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