[Ip-health] Bio Tech week on UAEM and "recent signs of an increasing awareness of the role that universities play in expanding global access"

[Ethan Guillen]

Biotech Transfer Week
October 29, 2007 | Vol. 1 No. 33



  Universities Urged to Wield =8CInfluence=B9 to
 Ensure Affordable Drugs in Poor Countries

  By Ben Butkus





Research universities have =B3considerable untapped influence=B2 that they
should use to make biomedical innovations available and affordable for
developing nations, according to a commentary published last week in the
Journal of the American Medical Association.

The commentary suggests that universities should modify their licensing
strategies to include terms that ensure low-cost access to medicines and
encourage generic competition in poor countries. In addition, according to
one of the article=B9s authors, universities are obligated to exert their
influence beyond licensing agreements by publicly pressuring licensees into
socially responsible pricing and forming alliances with other schools to
develop and execute pro-access policies.

The article is one of several recent signs of an increasing awareness of th=
e
role that universities play in expanding global access to biomedical
innovations developed with federally funded research. It comes in the wake
of a conference and controversial op-ed article from student movement
Universities Allied for Essential Medicines, and a =B3socially responsible=
=B2
vaccine licensing agreement between Harvard University and China=B9s
Morningside Group.

It also follows a white paper published earlier this year by tech-transfer
officials at the University of California at Berkeley and Stanford on
socially responsible licensing (see BTW, 3/19/2007).

Dave Chokshi, a medical student at the University of Pennsylvania School of
Medicine, and Rahul Rajkumar, a physician at Brigham and Women=B9s Hospital=
,
co-authored the commentary, which was published last week in a special issu=
e
of JAMA focusing on poverty and human development.

According to the authors, research universities play a critical role in
influencing the cost and availability of medical innovations in developing
countries =B3by virtue of their upstream contribution to the drug developme=
nt
pipeline=B2 =AD estimated at $19.6 billion in 2002 for the US alone.

In addition, the authors provide the example of several currently marketed
HIV drugs whose patent rights are held by universities. These include
stavudine (Yale University); abacavir (University of Minnesota); lamivudine
and emtricitabine (Emory University); and enfuvirtide (Duke University).
Overall, the authors write, university patents are associated with 10 of th=
e
30 HIV drugs approved by the US Food and Drug Administration between 1987
and 2007.

Chokshi and Rajkumar also point out the necessity to expand access to
treatments for chronic illnesses such as diabetes and cardiovascular
disease, noting that of the 35 million worldwide deaths from chronic diseas=
e
in 2005, 80 percent occurred in low- and middle-income countries.

When university-owned intellectual property is necessary for the developmen=
t
of a potential health-related product such as a drug, vaccine, or diagnosti=
c
test, the authors write, universities could craft exclusive licensing
agreements that ensure low-cost access to the product in developing nations=
.

One way to do this would be to engender generic competition in poor
countries by adopting, for example, the =B3equitable access license=B2 deve=
loped
by UAEM, which allows multiple producers in low- and middle-income countrie=
s
to manufacture and sell a version of a product free of IP constraints,
according to Chokshi and Rajkumar.

In situations where such a licensing provision is not feasible because
reverse engineering of the product is difficult =AD such as with a vaccine =
or
biologic medicine =AD universities should adopt a =B3global access strategy=
=B2
that would require the licensee to sublicense IP at a low cost, make its ow=
n
product available at a low cost, or participate in patent pools with other
companies or institutions to better enable cross-licensing agreements that
would increase access to the product in developing nations, the authors
write.

=B3What we were hoping to inject into this debate is some level of
specificity, because unfortunately it is all too easy for university
decision-makers to agree to this general principle of what should be done,
but when the rubber meets the road, it doesn=B9t make a difference if all t=
hat
is talked about is this high-level principle,=B2 Chokshi told BTW last week=
.
=B3We=B9re trying to take it to the next level to develop specific policies=
 that
could be implemented that actually bring that principle to bear.=B2

The full commentary can be seen here.

Increasing Awareness

The commentary echoes public policy changes suggested by UAEM, a group that
both Chokshi and Rajkumar have been involved with in the past that has been
particularly active in promoting its agenda in recent weeks.

UAEM is a university student movement that grew out of a successful 2001
campaign by students at Yale University to pressure Yale into expanding
third-world access to stavudine, Robynn Sturm, a graduate student at Yale
Law School and member of UAEM=B9s board of directors, told BTW.

Since that time, the movement has evolved primarily into a graduate student
organization with the backing of numerous university faculty members. UAEM
just completed its first fund-raising campaign, assembled an advisory board
and board of directors, and hired its first permanent staff.

