Info Service on Health Issues (Jun18/06)
Geneva, 15 June (TWN) – A proposal to amend a treaty regulation at the World Intellectual Property Organization (WIPO) will compromise TRIPS flexibilities, especially in relation to the scope of patentability for national patent offices.
The International Bureau (i.e. WIPO Secretariat) that is responsible for administering the Patent Cooperation Treaty (PCT) has proposed to introduce a new Rule 50bis in the PCT Regulations “which would expressly allow a Contracting State to delegate its designated Office functions to the national Office of any other Contracting State or to any intergovernmental organization”. Further, it proposes to amend Rule 76 to align with the proposed Rule 50bis.
The PCT Regulations contain the detailed rules to implement the provisions of the Treaty.
According to the WIPO document PCT/WG/11/7 the intent of the proposal is to allow PCT Contracting Parties, which are not Member States of a regional patent treaty, to effectively “close the national route” by delegating to an Office of another Contracting State or an intergovernmental organization. With this proposal, the WIPO document adds “patent protection for the delegating States would only be available ‘via’ the Office or intergovernmental organization to which the designated and elected Office function had been delegated, once a patent had been granted by that Office or intergovernmental organization” and that “the effects of that granted patent would be extended to the “delegating” Contracting State on the basis of a bilateral agreement between that State and the Contracting State of the Office or the intergovernmental organization to which the designated and elected Office functions had been delegated”.
Once the patent office functions have been delegated, the delegated patent office would “assume all rights and obligations in respect of the “delegating” Contracting States” and “would perform all delegated functions in accordance with the PCT”.
This proposal will be considered at the 11th Session of the PCT Working Group, which will take place next week from 18 to 22 June at the WIPO headquarters in Geneva (see http://www.wipo.int/edocs/mdocs/pct/en/pct_wg_11/pct_wg_11_7.pdf).
[The PCT facilitates applicants in seeking patent protection internationally; by filing one patent application under the PCT, applicants can simultaneously seek protection for an invention in a large number of countries from among the 152 countries that are members of the PCT instead of filing several separate national or regional patent applications. WIPO among others conducts a search on published patent documents and technical literature and provides an opinion on the patentability of the subject matter of the application that is published in the WIPO PCT system. The final decision to grant a patent lies with the national or regional patent offices that conducts a substantive examination of the application in accordance with the patentability criteria prescribed under the national patent law concerned. This national phase normally starts after 30 months from the date of filing of the PCT application.]
Under the current Regulations delegation is only permitted for a State if the State is also a party to a regional patent treaty and in such a case, the regional Office acts as the patent office for that State. The proposed new rule allows delegation by any PCT Contracting State to any another national patent office or to any intergovernmental organization.
This proposal in effect means that a national patent office of a PCT Contracting Party can delegate its patent examination function to any other national patent office or any intergovernmental organization. The immediate implication of such delegation is that the examination of the patent application will be determined by the patentability criteria and practices of the delegated offices. The risk is the further erosion of the use of TRIPS flexibilities including with regard to patentability standards by developing countries. .
Article 27 of the Trade-related Intellectual Property Rights (TRIPS) Agreement administered by the World Trade Organization (WTO) requires patents for inventions that “new, involve an inventive step and are capable of industrial application” but leaves it to national patent law to define these criteria. This flexibility is the right of WTO Member States as it allows for the exclusion of patents for discoveries or known pharmaceutical substances.
Experts in the field have advised developing countries to apply rigorous patentability standards to exclude patents on, among others, naturally occurring microorganisms, genes, plants, seeds, new uses and forms of existing pharmaceutical substances. The application of rigorous patentability standards is especially important in the pharmaceutical sector to prevent the grant of low-quality patents that erect barriers to entry of generic competition and access to affordable medicines. Pharmaceutical companies are known for abusing the patent system by filing multiple patent applications for new uses and forms of existing medicines with the aim to extend the patent monopoly over the pharmaceutical products, a practice commonly known as “patent evergreening”.
In this context, the September 2016 report of the UN Secretary-General’s High Level Panel on Access to Medicines has also specifically recommended that WIPO should strengthen the capacity of patent examiners at both national and regional levels to apply rigorous public health-sensitive patentability criteria.
However the WIPO Secretariat’s proposal does the exact opposite in that it is promoting reliance on foreign patent offices, which in turn weakens national patent examination capacities. This move is unsurprising given that WIPO’s primary source of revenue (about 70%) is from patent applicants fees for use of the PCT system. It also has a long history of engaging in activities that erodes the national policy space in the area of patents with significant consequences for development and public policy.
The Secretariat’s proposal may also undermine the application of other TRIPS flexibilities in the examination process, for example disclosure of origin in patent applications to prevent misappropriation of genetic resources often championed by developing countries, as once patent examination is delegated, the law and practices of the delegated offices will apply.
Since the adoption of the TRIPS Agreement, developed countries have used various strategies such as free trade agreements, bilateral pressure, technical assistance programmes including training of patent offices to undermine the flexibilities in the Agreement. WIPO is often used by developed countries as a forum to erode and weaken the use of these flexibilities. In 2000 the WIPO Patent Agenda was launched with negotiations initiated on a substantive patent law treaty (SPLT), which aimed at harmonizing the substantive aspects of patent law, adversely impacting policy space for developing countries. This initiative was abandoned in 2006 following opposition from the developing countries.
Again in 2009, the WIPO Secretariat proposed to reform the PCT system by proposing that the grant of patents in three PCT member states should be considered as a grant of the patent in other PCT countries after the expiry of 6 months. This did not get the support of the WIPO membership.
Further, there are proposals from the developed countries in the Standing Committee of Patents (SCP) to fast-track patent examination under the Patent Prosecution Highway (PPH). The PPH fast track examination of a patent application can be requested based on the grant of a patent in a participating patent office of PPH.
Developed countries also undermine flexibility with regard to the scope of patentability through technical assistance provided to developing country patent offices, sometimes undertaken in collaboration with WIPO. Professor Peter Drahos in his paper "Trust me: Patent offices in developing countries”notes this development and observes: “Through their technical assistance programmes they have integrated developing country patent offices into an emerging global system of patent administration. The purpose of this global system is productive efficiency. It is to maximize the output of patents at minimum cost. All other things being equal, the patent offices of developing countries will end up granting more and more Pharmaceutical Patents. This will complicate access to medicines for citizens of developing countries. Developing country governments have to take a much more critical approach to the operation of their patent offices". [The paper is available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1028676]
The text of the proposed new PCT Regulations rule is as follows:
50bis .1 Delegation of Designated Office Functions
(a) Any Contracting State may agree with another Contracting State or any intergovernmental organization that the national Office of the latter State or the intergovernmental organization shall, for all or some purposes, act instead of the national Office of the former State as designated Office in respect of international applications in which the former State has been designated.
(b) Any agreement referred to in paragraph (a) shall promptly be notified to the International Bureau by the Contracting State which delegates the functions of designated Office to the national Office of another Contracting State or an Intergovernmental Organization. The International Bureau shall promptly publish any such notification in the Gazette.