Patenting lives

Document Sample
Patenting lives Powered By Docstoc
					    WIPO: Life Sciences symposium:
           IP and Bioethics

A framework for looking at IP and Bioethics

                     September 2007
                     A.S.Taubman
                     Global IP Issues
                     Division, WIPO
bioethics?

   as against ethics, moral issues writ large?
    –   what is distinctive about life sciences?
   is it about outcomes?
    –   a moral judgement as to right and wrong?
    –   who decides, and on what basis?
   is it about a way of making policy choices?
    –   consultation, consent, a broader framework?
   is it a judgement on behaviour?
    –   what kinds of research activities, ways of doing
        business do we favour?
IP and bioethics: law or ethics?

   IP systems largely a creature of statute
    –   Law vs. ethics:
        what is ethical aspect of lawmaking guided by public policy?
    –   Ethically neutral?
        Or policy space for ethical considerations?
    –   Law vs. morality: question of patentability of morally
        questionable technologies
   „Natural rights‟ basis for [some] IP laws and
    principles
    –   Article 15.1(c) ICESCR, Art 27.2 UDHR
   but strong utilitarian flavour to IP law and policy,
    increasingly emphasized in current debate on IP as
    a tool of public policy
    –   Article 7, TRIPS
distinguish…

   ethical aspects of a technology as such


   ethical aspects of national authorities granting IP


   ethical aspects of an individual seeking exclusive IP


   ethical aspects of the forms of exercising IP rights
distinguish…

   ethical aspects of a technology as such
    –   e.g. the ethics of stem cell research


   ethical aspects of national authorities granting IP


   ethical aspects of an individual seeking exclusive IP


   ethical aspects of the forms of exercising IP rights
distinguish…

   ethical aspects of a technology as such


   ethical aspects of national authorities granting IP
    –   e.g. ethics of a patent office granting patents on life forms


   ethical aspects of an individual seeking exclusive IP


   ethical aspects of the forms of exercising IP rights
distinguish…

   ethical aspects of a technology as such


   ethical aspects of national authorities granting IP


   ethical aspects of an individual seeking exclusive IP
    –   e.g. ethics of a public funded agency patenting research)


   ethical aspects of the forms of exercising IP rights
distinguish…

   ethical aspects of a technology as such


   ethical aspects of national authorities granting IP


   ethical aspects of an individual seeking exclusive IP


   ethical aspects of the forms of exercising IP rights
    –   e.g. ethics of licensing patents key medical technologies).
distinguish…

   ethical aspects of a technology as such
    –   e.g. the ethics of stem cell research


   ethical aspects of national authorities granting IP
    –   e.g. ethics of a patent office granting patents on life forms


   ethical aspects of an individual seeking exclusive IP
    –   e.g. ethics of a public funded agency patenting research)


   ethical aspects of the forms of exercising IP rights
    –   e.g. ethics of licensing patents key medical technologies).
?
Some distinctions

   Ethics and IP law and practice
    –   In the sense of guidance for right behaviour
    –   e.g. When is consent regarding seeking IP an
        ethical question?
   Morality and IP law and practice
    –   In the sense of determining innate right & wrong
    –   e.g. substantive references to „morality‟ in IP laws
            Exclude patent protection for technologies the
             exploitation of which would be contrary to morality
            Trademarks contrary to morality
            „Moral rights‟ in copyright and related rights
   International law: States may exclude from
    protection inventions on morality grounds
        (Article 27.2, WTO TRIPS Agreement).
   States agree to leave space for morality
    considerations to apply at the domestic level:
    –   They then have the option to create a specific morality
        exception within their own national patent laws.
    –   In exercising such an exception, a decision maker working
        within the national system may be required to undertake a
        specific ethical judgment about a particular technology.
distinguish…

   ethical aspects of a technology as such
    –   e.g. the ethics of stem cell research


   ethical aspects of national authorities granting IP
    –   e.g. ethics of a patent office granting patents on life forms


   ethical aspects of an individual seeking exclusive IP
    –   e.g. ethics of a public funded agency patenting research)


   ethical aspects of the forms of exercising IP rights
    –   e.g. ethics of licensing patents key medical technologies).
the BRCA gene patent
IP and bioethics: some themes

