ANALYSIS OF TRIPS AGREEMENT

Section 5: Patents
Article 27
Patentable Subject Matter
 A. TRIPS Agreement

The general rule on patentable subject matter and the criteria for patentability
under the TRIPS Agreement is contained in:
 Article 27(1) which provides inter alia that, Subject to the exceptions set
out in the Agreement, patents shall be available for all inventions, whether
products or processes, in all fields of technology, provided that they are
new, involve an inventive step and are capable of industrial application.
 Article 27(2) provides discretion for Members to exclude from patentability
subject matter where it is necessary to prevent the commercial exploitation
of such inventions to protect ordre public or morality including to protect
human health and the environment.
 Article 27(3) provides further discretion with respect to the patentability of
diagnostics, therapeutic and surgical methods for the treatment of humans
or animals and plants and animals and provides for a review.
 B. Brussels Draft

 Patents shall be available for all inventions, whether products or processes,

in all fields of technology, provided that they are new, involve an inventive
step and are capable of industrial application.
 PARTIES may exclude from patentability inventions, the prevention within
their territory of the publication or any exploitation of which is necessary to
protect public morality or order, including to protect human health and the
environment.
 PARTIES may also exclude from patentability:
1.Diagnostic, therapeutic and surgical methods for the treatment of humans
or animals;
2. A Animal Varieties abd biological processes for the production of
animals, other than microbial process or the products. PARTIES shall
provide for the protection of the plant varieties either by patents or by an
effective sui generis system.
3. Plants and animals, including microorganisms, and parts thereof and
processes for their production.
4. Certain products and their process of production, on ground of public
interest, national security, public health or nutrition, including food,
chemical and pharmaceutical products and their process of manufacture.
5. Invention relating to nuclear or fissionable materials.
 C. Draft of July 23, 1990 (W/76)

 Patents shall be available granted for any inventions, whether products or

processes, in all fields of technology, which are new, unobvious or involve
any inventive step and are useful or industrially applicable.
 Patents shall be available according to the first-to-file principle.
 Requirement such as filing of an adequate disclosure in a patent application
and payment of reasonable fees shall not be considered inconsistent with
the obligation to provide patent protection.
 Following may be excluded from patentability:
1.Invention contrary to public order, morality or human values.
2.Scientific theories, mathematical methods, discoveries and materials or
substances already existing in the same form found existing in nature.
3.Methods of medical treatment for humans or animals
4.Any variety of plant or animal including microorganisms or process of
production of plant or animals, does not include microbiological process or
product.
5.Production, application and use of nuclear and fissionable materials, and
substances manufactured through nuclear transformation.
 PARTIES shall provide for the protection of plant varieties by patents
and/or by sui generis system.
 The patent section of the TRIPS Agreement overcame the main
weakness of the Paris Convention, and instead of relying on
domestic law, TRIPS defined the scope of a patent.
 Art.27(1) requires that patent be available in all fields of
technology, based on the three criteria, i.e. novelty, industrial
applicability and involving an inventive step.
 Debate on traditional knowledge issues raised commentaries
regarding inability of the TRIPS Agreement to address the issues of
patent protection of traditional knowledge.
 Term “new” or “non-obvious” used in TRIPS Agreement proved
difficult to developing countries as TK is difficult to subsume under
this term and they lack the administrative or the judicial basis to
interpret these terms
 First-to invent contrary to first-to-file may involve long and costly
debates in the case of conflicting applications.
 Art.27(1) prohibits discrimination based on whether the invention is
locally produced or imported.
 Art.27(2) - restriction to the general principle of eligibility to be
patented
 Inventions may be excluded from patentability based on a risk that their
commercial exploitation within their territory of the WTO Member
concerned.
 The risk must not come from the invention as such, but from its
commercial exploitation and the impact that can be invoked is only within
the territory of the country concerned.
 Art.27(2) - that a national law prohibits the exploitation of an invention is
not sufficient to render such invention ineligible for patentability
 Art.27(3) contains more “focused” exceptions that do not need to be
justified in the same way as exceptions under Art.27(2).
 The reason for such exclusion may be ethical or moral, as is the case in a
number of European countries and under the 1973 Convention on the Grant
of European Patents.
 Developing countries insisted on biodiversity and the appropriation of
genetic resources and on the need for transfer of technology and local
availability.
 Art.27(3) requires that plant varieties be protected by patents by a sui
generis system or both.
 In the case of a sui generis system, a UPOV-type protection was
contemplated by a number of negotiators.
 If patent holders want to obtain global patent, to be granted by a selected or
worldwide office, the worldwide harmonization of substantive patent law in
necessary.
 Proposal for global patents have been circulating in certain industrialized
countries and in the Science, Technology and Industry Directorate of the
Organization for Economic Cooperation and Development (OECD).
 Dispute Settlement Issues

