[Ip-health] SCP 30: General statement of Knowledge Ecology International

Thiru Balasubramaniam thiru at keionline.org
Mon Jun 24 12:06:03 PDT 2019


https://www.keionline.org/31065

SCP 30: General statement of Knowledge Ecology International
Posted on June 24, 2019 <https://www.keionline.org/31065> by Thiru
<https://www.keionline.org/author/thiru>


On Monday, 24 June 2019, Knowledge Ecology International (KEI) delivered
this opening statement at WIPO’s 30th Session of the Standing Committee on
the Law of Patents (SCP). The Committee elected a new chair, Sarah
Whitehead, United Kingdom of Great Britain and Northern Ireland.

WIPO’s patent committee will discuss patents and health, exceptions and
limitations to patent rights, quality of patents including opposition
systems, confidentiality of communications between and their patent
advisors, and transfer of technology. Under patents and health, the WIPO
Secretariat published a draft reference document on compulsory licensing
(SCP/30/3)
<https://www.wipo.int/edocs/mdocs/scp/en/scp_30/scp_30_3-main1.pdf>. One
critique that KEI provided on this study was in relation to non-voluntary
use as a limitation on remedies.

However, we would note one shortcoming in WIPO’s draft reference document
on compulsory licensing – namely the absence of analysis of situations
where non-voluntary use was permitted as a limitation on remedies. We
recommend that WIPO’s study be revised to examine cases 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.

For SCP 30, the WIPO Secretariat will convene two sharing sessions: 1)
sharing of experiences on capacity building activities relating to
negotiating licensing agreements and 2) a sharing session on approaches
used by delegations to ensure the quality of the patent grant process
within IP offices, including opposition systems (with special attention to
the capacity building of patent examiners and offices).
------------------------------

24 June 2019
WIPO Standing Committee on the Law of Patents (SCP) – 30th session
General statement – Knowledge Ecology International

Thank you Chair. We welcome the Secretariat’s publication of the draft
reference document (SCP/30/3) on compulsory licensing.

The Secretariat paper endeavors to provide an overview of compulsory
licensing within the context of the international legal architecture while
furnishing state practice on compulsory licensing including challenges
faced by WIPO member states in the implementation of compulsory licensing.
However, we would note one shortcoming in WIPO’s draft reference document
on compulsory licensing – namely the absence of analysis of situations
where non-voluntary use was permitted as a limitation on remedies. We
recommend that WIPO’s study be revised to examine cases 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.

We request the Committee, at its 31st session in December 2019, to convene
an expert workshop to address the 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 the TRIPS, including specifically cases of
running royalties for infringement of medical devices and diagnostic tests,
and the export of those products outside of the WTO 31bis framework.

As part of the Committee’s ongoing work on patents and health, KEI proposes
that the SCP investigate the extent to which patent exceptions for the
treatment of humans apply to new cell and gene therapies, such as CAR T
treatments for cancer. We recommend that the Committee convene an expert
workshop on the patenting of cell and gene therapies.

In May 2019, the World Health Assembly (WHA) passed resolution the
transparency resolution, WHA72.8. Operative paragraph 2.6 of the resolution
requested WHO’s Director-General to “continue supporting existing efforts
to determine the patent status of health products and promote publicly
available user-friendly patent status information databases for public
health actors.”

As part of WIPO’s trilateral cooperation obligations, we request that the
SCP discuss the implementation of WHO transparency resolution, including
the following issues.

   1.

   What can be done to address the lack of transparency for patent
   landscapes relating to biologic drugs and new cell and gene therapies?
   2. What should be done to have better information sharing over the
   litigation over patent validity and scope?
   3. Should a UN agency rely upon the IFPMA to manage this project, given
   conflicts of interest?



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


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