[Ip-health] Letter from BIO to USTR on Special 301
Thiru Balasubramaniam
thiru@keionline.org
Fri Feb 15 15:42:05 2008
--
[ Picked text/plain from multipart/alternative ]
Bio
BIOTECHNOLOGY
INDUSTRY ORGANIZATION
February 11, 2008
By electronic mail and fax
Jennifer Choe Groves, Director for Intellectual Property and
Innovation and Chair of the
Special 301 Committee
Office of the United States Trade Representative
Washington, D.C.
FR0606@ustr.eop.gov
Fax: 202-395-9458
Re: Special 301: Identification of Countries Under Section 182 of
the Trade Act of 1974:
Request for Public Comment, 73 Fed. Reg. 2958 (January 16, 2008)
Dear Ms. Groves:
The Biotechnology Industry Organization (BIO) is submitting this
letter in response to
the request by the United States Trade Representative (USTR) for
comments involving the
=93Special 301=94 provisions of the Trade Act of 1974. BIO is very
pleased to have the opportunity
to submit these comments, and respectfully requests that USTR consider
the following remarks.
BIO represents more than 1,100 biotechnology companies, academic
institutions, state
biotechnology centers and related organizations in the United States
and 31 other nations. BIO
Members are involved in the research and development of healthcare,
agricultural, industrial and
environmental biotechnology products and services.
Intellectual property rights are the foundation of the biotechnology
industry. BIO
Members depend on obtaining patents and related rights in a timely and
predictable manner, and
the ability to enforce those patents is critical. Biotechnology is
also a uniquely global enterprise.
If a country=92s patent system or the political structure for enforcing
patent rights is ineffective, a
competitor can use an invention with impunity, depriving the patent
owner of the economic
value of the invention. BIO Members have a particular interest in
encouraging uniform and
robust intellectual property protection in all countries and regions
of the world.
As a general matter, BIO notes with concern recent trends in a
number of countries that
undermine the intellectual property protection essential to provide an
enabling environment for
innovative biotech companies. This includes the persistence of
exceptions for transgenic plants
and animals in the patent laws of a number of countries that deprive
important inventions of
adequate protections. In addition, we note with concern ongoing
efforts in a number of
countries, including members of the European Union, to unduly broaden
research and breeder=92s
exemptions in a manner that would undermine effective intellectual
property protection for plant-
related inventions.
We focus our comments this year on a limited number of countries
that are of particular
concern.
Priority Foreign Country. In light of continued egregious and onerous
policies relating to
compulsory licensing of patents that systematically deny adequate and
effective intellectual
property protection, and the lack of any significant progress in
addressing these policies, BIO
urges USTR to designate Thailand as a Priority Foreign Country.
Priority Watch List. BIO requests that USTR place Brazil and the
Philippines on the Priority
Watch List. BIO also requests that Argentina, Chile, China, Egypt,
India, Israel, and Ukraine
maintain their current status on the Priority Watch List.
Watch List. BIO requests that USTR place Switzerland on the Watch
List, and that Colombia,
Mexico and Saudi Arabia maintain their current status on the Watch List.
PRIORITY FOREIGN COUNTRY
Thailand
In light of continued egregious and onerous policies relating to
compulsory licensing of
patents, and the lack of any significant progress in addressing these
policies, BIO urges USTR to
designate Thailand as a Priority Foreign Country.
Throughout 2007, the Thai Government continued its support of
compulsory licensing of
patented pharmaceutical products as part of its trade policy. Last
year=92s widely publicized
compulsory licenses for SUSTIVA (efavirenz), KALETRA (lopinavir/
retonavir) and PLAVIX
(clopidogrel) continue to be a cause for alarm for BIO Members. Of
even greater concern, just
recently, the government has announced its intention to move ahead
with at least three more
compulsory licenses on FEMARA (letrozole), TAXOTERE (docetaxel) and
TARCEVA
(erlotinib), which are patented drugs used for the treatment of types
of cancer. These actions
illustrate an unabated disregard for intellectual property rights that
are critical for the
development of new medicines and constitute an egregious and onerous
policy that denies
adequate and effective protection of intellectual property rights.
BIO remains concerned that these licenses go well beyond the letter
and spirit of the
Doha Declaration provisions relating to health emergencies. As noted
in our previous comments
to USTR, Thailand=92s policy appears to be driven in significant part by
its own budget constraints.