 In Canada-Patent Protection of Pharmaceutical Products, the panel

considered the scope of the non-discrimination principle contained in Art
27(1)
 The EC, on December 19, 1997, alleged that Canada's Patent Act was not
compatible with Canada's obligations under the TRIPS Agreement.
 This is because it did not provide for the full protection of patented
pharmaceutical inventions for the entire duration of the term of protection
envisaged by Arts 27(1), 28 and 33 of the TRIPS Agreement.
 Two sections of the Canadian Patent Act were at issue in this dispute,
namely s.55.2(1), known as the regulatory review exception, and 5.55.2(2),
known as the stockpiling exception.
 The regulatory review exception allowed a potential competitor of the
patent owner to use the patented invention without the authorisation of the
patent owner during the term of the patent for the purposes of obtaining
government marketing approval, so that they would obtain regulatory
permission (i.e. to sell a "generic" in competition with the patent owner).
 The "stockpiling exception" allowed a competitor to start manufacturing
and stockpiling patented goods during a -period-of six months prior to the
expiry of the patent, but goods thus manufactured could not be sold until
after the patent had in fact expired.
 The stockpiling exception was available only to persons who had invoked
the regulatory review exception.
 The EC argued that these provisions of the Canadian Patent Act were
inconsistent with Canada's obligation under Art.27(1) and 28(1) of the
Agreement, and that s.55.2(2) was also inconsistent with Canada's
obligations under Art.33.
 The DSB adopted the Panel's report on April 7, 2000.
 The Panel found that the regulatory review exception was not inconsistent
with Art.27(1), and was covered by the exception in Art.30 of the TRIPS
Agreement, and therefore not inconsistent with Art.28(1) of the TRIPS
Agreement.
 The Panel found that the stockpiling exception was inconsistent with
Art.28(1) of the TRIPS Agreement and was not covered by the
exception in Art.30.
 The Panel found that the stockpiling exception abrogated the patent
owner's rights to exclude others from making and using the invention.
 an implementation period of six months from the date of adoption of
the Panels' report was determined by arbitration, pursuant to Art.21(3)
of the DSU.
1. Review of Art.27(3)(b)
2. Article 28 Rights Conferred
3. Article 29 Conditions on Patent Applicants – Disclosure norms
4.Article 30 Exceptions to Rights Conferred
5. Article 31 Other Use Without Authorization of the Right Holder
6. Article 32 Revocation/Forfeiture
7. Article 33 Term of Protection
8. Article 34 Process Patents: Burden of Proof
 1. Review of Art.27(3)(b)
 The most controversial discussion in the work of the Council for
TRIPS.
 The discussions dealt with the review of Art.27(3)(b) and also with
the relation with the Convention on Biological Diversity (CBD) and
traditional knowledge.
 The Doha Ministerial Declaration addressed the review of
Art.27(3)(b) together with the review of Art.71(1) and negotiations
on outstanding implementation issues.
 Issues raised during the Review:
1.Protection for plant varieties and animal inventions
2.Scope of the exceptions to patentability
3.Ethical exceptions to patentability
4.Applicability of patent protection to plant varieties
5.Sui generis protection to plant varieties
6.Element of effective sui generis protection
7.Relation to UPOV
8.Relationship with TK and farmer’s rights
9.Transfer of technology
1.Review of Art.27(3)(b) : Relationship between TRIPS
Agreement and CBD

 There is inherent conflict and the TRIPS Agreement should be amended to

remove such conflict.
 There is no conflict between the two instruments and they can be
implemented in mutually supportive manner.
 There is a possible conflict which requires clarifications so that the
instruments could be implemented in mutually supportive manner.
 1. Review of Art.27(3)(b) : Patentability of genetic
material and CBD

