[Ip-health] WIPO Patent Committee to discuss critical issues on patents and public policy

K.M. Gopakumar kumargopakm at gmail.com
Mon Nov 3 03:12:23 PST 2014


*Contents:*

TWN Info Service on Intellectual Property Issues (Nov14/01)
3 November 2014
Third World Network
www.twn.my

_________________________________________________________________________________________

*WIPO Patent Committee to discuss critical issues on patents and public
policy*

Geneva, 3 November (TWN) – The Standing Committee on the Law of Patents
(SCP) is to discuss critical issues on patent and public policy including
exceptions and limitations, patent and health and technology transfer.

The 21st session of the SCP of the World Intellectual Property Organization
(WIPO) is taking place on 3-7 November, Geneva. It will also discuss issues
such as quality of patents and the confidentiality of communications
between clients and attorneys.

[The SCP was established in 1998 as a forum to discuss issues, facilitate
coordination and provide guidance concerning the progressive international
development of patent law including the harmonization of national laws and
procedures. However, the overt attempt to harmonise the patent law is on
backburner due to resistance form the developing countries.]

The work program of the SCP was adopted at the 20th session of SCP, which
was held on 27-31 January 2014. The 21st session is expected to discuss the
following issues along with new documents.

The discussion on *exceptions and limitations to patent rights* will focus
on the following documents: obtaining regulatory approval from authorities
(SCP/21/3); compulsory licensing and/or government use (SCP/21/4 and
SCP/21/5); exceptions and limitations relating to farmers’ and/or breeders’
use of patented inventions (SCP/21/6); and exhaustion of patent rights
(SCP/21/7).

These documents have been prepared without evaluating the effectiveness of
those exceptions and limitations. However, the documents cover practical
challenges encountered by Member States in implementing the abovementioned
exceptions and limitations.

A half-day seminar will be held on exceptions and limitations on 3 November
(3-6 pm). This seminar was proposed by Brazil at the 19th Session of the
SCP held on 25-28 February 2013 (SCP/19/6).

As per the agenda the Secretariat is to make a presentation on the
exceptions and limitations on the abovementioned topics. This will be
followed by a panel discussion on the “Effectiveness of exceptions and
limitations when addressing developing country concerns and how national
capacities affect the use of exceptions and limitations”. The panellist
are: Mr. Carsten Fink (Chief Economist, WIPO), Ms. Margaret K. Kyle,
(Professor, MINES ParisTech, France), Ms. Jayashree Watal (Counsellor,
Intellectual Property Division, World Trade Organization). The panel
discussion will be followed by a presentation of case studies on the use of
exceptions and limitations by Member States.

The discussions on *patents and health* will focus on three new documents.
First, the study on the role of patent systems in promoting innovative
medicines, and in fostering the technology transfer necessary to make
generic and patented medicines available in developing countries/least
developed countries (SCP/21/8). Secondly, the feasibility study on the
disclosure of International Nonproprietary Names (INNs) in patent
applications and/or patents (SCP/21/9). Thirdly, a document on the
potential of a study on the implementation of flexibilities concerning
different types of exhaustion of rights in Member States.

The deliberation on *technology transfer* will focus on an updated document
(SCP/21/10). This document is expected to incorporate further practical
examples and experiences on patent-related incentives and impediments to
transfer of technology from Member States and observers of the SCP, in
particular from least developed countries, taking into account the
dimension of absorptive capacity in technology transfer.

The *quality of patents* discussions are based on the existing documents
and an information sharing discussion among Member States regarding
experiences on international work sharing and collaboration. Developing
countries have reasonable apprehension about the proposals made by
developed countries on the quality of patents because many of these
proposals are covert attempts for the harmonisation of patent law.

The Secretariat is expected to produce two studies for the 22nd session of
the SCP. The first study focuses on a study on inventive step that contains
the following elements: the definition of the person skilled in the art,
methodologies employed for evaluating an inventive step and the level of
the inventive step. The second study focuses on sufficiency of disclosure
that contains the following elements: the enabling disclosure requirement,
support requirement and written description requirement. These studies are
supposed to be simply factual information without analysis or
recommendation.

[The developed countries’ proposals are in the following documents:
SCP/19/5 REV: Proposal of the Delegation of Spain and other Member States
of the European Union for the Improvement of Understanding of the
Requirement of Inventive Step; SCP/19/4: Proposal by the Delegation of the
United States of America regarding Efficiencies of the Patent System;
SCP/17/7: Proposal by the Delegation of Denmark; SCP/17/8: Revised Proposal
from the Delegations of Canada and the United Kingdom.]