   Transparency
   Consent
   Benefit sharing
   Crossover between law and morality
   Accommodating different value systems
Transparency in the patent system

Transparency as the basis for ethical scrutiny of relevant
  technologies
Patent information systems used to monitor:
       trends and background in key technologies
       state of the art in key technologies
       research and patenting activities of
    firms/institutes/individuals

But need for improved use/access of patent information,
  and value-added information products to guide
  policymaking
250


200


150


100


 50


  0
      1980   1983   1986     1989    1992     1995    1998     2001    2004

International patent applications on human, animal or plant cell lines by year of
publication (Source: Patentscope)
MC/C12N-5/08 PCT publications 1995-
        2007 by applicant




                               Public
                               Public/Private
                               Private
Source: Wikimedia Commons. Permission is granted to copy, distribute and/or modify this document under the terms of the GNU Free
Documentation License, Version 1.2 or any later version published by the Free Software Foundation; with no Invariant Sections, no Front-
Cover Texts, and no Back-Cover Texts. A copy of the license is included in the section entitled "GNU Free Documentation License".
NOVEL BIODEGRADABLE AGRICULTURAL AND PHARMACEUTICAL
FORMULATIONS BASED ON COW URINE, NEEM AND OTHER HERBS,
EFFECTIVE AS PEST REPELLENT, PLANT IMMUNO-STIMULANT, PLANT
GROWTH PROMOTING AND ANTI-FUNGAL AGENT.


Application 1104/MUM/2002 published 2005-01-28, filed 2002-12-09 A process for
production of sustained release formulation based on active fraction of cow urine
with herbs which is useful as pest repellant, plant immunostimulant and plant
growth promoting agent is described. The characteristic features are:- 1) There is
combination of fraction of cow urine with extracts of some active herbs. 2) Dried
mixture is palletized with the help of suitable binders. 3) The pellets are coated wit
suitable polymers to controlled/desired release rate. 4) The product is
biodegradable, ecofriendly and polyfunctional.
Applicant
DORLE AVINASH KESHAV & 16 OTHERS
42, RAMNAGAR, PIROJSHANAGAR, NAGPUR: 440 010, MAHARASHTRA,
INDIA. Inventor
AS ABOVE. International Info
Classification:
United States Patent 6,410,059
Khanuja , et al. June 25, 2002
Pharmaceutical composition containing cow urine distillate and an
  antibiotic

A pharmaceutical composition comprising an antibiotic and cow urine distillate
   in an amount effective to enhance antimicrobial effect of the antibiotic is
   disclosed. The antibiotic can be an antifungal agent. The antibiotic can be a
   quinolone or a fluoroquinolone. The antifungal agent can be azoles,
   clotrimazole, mystatin or amphotericin.

Inventors: Khanuja; Suman Preet Singh (Lucknow, IN), Kumar; Sushil
   (Lucknow, IN), Shasany; Ajit Kumar (Lucknow, IN), Arya; Jai Shankar
   (Lucknow, IN), Darokar; Mahendra Pandurang (Lucknow, IN), Singh;
   Monika (Lucknow, IN), Sinha; Prachi (Lucknow, IN), Awasthi; Soumya
   (Lucknow, IN), Gupta; Subhash Chandra (Lucknow, IN), Gupta; Vivek
   Kumar (Lucknow, IN), Gupta; Madan Mohan (Lucknow, IN), Verma; Ram
   Kishore (Lucknow, IN), Agarwal; Sweta (Lucknow, IN), Mansinghka;
   Sunil Balkrishna (Nagpur, IN), Dawle; Suresh Haribhau (Nagpur, IN)

Assignee: Council of Scientific and Industrial Research (New Delhi, IN)
Citations: U.S. 6231849 May 2001 Schiller, Japan 3039865 May2000
Traditional chinese medicine
180

