Principles of Plant Genetics and Breeding

The development of truly new and unexpected phenomenon
is not common. Progress is made incrementally.
It is often a challenge to satisfy the traditional
criteria stipulated by the patent office – obvious phenomenon,
specific utility, and teaching others how to
make and use the invention. Another limitation is that
ideas and properties of nature are not patentable.
Patenting hereditary material
The turning point in patenting genes and other biological
resources occurred in 1980, with the US Supreme
Court decision in Diamond vs Chankrabarty to grant a
patent for an oil-dissolving microbe. The technologies
of genetic engineering and genomics have resulted in
the discovery of millions of genes and fragments of
genes (expressed sequence tags or ESTs) that have been
submitted for patenting. However, not all players are
satisfied with the scope of protection provided by the
patent laws. A microscopic view will allow nearly anything
novel to be patentable, while opening up the
doors for competitors to easily circumvent the narrow
claims. Some scientists are opposed to the granting of
broad patents to what they describe as the early stages of
the biotechnology game. Some of the genes submitted
for patents have not been characterized, neither have
the applicants determined their functions and specific
uses. The concern is that large-scale and wholesale
patenting of genes by biotechnology researchers or
companies, who have no clue about the functions of
these genes, is tantamount to staking a claim to all
future discoveries associated with those genes (the
so-called “reach-through patents”).
This concern is a genuine one. Until recently,
genomic companies had a field day staking claims to
the genome landmark (the “genome run”). But with
the focus now on understanding gene function, the
proteomic companies now have their chance to do
likewise. This is stirring up new controversies in the
patenting of biotechnology inventions.
Another issue with biotechnology patents is “patent
stacking”, a situation in which a single gene is patented
by different scientists. This situation is not favorable to
product development because users are deterred by the
possibility that they would have to pay multiple royalties
to all owners of the patent. Further, because patent
applications are secret, it is possible for an R&D team in
a different company to be working on the development
of a product only to be surprised at a later date by the
fact that a patent (called a submarine patent) has
already been granted.
ISSUES IN THE APPLICATION OF BIOTECHNOLOGY IN PLANT BREEDING 261
Patenting proteins
A patent on a specific DNA sequence and the protein it
produces may not cover some biologically important
variant. It is estimated that the top genomic companies
have collectively filed over 25,000 DNA-based patents.
The business rationale to their strategy includes the
potential to receive royalties from third parties that use
any of them. But this may not be as simple as it sounds,
unless one gene makes one mRNA, which in turn makes
one protein – something that is not true anymore (see
Chapter 3, p. 50).
It is most likely and perhaps inevitable that some
protein discovery projects will turn out proteins that
correlate better with a disease than those for which
patent claims are already in existence. In such cases,
litigation seems the likely recourse. However, it is also
likely that potential litigants may opt for the less costly
route of cross-licensing, whereby each party can crosslicense
another’s patents.
Patenting products of nature
Patent laws protect the public by enforcing the “product
of nature” requirement in patent applications. The public
is free to use things found in nature. That is, if for
example a compound occurs naturally but it is also produced
commercially by a company via a biotechnology
method, the genetically engineered product is technically
identical to the natural product. However, in the
case of Scripp vs Genentech, a US court ruled that a
genetically engineered factor VIIIc infringed a claim to
VIIIc obtained by purification of a natural product. This
indicates that a previously isolated natural product had
first claim to patent rights over a later invention by
genetic engineering. If a company seeks to apply for a
patent for an invention to produce a rare, naturally
occurring compound in pure form, the argument will
have to be made for the technique used for extraction,
purification, or synthesis, not for the material per se.
Moral issues in patenting
Biotechnology also faces a moral dilemma in patent
issues. Specifically, is it moral to patent any form of life?
Further, if the discovery has medical value, should it be
patented? Then there is the issue of the poor. Is it moral
to demand that the poor pay royalties they can ill afford
for using patented products for survival purposes? A
debated issue is the plant breeder’s rights. Should
breeders be permitted to incorporate seed-sterilizing