In particular, the Government=92s issuance of compulsory licenses for
drugs that treat non-
communicable diseases, such as cancer and stroke or myocardial
infarction, is particularly
alarming. The medical management of such non-communicable diseases
may be complex and
costly, but it does not rise to the level of a public health
emergency. The Doha Declaration
provides a mechanism for governments to deal with acute crises. It
was not meant as an
expedient to facilitate budgetary planning.
We note that the Thai Government has been more active in
communications with the
relevant intellectual property owners, and that this is a positive
development. We also continue
to appreciate that diseases that can be treated with drugs such as
these affect a great many people
and are matters of national concern for many governments. At the same
time, the decision to
maintain policies relying on compulsory licenses continues to raise
questions about ability to
obtain protection of intellectual property that is important to BIO
Members. BIO continues to
believe that the most effective global solutions will result from
policies that respect and
encourage innovation. The actions of the Thai government are in
direct contravention of these
goals.
The continued actions of the Government of Thailand seriously
undermine the
confidence of managers and investors in the ability of BIO Member
companies to obtain and rely
on patent rights in that country. The inevitable result of that
approach to compulsory licensing is
to provide a powerful disincentive to our Members to invest and do
business in Thailand.
We strongly urge USTR to designate Thailand as a Priority Foreign
Country. Thailand=92s
continued pursuit of compulsory licensing as part of its trade
policies denies U.S. industry
adequate and effective protection of its intellectual property
rights. In light of the recent
announcements of further compulsory licenses, it is clear that this
disregard for the intellectual
property rights that are critical to innovative biotechnology
companies will continue unabated.
More aggressive monitoring and engagement with Thailand on this issue
is fully warranted.
PRIORITY WATCH LIST
Brazil
Brazil=92s recent grant of a compulsory license for a patented
pharmaceutical product and
persistent deficiencies in its patent system continues to deny
adequate and effective intellectual
property protection for the biotechnology sector. Therefore, BIO
urges USTR to restore Brazil
to the Priority Watch List.
In 2007, Brazil granted a compulsory license for SUSTIVA
(efavirenz). This act raises
significant concerns about the ability to adequately and effectively
protect intellectual property
rights in Brazil. Based on the information available, it appears that
this action goes beyond the
letter and the spirit of the Doha Declaration provisions relating to
health emergencies and signals
a policy that raises significant concerns about the ability of BIO
Members to obtain intellectual
property protection in Brazil. While BIO understands the challenges
that countries face in
providing effective and affordable healthcare systems, BIO Members
continue to believe that the
most effective solutions will result from policies that respect and
encourage innovation. Instead,
the granting of compulsory licenses in this manner will undermine
incentives needed to develop
new medicines. As further cause for alarm, press reports indicate
that Brazil may be considering
further compulsory licenses of pharmaceutical products. The
inevitable result of this approach is
to provide a strong disincentive to our Members to invest and do
business in Brazil.
The Brazilian patent law also remains a cause for concern. Brazil
maintains a provision
in its patent law that requires all drug patents to be approved not
only by its patent office (the
National Institute for Industrial Property or =93INPI=94), but also by the
Ministry of Health (through
the drug regulatory agency, =93ANVISA=94). Brazil therefore has imposed a
special, higher and
discriminatory standard for obtaining a patent on pharmaceutical
technology. These higher
standards are not consistent with Brazil=92s obligations under the TRIPS
Agreement.
Article 27 of the TRIPS agreement provides that patents are to be
available =93for any
inventions =85 provided they are new, involve an inventive step and are
capable of industrial
application.=94 A member state may not impose additional requirements
as a condition for
establishing patentability. In addition, these patents are to be
available =93without discrimination
=85 as to field of technology.=94 Technology-specific conditions, such as
the approval by ANVISA
of drug patents that have already been found to satisfy the criteria
of novelty, inventive step, and
industrial applicability are inconsistent with the express provisions
of the TRIPS agreement.
BIO urges USTR to restore Brazil to the Priority Watch List.
Brazil=92s pursuit of
compulsory licensing as part of its trade policy as well as the
continued deficiency of its patent
regime with respect to pharmaceutical products deny adequate and
effective intellectual property
protection for BIO members. We urge USTR to continue its engagement
with Brazil to
implement an intellectual property regime that respects patent
rights, provides an enabling
environment for innovation and is fully compliant with the TRIPS
Agreement.
