Transcript Intellectual property - University of Sheffield

Aurora Plomer, BA, MA, LLB, PhD
Professor of Law & Bioethics
Director of SIBLE
University of Sheffield
[email protected]
Core Assumptions
of the Patent System

“Intellectual Property is a critical component of our
present and future success in the global economy.”

“The ideal IP system creates incentives for innovation,
without unduly limiting access for consumers and follow
on innovators. It must strike the right balance in a rapidly
changing world so that innovators can see further by
standing on the shoulders of giants.”
(Gower Report, 2006)
Ethical Rationale of IP
 Reward inventors for their work
Natural Right to Property
Locke (1690)/Nozick (1974)
 Incentive for investment & innovation
Utilitarian maximization of social welfare
(Un)Ethical Patents
Unjust Patents
 Unjust rewards: i.e. patents on ‘discoveries’ rather
than ‘inventions’, subject matter of the patent lacks
novelty/inventive step/utility
 Blocking patents
Patents on Unethical Inventions
 The subject matter of the patent - the invention- is
unethical per se (i.e. letter bombs).
What is patentable?
 1. The human body, at the various stages of its formation and
development, and the simple discovery of one of its elements,
including the sequence or partial sequence of a gene, cannot
constitute patentable inventions.
 2. An element isolated from the human body or otherwise
produced by means of a technical process, including the
sequence or partial sequence of a gene, may constitute a
patentable invention, even if the structure of that element is
identical to that of a natural element.
 3. The industrial application of a sequence or a partial sequence
of a gene must be disclosed in the patent application.
(UK Patents Act (1977) Regulations 2000, implementing EU Directive
Biotechnological Inventions (1998)
Moral Exclusions
Article 6(1)/Article 53(a)
Inventions shall be considered un patentable where
their commercial exploitation would be contrary to
ordre public or morality …
Article 6(2)/Rule 23(d)
(c) uses of human embryos for industrial or commercial
purposes
EU Directive on Biotechnological Inventions (1998)
The WARF Patent
 US Patents 780 and 806 contain broad, reach-through
claims on purified preparations of primate and
pluripotent ES cells and methods of isolating them.
The USPTO review board refused to invalidate the
patents on the basis of prior art & obviousness.
 The European patent was rejected on moral grounds
by the EPO. WARF’s appeal is awaiting judgment of
Enlarged Board of Appeal.
 Stem Cell Patents Report (2006) argues that the EU
Directive does not preclude the grant of patents on
hESC derivatives.
Displaced Moral Discourse?
 The ‘moral’ question which is the focus of attention at the
EPO properly belongs to social debates on the morality of
research within the distinct moral and legal cultures of
each European State.
 Patent offices lack the competence or legitimacy to settle
questions on research involving morally contested
technologies.
 The focus on the ethics of hESC patents is obscuring the
ethical, social, economic and legal issues relating to the
hESC patents already granted by national patent offices in
Europe.
 Patents have only national/territorial validity
 A patent granted by the EPO may be revoked or
invalidated by national jurisdictions.
 Applicants may concurrently file applications at the
EPO and at national patent offices.
 National patent offices retain the right to grant
national patents.
UK Stem Cell Patents
 The UK patent office has granted a number of
foundational patents on hESCs
(Plomer, Taymor & Scott, Cell Stem Cell (2008)
 The existence of the patents is not widely known,
neither is their potential scope and reach
(IP Workshop, UK Stem Cell National Network, Inaugural Conference,
Edinburgh, April 2008).
 Some of these patents are very broad and cover a wide
range of research taking place in the UK
(Plomer & Denning, Patents on Cardiomyocytes, forthcoming)
 Scientists working within the patents are infringing.
 There is no clear ‘research exemption’ defence in
English law (Gower, 2006).
Distribution UK grants per
patentees country of residence
Australia, 1, 1.39%
Ireland, 1, 1.39%
Cyprus, 1, 1.39%
New Zealand, 1, 1.39%
India, 1, 1.39%
Taiwan, 1, 1.39%
Canada, 1, 1.39%
Total Number =
72
Germany, 3, 4.17%
Sweden, 2, 2.78%
US, 26, 36.11%
South Korea, 2, 2.78%
Japan, 3, 4.17%
France, 6, 8.33%
Singapore, 8, 11.11%
UK, 15, 20.83%
Number of Patents per US Based Institution
Charles Rosenkrans Jr., 1
Salk
Institute, 1
Wistar
Inst., 1
Total Number
= 26
XY INC, 3
Denis Eon Solomon, 1
Geron Corp., 14
e Regents of the University of
California, 1
UAB Res Foundation, 1
Wisconsin Alumni Res Foundation,
1
US Gov, 1
Some Patents under the Radar
 GB2415781B2
 Genes that are up- or down-regulated during
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differentiation of human embryonic stem cells
GB2412379B2
Hematopoietic cells from human embryonic stem cells
GB2393734B2
Cells of the cardiomyocyte lineage produced from
human pluripotent stem cells
GB2379447B2
Neural progenitor cell populations
Could GB Patent 393734 B have been averted?
The scientific community has the power to
influence patent scrutiny pre-grant
Following publication of a patent application
21.-(1) …. any other person may make observations in
writing to the comptroller on the question whether the
invention is a patentable invention, stating reasons for
the observations, and the comptroller shall consider
the observations in accordance with rules.
(UK Patents Act 1977)
Conclusion:
What can/should the scientific community do?
 Assist in the identification and evaluation of systemic
institutional and structural weaknesses in training,
patent awareness and access to patent data.
 Encourage/forster culture of patent awareness and
engagement with the patent system.
 Participate in social debates about the ethical, legal
and social impact of advances in the biosciences on the
patent system and vice-versa.