Business Law Plant Patents and Genetics Essay

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1.  After watching “Seeds of Freedom”, summarize the arguments in favor of protecting plant patents in terms of incentivizing innovation to develop crops that are higher yielding and pest resistant vs the inherent problems of the domination of large multinational companies on international agriculture markets.

2.  After watching “Pig and a Patent” summarize the arguments in favor of genetic modifications of animals and the patents associated with such modifications as well as the arguments against it.

3.  After watching “Cracking your Genetic Code”, summarize the arguments in favor of genetic coding in the advancement of medicine and the arguments against the collection of genetic codes from people in terms of privacy and how that can be abused (for instance, with pricing or eligibility for health insurance coverage).

Intellectual Property Issues:
Plants and Microorganisms
Criteria for U.S. Patent
•Novelty (New)
•Utility (Useful)
•Non-obvious
Types of Patents
• Utility
• Plant
• Design
Plant Patents
• Newly-discovered, asexually propagated plants
• invented or discovered and asexually reproduced a
distinct and new variety of plant, other than a tuber
propagated plant or a plant found in an uncultivated
state
• 20 years from the date of filing the application
• exclude others from asexually reproducing, selling, or
using the plant so reproduced
Types of Asexual Reproduction
Rooting Cuttings
Grafting and Budding
Apomictic Seeds
Bulbs
Division
Slips
Layering
Rhizomes
Runners
Corms
Tissue Culture
Nucellar Embryos
Biotechnology Issues
• Protect Plant genes
• Utility patent, NOT plant patent
• Control use of genetic material
• Number of different plants
• Multiple uses
• disease resistance
• herbicide resistance
• pharmaceutical production
• oil production
Biological Patent Historical Timeline I
• 1873 – Louis Pasteur: disease-free yeast
• 1980 – Chakrabarty: Pseudomonas bacterium (microorganism) that “ate”
(broke down) petroleum (oil)
• 1985 – Hibberd Patent: USPTO awarded patent to Molecular Genetics and
Research and Development (tryptophan-overproducing maize)
Biological Patent Historical Timeline II
• 1987 – Patent for polypoid oysters (multicellular organism – nonhuman)
• 1988 – Harvard “onco-mouse”: transgenic animal
• 1993 – Agrecetus Company, USA: patent for all geneticallyengineered cotton varieties
Biological Patent Historical Timeline III
• 1994 – Agrecetus Company, USA: patent for all geneticallyengineered soybean varieties in Europe
• 1995 – NIH: patent for all ex vivo gene therapies
IP Protection for Plants I
• Plant Patent Act of 1930
• Restricted to asexually propagated plants
• Over 6500 patents issued (mostly roses and fruit trees)
IP Protection for Plants II
• Plant Variety Protection Act of 1970
• Confers limited period of legal control to breeders of
sexually reproduced or tuber propagated plant varieties.
• Term of protection:
• 20 years from the certificate’s date of issue
• 25 years in the case of a tree or vine
IP Protection for Plants III
• International Union for the Protection of
New Varieties of Plants (UPOV)
• Intergovernmental organization in Geneva, Switzerland
established by the International Convention for the
Protection of New Varieties of Plants (adopted in Paris in
1961, revised in 1972, 1978 and 1991)
• Establishes basic legal principles of protection by
providing the breeders exclusive rights to their plant
invention for a specific period of time, while making
available the genetic material to others to use in their
breeding programs
IP Protection for Plants III
• UPOV (continued)
• an effective system of intellectual property protection
to provide incentives for innovation by permitting
breeders to recover their investment and, at the same
time, encourage the development of new plant
varieties
Plant Variety Protection Act of 1970
• Plant variety certificate gives the breeder the right
to exclude others from selling the variety, or
offering it for sale, or reproducing it, or importing
it, or exporting it, or using it in producing (as
distinguished from developing) a hybrid or
different variety.
Plant Variety Protection Act of 1970
• To be eligible for a certificate under the
PVPA;
• Four (4) Requirements:




New
Distinct
Uniform
Stable
Plant Variety Protection Act of 1970
1)Must be new, in the sense that propagating or
harvested material has not been sold or
otherwise disposed of for purposes of
exploitation for more than one year in the
United States, or more than four years in any
foreign jurisdiction (or six years in the case of a
tree or vine).
Plant Variety Protection Act of 1970
2) Variety must be distinct — that is, clearly
distinguishable from any other publicly
known variety. Distinctness may be based
on one or more identifiable morphological,
physiological, or other characteristics,
including commercially valuable
characteristics affecting activities such as
milling and baking (in the case of wheat).
Plant Variety Protection Act of 1970
3) Variety must be uniform, in the sense that
any variations are describable, predictable,
and commercially acceptable.
4) Variety must be stable, in the sense that
the variety, when reproduced, will remain
unchanged with regard to its essential and
distinctive characteristics within a
reasonable degree of commercial reliability.
Microorganisms
• 1980 – Diamond v. Chakrabarty: U.S. Supreme Court case (ruling was 5-4)
holding that “a live, human-made micro-organism is patentable subject
matter….the micro-organism constituted a “manufacture” or “composition of
matter” within the statute.
• Pseudomonas bacterium (microorganism) that “ate” (broke down)
petroleum (oil)
Budapest Treaty on the International Recognition
of the Deposit of Microorganisms for the Purposes
of Patent Procedure (1977) – World Intellectual
Property Organization
• The treaty allows “deposits of microorganisms at an
international depositary authority (IDA) to be
recognized for the purposes of patent procedure”.
• To meet the legal requirement of sufficiency of
disclosure, patent applications and patents must
disclose in their description the subject-matter of
the invention in a manner sufficiently clear and
complete to be carried out by the person skilled in
the art
Budapest Treaty (1977)
• When an invention involves a microorganism,
completely describing said invention in the
description to enable third parties to carry it out is
usually impossible.
• This is why, in the particular case of inventions
involving microorganisms, a deposit of biological
material must be made in a recognized institution.
Budapest Treaty (1977)
• The Budapest Treaty ensures that an applicant, i.e.
a person who applies for a patent, needs not to
deposit the biological material in all countries
where he/she wants to obtain a patent.
• The applicant needs only to deposit the biological
material at one recognized institution, and this
deposit will be recognized in all countries party to
the Budapest Treaty.
Potential Uses and Benefits
• Improved Food Quality
• Improved Nutritional Quality
• Increased Tolerance
• Viral Diseases
• Bacterial Diseases
• Insect pests
• Bioreactors
• Immunotherapeutic Agents (MAB)
• Proteins (Insulin)
Potential Uses and Benefits
• Research Tools
• Therapeutic
• Environmental “clean-up”:
• Breakdown petroleum
• Water and Soil contamination
• Heavy metals (Lead, Mercury, Arsenic, Cadmium)

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