Transcript Measures Necessary for the Balanced Co-Existence of Patents and Plant Breeders‘ Rights - From a European Perspective – Joseph Straus, Munich WIPO-UPOV Symposium on.

Measures Necessary for the Balanced Co-Existence
of Patents and Plant Breeders‘ Rights
- From a European Perspective –
Joseph Straus, Munich
WIPO-UPOV Symposium on the Co-Existence of Patents and Plant
Breeders‘ Rights in the Promotion of Biotechnological Developments
Geneva, October 25, 2002
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Factual & Legal Anomaly of the Interface Issue in Europe
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Remarks on Patentability of Plants, Scope of Patent Protection
and its Limitations
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Measures for the „Balanced Co-Existence“ of Patents & PBRs
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Some Reflections on the Necessary Balance
© J. Straus 2002
© J. Straus 2002
EU VC investments in the Life Sciences sectors
3000
Biotechnology
Medical/Health
Agriculture
millions of euro
2500
2000
1500
1000
500
0
1995
1996
1997
1998
1999
2000
H1 2001
YEAR
Fig. 2: Venture capital investments in the life sciences sectors in Europe.
VC investments in biotechnology and medical health increased steadily in recent years and are
now at 3,5% and 5% of total investment respectively. The VC investments in the agri sector have
strongly decreased from the mid 90s (2% of total VC investment) and now represent only 0.25%
of total VC investment.
© J. Straus 2002
US „Experimental Use Defense“
“..., regardless of whether a particular institution or entity is
engaged in an endeavour for commercial gain, so long as the act
is in furtherance of the alleged infringer‘s legitimate business and
it is not solely for amusement, to satisfy idle curiosity, or for
strictly philosophical inquiry, the act does not qualify for the very
narrow and strictly limited experimental use defense. Moreover,
the profit or non-profit status of the user is not determinative.“
[US CAFC of October 3, 2002 – John M.J. Madey v. Duke University]
© J. Straus 2002
China a global leader in the field?
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Research work on over 50 plant species and more than 120
functional genes
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On some 700.000 hectars - compared with 2000 in 1997
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90 % of field trials target insect and disease resistance
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Approved for commercialisation
– Cotton: insect resistance – reduced pesticide use by ~ 13
spraying (49.9kg/per hectare/season (i.e. $ 762
hectare/season))
– Tomato: virus resistance; Shelf-life altered
– Sweet pepper: virus resistance
– Petunia: colour altered
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Total benefits from the adoption of BT cotton in 1999 - $ 334
million
Huang et al., 295 Science 675 (2002)
© J. Straus 2002
Annex 1: The agricultural sector in Europe: Field trials and venture capital
investment between 1995-2001
Fig. 1: Field trials in Europe 1995-2001
E. Magnien
© J. Straus 2002
International Mandatory Standards for Protecting Inventions in Plants
under TRIPS Agreement
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Patents must be available for inventions whether products (also
foodstuff, pharmaceuticals, etc.) or processes in all fields of
technology, provided the usual patentability requirements are met
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Members may exclude from patentability plants and essentially
biological processes for their production other than nonbiological and microbiological processes
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Members have to protect plant varieties either by patents or by an
effective sui generis system or by any combination thereof
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However: Plants have to be protected as direct products of
patented non-biological and microbiological processes.
© J. Straus 2002
Patentable under EU Directive 98/44 of July 98 –
New EPC Rules
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Biological material, i.e. material containing genetic information
and capable of self replication, or reproduction in a biological
system, isolated from its natural environment or produced by
means of a technical process even it it previously occurred in
nature
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Plants, if the technical feasibility of the invention is not confined
to a particular plant variety (plant varieties generally excluded)
© J. Straus 2002
EU Directive 98/44/EC - Scope of Protection
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Product protection on a biological material extends to:
– Any biological material derived from the patented one through
propagation or multiplication in an identical or divergent form
and possessing those same characteristics.
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Protection of a product containing/consisting of genetic
information extends to
– All material in which the product (e.g. DNA sequence) is
incorporated and in which the genetic information is contained
and performs its function.
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Process protection extends to:
– Biological material directly obtained through that process
– To any other biological material derived from the directly
obtained one through propagation or multiplication in an
identical or divergent form and possessing those same
characteristics
© J. Straus 2002
Limits of the Scope of Protection
Statutory Research Exemption Based on Article 27 (b) CPC
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Covers any use of patented material for its further development,
improvements, detection of further uses, etc. – even if in pursuit
of commercial interests
[UK Court of Appeals – Monsanto v. Stauffer; BGH -
Clinical Trials I & II, confirmed by Federal Constitutional Court]
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Access to patented plant material secured through deposits in
publicly accessible depository institutions
© J. Straus 2002
Compulsory Cross-licensing
(EU Directive 98/44)
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If unsuccessfully applied for a contractual one,
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If the variety constitutes significant technical progress and if of
considerable economic interest
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Payment of an appropriate royalty
© J. Straus 2002
Balancing Measures to be Attempted
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In the U.S. and other laws without statutory „research exemption“
– introduction of such exemption clearly covering R & D activities
for developing new varieties of plants and plant germplasm in
general should be considered
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In Europe – with its not yet tested regime in practice – respective
clarifications should be envisaged
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In both systems rules of compulsory cross-licensing – i.e. of
patents and PBRs – either do not exist or are inadequate –
therefore in need of careful review based on empirical evidence
© J. Straus 2002
Some Reflections on the Necessary Balance
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Abelson‘s vision:
„Ultimately, the world will obtain most of its food, fuel, fibre,
chemical feed stocks and some of its pharmaceuticals from
genetically altered vegetation and trees.“ [279 Science 219 (1998)]
requires:
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Equal treatment of those contributing generic inventions in plants
and those breeding new varieties of plants
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Both groups necessitate and should have free access to protected
germplasm for R & D activities for the production of new plant
material and new varieties of plants
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All contributing must get a fair share in resulting benefits – free
riding at the expense of others not tolerable and counter
productive
© J. Straus 2002