Overview of Public Health-Related TRIPS Flexibilities

1
Overview of Public Health-Related TRIPS
Flexibilities

• Sisule F. Musungu,
• IQsensato
• (http//www.iqsensato.org)

2
Conceptual and Legal Basis for Flexibilities

• The Preamble
• There are three important paragraphs in the
  Preamble of the TRIPS Agreement that are relevant
  to public health considerations. First, there is
  the recognition that IPRs are private rights.
  This paragraph is particularly relevant with
  respect to enforcement of IPRs. Second, is the
  paragraph recognizing the public policy
  objectives underlying the protection of IP,
  including developmental and technological
  objectives. Finally, is the recognition of the
  special needs of least-developed countries (LDCs)
  which necessitate maximum flexibility in the
  domestic implementation of laws and regulations
  in these countries with a view to enabling them
  establish a viable technological base.

3
Conceptual and Legal Basis for Flexibilities

• The Objectives of IP Protection under TRIPS (art
  7)
• The protection of IP contributing to the
  promotion of technological innovation and to the
  transfer and dissemination of technology, to the
  mutual advantage of producers and users of
  technological knowledge and in a manner conducive
  to social and economic welfare, and to a balance
  of rights and obligations

4
Conceptual and Legal Basis for Flexibilities

• Principles for Guiding the formulation of
  implementing legislation (art 8)
• Members in formulating or amending their laws
  may adopt measures necessary for the protection
  of public health and nutrition and take measures
  to promote public interests in sectors of vital
  importance to their socio-economic and
  technological development and, they may adopt
  appropriate measures to prevent the abuse of IPRs
  by right holders or the resort by them to
  practices that unreasonably restrain trade or
  adversely affect the international transfer of
  technology.

5
Freedom to determine Appropriate Method of
Implementing TRIPS Obligations

• Article 1
• The relevant provisions here are the provisions
  of paragraph 1 which provides inter alia that WTO
  Members may, but shall not be obliged to,
  implement in their law more extensive protection
  than is required and that they shall be free
  to determine the appropriate method of
  implementing the provisions of the Agreement.
  See India-Mailbox case Appellate Body (AB)
  interpretation

6
Freedom to Determine Exhaustion Regime (parallel
imports)

• Article 6
• The TRIPS Agreement states that the issue of
  exhaustion is left to each Member to decide. In
  other words, TRIPS does not create minimum
  standards on this matter. The Doha Declaration on
  the TRIPAS Agreement and Public Health confirms
  this interpretation of article 6 in Para....
  Which provides that .........

7
Patentable Subject Patentability Criteria

• Article 27
• 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 its 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.

8
Permissibility to Impose Certain Conditions on
Patent Applicants

• Article 29
• Article 29 in addition to establishing one
  mandatory disclosure condition also establishes
  two optional condition that WTO Members may
  require patent applicants to fulfil before they
  are granted patent rights. The mandatory
  requirement is that Members shall require that
  the 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. This is what in
  patent law is commonly referred to as enabling
  disclosure. The two optional disclosure
  conditions, that is conditions which WTO Members
  may choose to impose on applicants, are (1) that
  Members may require the applicant to indicate the
  best mode for carrying out the invention as known
  to the inventor at the filing date, or where
  priority is claimed at the date of the priority
  claim and (2) that they may require the
  applicant for a patent to provide information on
  corresponding foreign applications and grants.

9
Freedom to include Exceptions to Patent
Rights, subject to three-Step-Test

• Article 30
• Article 30 of the TRIPS Agreement establishes
  the general parameters for exceptions to the
  exclusive rights envisaged in article 28 the
  Agreement. The rule is that exceptions to the
  patent rights are permissible provided that,
  taking into account the legitimate interests of
  third parties, the exceptions (1) must be
  limited (2) should not unreasonably conflict
  with the normal exploitation of the patent and
  (3) should not unreasonably prejudice the
  legitimate interests of the patent owner. Note
  there is no closed list of exceptions but
  includes, among others, research and
  experimentation exception, the early working
  exception (bolar exception), preparation of
  medicines for personal use and prior use.