 Patenting the genetic material according to the TRIPS Agreement is

inconsistent with the CBD because it limits access to such material and
conflicts with the sovereign right of countries over their genetic resources.
 It enables the patenting of genetic material in its natural state or of material
that has been isolated from its natural state.
 The opposing view is that patenting of the genetic material does not
conflict with the sovereign rights of WTO Members.
 It only permits the right holder to prevent others from using, producing or
marketing the protectable subject matter.
 The criteria of patentability are not too broad per se; the broad scope
derives from the incorrect application of the principles of the TRIPS
Agreement.
1. Review of Art.27(3)(b) : The TRIPS Agreement and
Prior Informed Consent

 Inconsistency theory (between the TRIPS Agreement and the CBD) argued
- that TRIPS is incompatible with the CBD because allows for a grant of a
patent on genetic material without requiring prior informed consent and
benefit sharing, as provided in the CBD.
 Therefore, Arts 27(3)(b) and 24 of TRIPS amended to include the following
conditions for patentability:
1.disclosure of any source of genetic material used,
2.disclosure of any traditional knowledge,
3.evidence of prior informed consent and the evidence of (equitable) benefit-
sharing.
1. Review of Art.27(3)(b) : The Protection of Traditional
Knowledge, including Folklore
The reasons for the protection of the traditional knowledge and folklore are:
 Common economic interest of mankind.
 Equity- to share economic benefits deriving from that knowledge;
 Discrimination in current intellectual property regime
 Food Security- saving, sharing and replanting seeds
 protection of the culture of those communities
 protection of the environment
 Contribution to the development of traditional communities and countries.
 TK is consistent with the CBD and other international systems, such as the
International Undertaking on Plant Genetic Resources and the model law of
the Organization of African Unity.
 WIPO has been considered as the "natural" primary and most appropriate
forum for discussions on the protection of traditional knowledge.
 The fact that patents that applied to traditional knowledge were awarded to
persons other than the communities where that knowledge originated
sparked the debate on the relationship between TRIPS and traditional
knowledge
 Main areas where the current patent system falls short with respect to
traditional knowledge include the definition and the adequacy of the prior
art/novelty requirement, and the fact that most forms of intellectual
property, including patents, cannot be awarded to an entire community
(unless they are all considered inventors").
 With respect to the consent and benefit sharing several suggestions have
been made:
1. Use of the existing IPR system: a certain level of protection of traditional
knowledge can be to accommodated in existing IPR.
2. Contract-based relationships: Bilateral contracts between the
communities concerned and those who exploit such knowledge have been
proposed for protecting certain forms of traditional knowledge.
3. Sui generis system of protection: A system that provides erga omnes
proprietary rights to communities that hold traditional knowledge is the
most suitable for the protection of the traditional.
 Article 28 Rights Conferred: A. TRIPS Agreement

 1. A patent shall confer on its owner the following exclusive rights:

 (a) where the subject matter of a patent is a product, to prevent third parties
not having the owner's consent from the acts of: making, using, offering for
sale, selling, or importing" for these purposes that product;
 (b) where the subject matter of a patent is a process, to prevent third parties
not having the owner's consent from the act of using the process, and from
the acts of: using, offering for sale, selling, or importing for these purposes
at least the product obtained directly by that process.
 2. Patent owners shall also have the right to assign, or transfer by
succession, the patent and to conclude licensing contracts.

Note:
(a) This right, like all other rights conferred under this Agreement in respect
of the use, sale, importation or other distribution of goods, is subject to the
provisions of Article 6 .
 Article 28 Rights Conferred: B. Brussels Draft

 1. A patent shall confer on its owner the following exclusive rights:

 (a) to prevent third parties not having his consent from the acts of: making,
using, offering for sale, selling, or importing- for these purposes the
product which is the subject matter of the patent;
 (b) where the subject matter of a patent is a process, to prevent third parties
not having his consent from the act of using the process [, and from the acts
of: using, offering for sale, selling, or importing for these purposes at least
the product obtained directly by that process].