The deliberation on *confidentiality of communication between client and
attorney* will be based on an existing document. However, there will be a
seminar on the confidentiality of advice from patent advisors scheduled for
3-6 pm on 5November.  It will begin with a presentation from the
Secretariat followed by two panel discussions.  The first panel will focus
on patent advisors’ perspectives from Mr. Steven Garland (Smart &
Biggar/Fetherstonhaugh, Canada), Mr. Pravin Anand (Anand and Anand, India),
Mr. Jeffery Lewis (Patterson Belknap Webb & Tyler, United States of
America), Mr. Wouter Pors (Bird & Bird, Netherlands). The second panel will
focus on clients’ perspectives from Mr. Hans B L๖chle (Head Global
Intellectual Property of the Schindler Group, Switzerland) Ms. Manisha A.
DESAI, Assistant General Patent Counsel, Eli Lilly and Company,
Indianapolis. The last session will focus on perspectives of Member States.

The apprehension about the confidentiality of communication between the
patent attorney and client has the potential to create legal protection to
prevent the full disclosure of the invention by preventing the discovery of
documents.

*Exceptions and Limitations*

The exceptions and limitation discussions were initiated at the SCP on the
basis of a proposal by Brazil at the 14th session of the SCP on 25-29
January 2010.  Brazil’s proposal contains the following three components:

“The first phase shall promote the exchange of detailed information on all
exceptions and limitations provisions in national or regional legislations,
as well as on the experience of implementation of such provisions,
including jurisprudence. The first phase shall also address why and how
countries use – or how they understand the possibility of using – the
limitations and exceptions provided in their legislations. The second phase
shall investigate what exceptions or limitations are effective to address
development concerns and what are the conditions for their implementation.
It is also important to evaluate how national capacities affect the use of
exceptions and limitations. The third phase shall consider the elaboration
of an exceptions and limitations manual, in a non-exhaustive manner, to
serve as a reference to WIPO Members”. (SCP 14/7.)

Brazil brought much more clarity on the second component of the original
proposal though a subsequent proposal submitted at the 19th session of the
SCP on 25-28 February 2013 (SCP/19/6). This subsequent proposal asked the
Secretariat “to take into account public policy objectives and society
needs as a whole, including, inter alia, development needs, public health
goals and competition”. Further “it should also consider the obstacles
Member States found when implementing such” exceptions and limitations.

The discussions on the exceptions and limitations on patents are mainly
expected to inform WIPO Member States, especially developing countries, to
use these exceptions and limitations (flexibilities) to achieve public
policy objectives in key areas like health, environment, food etc. Further,
these discussions are also expected to change the way WIPO looks at
exceptions and limitations and to enhance the capability of developing
country Member States to use the limitations and expectations. WIPO often
ignores the importance of the use of limitations and exceptions to patent
rights and instead stresses the need for patent protection. Often this is
coming out of a vested interest to serve the interests of patent owners and
also increase the organization’s revenue through the facilitation of filing
of patent applications under Patent Cooperation Treaty (PCT) at the cost of
public interests.

Developed countries maintain a double standard on the use of limitations
and exceptions; while developed countries use the limitations and
exceptions in their domestic law they discourage developing countries from
doing it. Some developed countries often exert political pressure as well
as unleash propaganda tactics using international media to prevent
developing countries from using limitations and exceptions such as
compulsory licenses in order to protect the commercial interest of their
industry.

*Patent and Health *

The work program on patent and health is the result of a joint proposal
from the Africa Group and the Development Agenda Group (DAG) at the 16th
session of the SCP on 16-20 May 2011 (SCP/16/7). The proposal has three
elements: (i) the elaboration of studies to be commissioned by the WIPO
Secretariat, following consultations with the Member States at the SCP,
from renowned independent experts; (ii) information exchange among Member
States and from leading experts in the field; and (iii) the provision of
technical assistance to Member States, and particularly developing
countries and least developed countries (LDCs), in relevant areas, and
building upon work undertaken in the first two elements of the work program.

On studies, the original proposal contains the following studies by leading
independent experts:

“(a) A component on the law and practices with regard to compulsory and
government use licenses in WIPO Member States. Such a study will also
provide as detailed information as possible, as to Member States that have
issued or that have attempted to issue compulsory and government use
licenses, the details of the license issued, the challenges faced as well
as the impact on public health. This should also include the provision of
empirical data on the royalty rates set in each case.

(b) An examination on the extent to which countries use exhaustion of
rights to allow parallel trade in medicine.

(c) An assessment of the benefits of mandatory disclosure of International
Non-Proprietary Names (INNs) in the abstract or title of patent
applications. This would enable an easier identification of the generic
name of the medical product subject of the patent application.

(d) Conduct a cost-benefit analysis of the admissibility of Markush claims
(broad patent claims that may apply to a broad range of compounds). It
could be worthwhile to analyze whether such claims based merely on
theoretical inference can be considered to satisfy the criteria for
patentability.”