Late last month, UAEM held its fourth annual conference on Harvard=B9s camp=
us.
Chokshi and Rajkumar were among the speakers at the conference, which,
according to UAEM, attracted more than 300 students from the US, Canada, an=
d
the UK.

Following the conference, UAEM board president Rachel Kiddell-Monroe and
executive director Ethan Guillen co-authored an op-ed piece that was
published in the Boston Globe. In the piece, UAEM called on US research
universities to join the UAEM movement, and urged current member
institutions to =B3turn the promises of their commitment from words into
action.=B2

In particular, the article criticized the University of Wisconsin and its
tech-transfer operation, Wisconsin Alumni Research Foundation, for it=B9s
involvement with Abbott=B9s kidney medication Zemplar, which was originally
developed by UW researchers.

In the fall of 2006, Abbott lowered the price of its AIDS drug Kaletra in
Thailand in response to a request from the Thai government. However,
Thailand officials, feeling the price reduction was not enough, instituted
their own compulsory drug license allowing generic versions of Kaletra to b=
e
manufactured and sold in the country without regard to Abbott=B9s patents o=
n
the medicine.

Abbott responded by withdrawing several of its new drugs, including Zemplar=
,
from entry into the Thai market. According to UAEM, WARF essentially ignore=
d
the requests of a group of concerned UW students to urge Abbott to
reintroduce Zemplar into Thailand. In the op-ed piece, Kiddell-Monroe and
Guillen wrote that UW =B3must demand that Abbott Industries reinstates Zemp=
lar
on the Thai market, along with the other essential medicines.=B2

Sturm told BTW that UAEM ideally would like to see universities include in
every single license a provision that would enable any qualified supplier t=
o
provide generic versions of essential medicines to poor countries, even
before the patents expire or lose their exclusivity.

=B3The pharmaceutical company would maintain full and exclusive rights with=
in
developed countries,=B2 she said. =B3But in those spaces where they=B9re no=
t
making any money anyway, because people can=B9t afford brand-name drugs, th=
ey
would allow for other companies to step in and do it at a much lower price.=
=B2

In an e-mail to BTW regarding UAEM=B9s article, WARF communications directo=
r
Janet Kelly wrote: =B3WARF's license to Abbott Laboratories for the compoun=
ds
used to manufacture Zemplar dates back to 1998. It is an exclusive license
and legally binding contract for both parties. Abbott has met the terms of
our licensing agreement. It is not feasible for WARF to seek changes to
existing agreements with customers in good standing.=B2

Kelly added that Abbott has been an =B3excellent partner=B2 for WARF with
=B3proven ability to successfully develop and commercialize new drug
discoveries that benefit patients around the world.=B2

But Chokshi said that WARF =AD and other universities that have espoused
similar comments =AD are guilty of a =B3unidimensional view=B2 of the influ=
ence
that universities can have on the access to medicines in poor countries.

=B3There are various forms of leverage. It doesn=B9t have to do solely with
legal or licensing interventions,=B2 Chokshi said. =B3It can be anything fr=
om
making an informal phone call and trying to do the right thing with respect
to a technology developed by a scientist at your school, to taking a more
publicly confrontational stance if the university believes that the claim i=
s
justified that people in Thailand should have access to this medicine.=B2

According to Chokshi and Sturm, the WARF-Zemplar situation is similar to
that of stavudine, for which a license had already been negotiated between
Yale and Bristol-Myers Squibb. However, barriers existed that kept South
Africa from affording the drug or importing generic versions.

Humanitarian group Doctors Without Borders subsequently asked Yale and BMS
to allow South Africa to import a generic version of the drug; and the Yale
professor who discovered the drug authored an op-ed piece, published in the
New York Times, that called for BMS to act. This put public pressure on BMS
to expand access to the drug, Chokshi said. In 2001, BMS said it would no
longer attempt to stop generic drug makers from selling low-cost versions o=
f
the drug in Africa

=B3This is the difference in thinking,=B2 Chokshi said. =B3If you believe t=
hat
this is a bad decision by Abbott, then the university has some
responsibility for trying to change that decision.=B2

Harvard Sets an Example?

Also earlier this month, Harvard seemingly =B3put the rubber to the road=B2=
 when
it announced a licensing deal with China=B9s Morningside Group for vaccine
technology developed by John Mekalanos.

Mekalanos=B9 technology is called the protein capsular matrix vaccine. The
PCMV, according to Harvard, enables pharmaceutical companies to produce
vaccines rapidly and inexpensively; and to more easily develop multivalent
vaccines =AD a potentially important technology in developing countries
because can protect against multiple pathogens in one vaccination. A patent
application for the technology is currently under review by the US Patent
and Trademark Office.

