Third Party Observations at WIPO

Since July 2012, there is a Third-Party Observation (TPO) procedure under the Patent Cooperation Treaty (PCT) administered by the World Intellectual Property Organization (WIPO). This permits third parties to submit to the International Bureau of WIPO observations referring to prior art which they believe may be relevant to the question of whether the invention claimed in an international patent application is novel and/or involves an inventive step.[1]

Before this, observations or oppositions on patent applications could be filed by third parties only when the patent application entered a national or regional patent system. Setting up of the TPO system under WIPO’s PCT system was an important step forward towards improving the quality of patents granted across the world. The TPOs are accessible to national authorities in addition to the International Search Report (ISR) on the PATENTSCOPE database. This is important as most patent applications are now filed through the PCT system.

In October 2018, Third World Network initiated a project to determine if the PCT’s TPO system could assist in providing access to additional prior art documents for over-burdened patent offices in developing countries, that tend to be over-reliant on the PCT’s search and preliminary examination services. The objectives of the TPO Project are threefold:

• To ensure that access to affordable medicines is not compromised by unwarranted patent barriers;
• To use the PCT’s TPO system to provide key prior art documents through the international system; and
• To document the challenges and experience of using the TPO system to determine if it can help in deciding appropriately on the patentability of a claimed invention and/or prevent evergreening.

The TPO Project runs across several years, and began with the filing of TPOs concerning PCT international patent applications related to pharmaceutical compounds/drugs that may be used for the treatment of human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection and tuberculosis (TB). The scope was subsequently expanded to include COVID-19 PCT applications.

Every week WIPO publishes about 1,000 to 1,500 patent applications related to pharmaceutical products. From the numerous applications filed using the PCT system, relevant ones were screened and identified for the purpose of filing TPOs under the Project, which screened PCT applications beginning from May 2018. A pilot TPO was filed in December 2018. Thereafter, over the course of 4 years, around 200 TPOs have been filed under the Project and accepted by the WIPO International Bureau.

The applicants in at least two applications for which a TPO was filed have responded to the TPO submitted. Their responses are also available to the national and regional patent offices on PATENTSCOPE. For some applications that have reached the national phase in Europe, the TPOs have been taken note of by the European Patent Office, which asked the patent applicant to respond to the prior art and arguments in the TPO. The Project’s first year’s experience in using the TPO procedure has been documented and published by TWN: Report: Third Party Observations of International Patent Cooperation Treaty Applications Relating to Pharmaceutical Products

Summaries of TPOs submitted to WIPO under the Project are herein listed. These summaries will provide an insight into PCT applications that are of public health importance in the area of HIV, TB, HCV and COVID-19. The brief summaries provide links to the relevant PCT application on PATENSCOPE. This site also contains tabs on “National Phase” with information on national phase entries and another tab on “Documents” that contain documents relevant to the PCT application, including search- and examination-related documents and the TPO that has been submitted under this Project with respect to the PCT application. The summaries and TPOs filed could greatly accelerate efforts to file oppositions and observations at the national level, and support patent offices in examining the patent applications.

Under the PCT rules, information on patent applications is transmitted to patent offices only if they have specifically requested for it.[2] However, it appears that most patent offices have not requested for this information.[3] Civil society groups should consider methods of bringing the TPOs to the attention of their national or regional patent offices and monitor whether their patent office take note of and use the TPO documents. In particular, civil society should reach out to their patent office ensuring that the patent office requests for the TPOs and considers them in the national or regional examination process.

Summaries of TPOs submitted under the Project

• TPOs filed between December 2018 and April 2020
• TPOs filed between May 2020 and December 2020
• TPOs filed between January 2021 and December 2021
• TPOs filed between January 2022 and December 2022

Acknowledgement: Third World Network gratefully acknowledges the effort of the Courtyard Attorneys team in filing Third Party Observations under the Patent Cooperation Treaty System and appreciates the financial support of Unitaid for this initiative. Any opinions, findings, conclusions or recommendations expressed herein do not necessarily reflect the view of Unitaid.