Principles of Plant Genetics and Breeding

262 CHAPTER 15
technology (e.g., the so-called “terminator technology”)
in their products to prevent farmers from using seed
from harvested proprietary material for planting in the
field the following season? For balance, is it fair to expect
a company to invest huge amounts of resources in an
invention and not recoup its investments? There are no
easy answers to these questions.
International issues in patenting
Courts in Europe and the USA, as well as other parts
of the world, differ in their positions on patent issues.
Patent laws and how they are enforced may also differ
among nations. For example, the European Directive
on the Legal Protection of Biotechnological Inventions
passed in 1998 declares that a mere discovery of the
sequence or partial sequence of a gene does not constitute
a patentable invention. Genes are not patentable
while they are in the body (in situ). However, genes
isolated from the organism or artificial copies of the
genes produced by some technical process may be
patentable, provided the novelty, inventive step, and
utility are clearly demonstrated. The US laws have
been tightened to include a clause to the effect that the
utility of the invention must be “specific, substantial,
and credible” (i.e., readily apparent, well-established
utility).
In addressing the issue of morality, the European
Directive also specifically excludes certain inventions
from patentability. These include processes for reproductive
cloning of human beings, processes for modifying
the germline genetic identity of human beings, and
uses of human embryos for industrial or commercial
purposes. Essentially, if the publication or exploitation
of an invention would generally be considered immoral
or contrary to public order, it cannot be patented.
Protecting plant varieties:
a brief history of US efforts
Intellectual property rights issues impact plant breeders,
researchers, producers, seed companies, as well as consumers.
A formal specific government protection for
plant varieties in the USA was first implemented in
1930. Called the Plant Patent Act, it was (and still is)
limited to clonally (vegetatively) propagated plants. The
International Union for the Protection of New
Varieties of Plants (UPOV) was established in 1961.
Protection of all new plant varieties was first adopted in
the USA in 1970 under the Plant Variety Protection
(PVP) Act of 1970. This act was amended in 1994,
when the US implemented the UPOV Act of 1991. As
previously indicated, the use of utility patents for plant
variety protection was made possible following the US
Supreme Court ruling in favor of Chankrabarty in 1980,
declaring that “anything under the sun that is made
by man” may be patented. This ruling originally pertained
to microorganisms. However, the US Patent and
Trademark Office extended patent protection to plant
varieties in 1985. Plant variety protection in Canada
is presented in the second industry highlights box in
Chapter 24 (p. 442).
A plant breeder wishing to patent a plant variety in the
USA currently has three options:
1 Plant patents. This is limited to vegetatively propagated
varieties.
2 Plant variety protection. This is applicable to all
sexually or asexually propagated varieties, pure lines,
and hybrids produced from pure lines.
3 Utility patent. This is applicable to all plant varieties
(including pure lines and hybrids produced from
pure lines).
These plant patents are honored in the US only, but
members who are signatories to UPOV operate similar
laws. Utility patents are honored mainly in the USA,
Japan, and Australia. Most plant breeders protect their
inventions under either plant variety protection or utility
patents. A major difference between the two protection
systems is that PVP-protected varieties may be used
as breeding material by a researcher without requiring
the permission of the rights holder. Should the breeder
develop a product that is distinct from the parental
germplasm, it may qualify for protection in its own
right. On the other hand, the claims in a utility patent
may be so designed to exclude breeding use without
express permission from the owner of the property.
Breeding companies use utility patents to protect their
germplasm base. This is because breeding progress
usually proceeds by serial improvement on the current
optimal materials. Whereas this is advantageous to commercial
companies, the research exemption it denies to
the wider scientific community is viewed by some as
undesirable. However, patents would allow the company
to recoup its investments in developing a breeding
material that can be utilized by its competitor. For
example, developing a breeding material by prebreeding
(germplasm enhancement, see Chapter 6) can be risky,
expensive, and of long duration. The developer needs to
protect his or her invention.