[Ip-health] SCP28: KEI intervention on patents and health

Thiru Balasubramaniam thiru at keionline.org
Wed Jul 11 03:37:18 PDT 2018

SCP28: KEI intervention on patents and health
Posted on July 11, 2018 <https://www.keionline.org/28389> by Thiru

On 11 July 2018, Knowledge Ecology International delivered the following
statement on patents and health at the 28th session of WIPO’s Standing
Committee on the Law of Patents (SCP).

Statement of Knowledge Ecology International

Agenda item 7 – Patents and health

As this Committee deliberates on a work program on patents and health, it
may be worthwhile revisiting recent discussions at the World Health
Organization (WHO) on this topic.

At the Executive Board in January 2018, the Netherlands underscored that
“increased transparency on relevant data, such as innovation pipelines,
pricing, market power, and patents” was unconditional for achieving SDG
3.8, and noted that “countries like the Netherlands” were considering the
use of compulsory licensing to address the high prices of medicines.

At the World Health Assembly in May 2017, Portugal noted:

All regions of the world face, at different levels, insufficient access to
medical products. In recent times, the dramatic increase of prices of new
and innovative medicines made them unaffordable to large segments of the
population also in rich countries, while threatening the sustainability of
health care systems. In too many countries, prices of new medicines (to
treat Hepatitis C and cancer, for instance) are particularly shocking.

KEI underscores our strong support for the African Group’s timely proposal
contained in document SCP/24/4
<http://www.wipo.int/edocs/mdocs/scp/en/scp_24/scp_24_4.pdf> as a sound
basis for the Committee’s work on patents and health. We urge the SCP to
schedule a presentation by experts on the legal basis and experience of
states in permitting the non-voluntary use of patents on medical inventions
as a limitation on the remedies available in Part 3 of TRIPS, including
cases of running royalties for infringement of medical devices and
diagnostic tests, and the export of those products outside of the WTO 31bis

In relation to the paper submitted by Canada, Switzerland, Brazil, and
Argentina <http://www.wipo.int/edocs/mdocs/scp/en/scp_28/scp_28_9.pdf>, we
would suggest that the proposal be expanded to address issues on
transparency as they relate to the litigation over patent validity and
scope, the economic aspects of drug development and commercialization,
including the costs of R&D and the prices and revenues of products, as well
as the utilization and gaps in access for new drugs.

The need for greater transparency of R&D outlays is quite important for
several reasons. First, the only reason to grant a legal monopoly on a life
saving drug is to induce private investments in R&D. If we don’t have
reliable data on R&D outlays, including data on each clinical trial used to
support the registration of a novel drug, we cannot evaluate the efficacy
and efficiency of the patent monopoly as an incentive nor properly design
or evaluate alternatives to the monopoly, such as cash market entry
rewards, which can be implemented as alternatives to the monopoly, and are
consistent with greater and more fair access to medical innovations.

The terms of reference of Canada’s proposed work program on assessing the
role of compulsory and voluntary licensing mechanisms and patent pools in
facilitating the affordability and availability of medical products and
health technologies should provide information about all cases between 2005
to 2017 where non-voluntary use has been allowed as a limitation on
remedies, including, for example, recent limitations on remedies for
infringement of patents on medical diagnostic tests and medical devices in
the United States. KEI has compiled an extensive catalogue of state
practice on this, and would be happy to share this research with the
Committee. The study should also examine the use and impact of compulsory
licensing of medicines for HIV, cancer and heart disease in developing
countries between 2001 to 2017. For that purpose we draw attention to a
recent study of the use of TRIPS flexibilities published in the Bulletin of
the World Health Organization in March 2018.

KEI supports the disclosure of International Nonproprietary Names (INN) in
patent applications and / or patents. Such disclosure should be required
when a patent application relates to a product with a designated INN or as
soon as the INN has been designated by the WHO. The document SCP/28/5
prepared by the secretariat does not identify any significant obstacles for
this disclosure requirement. Disclosure of INN in patent applications and
patents will help increase transparency of patents related to medical
products and is consistent with the current drive towards greater
transparency with regard to patent status information as is evidenced by
this Committee’s interest in publicly available patent status databases
such as MEDSPAL (by the Medicines Patent Pool) and WIPO’s new partnership
with the pharmaceutical industry: the Patent Information Initiative for
Medicines (Pat-INFORMED).

In closing, KEI would like to draw the Committee’s attention to
negotiations at the UN in New York on political declarations for
tuberculosis (TB) and for non-communicable disease. It has come to our
attention that a certain Member State is hellbent on purging all references
to WTO TRIPS flexibilities and to the progressive delinkage of R&D costs
from the prices of medical technologies (which is essential to reducing
prices without undermining innovation). This is a sad state of affairs and
undermines commitments to multilateralism to the detriment of balanced IP
systems and the international trade architecture.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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