The Philippines
In 2007, both houses of the Philippine legislature passed bills that
would provide for
amendments to the Intellectual Property Code of the Philippines.
These amendments would
weaken the protection of biopharmaceutical inventions in the
Philippines and raise significant
concerns for BIO Members.
The recently passed amendments would exclude from patentability a
new form of a
known substance which does not result in =93enhancement of the known
efficacy, safety and purity
of that substance.=94 The amendments would appear to exclude from
patentability many
significant inventions in the pharmaceuticals area. For example, a
new form of a known
substance that may have improvements in heat stability for tropical
climates, or other benefits
that may not result in =93enhanced efficacy,=94 per se, would be denied
patent protection even if it
met all other patentability criteria. Such a requirement would thereby
appear to be an additional
patentability requirement inconsistent with the obligations of the
Philippines under Article 27.1
of the TRIPS Agreement, which provides that patents be made available
to =93any inventions =85 in
all fields of technology, provided that they are new, involve an
inventive step and are capable of
industrial application.=94
Moreover, the amendments provide that this additional requirement is
applied only to
drugs or medicines, and therefore creates a higher standard of
patentability for this category of
invention. This is inconsistent with the non-discrimination
requirement of Article 27.1 of the
TRIPS Agreement that =93patents shall be available and patent rights
enjoyable without
discrimination as to the =85 field of technology.=94
The recent amendments also contain provisions that expand the
grounds on which
compulsory licenses may be granted. This includes a new ground that
permits a compulsory
license =93[i]n the case of drugs or medicines, [when] the demand for
the patented article in the
Philippines is not being met to an adequate extent and on reasonable
terms, as determined by the
Department of Health.=94 This provision has the potential to undermine
adequate and effective
protection of patent rights for biopharmaceuticals and is not
consistent with the non-
discrimination clause of TRIPS Article 27.1.
BIO requests that USTR further engage the Philippines to revisit
this legislation and to
work with the Philippines to provide for an intellectual property
regime that provides adequate
and effective protection of intellectual property rights for U.S.
rights holders in that country. In
light of this weakening of patent protection for biotechnological
inventions, BIO requests that
USTR place the Philippines on the Priority Watch List.
Argentina
Argentina continues to have deficiencies with respect to its patent
system and the
protection of data supplied to regulatory agencies in support of
product marketing authorizations.
BIO requests that USTR maintain Argentina in its current status on the
Priority Watch List.
Argentina=92s patent system continues to suffer from a persistent
backlog of patent
applications that delays the grant of patent protection for valuable
inventions and thereby denies
the adequate and effective protection of intellectual property rights
for BIO Members. We
understand the Argentina has taken steps in recent years to reduce its
backlog, but excessive
delays are persistent. In addition, the National Institute of
Industrial Property (INPI) in
Argentina has issued highly restrictive patent examination guidelines
in Resolution 243/2003
that provide for the denial of patent claims directed to transgenic
plants and animals. This
excludes protection for a wide class of biotechnological inventions,
and also appears to be
inconsistent with the Argentine patent law that provides an exclusion
to patentability only for
living material that is =93pre-existing in nature.=94 BIO members also
continue to experience
difficulties in enforcing patent and plant variety protections in
Argentina.
Argentina also does not provide adequate protection for the data
that must be generated in
support of marketing authorization to prove that pharmaceutical and
agricultural chemical
products are safe and effective. This protection is critical to the
ability of biotechnology
companies to market pharmaceutical products in a particular market and
is an obligation of
Argentina under Article 39.3 of the TRIPS Agreement that requires such
data to be protected
against =93unfair commercial use.=94 Persistent deficiencies in the
patent and data protection regime
in Argentina deny adequate and effective protection for inventions of
BIO Members.
Chile
Chile does not provide adequate protection of data that is required
for submission in
support of marketing authorization for pharmaceuticals that is
consistent with its obligations
under Article 17.10.1 of the US-Chile Free Trade Agreement (FTA).
