On Wednesday, 4 October 2017, Knowledge Ecology International (KEI) delivered the following statement at the WIPO General Assembly during discussions on the Report of the Standing Committee on the Law of Patents (SCP).
WIPO General Assembly 2017 – Statement of KEI on the Report on the Standing Committee on the Law of Patents (SCP)
4 October 2017
Agenda item: 14. Report on the Standing Committee on the Law of Patents (SCP)
KEI welcomes the conclusions of SCP 26 which call on the Secretariat to “supplement the study on the constraints faced by developing countries and LDCs in making full use of patent flexibilities and their impacts on…access to essential medicines with inputs from members and observers of the SCP.”
We welcome the the Committee’s decision to invite the Medicines Patent Pool (MPP) to make a presentation on its Medicines Patents & Licenses Database (MedsPaL), and note in particular the value of the annotations to patents the MPP provides on such issues as licensing and patent oppositions.
Create pool for shared rights in publicly funded R&D
KEI proposes that WIPO establish an instrument that would create reciprocal rights in government funded inventions, so that the countries that were members of such an agreement would agreed to the terms and modalities under which they could share access to government funded inventions. Examples of drugs impacted by such an agreement include Zinbryta for MS, Xtandi for prostate cancer, expensive treatments like Spinraza for rare diseases, new CAR T treatments for cancer, or new vaccines for the Zika virus.
Flexibilities in Part 3 of the TRIPS Agreement
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.
In addition, the WIPO secretariat should undertake a study which would provide information about all of the 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.
Transparency
We also suggest that the Secretariat address issues relating to transparency as it relates to patent landscapes on biomedical inventions, including biologic drugs and vaccines, the litigation over patent validity and scope, the growing state practice of limiting the grant of injunctions when infringement occurs, and 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.