Agricultural Biotechnology Intellectural Property Database—Patent Selection
This database contains several features. The heart of the database is
provided by U.S. Utility Patents—with issue dates between 1976 and
2000—relevant to agricultural biotechnology and other biological
processes in food and agriculture. It also includes U.S. Plant Patents
issued between the same dates, Plant Variety Protection Certificate applications
and grants (1971-2001), and data on permits for field trials of genetically
engineered crops.
Out of over 2 million utility patents issued between 1976 and 2000,
patents were selected to be broadly representative of those relevant to
biological processes in agriculture and food. The selection procedure
was designed to include patents not only on genetically engineered agricultural
plants or animals, or the processes used to produce such genetically engineered
species, but also other research approaches such as tissue culture, research
tools with potential applications to agriculture, patents on nongenetically
engineered species (e.g. other new crop varieties), and other biological
processes used in the food and nutrition industries (e.g., fermentation).
Filtering Patents for Inclusion in or Exclusion From the Database
Initial Filtering Using International Patent Classifications as Applied
to U.S. Patents
We began by obtaining from the U.S. Patent and Trademark Office
a tape with full text for all patents issued from 1976 to 2000. This tape
was sent to the Centre for Agricultural
Molecular Biology in International Agriculture (CAMBIA) in Australia.
CAMBIA, which was developing a full text search engine for international,
Japanese, and Australian patents relevant to agricultural biotechnology,
added the U.S. patents to their data and, in exchange, read a subset of
the U.S. patents onto compact discs for return to ERS. This subset was
selected on the basis of the international classification codes applied
to the U.S. patents. The relevant international codes were provided to
CAMBIA by the ERS researchers and were specifically relevant parts of
the following subject areas: agriculture, baking and foodstuffs, veterinary
or medical science, fertilizers, organic chemistry and organic compounds,
and biochemistry. This resulted in slightly more than 130,000 patents
with grant dates from 1976 to 2000 ready for further filtering.
Simple Criteria for Inclusion in the Database
Initially, several straightforward criteria were used to select
patents into the database. First, all plant patents (patent numbers beginning
with PP) were placed in a separate database for plant patents alone.
Then, any patents in our list of 130,000+ also found in databases of
agricultural biotechnology patents compiled by Foltz
et al. and Graff et al. were placed into the utility
patent database. These lists were kindly provided to us by the respective
research teams. Foltz and colleagues had compiled a list of some
800 agricultural biotechnology patents held by universities, based on
criteria determined by U.S. patent classifications. Graff and colleagues
had compiled a list of about 4,300 agricultural biotechnology patents
based on proprietary software from Aurigin, Inc., that assessed
keyword similarity between patents. In both cases, 90 percent or more
of the patents selected by Foltz et al. and Graff et al.
were found in our initial list of 130,000.
Inclusion of USPC 800 Patents in the Database
Our next step was to check all patents remaining in the initial
list, but still unclassified, for those patents whose class (original
or cross reference) was 800: Multicellular Living Organisms And Unmodified
Parts Thereof And Related Processes. Genetically modified animals such
as mice or rats, used for study of human diseases like cancer, were not
placed into the utility patent database, but all other patents in this
class were included.
Filtering of Patents Whose Assignees Were "Ag Biotech" Firms
In the meantime, ERS research partners at Rutgers University had
compiled a list of about 350 firms with some research capacity in agricultural
biotechnology. Our next step in selecting patents was to choose, temporarily,
all remaining unclassified patents whose assignees were found in this
list of agricultural biotechnology firms. Following this, the titles,
abstracts, claims, and descriptions were checked against lists of crop
species, livestock species, aquaculture species, and biotech terms that
we had developed. If any of these terms were found in these parts of the
patent, they were placed in one file. If none of the terms were found,
they were placed in another file. Then the patents in the first and second
files were reviewed visually, with patents either placed in the database
or discarded on the basis of this review. In general, patents with assignees
in this list of ag biotech firms and with at least one hit from the species
and biotech terms lists were reviewed more carefully. Those patents that
contained no terms from the species or biotech terms lists were reviewed
more quickly.