This protection is essential
for marketing of biopharmaceuticals in key markets. The Chilean laws
undermine this protection
by providing onerous conditions on the ability to obtain this
protection, and by providing that
such protection, where available, may be revoked for broad grounds,
including =93reasons of
public health, national security, public non-commercial use=94 and other
circumstances that are not
consistent with the obligations of Chile under either the FTA
provisions or the obligations of
Chile with respect to data protection set forth in Article 39.3 of the
TRIPS Agreement. Further,
Chile is not in compliance with its obligations under Article 17.10.2
of the US-Chile FTA, to not
grant marketing approval to a third party for a drug prior to
expiration of the relevant patent
term. This protection is highly important to prevent infringement of
patents covering valuable
inventions for BIO Members. The lack of such protections is
particularly troubling in light of
the clear obligations provided under the FTA.
In addition, Chile=92s patent laws do not provide for patent term
extensions to compensate
for unwarranted delays in the marketing approvals process. The patent
law in Chile also excludes
transgenic plants and seeds from patent protection, thereby further
limiting the availability of
meaningful protection for valuable biotech innovations. To the extent
that protection is
available, significant backlogs delay ability to obtain rights
essential to adequately protection
these inventions.
Chile=92s intellectual property regime falls short in a number of ways
that deny protection
for biotechnological inventions. In light of these deficiencies of
the intellectual property regime
in Chile, BIO requests that Chile remain on the Priority Watch List.
China
China=92s intellectual property system has made important improvements
in recent years.
Nonetheless, there are still many areas of concern relating to the
protection of biotechnological
inventions in China. BIO requests that USTR maintain China on the
Priority Watch List.
BIO Members remain deeply concerned about the trafficking of
counterfeit
pharmaceuticals and biologics in China. Counterfeiting not only
deprives the owners of
intellectual property of the value of their assets, but further poses
a threat to public health, along
with the consequent economic costs. Counterfeit medications place the
public at unnecessary
risk, and they divert the resources of industry and government
agencies from productive uses.
BIO urges USTR to promote more effective interdiction and enforcement
directed toward
traffickers and distributors of counterfeit biopharmaceuticals in China.
BIO Members remain concerned about some of the proposed changes to
the patent law of
China contained in the Draft Third Patent Law Amendments. In
particular, the draft
amendments to Article 25 of the Chinese Patent law would provide that
claims in a patent
application may be rejected if the completion of the invention
depended on the acquisition and
exploitation of genetic resources that is contrary to the =93relevant
laws and regulations of the
state.=94 Further, the amendments to Article 26 would require patent
applicants to indicate the
source of genetic resources if the completion of the claimed invention
depended on genetic
resources. BIO notes that these amendments appear to be intended to
promote compliance with
provisions of the Convention on Biological Diversity (CBD) related to
access to genetic
resources and equitable sharing of benefits from utilization of these
resources. However, such a
requirement would not help to further these goals, which can be
accomplished more effectively
by improved transparency in national access and benefit-sharing
regimes. Pursuant to these draft
amendments, each patent applicant would be responsible for tracing the
=93history=94 of all
naturally-derived biological materials contributing to the invention,
even if the applicant
obtained the material from a commercial supplier and the material has
been available from
secondary sources for decades. The failure to identify the
geographical source of a biological
material used in the invention would apparently also be a basis for
opposition or revocation
proceedings. These special disclosure requirements impose
unreasonable burdens on patent
applicants, subjecting valuable patent rights to great uncertainty.
Moreover, these amendments
would not be consistent with China=92s obligations under the TRIPS
Agreement.
Draft amendments to Articles 48 to 52 of China=92s patent law would
provide changes with
respect to compulsory licensing of inventions. While BIO applauds a
number of changes in this
area, including the elimination of compulsory licenses for failure to
obtain a voluntary license
(draft Article 48) and the introduction of limitation on the use of
patented inventions under
compulsory license in accordance with the TRIPS Agreement (Article
52), significant
clarification regarding the events that would trigger compulsory
licensing, as well as the scope
and duration of the licenses granted, is needed.
The draft amendments also seek to add a =93Bolar exemption=94 to patent
infringement for
pharmaceutical products in Article 74(5). However, unlike the law of
many countries that
provide this exemption, the exemption proposed in the patent law
amendments does not balance
this provision by providing extensions of patent terms for patent
owners to compensate for
delays encountered in the regulatory approval process. Without this
balancing provision, the
amendment, standing alone, does not provide equitable treatment to
owners of intellectual
property rights relating to pharmaceutical inventions.
The Third Patent Law Amendment is an opportunity for China to
implement changes to
its law that better reflect international standards and provide for
improved protection for
intellectual property rights holders and the consequent improved
enabling environment for
innovation in that country. BIO urges USTR to engage with China to
improve these
amendments prior to enactment in order to achieve a patent law that is
fully TRIPS-compliant
and that adequately and effectively protects intellectual property
rights.
