SCP29: General statement of Knowledge Ecology International

On Monday, 3 December 2018, Knowledge Ecology International (KEI) delivered this opening statement at WIPO’s 29th Session of the Standing Committee on the Law of Patents (SCP).

Thank you Chair.

KEI welcomes the conclusions of SCP 28 which call upon the International Bureau to prepare a draft reference document on compulsory licensing for SCP 30 in June 2019. For this reference document on compulsory licensing, we recommend that this study analyze 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.

In addition, 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 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.

We welcome the Committee’s decision convene a half-day conference on publicly available databases on patent information status and data on medicines and vaccines and a sharing session by practitioners of voluntary licensing at this session; we thank the delegations of Argentina, Brazil, Switzerland and Chile for their initiative as documented in SCP/28/10.

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.