[Ip-health] Patent pools: should pharma share IP with the developing world?

[mko]

One issue on IFPMA's agenda is wildcard patents, or transferable
intellectual property rights.  This is a radical idea, breaking the histori=
c
connection between patent rights and the invention itself.  In a recent
article in Lancet Infectious Diseases, we estimate that a 6-month patent
extension will cost from US$ 8.7 to US$11.9 billion per delivered drug.  Th=
e
article relates to antimicrobials, but similar cost factors would apply to
wildcards for neglected diseases.

Will longer antimicrobial patents improve global public health?
Lancet Infect Dis. 2007 Aug;7(8):559-66.

snip:

IFPMA, whose members include 25 leading international companies and 46
national and regional industry associations, has proposed a
=B3transferable market exclusivity=B2 model under which a company would be
granted patent extension for products marketed in developed countries,
in exchange for doing R&D on neglected diseases, to improve the supply
of medicines.


On 11/8/07 7:51 AM, "Judit Rius Sanjuan" <judit.rius@keionline.org> wrote:

>
> http://bulletin.sciencebusiness.net/ebulletins/showissue.php3?page=3D/548=
/art/91
> 82&ch=3D1
>
>
> Patent pools: should pharma share IP with the developing world?
>
> A proposal to change patent protection rules to speed the development of
> affordable drugs for the developing world is under debate this week at
> the World Health Organisation (WHO) in Geneva. The suggestion is being
> put to the second meeting of the intergovernmental working group on
> Public Health, Innovation and Intellectual Property, set up in September
> 2006 to prepare a global strategy and plan of action to bring the
> benefits of modern medicines to developing countries.
>
> The call for the creation of patent pools comes from governments of
> developing countries and non-governmental organisations (NGOs), and has
> been championed by the US NGO Knowledge Economy International (KEI),
> based in Washington DC. KEI claims that countries including France,
> India, Thailand, the Netherlands and Brazil have indicated they are in
> favour of pooling.
>
> Inevitably, such a move is not favoured by the industry, which launched
> a pre-emptive strike at the end of last week in the form of a progress
> report on pharmaceutical company projects to develop new medicines and
> vaccines for ten diseases of the developing world that have been
> prioritised by WHO and the United Nations.
>
> In its submission KEI says the collective management of intellectual
> property rights can help the intergovernmental working group achieve its
> goals. By pooling patent assets it is possible to overcome market
> inefficiencies, lower transaction costs, and make it easier to access
> multiple rights. Such arrangements can be made voluntarily or
> non-voluntarily, notes KEI.
>
> Precedents for pooling
>
> But patent pools are not just a heavy-handed way of knocking heads
> together to achieve policy objectives. One of the key motives behind
> voluntary pooling is to clear blocking patents that would be infringed
> when practising other patents. It also vastly simplifies the whole
> process of intellectual property management, leading to a reduction of
> licensing transactions, making it easier to deal with multiple owners
> and handle the payment and collection of royalties.
>
> The idea of pooling patents has plenty of precedents, dating from
> industrial age sectors such as sewing machine and aircraft
> manufacturing. More recently, it has been used to bring together
> intellectual property in the creation of international technology
> standards including DVD and MPEG.
>
> Pools can involve simple cross-licensing among two or more competitors,
> to share a handful of patents needed for a particular product, or they
> may involve an industry-wide pool encompassing hundreds of manufacturers
> and thousands of patents.
>
> KEI notes that there are precedents for government intervention to
> create a pool, citing the US Manufacturers=B9 Aircraft Association pool,
> formed in 1917 against the backdrop of legislation threatening
> compulsory license of patents to overcome barriers to the scale up of
> aircraft manufacturing, as the US prepared to enter the second world war.
>
> The US government also insisted that rights to license patents for radio
> technologies should be consolidated to foster development of the radio
> industry.
>
> Now KEI and others want to promote the use of patent pools with the
> specific objective of increasing the level of generic competition to
> branded medicines.
>
> Lower prices, greater innovation
>
> Providing much more efficient and effective mechanisms for the voluntary
> or compulsory licensing of patents will lower prices and promote
> innovation. =B3The multitude of patents, potential claims of infringement=
,
> variance of national laws, complexity of international treaties and
> national patent laws, and complicated rules for the export of medical
> technologies under compulsory licenses present barriers for the expanded
> use of generic medicines,=B2 KEI says in its submission to the WHO.
>
> Ahead of the meeting the International Federation of Pharmaceutical
> Manufacturers & Associations (IFPMA) published a progress report on
> industry R&D projects for diseases of the developing world, in attempt
> to demonstrate that current measures to foster the development of
> suitable medicines are bearing fruit.
>
> The figures show member companies are working on 50 treatments compared
> with 43 at the end of 2006. At the same time, the number of ongoing
> IFPMA company vaccine projects to address developing world diseases has
> grown from six to eight.
>
> The combination of the industry-based model and public-private product
> development partnerships is increasing R&D in this field, said Harvey
> Bale, Director General of the IFPMA, saying =B3The R&D pharmaceutical
> industry encourages [intergovernmental working group] participants to
> support positive proposals that would reinforce this important trend.=B2
>
> Bayle added that the number of candidate products in development for
> tuberculosis, the leading cause of mortality in the developing world,
> has increased to 22, of which six are in phase II or phase III clinical
> trials.
>
> IFPMA, whose members include 25 leading international companies and 46
> national and regional industry associations, has proposed a
> =B3transferable market exclusivity=B2 model under which a company would b=
e
> granted patent extension for products marketed in developed countries,
> in exchange for doing R&D on neglected diseases, to improve the supply
> of medicines.
>
> It would not be unprecedented for WHO to get involved in moves to form
> patent pools. Following the outbreak of severe acute respiratory disease
> (SARS) there was a rush to sequence the SARS genome and apply for patents=
.
>
> In response the WHO SARS Consultation Group got together with SARS
> intellectual property owners to create the SARS IP Working Group to
> examine the implications of this land grab. The working group concluded
> the patent thicket developing in the field would discourage investment
> in R&D, potentially delaying the development of a vaccine. It suggested
> the formation of a patent pool to steer round this road block.
>
> How to manage patent pools
>
> In the Report of the Commission on Intellectual Property Rights,
> Innovation and Public Health, published in 2006, WHO encouraged
> pharmaceutical companies to grant voluntary licences. But NGOs argue
> that such disparate, voluntary agreements will not give generics
> manufacturers the confidence they need to invest.
>
> KEI and others have proposed the creation of the Essential Medical
> Invention Licensing Agency, a non-profit entity, to manage patent pools.
> Patent owners would be asked to voluntarily license patents for use in
> countries not designated as high income by the World Bank. In cases
> where the pool failed to obtain voluntary licences, it might ask
> governments under the terms of the memorandum of understanding to seek
> compulsory licences.
>
> The agency would collect royalties from generic manufacturers and pay
> royalties to patent owners on a pre-determined transparent and
> predictable formula basis that takes into account the actual use of each
> patent in the manufacture of products by patent pool licensees.
>
> --
> Judit Rius Sanjuan
> Attorney
> judit.rius@keionline.org
>
> Knowledge Ecology International (KEI)
> www.keionline.org / www.cptech.org
> 1621 Connecticut Ave, NW, Suite 500 Washington, DC 20009 USA
> Tel.: +1.202.332.2670, Ext 18  Fax: +1.202.332.2673
>
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