10
Freedom to Issue Determine the Grounds for
Issuing Compulsory Licenses

• Article 31
• In addition to the exceptions permitted under
  article 30, which can be used without any other
  formal requirement other than fulfilling the
  three-step-test, article 31 of TRIPS establishes
  an additional exception, referred to in the
  Agreement as use without the authorisation of the
  right holder, and special rules for the use of
  the exception. In common parlance, compulsory
  licensing. Compulsory licensing as a policy
  mechanism can be used to address a number of
  situations in the context of public health
  including, among others high prices of
  medicines anti-competitive practices by
  pharmaceutical companies failure by
  pharmaceutical patent holders to sufficiently
  supply the market with needed medicines
  emergency public health situations and, the
  needs for establishing a pharmaceutical
  industrial base.

11
Freedom to Revocation Patents and Require
Forfeiture subject to Judicial Review

• Article 32
• The TRIPS Agreement does not regulate the
  question of revocation or forfeiture. The
  Agreement only imposes a procedural requirement
  to be met in cases of revocation or forfeiture a
  patent. In particular, article 32 provides that
  An opportunity for judicial review of any
  decision to revoke or forfeit a patent shall be
  available. In certain circumstances, a patent
  can be revoked or forfeited. Various grounds for
  revocation and forfeiture exist in national laws.
  Under the European Patent Convention (CPC), for
  example, a patent can be revoked if it is
  determined that the invention did not meet any
  of the patentability criteria the patent was
  granted to a person not entitled to it and
  failure to provide enabling disclosure.

12
No Requirement for Patent Term Extension

• Article 33
• The TRIPS Agreement, under article 33,
  establishes the patent term to be at least 20
  years from the filing date. The length of this
  period is of critical importance. The longer the
  period, the longer the monopoly on the protected
  product or process.

13
Except for Process Patents no Reversal of Burden
of Proof in Infringement Actions

• Article 34
• The general rule of evidence is that he who
  alleges proves. This general rule applies under
  TRIPS except with respect to process patents. In
  this regard, article 34 provides that, subject to
  the conditions set out under the article where
  there is a patent for obtaining a product, the
  defendant can be ordered to prove that the
  process for obtaining an identical product is
  different from the patented process

14
Protection of Undisclosed Information No Data
Exclusivity Requirement

• Article 39
• In addition to patent protection for
  pharmaceuticals, the TRIPS Agreement also
  requires protection for test data that may be
  submitted by pharmaceutical and agro-chemical
  companies to regulatory authorities. The article
  provides that in ensuring the effective
  protection against unfair competition as provided
  for in article 10bis of the Paris Convention
  Members, when requiring, as a condition of
  approving the marketing of pharmaceutical or of
  agricultural chemical products which utilize new
  chemical entities, the submission of undisclosed
  test data or other data, the origination of which
  involves a considerable effort, shall protect
  such data against disclosure. Article 39
  therefore only requires protection of test data
  from unfair competition when such data relates to
  new chemical entities and where the origination
  of the data involved considerable effort and
  provides for exceptions, such as where disclosure
  is necessary to protect the public

15
Freedom to Control of Anti-competitive in
Contractual Licenses

• Article 40
• The article establishes a regime for the control
  of anti-competitive practices in contractual
  licenses which allows countries to prohibit the
  use of terms such as exclusive grant back
  clauses, clauses that preclude challenges to
  validity of the patent and coercive packaging.

16
Flexibilities in the TRIPS Enforcement Regime

• Part III (21 articles)
• The minimum standards established here cover
  from general obligations on enforcement to
  specific rules on evidence, injunctions, damages,
  remedies, border measures as well as the
  application of criminal procedures. the
  provisions on enforcement have a direct impact of
  public health because they determine the
  practical effect of patent rights at the national
  level including the extent to which the
  individuals and groups can protect their access
  to medicines. For example, while article 44(2)
  permits members to exclude government use
  licenses from injunctions, if this is not done,
  pharmaceutical companies can easily frustrate
  governments effort to acquire essential medicines
  even in the cases of emergency by obtaining
  injunctions. Another example relates to the
  balance of rights between applicants and
  defendants contemplated in article 42. Ensuring
  that both the patent holder and defendants have
  practical means of exercising the rights
  contemplated is important to public health
  policy.

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Transition Periods

• Articles 65 66.1
• 1996 for developed
• 2000 2005 for developing countries
• 2005, 2013 2016 for LDCs