160

140

120

100

 80

  60

  40

  20

      0
          IGC 1 IGC 2
                      IGC 3 IGC 4
                                    IGC 5   IGC 6   IGC 7
                                                            IGC 8   IGC 9   IGC 10
                                                                                     IGC 11
inclusion and consultation
               NGO accreditation to the IGC




                       Where accredited organizations are active

      1 organization        2 to 5 organizations     more than 5 organizations
Traditional knowledge and IP

 “indigenous peoples have rarely placed
 anything in the so called „„public domain‟‟, a
 term without meaning to us . . . the public
 domain is a construct of the IP system and
 does not take into account domains
 established by customary indigenous laws”
                                - Saami Council
Traditional knowledge and IP

   misuse of TK can cause severe physical or spiritual
    harm to the individual caretakers of the knowledge or
    their entire tribe from their failure to ensure that the
    Creator‟s gifts were properly used, even if misuse was
    used by others outside of the tribe, or by tribal
    members who were outside of the control of customary
    authority.
   For this reason . . . misappropriation and misuse [is]
    not simply a violation of „„moral rights‟‟ leading to a
    collective offense, but a matter of cultural survival for
    many indigenous peoples.
                                                 – Tulalip Tribes
IP and the sharing of benefits

   UNBHR: equitable access to medical,
    scientific and technological developments as
    well as the greatest possible flow and the
    rapid sharing of knowledge concerning those
    developments and the sharing of benefits,
    with particular attention to the needs of
    developing countries;
IP in research agreements

 UNBHR: When negotiating a research
 agreement, terms for collaboration and
 agreement on the benefits of research
 should be established with equal
 participation by those party to the
 negotiation. (art 21.4)
IP and bioethics
in the innovation process

   research policy and planning
   the research phase
   the acquisition of IP rights
   the use of new technology, and exercise IP
    of rights
 reviewing IP and bioethics issues throughout the
 technology development pipeline




Ideally: each stage guided by an overarching
conception of workable, equitable and effective
arrangements for innovation in the public interest,
consistent with legitimate private interests
-- the ethical basis of good public policymaking?
a concluding example

   many have called for an „open source‟
    approach to biotechnology

   what are the bioethics-IP implications?
“should”

   protection of IP “should contribute 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.”

                             WTO TRIPS Agreement, art. 7
but what is the nature of that „should‟?

   “should” - as
    –   ethical (deontological),
    –   ethical (utilitarian),
    –   legal (obligatory)
    –   aspirational, or
    –   predictive?
   within legal text, guide to broader interpretation
   within policy context, guide to policymaker – an
    heuristic?
   what message to life science policymakers?
   if one should encourage or adopt „open source‟
    innovation in the life sciences
    –   prudential – it is good for you, it serves your objective interests;
    –   ethical: any „right thinking person‟ would do so;
    –   social utilitarian: – it yields overall welfare outcomes;
    –   legal – you must do it, whether or not it is in your real or
        perceived interests.
   Each has been made for „open source‟ approaches to
    life sciences innovation.
   How does the nature of the „should‟ depend on who and
    where you are?
two layers of „should‟

   essence of IP policymaking is setting what legally defined
    exclusivities over knowledge resources will advance innovation, fair
    competition and public welfare, and how those exclusivities should
    be shaped and governed.
     –   some „open source‟ ideas hard-wired at the legislative level (or can be)

   individual holders of exclusive rights are also presented with a range
    of obligations – ethical and legal - and motivations.
     –   when and how is there a convergence of the overall architecture of the
         IP system, the interests and behaviour of players within that system,
         and the kinds of modes characterized as open source in the life
         sciences?
some approaches to IP and bioethics…

    bioethics within the law of patents: the scope
     for judgements about morality in
     assessments on patentability
    bioethics considerations in consultations on
     policymaking
    bioethics as a guide to practice in medical
     research and in business
    bioethics and fundamental rights and
     responsibilities

				
DOCUMENT INFO