Due to opposition from developed countries, mainly from the Group B
countries, there was no progress in this proposal. It was only at the 20th
session of the SCP that agreement was reached to prepare two studies under
this program. First is a study the feasibility study on the disclosure of
INNs in patent applications and/or patents (SCP/21/9). Second is a document
on the potential of a study on the implementation of flexibilities
concerning different types of exhaustion of rights in Member States. The
study on “the Role of Patent Systems in Promoting Innovative Medicines, and
in

Fostering the Technology Transfer necessary to Make Generic and Patented
Medicines available in Developing Countries and Least Developed Countries”
is carried out at the request of the USA.

Unlike the original proposal these studies are carried out by the
Secretariat.  Further, no agreement was reached to start the work program
on element two and three under the joint proposal. Element two on
information contains a proposal to invite the UN Special Rapporteur on the
Right to Health, to present his report to the Human Rights Council on
Intellectual Property Rights and Access to Medicinesthe. The third element
on technical assistance contains a proposal: “Flowing from the outcomes of
the studies and information exchange as contained in elements I and II
above, the WIPO Secretariat, in consultation with Member States, should
develop targeted technical assistance programs”.

The developed countries that are part of Group B are systematically
blocking the adoption of the working program contained in the joint
proposal.

*Transfer of Technology *

The technology transfer document for the discussion at the current SCP
session is an updated version of a paper prepared by the Secretariat and
submitted at the 14th session of the SCP as per the decision of the 13th
session. This document was revised and resubmitted at the 17th session.
Again, the 20th session instructed the Secretariat to prepare a document to
collect further practical examples and experiences on patent -related
incentives and impediments to the transfer of technology from Member States
and observers of the SCP, in particular, from least developed countries,
taking into account the dimension of absorptive capacity in technology
transfer.

The main issue with regard to the Secretariat study is their reluctance in
recognising barriers created by patents to facilitate technology transfer
on fair and equitable terms. Generally speaking, the Secretariat in the
past has taken a view that a patent itself facilitates the technology
transfer and exceptions and limitations in the patent system are enough to
facilitate technology transfer. Further, WIPO does not carry out any
technical assistance for developing countries to navigate the barriers
created by patents so as to facilitate the technology catching up process
in those countries.

In contrast, the United Nations Committee on Development Policy (CDP)
recognised the negative aspect of patents on technology transfer in its
2013 submission to the Economic and Social Council (ECOSOC) on the role of
science, technology and innovation whichstated: “… there have been revived
concerns about the negative effects of the current IP system and
recognition that the IP system needs to evolve to foster dissemination of
technology, including by allowing countries to have room to tailor their
own national IP system to their specific development needs. In this regard,
patent based regimes are not necessarily compatible with the technological
development stage of many developing countries and may deter innovation in
these countries” (http://www.un.org/en/ecosoc/newfunct/pdf13/sti_cdp.pdf).

A background paper by the CDP titled  “Science, Technology and Innovation
for Sustainable Development” also spells out the negative impact of
intellectual property protection on technology transfer.(
http://www.un.org/en/development/desa/policy/cdp/cdp_background_papers/bp2013_16.pdf
)

According to this background paper, “intellectual property rights are now
ruled by the TRIPS agreement and also increasingly by regional and
bilateral free trade agreements (FTAs), which may restrict the range of
policy options available for developing countries. These patent-based
regimes are not necessarily compatible with the technological development
stage of many developing countries and may deter innovation in these
countries.”

The approach of the Secretariat to transfer of technology clearly
contradicts the agreement between the UN and WIPO, which recognises WIPO as
a specialised agency of the UN. Article 1 of the agreement states: “The
United Nations recognizes the World Intellectual Property Organization
(hereinafter called the " Organization ") as a specialized agency and as
being responsible for taking appropriate action in accordance with its
basic instrument, treaties and agreements administered by it, *inter alia,*
for promoting creative intellectual activity and for facilitating the
transfer of technology related to industrial property to the developing
countries in order to accelerate economic, social and cultural development,
subject to the competence and responsibilities of the United Nations and
its organs, particularly the United Nations Conference on Trade and
Development, the United Nations Development Programme and the United
Nations Industrial Development Organization, as well as of the United
Nations Educational, Scientific and Cultural Organization and of other
agencies within the United Nations system.”

As a result of external submissions, the new document on technology
transfer for the current SCP session (SCP/21/10) includes references of
studies which recognise the barrier created by patents to facilitate
technology transfer (
http://www.wipo.int/edocs/mdocs/scp/en/scp_21/scp_21_10.pdf).

Technology transfer and intellectual property especially patents will be
discussed again at the Committee on Development and Intellectual Property
(CDIP), in its 14th session next week.

The uphill task before developing country Member States is to reorient the
WIPO Secretariat to recognise patent barriers on technology transfer and to
assist developing countries to successfully negotiate such barriers.+




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