[Ip-health] Medicines Patent Pool: Industry's Toe Still in the Water

Jamie Love james.love at keionline.org
Mon May 13 07:58:38 PDT 2013


http://blog.pharmexec.com/2013/05/13/medicines-patent-pool-industry%E2%80%99s-still-toe-in-the-water/

Medicines Patent Pool: Industry's Toe Still in the Water

By WILLIAM LOONEY | Published: MAY 13, 2013

At a time when Big Pharma is struggling with new business models
geared to the demands of a changing marketplace, the Medicines Patent
Pool (MPP) is offering a way forward through voluntary licensing and
patent deals that it insists will deliver what the drug majors say
they want: more innovation; better market access; and the opportunity
to demonstrate measurable improvements in public health. Is the MPP,
as founding chair Phillipe Douste-Blazy claims, that “new business
model for the future?”

Not yet. Progress in bringing companies into the fold has been slow.
But this Geneva-based wing of the multilateral donor group UNITAID is
redoubling its efforts under new, pragmatic leadership more interested
in scoring deals that scoring points, particularly as the global
health debate expands beyond the ideologically-charged context of
AIDS, money and medicine to multiple disease partnerships focused on
system-wide solutions.

MPP was established three years ago to support UNITAID’s mission in
financing new treatments to fight the AIDS pandemic. It has a mandate
to promote development and distribution of low-cost medicines through
the negotiation of a “pool” of patents that can be licensed for
production and sale in countries where access to HIV treatment is
limited by resource constraints or cost. Staff are charged to
negotiate licenses and sub-licenses with public and private sector
partners; they also administer a data base to identify patented
originator products relevant to addressing what the WHO and other aid
agencies see as the most pressing treatment priorities in the HIV
space. Terms of engagement are transparently clear: MPP only works
around “live” patented medicines that can positively impact these
priorities; if the patent has expired or is close to LOE, MPP doesn’t
bite.

To date, MPP has forged deals with three partners. The first, with
Gilead Sciences, gives it licenses on four HIV medicines plus a fixed
dose combination of these four in a single pill known as the “Quad.”
Three of the five [cobicistat, elvitegravir, and the Quad] are
products still in clinical development, and the agreement allows for
the development and manufacture of other combinations based on these
medicines. One drug — tenofovir — is also licensed for use in
Hepatitis B. In February, MPP agreed a license with the HIV joint
venture ViiV Healthcare [GSK, Pfizer and Shionogi] for the pediatric
AIDS drug abacavir, which will be distributed in 118 countries that
cover almost 99 per cent of the world’s children with HIV. The pact
calls for additional work to secure licenses and development rights
for new fixed dose combinations geared to young patients. The third
deal is with the US National Institutes of Health that awarded MPP its
licenses on darunavir, a protease inhibitor for HIV, for production in
low and middle income countries.

A fundamental sidebar to these deals is the sub-licenses MPP has
secured for a whole host of low-cost generic manufacturers, including
Shasun, Aurobindo, Hetero and Emcure. Hetero, based in India, alone
produces ARV treatments for over 2 million HIV patients, in 100-plus
countries.

Greg Perry, MPP’s new Executive Director who took up the post in
January, told Pharm Exec that, while three partnerships in three years
may seem a modest achievement, each sets important precedents for
access. “Our work with the NIH is a badge of political support and
established our credibility on public health. The Gilead partnership
focuses on products still in the development pipeline, which allows us
to accelerate the timing for uptake of these critical medicines in the
field. And ViiV has committed to place its pipeline products into the
pool once they are approved by regulatory authorities, with additional
transfers of technology to assist generic sub-licensors in
manufacturing, bioequivalence studies, and quality control. In
essence, we are building with them an IP platform to help facilitate
the registration of a new drug – you could say our original
‘imitation’ pool is actually becoming an innovation pool.”

Three and counting

MPP is currently in active negotiations with three other pharma
companies: BMS, Roche and Boehringer-Ingelheim. Talks are “most
advanced” with the first two. Other targets include AbbVie, Merck, and
J&J. According to Perry, who most recently served as founding Director
of the European Generic Medicines Association, “talking to big
companies takes an equally big commitment of time. It’s no different
than any other complex bilateral transaction, with the main issues
being geographical scope, timing and conditions for transfers of
technology, royalty terms, and provisions to structure relations with
third parties.“ Perry contends his background as a trade group
executive gives him a good understanding of how to work productively
with the private sector. Companies seem to prefer him to the political
baggage that the MPP’s first director, Ellie ‘t Hoen, carried as a
prominent consumer activist, industry public scold – and key target
for free-market think tanks financed largely by the big drug makers.

Perry says the message he takes to industry is all about
predictability. “We reduce transaction costs and alleviate risk
through our guarantees of efficacy and quality for all sub-licensors.
With the patent pool, you will get the product on the market and
deliver access to the target population we all identify as necessary
to reach. It precludes the wasted time and effort when a license is
agreed but never activated by the contracting parties. There are no
such lost opportunities with us.”

Still, many companies remain to be convinced, with one executive that
has been in talks with the MPP noting that it will not budge on one
key concern: limiting the geographic reach of concessionary patent
terms to bar those high growth, middle-income countries outside
sub-Saharan Africa. This comes as no surprise, given that all the
MPP’s principal sub-licensors to date are Indian. Other issues are the
MPP’s reluctance to tighten and clarify contract terms [the MPP relies
on a standardized 30-page text] covering the respective management and
execution roles between licensors and licensees. Likewise, while there
is much optimism about generic sub-licensors taking the lead in
working with patent holders to commercialize new fixed dose
combinations and other novel approaches to access, no guarantee exists
that this will occur, particularly as the financial incentives for
them to do so appear lacking.

Perry seems sensitive to these concerns and told Pharm Exec he is
looking to see what additional dividends the MPP can offer to persuade
industry to collaborate. “One improvement we’d like to facilitate is
helping the industry obtain faster approval times for new drugs that
meet a designated public health need. We are talking with numerous LDC
governments to accelerate cooperation around faster time lines and
more transparency on drug registration. The MPP is also involved in a
WHO pilot project on a standard regime for the prequalification of
priority medicines.”

So we return to that mission of the MPP – is it truly the vanguard of
a new business model for pharma on the global stage? Could it be a
tool for the hidden agendas of profit-seeking generic suppliers posing
as alms for the poor? Or is it a public policy experiment with no
grounding in the brutal logic that drives decisions in real-world
markets? For now it’s anyone’s guess, but time will eventually cast a
verdict. Licensing is, by definition, a transactional business –
someone has to come to the table.

William Looney is Pharm Exec’s Editor-in-Chief.




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