Egypt
Egypt=92s patent laws continue to lack adequate and effective
protection for a wide range of
technologies that are important to BIO Members. In that light, BIO
requests that Egypt be
maintained in its current status on the Priority Watch List.
The Egyptian patent law prohibits patent protection for many
valuable innovations.
Inventions in the subject matter areas of organs, tissues, viable
cells, natural biologic substances,
and genome are expressly excluded from patentability. These are areas
of subject matter that
must be extended protection according to the obligations contained
TRIPS Agreement, provided
the material in question is new, involves an inventive step and is
industrially applicable. While
TRIPS Article 27.3 does recognize some permissible areas of exclusion
from patentability, these
areas in the Egyptian patent laws do not fall within those permissible
exclusions. In addition,
Egypt precludes the patenting of genetically engineered plants and
animals. In sum, the
Egyptian law precludes patenting of most basic commercial products and
processes in the
biotechnology industry.
Further, Egypt still does not provide for adequate and effective
protection of data
supplied to regulatory agencies in support of product marketing
authorizations. Data protection
is critical for biopharmaceutical companies that want to market
products in a particular country.
This lack of protection is not consistent with Egypt=92s obligations
under the TRIPS Agreement
Article 39.3.
BIO requests that USTR continue to engage Egyptian counterparts in
order to make
improvements to the protection of intellectual property rights in
Egypt and to provide for the
eventual adoption of a fully TRIPS-compliant regime in that country.
India
At the outset, BIO notes with appreciation the several steps that
India has taken toward
enhancing both its intellectual property laws and the capacity of its
patent office to examine and
grant patents. While BIO welcomes this trend, the reforms to date
fail to achieve adequate and
effective protection for intellectual property rights in the
biotechnology industry. BIO requests,
therefore, that India remain on the Priority Watch List.
The Indian patent system still excludes from protection many
biotechnology inventions.
The Patent Office has determined that the Indian Patents Act excludes
from eligibility many
living organisms, such as transgenic plants and animals, and parts
thereof. Further, inventions of
tissues, cells, viruses, and the processes of preparing them are not
eligible for patent protection,
even though protection is mandated by the TRIPS Agreement for
inventions in these areas,
provided the invention is new, has an inventive step and has
industrial applicability.
Additionally, it remains unclear whether polypeptides, nucleic acids,
and other biomolecules are
eligible for patents under the Act. Thus, it remains difficult to
obtain legal rights in India of any
significant commercial value for a biotechnology product.
Further, the 2005 amendment to the Indian Patents Act introduced
Section 3(d), which
explicitly excludes from patentability new forms of a known substance
which does not result in
=93enhancement of the known efficacy of that substance.=94 This type of
requirement would appear
to exclude from patentability many significant inventions in the
pharmaceuticals area, e.g., new
forms of known substances that may have improvements in heat stability
for tropical climates, or
safety or other benefits that may not result in =93enhanced efficacy,=94
per se. In addition, such a
requirement would appear to be inconsistent with the obligations of
India pursuant to Article 27
of the TRIPS Agreement, which requires that patents be made available
to =93any inventions =85 in
all fields of technology, provided that they are new, involve an
inventive step and are capable of
industrial application.=94 Section 3(d) also creates an additional
hurdle of patentability beyond
novelty, inventive step and industrial application. Furthermore, this
additional hurdle is applied
only to certain chemical compounds and therefore appears to be
violative of the non-
discrimination clause with respect to field of technology set forth in
the TRIPS Agreement.
India=92s Patents Act also requires applicants to disclose the source
and geographical origin
of biological materials used to make an invention that is the subject
of a patent application.
These requirements appear intended to promote compliance with goals of
the CBD relating to
appropriate access to genetic resources by patent applicants and
equitable benefit-sharing from
utilization of such resources. However, such a requirement would not
help to further these goals,
which can be accomplished by improved transparency in access and
benefit-sharing regimes.