Under the terms of the agreement, Morningside will form a new company that
will develop and commercialize the PCMV technology and ensure that vaccines
incorporating the technology are made available at =B3reasonably affordable
prices=B2 in countries eligible to receive support from the Global Alliance
for Vaccines and Immunization, Harvard said in a statement.

In addition, Harvard has agreed to relinquish its share of future royalties
on sales made by Morningside=B9s company and its affiliates in GAVI countri=
es,
and has reserved the right to directly license qualified governmental bodie=
s
and non-governmental organizations to distribute vaccines made with the PCM=
V
technology for humanitarian purposes, the university said.

In an e-mail to BTW, Larry Schlossman, director of business development at
Harvard=B9s Office of Technology Development, wrote that the school chose t=
o
partner with Morningside Group primarily because of its willingness to
negotiate socially responsible terms into the license agreement.





 =B3What we were hoping to inject into this debate is some level of
specificity, because unfortunately it is all too easy for university
decision-makers to agree to this general principle of what should be done,
but when the rubber meets the road, it doesn=B9t make a difference if all t=
hat
is talked about is this high-level principle.=B2



=B3Like vaccine manufacturers or biotech companies in the US, we believe th=
at
Morningside has the technological and other resources to develop this
vaccine platform and bring products successfully to market,=B2 Schlossman
wrote. =B3Unlike other potential partners, however, Morningside was willing=
 to
adopt the technology at an early stage and, despite the typically long time
to launch of a vaccine product, to address Harvard's and Dr. Mekalanos'
concerns regarding global access.=B2

Schlossman added that the agreement grants Morningside a worldwide license
to Harvard's PCMV patent rights and, =B3except as regards royalties in GAVI
countries, contains financial terms typical of academic-to-industry license=
s
to therapeutic or vaccine platform technologies.=B2

Chokshi called the deal =B3laudable,=B2 and Sturm said that it was =B3wonde=
rful=B2
that Harvard has waived its royalty rights to the PCMV technology.

Both, however, also expressed reservations about the agreement, stressing
that it would take time to see if Harvard backs up the terms regarding
expanded access to the technology in developing nations.

=B3[Waiving royalties] really only reduces prices at the margins,=B2 Sturm =
said.
=B3We=B9ve seen over time that the most important factor to bringing down t=
he
price of drugs is allowing for generic competition. That drives the price
down very fast.=B2

Chokshi said that Harvard has =B3done the right thing with respect to this =
one
circumstance,=B2 but added that the agreement raises questions about =B3why
they=B9re only considering these types of provisions, for example, in a
license to a developing country manufacturer for the purpose of supplying t=
o
developing countries.=B2

The agreement, he said, =B3should be quickly followed with evidence that th=
is
idea of socially responsible licensing extends not just to technologies for
neglected diseases, but also for any technology that comes out of Harvard=
=B9s
research enterprise.=B2

Chokshi explained that a distinction needs to be drawn between =B3global
diseases=B2 and neglected diseases that primarily affect poor countries. In
the case of global diseases such as cancer, HIV, and cardiovascular disease=
,
Chokshi said that access-minded licensing terms =AD such as allowing generi=
c
competition or engendering lower prices in poor countries =AD are needed
because there is an incentive for companies in the developed world to take =
a
university technology and turn it into a medicine.

=B3The second case is more in line with [the] Morningside and Harvard
[agreement],=B2 Chokshi said.

Harvard=B9s Schlossman wrote that =B3it is our understanding that the profi=
t
margin on most vaccine products is low,=B2 and explained that waiving
royalties in developing countries is =B3one tool=B2 for reducing vaccine
production costs.

=B3While we do not favor a one-size-fits-all approach, as UAEM does, given =
the
unique nature of each licensing arrangement, Harvard avails itself of what
we believe are creative and innovative strategies in addition to royalty
reductions/waivers to accomplish humanitarian distribution of key medical
innovations,=B2 Schlossman added.

The recent actions of Harvard and other universities that have considered
widespread adoption of UAEM=B9s suggested policies =AD many of which contri=
buted
to the =B3socially responsible=B2 licensing white paper earlier this year =
=AD have
created momentum for the movement, Chokshi said.

=B3We know of about a dozen major research universities that are seriously
considering these types of changes,=B2 he said. =B3But those universities n=
ow
need to have some sort of inter-university collaboration to proactively say
they are interested in this and to meet that principle with some statement
of commitment to actually make the changes.=B2