This is identical to the final agreement

Article 28 Rights Conferred: C. Draft of July 23, 1990
(W/76)
 A patent shall confer on its owner at the following exclusive rights:
(a) to prevent third parties not having his consent from the acts of: making or
using the product which is the subject matter of the patent.
(b) where the subject matter of a patent is a process, to prevent third parties
not having his consent from the act of using the process, and from the acts
of: using, [putting on the market, offering] [selling,] [or importing,] [or
importing or stocking for these purposes,] at least the product obtained
directly by that process.
 After getting grant, the owner of the patent shall have the following rights:
(a) The right to prevent others from making, using or selling the patented
product or using the patented process for commercial or industrial
purposes.
(b) The right to assign, or transfer by succession, the patent and to conclude
licence contracts.
(c) The right to a reasonable remuneration when the competent authorities of a
PARTY to the present agreement use a patent for government purpose or
provide for the granting of a licence of right or a compulsory license. Such
reasonable remuneration will be determined having regard to the economic
situation of the PARTY, the nature of the invention, the cost involved in
developing the patent and other relevant factors.
 Art.28(1) was inspired by Art.l9 of the draft Patent Law Treaty.
 It embodies standards that may be considered fairly common in
industrialised nations.
 The inclusion of products obtained by a patented process in the scope of
protection of process patents was the result of a long and difficult debate.
 The main argument for the inclusion of this protection is the possibility that
a process would be used in a country and the product obtained by the
process shipped to another country, thus rendering enforcement potentially
very complicated.
 Art.28(2) provides a relative freedom to transfer or a sign patent rights.
 WTO Members may imposed conditions to allow such transfers, such as
the transfer of the business or goodwill (see Art.31(e)) to which it is related,
or conditions concerning possible anti-competitive practices
Article 29 Conditions on Patent Applicants: A. TRIPS
Agreement

 1. Members shall require that an applicant for a patent shall disclose the
invention in a manner sufficiently clear and complete for the invention to
be carried out by a person skilled in the art and may require the applicant to
indicate the best mode for carrying out the invention known to the inventor
at the filing date or, where priority is claimed, at the priority date of the
application.
 2. Members may require an applicant for a patent to provide information
concerning the applicant's corresponding foreign applications and grants.
Article 29 Conditions on Patent Applicants: B. Brussels
Draft

[The title of this Article was "Conditions and Obligations on Patent

2.285 Applicants and Owners"]
 1. Essentially identical to A.
 2. Essentially identical to A.
 3. PARTIES provided that the following obligations to the patent
owner:
(a) To ensure the exploitation of the patented invention in order to
satisfy the reasonable requirements of the public.
(b) In respect of licensing contracts and contracts assigning patents, to
refrain from engaging in abusive or anti-competitive practices
adversely affecting the transfer of technology.
 4. PARTIES may adopt the measures referred to in Articles [31, 32
and 40] to remedy the non-fulfillment of the obligations mentioned in
paragraph 3 above.
Article 29 Conditions on Patent Applicants: C. Draft of
July 23, 1990 (WI76)

 1. Obligations to the owner of the patent:

1.1 to disclose prior to grant the invention to permit a person versed in the
technical field to put the invention into practice.

1.2 to give information concerning corresponding foreign applications and

grants;

1.3B to work the patented invention in the territory of the Party granting it
within the time limits fixed by national legislation;

1.4B in respect of licence contracts and contracts assigning patents, to

refrain from engaging in abusive or anticompetitive practices adversely
affecting the transfer of technology.
 Article 29 Conditions on Patent Applicants: D.I
Comment

 Art.29(1) introduces rule lacking in the Paris Convention, namely the

precise test imposed on patent applicants in respect of the description of the
invention.
 In the test an invention must be described in such a way as to permit a
"person skilled in the art" to carry out the invention.
 Inventor brings the full disclosure in exchange for a monopoly whose
duration is limited in time.
 This ensures that the invention can be exploited without undue difficulty by
others after the expiry of the non-renewable exclusive right, since patents
are not renewable.
 In the pharmaceutical field, they may be extended to compensate rights
holders who had to wait before exploiting the invention due to regulatory
approval processes.
 Art.29(1) also allows those WTO Members that require a disclosure of the
best mode'" (or method) to carry out the invention known to the applicant at
the time of filing of the application to maintain such a system.
 Art.29(2) allows WTO Members to require information on foreign patent
grants and applications corresponding to the same invention.
Article 30 Exceptions to Rights Conferred: A. TRIPS
Agreement

 Members may provide limited exceptions to the exclusive rights conferred

by a patent, provided that such exceptions do not unreasonably conflict
with a normal exploitation of the patent and do not unreasonably prejudice
the legitimate interests of the patent owner, taking account of the legitimate
interests of third parties.
Article 30 Exceptions to Rights Conferred: B. Brussels
Draft

 Essentially identical to A.
Article 30 Exceptions to Rights Conferred: C. Draft of
July 23, 1990 (WI76)

Exceptions to the exclusive rights conferred by a patent:

 Rights based on prior use.
 Acts done privately and for non-commercial purposes.
 Acts done for experimental purposes.
 Preparation in a pharmacy in individual cases of a medicine in accordance
with a prescription, or acts carried out with a medicine so prepared.
 Acts done in reliance upon them not being prohibited by a valid claim
present in a patent as initially granted but subsequently becoming
prohibited by a valid claim of that patent changed in
 accordance with procedures for effecting changes to patents after grant.
 Acts done by government for purposes merely of its own use.
 Article 30 Exceptions to Rights Conferred: D.1
Comment

 Exceptions to the exclusive rights of patent owners are established on

the same basis as exceptions from patentability.
 Art.30 resembles other "general exceptions" (Arts 13, 17 and 26(2))
contained in the TRIPS Agreement.
 It is difficult to determine the exact scope of this provision, because it
resembles Art.9(2) of the Berne Convention, the interpretation of which
includes possible compulsory licensing.
 The phrase "taking into account the interests of third parties" broadened
the scope of this exception as compared with its Berne "parent".
 Art.30 typically applied to cases such as non-commercial research.
 Article 30 Exceptions to Rights Conferred: Dispute
Settlement Issues
 In Canada-Patent Protection of Pharmaceutical Products" the Panel had to interpret
the scope of exceptions in Art. 30.
 The Panel established that the limitations and exceptions permitted under Art.30
should fulfil three separate, cumulative criteria, namely
(a) the exception must be limited,
(b) the exception must not unreasonably conflict with normal exploitation of the
patent, and
(c) the exception must not necessarily prejudice the legitimate interest of the patent
owner, taking account of the legitimate interests of third parties.

 First condition, indicated that an exception had to be narrow in scope, i.e., it should
"make only a small diminution of the right in question.

 The Panel established that the first condition of Art.30 did not address the issue of
economic impact of an exception, but that the second and the third condition dealt
with this issue.

 Second condition means that the patent owner had the right to "exclude all form of
competition that could detract from the economic return anticipated from a patent's
grant of market exclusivity.
 Third condition means "interests that are 'justifiable' in the sense that they are
supported by relevant public policies or other social norms.
 Article 31 Other Use Without Authorization of the
Right Holder
Comment:
 This Article deals with what are traditionally referred to as compulsory
licences, non-voluntary licences or licences of right.
 It sets specific conditions for the grant, but does not list or define the cases
where a licence may be granted (except for semiconductor technology).
 The compulsory licences must be granted only on a case-by-case basis.
 The Article constitutes a detailed checklist for WTO Members.
 The compulsory licence may be granted provided that the following
conditions are met:
Prior negotiation with right holder:
 except where a compulsory licence is granted to remedy an anti-
competitive practice,
 the proposed user must have made (reasonable) efforts to obtain
authorisation from the right holder, for a reasonable period of time.
 Here reasonableness depends on the nature of the technology and
particularly the case where the technology field in question is not
developed (on a normal contractual basis) in the WTO Member where the
grant of the compulsory licence is contemplated.
 Article 31 Other Use Without Authorization of the
Right Holder contd
 It not only practices in the WTO Member concerned, but in the light of
practices in relevant neighbour.
 In light of the Doha Declaration on TRIPS and Public Health WTO
Members are free, within reason, to determine what constitutes a national
emergency.
 The need for prior negotiation does not apply in case of public non-
commercial use, but the right holder must be informed if the user
(government or contractor) knows or has reasonable grounds to know that
the technology is patented.
 The Article specifically excludes any duty to conduct a patent search.
Duration:
 a compulsory licence should be "liable to be" revoked as soon as the
purposes for which it was granted no longer justify the licence (e.g. the end
of a national emergency) and are unlikely to recur.
 The competent authority (either the authority that ~ranted the licence or
judicial authorities) must have, under domesticllaw, the authority to review
the existence of the circumstances that led to the grant of the licence.
 Article 31 Other Use Without Authorization of the
Right Holder contd
Scope:
 The scope of a compulsory licence must be proportional, i.e. limited to the
purposes for which it is granted. This may result in a licence being limited,
e.g. to certain claims of a patent.
Semi-conductor technology:
 Compulsory licences may only be granted for public non-commercial use
or to remedy an anti-competitive practice (after due process).
 It should be noted that a proposal by Switzerland and the United States
concerning non discrimination with respect to the technological field (see
para.(k) of the Brussels draft) was not retained.
 The "individual merits" obligation (in para.(a) of the TRIPS Agreements)
imposes significant constraints on any "area" compulsory licence
General licensing terms:
 all compulsory licences must be non-exclusive and non-assignable, in the
latter case except with the part of the enterprise or goodwill IS in respect of
which the licence was granted the provision does not expressly extend to
sub-licensing, however.
 Article 31 Other Use Without Authorization of the
Right Holder contd
Domestic market supply:
 except in cases where a compulsory licence is granted to remedy an anti-
competitive practice.
 compulsory licences should be used to ensure predominantly the supply of
the domestic market of the WTO Member granting the licence.
 Some exports are

