[A2k] WIPO General Assembly 2014: KEI Statement on the Standing Committee on the Law of Patents

Thiru Balasubramaniam thiru at keionline.org
Thu Sep 25 08:12:48 PDT 2014

WIPO General Assembly 2014: KEI Statement on the Standing Committee on the
Law of Patents

On Thursday, 25 September 2014, Knowledge Ecology International (KEI)
delivered this statement on agenda item 17(i), Reports on other WIPO
Committees, (i) Standing on the Law of Patents (SCP).

WIPO General Assembly 2014

17. Reports on other WIPO Committees
(i) Standing Committee on the Law of Patents (SCP);

Statement of Knowledge Ecology International

The 2001 WTO Doha Declaration on TRIPS and Public Health says patent laws
“can and should be interpreted and implemented in a manner supportive of
WTO members' right to protect public health and, in particular, to promote
access to medicines for all.”

The work of the SCP should help countries find a way to achieve this goal,
one that was reached by consensus among all members of the WTO.

KEI is among those exploring models for delinking R&D costs from drug
prices. In order to do this, laws on patents and other intellectual
property rights need to accommodate new business models for funding
innovation, including those that feature innovation inducement prizes
rather than drug monopolies as the reward for successful innovation, or
measures such as patent buy-outs.

The US Senate and the US National Academies have proposed a study of full
delinkage, as an alternative to drug monopolies. This month, the US White
House issued a statement asking to explore delinkage in the context of
antibiotic drug development, an approach endorsed by some of the leading
European R&D focused drug companies. The World Health Organization is also
experimenting with delinkage drug development models, for a wide range of
diseases for which market failures exist.

KEI suggests the SCP undertake a review or ask for a study of the
provisions in national patent laws that would enable full delinkage of drug
prices and R&D costs.

KEI also notes that some proposals in regional or bilateral trade
agreements may present significant barriers to the introduction of full
delinkage drug development models.

*ANNEX, not read*

In the field of antibiotic resistance, the White House has shown leadership
and highlighted de-linkage as feasible option for attracting innovation
into developing new antibiotics (in its Report to the President on
Combating Antibiotic Resistance). The report noted,

Under such schemes, a successful developer of an antibiotic that addresses
an important public health need would receive a financial reward that is
not directly tied to the usage of the drug. A variety of incentive models
have been proposed, including user licenses, lump sum prizes, patent
buy-outs, and payments to hold drugs in strategic reserve These models
would provide reduced risk to potential developers (the economic reward is
defined), reduced risk to users (their cost is contained), and would allow
the resulting antibiotics to be managed as a strategic resource so as to
preserve their effectiveness for critical uses. In addition, these models
would not create incentive for a drug maker to increase sales of the
antibiotic in order to make more money.

The White House also announced the launch of a $20 million prize by the US
National Institutes of Health and Biomedical Advanced Research and
Development Authority to facilitate the development of of a rapid, point of
care diagnostic test to identify highly resistant bacterial infections.

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