[Ip-health] KEI comment on the Medicines Patent Pool license and MoU with ViiV Healthcare

Jamie Love james.love at keionline.org
Thu Feb 28 02:43:32 PST 2013


http://keionline.org/node/1665

KEI comment on the Medicines Patent Pool license and MoU with ViiV Healthcare

28 February 2013

FYI: James Love (james.love at keionline.org, +1.202.361.3040), Krista
Cox (krista.cox at keionline.org, +1.202.332.2670) or Thiru
Balasubramaniam (thiru at keionline.org).
The 27 February 2013 agreements between the Medicines Patent Pool
(MPP) and ViiV Healthcare, a joint venture of GlaxoSmithKline, Pfizer,
and Shionogi will expand access to affordable pediatric formulas for
HIV/AIDS.

The License and the MOU between ViiV and the MPP for Abacavir are
online here: http://www.medicinespatentpool.org/licensing/current-licences/.
The licenses and the MoU were reviewed by the MPP Governance Board,
and by a 12 member Expert Advisory Group (EAG) chaired by Maximilliano
Santa Cruz of the National Institute of Industrial Property in Chile.
The EAG includes many well known and highly regarded experts from
different disciplines including for example Professor Carlos Correa
and Jonathan Berger from Section 27 in South Africa. The MPP
documentation about the decision are available here:
http://www.medicinespatentpool.org/who-we-are2/governance/governance-decisions/.

The following are KEI's initial comments on the 42 page Abacavir
license and the four page MoU.

KEI's comments on the Abacavir license

GSK, Pfizer and Shionogi deserve credit and goodwill for entering into
a license with the Medicines Patent Pool that includes patents on
Abacavir, an important drug for HIV/AIDS that is particularly useful
for pediatric AIDS. The geographic coverage of the license is broader
than any other license from a drug company, and includes several
countries in Latin America than did not previously benefit from an MPP
license from a drug company. According to the MPP, the geographic area
of the new license will allow generic Abacavir to be supplied in 118
countries where 98.7% of children living with HIV reside. The license
does not require any royalty payments, does not designate countries
where the drug is manufactured, is non-discriminatory as regards
manufacturers, allows the product to be used in new fixed dose
combinations or formulations, and provides that the licenses may be
used even by companies that seek compulsory license or challenges to
Abacavir patents. The patent coverage for Abacavir is uneven, and
non-existent in many countries in the licensed area, but the ViiV/MPP
license expands the market for generic products and provides more
certainty for generic manufacturers. By offering the license, ViiV has
created new momentum for open licensing of HIV/AIDS related patents,
and that is a good thing.

Patent Landscape

Abacavir is an older compound, but the license covers eight patents
related to its manufacture, formulation and use, including at least
one patent in 65 countries. The patent landscape is set out in
Appendix A to the license (pages 24-29 of the license).

Grant back provisions

Section 8 of the license addresses the issues of intellectual property
relating to grant backs to improvements, and includes a grant back of
a "perpetual, irrevocable, worldwide, royalty free, non-exclusive
license to use any Improvement, Improvement Patent and related know
how" to both the MPP and ViiV. Without negotiating additional rights,
ViiV is entitled to grant sublicenses only to its Affiliates or
contract manufacturers, distributors and service providers, and solely
relating to the commercialization of ViiV products. Section 8 also
provides that MPP can enter into negotiations for further sublicensing
of any improvements developed by the licensee.

The ViiV/MPP Memorandum of Understanding

The four page MoU between ViiV and the MPP provides details of future
collaboration between ViiV and the MPP for new pipeline products for
pediatric AIDS. According to the MoU, the intention is to make the
products available in the same 118 countries covered in the Abacavir
license. One of the pipeline products is the new integrase inhibitor
dolutegravir, a highly regarded product developed in collaboration
with Shionogi.

Test data

Section 5.7 of the license extends the rights to include rights in
regulatory test data.

5.7 ViiV shall provide any Sublicensee with NCE Exclusivity or other
regulatory exclusivity waivers to the extent required by the
applicable regulatory authorities in order to manufacture or sell
Product in the Territory in accordance with the terms of the
Sublicence. ViiV shall further provide to any Sublicensee such
consents which it has the legal capacity to give as are necessary to
enable such Sublicensee to perform its obligations under Clauses 3.2
and 3.3 of the Sublicence.

Comparison to the Gilead license

The primary advantages of the ViiV/Abacavir license to the earlier
Gilead license are the freedom to manufacture APIs in different
countries (Gilead restricted API manufacturing to India), and the
larger geograpic scope. The new license territory includes the
following countries that were were not covered in the Gilead license
agreement for tenofovir (TDF): Algeria, Argentina, Azerbaijan, Chile,
Colombia, Costa Rica, Korea DPR, Egypt , Federated States of
Micronesia, Iraq, Iran, Kosovo, Lebanon, Libya, Marshall Islands,
Malaysia, Morocco, Panama, Paraguay, Philippines, Tunisia, West Bank
and Gaza. Many also see the zero royalty in the ViiV Abacavir license
as an advantage.

On the other hand, the Gilead licenses cover more products and include
licenses to pipeline products that have subsequently received FDA
approval, and importantly, a broader field of use. The ViiV MoU limits
the field of use of pediatric HIV/AIDS, while the Gilead licenses
covered not only both pediatric and adult AIDS, but also other
indications. In the Gilead license, for products using TDF as a sole
ingredient, the field of use is HIV and Hepatitis B. For EVG and COBI,
the field of use includes "any use that is consistent with" the labels
approved by the US FDA or other "applicable foreign regulatory
authority."

Transparency

Unlike virtually all other voluntary licenses in this area, the MPP
legal documents are available in unredacted form, and this is itself a
significant benefit and welcome precedent that we hope others will
follow, including governments and PDPs involved in licensing
intellectual property rights.

Concluding Comments

As noted above, the new ViiV license gives the MPP fresh momentum in
its efforts to expand the freedom to manufacture generic versions of
drugs for HIV/AIDS. Attention
should shift now to Johnson and Johnson, Abbott and other companies
that have refused to license products to the patent pool, and to the
challenge of adding more "middle income" countries to the geographic
area of the licenses. To this end, low and middle income government
should play a larger roll in pushing companies to license to the MPP
-- some that will add more products and expand the geographic area of
the licenses. Given how complex are these negotiations, we would also
note that the staff of the MPP, and its governance board and expert
advisory board have demonstrated sensitivities to the most important
issues in ensuring that the licenses promote robust generic
competition and do not undermine the use of compulsory licenses or
challenges to patent validity.

Additional details

   [snip]

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.
twitter.com/jamie_love




More information about the Ip-health mailing list