Remuneration of the right holder:

 Adequate remuneration must be paid to the patent owner, taking into
account the "economic value of the authorisation".
 Particularly in cases where the technology is not normally (i.e. under
contractual licences) available in the WTO Member concerned, and subject
to the economic and other circumstances of the country concerned,
practices in relevant neighbour territories and worldwide markets should be
used to assess such value.
 The term "adequate", a US proposal was chosen over "fair and equitable"
which was supported by several members.
 Article 31 Other Use Without Authorization of the
Right Holder contd
Judicial or similar review:
 Decisions to grant, continue, renew compulsory licences as well as decisions concerning
the level of the adequate remuneration of the patent owner must be subject to judicial
review or review by an authority higher than that which granted the licence, Principles
contained in Part III apply.
Dependent patents:
 In case of dependent patents (i.e. where use of a patent requires the authorisation to use a
prior patent), it must be shown that:
i) -the second (dependent) invention involves an advantage of considerable economic
significance in relation to the first invention.
-the test of "considerable economic significance" was aimed at countries which had a policy
concerning compulsory licenses in such cases.
ii) the right holder in the first patent is entitled to claim a crosslicence, i.e. a licence to use the
second patent, on "reasonable terms".
iii) Finally, the use authorised is non-assignable except with the second patent.
Current Negotiations
 The ongoing negotiations in this area are described in Part One, in the seetions dealing
with the Doha Ministerial Declaration and TRIPS and Public Health.
 Article 32 Revocation/Forfeiture

TRIPS Agreement
 An opportunity for judicial review of any decision to revoke or forfeit a
patent shall be available.

Comment
 This Article provides that any decision to revoke or forfeit a patent, for any
reason, must be subject to a judicial review.
 Standards contained in Part III apply in this respect.
 The term "judicial" implies that it must follow the formal legal procedure
of a court.
 During the negotiation, attempts were made to limit revocation to cases
where a patent had failed to meet the criteria for grant, but to no avail.
 Revocation on grounds of public interest thus remains possible, provided
the procedure is strictly followed.
 Article 33 Term of Protection

TRIPS Agreement
 The term of protection available shall not end before the expiration of a
period of twenty years counted from the filing date.
Note:
 (a) It is understood that those Members which do not have a system of
original grant may provide that the term of protection shall be computed
from the filing date in the system of original grant.

Comment:
 In some countries, the term of protection was sometimes calculated from
grant and in other cases from filing.
 In several countries, protection (in terms of being able to obtain full
damages) actually starts only from publication or even grant, which the
Agreement allows, subject to Art.62(2).
 During the negotiation, attempts were made to extend the protection for
certain products the marketing of which is often delayed by regulatory
approval processes, notably pharmaceuticals.
 Article 34 Process Patents: Burden of Proof

Comment
 Art.34 is designed to allow the enforcement of process patents in the
numerous cases where direct evidence of the use of the patented process is
not available.
 Art.34(1) specifies cases in which, contrary to normal evidentiary rules, the
judicial authorities may" put the burden on the alleged infringer to show
that he did not infringe the process patent.
 The Agreement first obliges WTO Members to give judicial authorities the
power to order such reversal where the alleged infringer's product is
identical to the product produced by the patented process.
 In implementing this provision, WTO Members should implement a prima
facie presumption that such identical product has been obtained by the
patented process in at least one of the two following circumstances:
-if the product obtained by the patented process is new; or
-if there is a substantial likelihood that the identical product (new or
existing) was made by such process and the owner of the patent was unable
through reasonable efforts to determine the process actually used.
 Article 34 Process Patents: Burden of Proof

 Art.34(3) provides that once the alleged infringer has produced evidence to
oppose the infringement allegation, his legitimate interests in protecting
manufacturing and business secrets must be taken into account.
 Art.34(2) makes clear that the obligation to reverse the burden may apply
in only one of the two above cases. During the negotiation, the European
Commission favoured the first option, while the United States preferred the
second.