[Ip-health] KEI's comments on the Biden administration's first Special 301 list

James Love james.love at keionline.org
Thu Feb 11 05:11:43 PST 2021

These were the comments that KEI filed in the USTR request for comments on
the Special 301 list.  The list, typically published around April 30, will
be an important indication of trade policy on IP and trade, for the Biden

Unlike previous years, there will be no hearing this year, only the
submitted public comments and the non-transparent  intense lobbying by
companies and others, making it difficult to respond to the specific asks
by the rights holders.

2021 Special 301 Review

Comments of Knowledge Ecology International (KEI)

To: Daniel Lee, Assistant U.S. Trade Representative for Innovation and
Intellectual Property (Acting), Office of the United States Trade

Date: January 28, 2021

KEI is a frequent commenter on the USTR Special 301 review.  Our comments
will address an issue concerning the procedures, as well as the policies
the USTR is seeking to advance.

1. Allow the public to respond to industry requests for trade pressures

The Special 301 submissions are primarily from rights holders and their
representatives, and contain assertions of facts and U.S. self interest.
Until we see what the industry is asking of the USTR, we can only speculate
on what misleading or erroneous data or bad policy proposals that may be

The hearings have provided some opportunities to respond to the initial
industry subjections, and there will be none this year.

We are among those who want the USTR to provide a more formal way to
respond in writing to the initial industry comments.  USTR can issue
another FR notice, or extend the comment period so that we can respond to
comments not yet filed by industry.

2. Objectives of the Special 301 review should be re-evaluated to reflect
changes over time.

Over time, the Special 301 review can benefit from periodic modifications
of context, process and objectives to reflect changing circumstances and
learning from past experiences.

Since the Special 301 list was first published in 1989, the world has

In 1995, the WTO and the TRIPS Agreement came into force, creating a set of
global rules for the minimum protection of intellectual property rights, as
well as a system of resolving disputes over those rules.

In 1996 WIPO adopted two new treaties, the WIPO Copyright Treaty (WCT) and
the WIPO Performances and Phonograms Treaty (WPPT). Today there are 107
contracting parties of the WPPT and 108 members of the WCT.  The WIPO
Beijing Treaty on Audiovisual Performances was adopted in 2012, and
currently has 38 contracting parties.

Countless bilateral and regional trade agreements that have chapters on
intellectual property have been signed, including not only those with the
United States as a partner, but those with members that have a strong
preference for high standards for intellectual property protection, such as
the European Union, Switzerland, Japan and Australia.

There have also been a series of agreements that seek to create protections
for the public. In 1999 the World Health Organization adopted the first of
several agreements that provided more consideration of health. WHA52.19,
The WHO Revised drug strategy, states that “there are trade issues which
require a public health perspective,” and urged WHO Member States “to
ensure that public health interests are paramount in pharmaceutical and
health policies.”  The United States, under President Bill Clinton,
supported this language.

In 2000, President Clinton issued Executive Order 13155—Access to HIV/AIDS
Pharmaceuticals and MedicalTechnologies, which stated:

Section 1. Policy. (a) In administering sections 301–310 of the Trade Act
of 1974, the United States shall not seek, through negotiation or
otherwise, the revocation or revision of any intellectual property law or
policy of a beneficiary sub-Saharan African country, as determined by the
President, that regulates HIV/AIDS pharmaceuticals or medical technologies
if the law or policy of the country:

(1) promotes access to HIV/AIDS pharmaceuticals or medical technologies for
affected populations in that country; and

(2) provides adequate and effective intellectual property protection
consistent with the Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS Agreement) referred to in section 101(d)(15) of the
Uruguay Round Agreements Act (19 U.S.C. 3511(d)(15)).

