold chain breaks are inre-

quent. Tis means that vaccine producers would

rely solely on developing country sales to recoup

their development investment. Second, the com-

mitment o vaccine purchasers to buy stabilizedvaccines or use in the developing world is uncer-

tain—especially at higher prices.

In the absence o a market or thermostable

vaccine products, PAH initially investigated

the easibility o stabilizing vaccines with und-

ing rom the U.S. Agency or International

Development (USAID) under a program called

Healthech: echnologies or Health. In 2003,

PAH received unding rom the Bill & Melinda

Gates Foundation to investigate the technical,

programmatic, and market easibility o stabiliza-

tion technologies. PAH is pursuing a portolio

approach to the project, working with a range o

private sector companies and universities to ac-

celerate the development o dierent stabilization

technologies that could be applied to a variety o

vaccines. PAH has also developed its own pro-

prietary technology to protect vaccines against

reeze damage (U.S. and Patent Cooperation

reaty [PC] patent applications are pending).

As certain technologies show themselves to be

more promising than others in terms o avail-

ability, accessibility, and aordability, the porto-lio will be narrowed. When the technologies are

mature enough to transer, vaccine producers will

need to help validate and scale up the technolo-

gies or commercial production.


Te primary ocus o PAH’s IP management

strategy or the vaccine stabilization project has

been to keep options open by holding some own-

ership o the new IP generated with partners. Tis

makes it possible to move orward with the tech-nology i the partner is unwilling and to improve

the eciency o research within the portolio

(that is, use the project IP with other partners).

Since the landscape o patents in the stabilization

eld is airly crowded, the strategy also involves

creating partnerships with those that hold oun-

dational IP to which others may eventually need

access.

In practice, this strategy requires a great deal

o creativity and fexibility. In many cases, or ex-

ample, PAH and its partner jointly own proj-

ect IP. Moreover, in certain circumstances, access

to background IP is negotiated at the start. Tis

is ideal because it gives PAH control without jeopardizing the partner’s access. However, two

specic partnerships illustrate the extremes o

managing IP. On one end o the spectrum is a

technology that PAH created in-house and is

developing in collaboration with a partner. Since

PAH owned the technology, it was able to ne-

gotiate ull ownership o all improvements, even

those to which the partner may contribute. On

the other end o the spectrum, a private sector

partner maintained very tight control over its

proprietary IP. Rather than accept unding rom

PAH, the company tested its technology against

the applications o interest to PAH, assuming

the entire R&D burden in order to ully control

the IP. In this case, PAH was able to obtain an

opportunity to negotiate access to their IP in the

uture. Although not ideal structurally, this col-

laboration allowed PAH to build a relationship

with a partner whose technology may be impor-

tant to other technologies in the portolio. Tis

may allow PAH to avoid a potential roadblock

to access in the uture.

In addition to IP management, the project’sglobal access strategy makes concerted eorts to

align partners along the vision o how the end

products might be made available in developing

countries. For such purposes, PAH developed a

Preerential echnology Access Program, which is

written into each partner’s agreement. For exam-

ple, partners must agree to license their technol-

ogy on nonexclusive terms to vaccine manuac-

turers in order to maximize access, place a royalty

cap on those licensing arrangements, and restrict

licensing and milestone ees. Te exact terms vary with each partnership. Te goal is to enable access

to these technologies as they move downstream in

the development pipeline.

2.3.3 Conclusions

When it comes to upstream research projects,

we know very little about which technologies

will emerge as promising, which may need to be



CHAPTER 17.17


eventually combined, and which may prove oun-

dational or others. PAH’s strategy has been to

invest in a wide variety o promising approaches,

promising to maximize the chances or success

and integration and to negotiate some degree o

access. PAH can thereby prevent those technol-ogies that are emerging rom the portolio—and

even technologies that already exist—rom lim-

iting the widespread adoption o stabilization

technologies by vaccine manuacturers serving

the developing world. Tis requires a constant

reexamination o product scenarios and players.

PAH uses as much fexibility and creativity as

possible to move orward a market that in its ab-

sence would stall. ■

AcKnowledgement

Some o the writing in this chapter was borrowed rominternal documents written under the Healthech proj-ect, which was made possible by the generous supporto the people in the United States through USAID un-der the terms o Healthech Cooperative Agreement# GPH-A-00-01-00005-00. Te ideas expressed in thischapter refect the principles and goals o PAH and donot necessarily refect the views o USAID or the U.S.

Government.

steVe BrooKe, Advisor, Commercialization and Corporate Partnerships, PATH, 1455 NW Leary Way, Seattle, WA,

98107, U.S.A. [email protected]

clAUdiA m. HArner-JAY, Program Ofcer, Commercializa-tion and Corporate Partnerships, PATH, 1455 NW Leary Way, Seattle, WA, 98107, U.S.A. [email protected]

Heidi lAsHer, Principal, Lasher Consulting, 410 N Willson Ave., Bozeman, MT, 59715, U.S.A. [email protected]

ericA JAcoBY, Senior Program Associate, Commercializationand Corporate Partnerships, PATH, 1455 NW Leary Way,Seattle, WA, 98107, U.S.A. [email protected]

1 A full description of PATH’s Guiding Principles for Pri-

vate-Sector Collaboration is available online at: www.path.org/les/ER_gp_collab.pdf. Additional readingand relevant articles are:

Free MJ. 2004. Achieving Appropriate Design andWidespread Use of Health Care Technologies in the

Developing World: Overcoming Obstacles that Impedethe Adaptation and Diffusion of Priority Technologies

for Primary Health Care. International Journal of

Gynecology & Obstetrics 85(Suppl. 1): 3–13.

Free MJ. 1992. Health Technologies for the DevelopingWorld. International Journal of Technology Assessment

in Health Care 8:4: 623–34.

Greenwood BM. 1999. Manson Lecture: Meningococcal

Meningitis in Africa. Transactions of the Royal Society of

Tropical Medicine and Hygiene 93: 341–53.

PATH. 2006. Global Partnerships for Malaria Control.Directions in Global Health 3:1. www.path.org/les/

ER_directions_spr_06.pdf.

PATH. 2006. Eliminating meningitis in Africa.Directions in Global Health 3:2. www.path.org/les/ER_directions_summer06.pdf.

Ramsay ME, N Andrews, EB Kaczmarski and E Miller.

2001. Efcacy of Meningococcal Serogroup C ConjugateVaccine in Teenagers and Toddlers in England. Lancet 357: 195–96.

Lloyd J. 2000. WHO Department of Vaccines and

Biologicals. Technologies for Vaccine Delivery in the

21st Century. whqlibdoc.who.int/hq/2000/WHO_V&B_00.35.pdf.

2 Jódar L, FM LaForce, C Ceccarini, T Aguado and DM

Granoff. 2003. Meningococcal Conjugate Vaccine forAfrica: A Model for Development of New Vaccines forthe Poorest Countries. Lancet 361: 1902–4 .

3 See supra note 2.

Documents

IpHandbook Ch 17 Brooke Et Al PATH