Instead, these special disclosure requirements impose unreasonable
burdens on patent applicants,
subjecting valuable patent rights to great uncertainty. Each patent
applicant is responsible for
tracing the =93history=94 of all naturally-derived biological materials
contributing to the invention,
even if the applicant obtained the material from a commercial supplier
and the material has been
available from secondary sources for decades. The failure to identify
the geographical source of
a biological material used in the invention may be the basis for
opposition or revocation
proceedings. Such requirements pose unacceptable risks for patent
applicants and would
undermine the incentives of the patent system to promote innovation in
biotechnological
inventions. Further, such requirements would not be consistent with
India=92s obligations under
the TRIPS Agreement.
The Indian Patents Act places many restrictions on the use of patent
rights. These
include broad exceptions for use of patented technology by the Indian
Government or third
parties, and an extensive authority for the grant of compulsory
licenses, including upon the sole
justification that the products falling under the patent are not
manufactured in India.
Further, the capacity of the Indian patent office to review and
grant patent applications is
not yet sufficient to support the industries that depend on
intellectual property. Moreover, patent
litigation remains rare in the Indian courts and there is a lack of
experienced judicial and
enforcement officials.
India also does not yet implement any meaningful protection for the
data that must be
generated to prove that pharmaceutical and agricultural chemical
products are safe and effective.
Under Article 39.3 of the TRIPS Agreement, protection must be extended
against unfair
commercial use of such data by makers of generic copies of innovator
products (i.e., products
that must be shown for the first time to be safe and effective, or to
not cause significant risk to
the environment). BIO notes the May 2007 release of the =93Report on
Steps to be Taken by the
Government of India in the Context of Data Protection Provisions of
Article 39.3 of the TRIPS
Agreement.=94. BIO views the report and its recognition that the
present legal provisions in India
do not adequately meet the spirit of TRIPS Article 39.3 as a positive
development. Further, BIO
views positively the suggestion that, in the =93post-transition period,=94
India should adopt a five-
year fixed data protection term during which the relevant regulatory
officials will not rely upon
data submitted by the originator when approving second and subsequent
applications for the
same product. Nonetheless, significant concerns remain. First, the
transition period is not
defined and is apparently indefinite. In that light, it appears that
meaningful protection for this
data will not be implemented in the near-term. In addition, even the
suggested post-transition
period protection is subject to numerous, and apparently wide-ranging,
proposed =93safeguards.=94
A number of these =93safeguards=94 would appear to undermine the proposed
protection almost
entirely.1 Effective market exclusivity for regulated pharmaceutical
and agricultural chemical
products would contribute significantly to providing adequate and
effective protection of
intellectual property rights in India for BIO Members.
BIO continues to urge USTR to place significant emphasis on the need
for India reform
its intellectual property laws to achieve full compliance with
obligations under the TRIPS
[Footnote]1
SATWANT REDDY AND GURDIAL SINGH SANDHU, REPORT ON STEPS TO BE TAKEN
BY THE GOVERNMENT OF INDIA
IN THE CONTEXT OF DATA PROTECTION PROVISIONS OF ARTICLE 39.3 OF THE
TRIPS AGREEMENT (May 31, 2007).
E.g., see safeguard (xi), which states that =93[i]n cases where
repeating the clinical trials for a drug is not considered
essential, the Regulatory Authority may allow marketing approval to
subsequent applicants of a drug similar to an
earlier approved drug by placing reliance on the first applicant=92s
undisclosed data.=94
Agreement so that these laws provide an adequate and effective level
of protection for
biotechnology inventions. BIO believes that India should remain on the
Priority Watch List.
Israel
Israel continues to fall far short of providing adequate and
effective legal protection for
biotechnology inventions. Accordingly, BIO requests that USTR
maintain Israel as a Priority
Watch List country.
Israel=92s regime for protection of data submitted by the originator
of a new drug to support
its application to market the drug remains inconsistent with
international standards. Data
exclusivity is essential to the biotechnology industry and is mandated
by TRIPS Article 39.3. In
recent years, changes to Israeli laws have weakened data protection
and patent protection for
pharmaceutical products in that country. The linkage of the
exclusivity period (5.5 years) to the
earliest registration in any of a list of =93recognized countries=94
substantially reduces the protection
available for U.S. companies in Israel. Further, growing delays in
the registration process for
innovative products further erodes the exclusivity period that is
necessary for effective
protection. In addition, the current laws relating to patent term
extension are burdensome and
severely restrict the ability to obtain these extensions, which are
needed to compensate for
administrative delays in the approvals process. Moreover, such
extensions, where available, are
significantly limited, as extensions of the patent term are linked to
the shortest extension given in
one of the reference countries. These deficiencies in the
intellectual property rights regime have
been raised for years by the United States, yet Israel has not
corrected these matters and
continues to fall well-short of international standards, particularly
those adopted by most
member countries of the Organization for Economic Cooperation and
Development (OECD) to
which Israel hopes to accede in the near term.