Filtering of Patents with Biotech Key Words in Title or Abstract
At this point, we went back to our unclassified patents (recall
that by this point the yet-unclassified patents did not have assignees
initially classified as ag biotech firms) and temporarily chose all patents
with one or more terms from the list of biotech terms in either the title
or abstract. Information in these patents was then reviewed, and patents
were either included in or excluded from the utility patent database.
Filtering the Remaining Patents
Remaining unclassified patents were then filtered as follows.
All remaining patents with at least one U.S. patent classification of
47, "Plant Husbandry," or 935, a no longer used classification
for "Biotechnology," were examined and sorted to the utility
patent database or to excluded patents. Finally, titles only of remaining
patents were examined briefly for possible keywords of interest, such
as "vaccine" or "vaccination," and a few were put
in the utility patent database. All remaining unclassified patents were
then excluded.
Some General Observations About the Filtering Procedure
A Few General Principles for Determining Patent Inclusion in the Utility
Patent Database
At nearly all stages of the selection process, several general
principles were used to determine whether a utility patent from the original
list of 130,000+ patents should be included in the utility patent database
or not. The most general principle—include all patents that refer
to biological products or processes in agriculture and food—was stated
above. In addition, we attempted to include patents in the following areas:
- Fermentation and other biological processes in food and nutrition
- General expression of peptides in agricultural species
- Production of vaccines and neutraceuticals in plants
- Bioremediation by higher plants
- General methods of inserting novel genetic material into an organism
- General genetic mapping, sequencing, or creation of genetic libraries
- Vaccines for agricultural animals
- Vaccines produced in agricultural species
- Antibiotics potentially used as growth stimulants in livestock feed
- Cloning
We attempted to exclude patents in the following areas:
- Primarily human health applications other than those mentioned
above (e.g., production of human vaccines in an agricultural species
would be included; use of an animal model of human disease would be
excluded)
- Human gene therapy
- General peptide expression in nonagricultural species
- Bioremediation by microbes
In addition to the possibility of outright selection errors, there are
subtler ambiguities in determining which patents are relevant to agriculture
and food, and which are not. In particular, some of the lines between
medical and general applications of molecular biology are not always clear.
Quite a few patents are held by firms or public sector institutions that
are working in the biomedical area. If a patent held by such entities
mentioned specific medical applications, we tended to exclude it; if it
mentioned only general applications (e.g., sequencing or identification
of single nucleotide polymorphisms, or SNPs, without proposing a specific
use), we tended to include it. It is in this area that the greatest number
of inconsistencies have probably arisen. We hope that both through our
classification of patents included in
the database and feedback from users, we can improve our inclusion criteria.
Inclusion Criteria Over Time
It is also worth noting that specificity probably increases over
time. Early patents for recombinant DNA procedures, for example, are perhaps
relevant for later recombinant work in all areas, including agriculture,
even if they involve only bacteria. Later patents for recombinant DNA
in nonagricultural species such as bacteria are probably less relevant
to agriculture. Again, inconsistencies may occur in our inclusion criteria
over the grant dates (1976 to 2000) available in this database.
Other Important Features of Patent Selection
At any particular point, when looking at a group of patents temporarily
selected because of a given criterion (e.g., the assignee was one of the
initial 350 or so "ag biotech" firms), several other considerations
were useful in the inclusion/exclusion decision. If the U.S. classification
code was the now defunct 935 (Biotechnology) or 435 (Chemistry: Molecular
Biology and Microbiology), the patent would tend to invite closer scrutiny.
At this point, certain additional keywords were also useful. For example,
words such as "human" or "cancer" or "dye"
were useful in choosing patents for exclusion; words such as "polymerase"
or "amplification" or "vaccine" were useful in choosing
patents for inclusion.
Citations
Foltz, J.D., K. Kim, and B. Barham, 2003, A Dynamic
Analysis of University Agricultural Biotechnlogy Potent Production,
AJAE 85, 1 (February): 187-197.
Graff, G., S. Cullen, K. Bradford and D. Zilberman,
2003, The Public-Private Structure of Intellectual Property Ownership
in Agricultural Biotechnology, Nature Biotechnology, 21, 9 (September):
pp. 989-995.
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