In 2001, the World Trade Organization (WTO) adopted the Doha Declaration on
the TRIPS agreement and public health, WT/MIN(01)/DEC/2, which stated “We
agree that the TRIPS Agreement does not and should not prevent Members from
taking measures to protect public health.  Accordingly, while reiterating
our commitment to the TRIPS Agreement, we affirm that the Agreement can and
should be interpreted and implemented in a manner supportive of WTO
Members' right to protect public health and, in particular, to promote
access to medicines for all.”

In May 2007, USTR reached a bipartisan consensus on trade with members of
Congress of trade that include a number of walk-backs in free trade
agreements on matters concerning access to medicine.

Also in 2007, the World Intellectual Property Organization (WIPO) adopted a
development agenda, the sought to create balance, and promote access to

In 2013, the WIPO Marrakesh Treaty to Facilitate Access to Published Works
for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled
was adopted, and today has 78 contracting parties.  The treaty mandates a
minimum set of exceptions to rights, to facilitate access.

The United States and the world have also seen dramatic changes in
information and medical technologies and business models.

Among our more dominant industries globally are digital services such as
Internet search engines or platforms for publishing and sharing user
generated content, services that cannot function without sufficient
flexibility and exceptions to rights in copyright laws. Attempts in Europe
to create rights in snippets of text and information from news articles
create conflicts with the mandatory exceptions in Articles 2(8) and 10(1)
of the Berne.

Following a stream of mergers, a growing number of scientific journals and
textbooks were owned by non-US companies, and today many disputes over
education exceptions pit US educators and graduate students against foreign
owned publishers.

Patent thickets became a growing problem for manufacturers and software
publishers.  In 2006, the U.S. Supreme Court issued an opinion in eBay Inc.
v. MercExchange, L.L.C. that effectively allowed every patent infringement
case to consider a compulsory license as an alternative to an injunction.
Beginning in 2011, China emerged as the country with the largest number of
patent applications.  In 2013, USTR overrode a USITC exclusion order and
cease and desist order for Apple Inc. smartphones and tablet computers that
infringed a U.S. patent owned by Samsung Electronics.

The current COVID-19 pandemic presents the entire world with many
challenges including those relating to intellectual property.  During
periods when schools and libraries are closed, having access to controlled
digital lending over the Internet is essential.  There is a massive need to
scale the manufacturing of diagnostic tests, therapeutics and vaccines, and
this includes the need for access to rights in inventions, designs and
data, as well as access to manufacturing know-how.

Today the costs of new medical technologies, including diagnostic tests,
drugs, vaccines, and cell and gene therapies, have become a significant
barrier to access and affordability, and the cause of shameful disparities
of access globally.

The United States is the largest government funder of biomedical research.
It is in the interest of the United States for other countries to increase
public sector outlays on and subsidies for biomedical research.  The United
States should end its efforts to raise prices for medical technologies in
foreign countries, and instead, see a trade framework that encourages
rather than discourages state biomedical R&D subsidies, as well as global
agreements to share access to government funded research across borders,
either as a global public good, or in some cases, between countries that
are will share share rights with the United States.

The USTR should not advance norms or discourage practices that are
important for reforms that delink biomedical R&D incentives from prices or
exclusive rights in products or services.

USTR should not prevent any country from creating patent exceptions for
gene and cell therapies that are the types of exceptions allowed under
Article 27(3)(a) of the TRIPS agreement or the provisions for limiting
remedies to infringement found in 35 USC § 287.

USTR should not enter into, maintain or enforce any bilateral, regional,
plurilateral or multilateral agreements on damages for infringement that
exceed the standards set out in the TRIPS agreement.  Flexibility in the
implementation of Article 44 of the TRIPS agreement is necessary to address
the Orphan Works problem in the United States and to create liability rules
for cases where exclusive rights are harmful but remuneration to inventors
or authors is in the public interest.

The United States should cease its intervention in South African
negotiations over copyright reform, and end all opposition to compulsory
licenses for patented inventions that satisfy the WTO TRIPS requirements.

James Love
Knowledge Ecology International (KEI)
james.love at keionline.org

James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org <http://www.keionline.org/donate.html>

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