PGRS and the Associated Traditional Knowledge: Does the

1
PGRS and the Associated Traditional Knowledge
Does the Distinction Between Lower and Higher
Life forms Matter?
Patenting Lives Law, Culture and Development
London, United Kingdom December 1-2, 2005
Chika B. Onwuekwe, LL.M, Ph.D Assistant Professor
of Law and Society University of Calgary, Alberta
2
Outline

• Introduction
• Paragraph 19 of 2001 WTO Ministerial Declaration
  at Doha
• Patentable Subject Matter (TRIPs v. National
  Patent Laws)
• The Nature of PGRs Associated TKN
• Debate over Patentability of Life Forms (Higher
  or Lower)
• Conclusion

3
Introduction

• The 1999 botched WTO meeting in Seattle
• Build up by members after Seattle Article
  27.3(b)
• Issues TKN on uses of PGRs, Patents on life
  forms, TRIPs sui generis, CBDs benefit sharing,
  Compulsory licensing, et al
• PGR TKN Common Heritage of Humankind?
• The Doha Ministerial Doha Development Agenda
• North vs. South divide (on patentable subject
  matter, et al)

4
Paragraph 19 of Doha Declaration

• Paragraph 19 of Doha Declaration
• - examine the relationship between TRIPs CBD
• - review modalities for the protection of TKN
  folklore
• - consider other relevant new dev. - re
  Article 71.1
• Thrust of Doha Declaration
• - most WTO member states are unsatisfied with
  TRIPs
• Nature of Task for Council for TRIPs
• - clear concerns on patentable subject matter
  (Art. 27.3) life forms?
• - build consensus on best way(s) to integrate
  TRIPs CBD

5
Patentable Subject Matter

• Articles 27(1)(2) of TRIPs general guidelines
  on patentable subject
• - provide patents for any inventionsin all
  fields of technology Article 27(1)
• - invention must be novel, involve inventive
  step and be capable of industrial application
• - permits denial of patents to innovations
  deemed/judged morally unacceptable Art. 27(2)
• Thrust of Articles 27(1)(2) of TRIPs
• - each country is free to determine patentable
  subject matter(s)
• - More power/freedom to exclude in Article
  27(3)(b)

6
Patentable Subject Matter (contd.)

• Article 27(2) of TRIPS
• Members may exclude from patentability
  inventions, the prevention within their territory
  of the commercial exploitation of which is
  necessary to protect ordre public, or morality,
  including to protect human, animal or plant life
  or health or to avoid serious prejudice to the
  environment"
• No universally accepted test for morality

7
Nature of PGRs Associated TKN

• Proprietary interest in PGRs TKN
• CBDs regime (with source country as trust
  holder of cultural and intellectual heritage?)
• Liberal property v. communal property concepts
• Property right as a social construct
• Diverse world and inclusive solution (to promote
  biodiversity, encourage holders of TKN, breed
  life into Art. 8(j) of CBD, etc.)

8
Nature of PGRs Associated TKN

• Problems
• Definition of Prior Art in relation to TKN
• Novelty standard for patentability
• Oral tradition public domain of TKN
• Query Should writing be the ultimate test for
  prior art?
• Adequacy of Information on Prior Art
• Development of databases on TKN
• Patent applicants to disclose any TKN used

9
Debate over Patentability of Life Forms (Higher
or Lower)

• Article 27.3.
• Members may also exclude from patentability
•     (a)     .
•     (b)     plants and animals other than
  micro-organisms, and essentially biological
  processes for the production of plants or animals
  other than non-biological and microbiological
  processes. However, Members shall provide for
  the protection of plant varieties either by
  patents or by an effective sui generis system or
  by any combination thereof. The provisions of
  this subparagraph shall be reviewed four years
  after the date of entry into force of the WTO
  Agreement

10
Debate over Patentability of Life Forms (Higher
or Lower)

• Developing countries (Africa, India, Brazil,
  Indigenous People, etc.)
• - no one can own what exists in nature
• - religious reasons (playing god argument)
• - moral, ethical and social reasons
• Indigenous Peoples Statement on Art. 27.3(b)
  TRIPs
• This Article makes an artificial distinction
  between plants, animals and micro-organisms and
  between (essentially biological) and
  (microbiological processes) for making plants and
  animals. As far as we are concerned all these
  are life forms and life creating processes which
  are sacred and should not become the subject of
  proprietary ownership.

11
Debate over Patentability of Life Forms

• Technology advanced countries (G7/G8 countries)
• - European Union (ordre public/moral
  limitations? Reconcile with EU Biotech Directive
  subsequent Harvard mouse patent)
• - United States (anything under the sun and
  made by man is patentable Chakrabarty
  Harvard mouse patents)
• - Canada (no moral limitations in Patent Act
  cf. Harvard mouse (2002) Monsanto v. Schmeiser
  (2004) cases)
• The civil society NGOs idea of moratorium

12
Debate over Patentability of Life Forms

• SCC held that Monsantos patent (on higher life
  form) was valid. Court stated (at para. 903)
• The respondents did not claim protection for
  the genetically modified plant itself, but rather
  for the genes and the modified cells that make up
  the plant. A purposive construction of the
  patent claims recognizes that the invention will
  be practised in plants regenerated from the
  patented cells, whether the plants are located
  inside or outside a laboratory

13
Conclusion

• The commons concept debate - PGRs and TKN
• Knowledge as public good?
• Patents on life forms re items of discovery?
• Reconcile various interests with biotech dev.
• Patentable subject matter who benefits?

14
Conclusion

• Patents Does the distinction between higher
  lower life forms (really) matter?
• - Redefine the criteria for patent protection?
• - Patent as reward for (disclosed) invention v.
  CBDs benefit sharing
• - Morality is culture specific

15
THANK YOU
Feb. 8, 2003