Israel=92s pre-grant opposition regime for patents also continues to
be of serious concern to
BIO Members. While we understand that certain actions have been taken
in recent years to
attempt to address some of the most egregious abuses of the opposition
procedure, the patent
statute nonetheless continues to provide that any person may file an
opposition to any pending
application within three months after the application is published.
The U.S. government has
long-recognized that such pre-grant opposition proceedings have
significant potential to harm
U.S. applicants, and domestic entities in Israel have a long history
of using pre-grant oppositions
to delay or deny the grant of patents for the deserving inventions of
foreign interests.
Israel is a modern, technologically advanced country and is looking
to become a member
of the OECD. It enjoys preferential access to the U.S. market for
pharmaceutical products made
by its domestic industry. Israeli interests routinely procure U.S.
patents, litigate them in U.S.
courts, and generally benefit from adequate and effective intellectual
property protection under
U.S. law. The failure of Israel to provide comparable protection for
U.S. interests in Israel
significantly distorts the trade in biotechnology products between the
United States and Israel.
BIO considers that these policies warrant continued close scrutiny
by USTR and urges
USTR to maintain Israel on the Priority Watch List.
Ukraine
BIO has significant concerns about the requirements being imposed
under the new
Ukrainian Plant Variety Protection (PVP) regime. The regulations
implementing the Law on
Protection of Rights in Plant Varieties require that the parental
inbred lines and pedigrees of
hybrids must be submitted to the government in order to obtain
protection and registration for the
hybrids themselves. This appears to a new requirement beyond the scope
of the 1991 UPOV
Convention. Further, such a requirement subjects highly valuable,
proprietary lines to public
availability, including potential availability to competing plant
breeders, without adequate
protection from unauthorized use.
The UPOV convention requires that the variety being protected be
examined for novelty,
distinctness, uniformity and stability. These can all be evaluated
with respect to the seed of the
hybrid itself, without access to the parental lines or the pedigree.
In addition, since uniformity is
a function of cultural practices such as detasseling and rogueing, the
uniformity of the hybrid
cannot be assessed by examination of the parent inbreds. There are
clear alternatives that would
permit the authorities to obtain equivalent information about the
novelty, identity, distinctness
and stability of the parental lines, such as submission of DNA either
directly or in leaf material
or devitalized seed, without exposing viable seed to misuse.
Ukraine=92s plant variety protection laws contain provisions that
subject the valuable
proprietary rights of BIO members to unwarranted risks. In this
light, BIO requests that USTR
retain Ukraine on the Priority Watch List.
WATCH LIST
Switzerland
BIO Members remain concerned about the potential of amendments made
to the Swiss
patent laws in 2007 to undermine the availability of adequate and
effective patent protection for
certain biotechnology inventions in Switzerland.
New Article 40b provides that any user of a patented
biotechnological invention used as
=93an instrument or tool for research=94 shall be entitled to a non-
exclusive compulsory license. The
intent of the provision appears to be to prevent the improper use of
patent rights from stifling
research. BIO supports this objective, but the legislation, as
drafted, is not limited to non-
commercial research. It should also be noted that the typical market
for many of the products of
the biotechnology industry is the research community. These include,
for example, products
such as reagents that are useful in biochemical assays. Article 40b
seems to categorically exempt
the users of such products from liability for infringement, without
regard to the commercial or
non-commercial nature of the activity. As this provision appears to
go well beyond the
legitimate policy objectives of the amendment, BIO urges USTR to
further engage the Swiss
Government to revisit this provision.
In addition, Article 49a of the recent amendments requires that
patent applicants disclose
the source of a genetic resource, =93insofar as the invention depends
directly=94 on the resource. The
Swiss law does attempt to minimize burdens on applicants by providing
that if the source is not
known to the applicant, they may so state. However, such a provision
raises a new potential
ground of challenge that may be asserted in litigation or during the
application process to prevent
the grant of a patent notwithstanding the fact that the information
that is the subject of the
requirement has nothing to do with the requirements for patentability
of the invention set forth in
TRIPS Article 27.1 or the disclosure of invention requirements of
TRIPS Article 29.
Other provisions in the law, such as Article 1b and Article 8c, also
contain language that
could be construed as limiting the patent-eligibility of DNA or gene
fragments. However, this
language is not clear, and we must look to the manner in which these
provisions are applied in
the Swiss Patent Office and courts. We urge that USTR engage with
Swiss officials to ensure
that these provisions are implemented in an appropriate manner.
The situation in Switzerland merits close monitoring to ensure that
adequate and effective
patent protection for biotechnological inventions in Switzerland is
not undermined. BIO
therefore requests that Switzerland be placed on the Watch List.
Colombia
The Colombian patent law contains a number of matters of concern to
BIO Members that
warrant further monitoring. In light of these deficiencies, BIO
requests that Colombia be placed
on the Watch List.
Andean Community Decision 486, which is applicable in Colombia,
denies patents to
inventions of =93biological material, as existing in nature, or able to
be separated, including the
genome or germ plasm of any living thing.=94 This exception appears to
exclude a wide array of
biotechnological inventions. This exception is inconsistent with
obligations of Colombia under
the TRIPS Agreement that require patents to be made available to =93any
inventions =85 provided
they are new, involve an inventive step, and are capable of industrial
application.=94 In addition,
BIO Members are systematically being denied protection in Colombia for
inventions in
polymorphs and isolates that are routinely patented in other
jurisdictions. This practice also
appears to be inconsistent with the requirements of Article 27.1. BIO
also notes with concern
significant delays in processing of patent applications for
commercially valuable pharmaceutical
inventions, essentially denying protection for these valuable
inventions.
Mexico
Mexico continues to deny adequate and effective intellectual
property protection to BIO
Members by failing to appropriately implement its obligations relating
to test data required to be
submitted for marketing approval of pharmaceuticals. Mexico has
obligations under TRIPS
Article 39.3 to provide protection for pharmaceutical test data
against =93unfair commercial use=94
and obligations under the North American Free Trade Agreement (NAFTA)
Article 1711 to
provide a five-year protection period against reliance by subsequent
applicants on the data
supplied by the originator. Nonetheless, Mexico still does not
provide protection consistent with
these obligations. The industrial property states that law will
implement requirements under
various international obligations of Mexico, however, we are not aware
of any implementing
regulations or practices that provide for a five-year term of reliance
consistent with Mexico=92s
international obligations.
BIO Members are also concerned about the lack of adequate
enforcement procedures in
Mexico that undermine the ability to enforce patents on pharmaceutical
products. In addition,
we remain concerned about the apparent proliferation of counterfeit
medicines in Mexico and the
consequent economic and public health risks. Mexico is a member of
the OECD. The data
protection regime and enforcement of intellectual property rights fall
far short of standards
widely implemented in OECD countries.
In light of these concerns, BIO requests that Mexico be retained on
the Watch List.
Saudi Arabia
BIO appreciates the positive steps taken by Saudi Arabia in recent
years in establishing a
new patent regime. However, the implementation of the new patent
regime in 2004 has
effectively denied protection for inventions contained in applications
that were filed prior to
2004. Prior to the enactment of the new law, Saudi Arabia had a type
of =93confirmation=94 system
permitting filing for protection of inventions that had been patented
in other countries. However,
the adoption of the new law eliminated the =93confirmation patents=94
process without providing a
conversion mechanism for applications under the prior system. This
has led to a situation in
which protection for many valuable inventions is unavailable under the
current system.
In addition to this, the new Saudi patent law excludes plants and
animals from patent
protection, further exacerbating the denial of important intellectual
property rights with respect
to an important class of biotechnological inventions.
BIO requests that USTR engage Saudi Arabian officials to establish a
transitional
mechanism to ensure meaningful protection is available for valuable
inventions filed prior to the
change of laws in 2004 and to encourage a fully developed patent
regime that can provide an
enabling environment for the biotechnology industry in Saudi Arabia.
In that light, BIO requests
that Saudi Arabia remain on the Watch List.
Concluding Comments
BIO appreciates this opportunity to submit its views for
consideration by USTR. We are
prepared to work with USTR to provide additional information regarding
the countries we have
identified.
Sincerely,
Lila Feisee
Managing Director, Intellectual Property
Biotechnology Industry Organization
------------------------------------------------------------
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org
Tel: +41 22 791 6727
Mobile: +41 76 508 0997