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 IP
Protection for Pharmacogenomics
January 3, 2005
By Nusrat Khaleeli
and Dennis Fernandez
The field of
pharmacogenomics helps develop drug therapies that compensate for
genetic differences that cause different responses in patients.
Companies working in pharmacogenomics should be aware of specific
ways to protect their intellectual property.
Tools available
to researchers involved in pharmacogenomics studies are considered
patentable. These include reagents, kits, chips, microarrays, instrumentation,
devices used for genetic tests, algorithms for searching and sequence
alignments and database technology. Certain proteins may also fall
under the tool category if they can be used as probes to identify
other biomolecules or small molecules
The composition
of isolated nucleic acid sequences, isolated protein and small molecules,
can be claimed. A patent application has to comply with the requirements
for utility, novelty and non-obviousness. Further, the patent application
must also comply with requirements for written description, enablement
and best mode. For example, one has not shown utility if one claims
a nucleic acid sequence that may be used as a gene probe, a primer
in PCR, a chromosome marker or an antigen generator, since such
utility is applicable to virtually any nucleic acid sequence.
However, if
the function of the gene is known and its utility is understood,
then claiming the DNA, as a gene probe, would be valid. Further,
if the gene function is known and the utility is accepted, then
a homologous DNA sequence would comply with the utility requirements
and could be claimed. Even if a portion of this homologous gene
was previously published as an expressed sequence tag (EST), the
patenting of this homologous gene still complies with the novelty
requirement. While a single nucleotide polymorphism or a nucleic
acid sequence containing such a variation can not be claimed, if
such a variation proved useful as a marker for a disease state or
for drug metabolism, the composition could be claimed. The written
description requirement is the greatest hurdle for patenting of
composition in inventions. In an age where "describing a method
of preparing a cDNA or even describing the protein that the cDNA
encodes...does not necessarily describe the cDNA itself" one
can be sure that the written description requirement is very strictly
enforced.
Patenting methods
that aid in the acquisition of pharmacogenomic data, such as screening
and genotyping methods, is standard practice. Further, methods used
in the diagnosis and treatment of subjects based on pharmacogenomic
knowledge are also patentable. Interestingly, methods for management
of complex data from pharmacogenomic studies, such as a method for
integrating clinical, diagnostic, genomic and therapeutic data,
is patentable. Finally, methods for pharmacogenomics-based clinical
trial design meet the criteria for patentability.
Challenges
to Patent Process in Pharmacogenomics
There exists
some challenges that are specific to the pharmacogenomics patent
process. The main issues for obtaining commercially relevant patent
protection in pharmacogenomics are utility, enablement and written
description. However, the challenges in enforcing pharmacogenomics
patents may prove to be the larger problem in the patent process.
Groups involved
in developing pharmacogenomic research tools and methods should
be aware of the Housey decision passed by the district court of
Delaware. In accordance with this decision the one can elude U.S.
protection on patented screening methods by performing the research
work outside the United States. Once the screening is completed
and a useful product is found, the Housey decision permits the information
to be brought back into the United States for further testing and
development into a commercial product.
The research
exemption is designed to protect actions performed "for amusement,
to satisfy idle curiosity, and for strictly philosophical inquiry".
As seen in the case of Madey vs. Duke University, the experimental
use defense is not valid if the activity furthered the "legitimate
business objectives" of the alleged infringer, whether or not
a profit was made. This defense is "very narrow and strictly
limited".
The exemption
to infringement under 35 USC 271 (e)(1) provides that it is not
an act of infringement to use a patented invention solely for uses
"reasonably related" to the generation of information
likely to be relevant to FDA approval of a product. This exemption
may be applied in the case of business methods, devices, research
tool and even chemical entities. Unlike the research exemption,
this exemption has been interpreted broadly and judged as non-infringement
in favor of the defendant in the Bristol-Meyers Squibb vs. Rhone-Poulenc
Rorer case. The scope of the 35 USC exceptions was reigned in by
an opinion from the Court of Appeals for the Federal Circuit in
the case of Integra vs. Merck. In this case, the use of patented
research tool in drug discovery was deemed as infringement, as pre-clinical
work is not included in the safe harbor of 35 USC 271 (e)(1).
The EPO also
has specific laws pertaining to biotechnology patents, described
in the EU Biotechnology Directive of July 1998, and the European
Patent Convention (EPC) of 1999. For instance, Article 53(a) of
the EPC states that "European patents shall not be granted
in respect of…inventions the publication or exploitation of
which would be contrary to 'ordre public' or morality", and
Rule 23d(d) excludes "processes for modifying the genetic identity
of animals which are likely to cause them suffering without any
substantial medical benefit to man or animal, and also animals resulting
from such processes". Thus, patents that cover genetically
modified animals, for example, that do not specify or imply medical
benefits can be rejected by the EPO or challenged in an Opposition,
a procedure in which any person may oppose a granted European patent
within nine months from publication.
Finally, the
notable rule pertaining specifically to biotechnology patents in
both the US and Europe is that of utility. Under amended guidelines
issued in January 2001, patentable subject matter is that which
has specific, substantial, and credible utility. The addition of
the substantiality requirement means that patent claims that require
considerable research by a person of ordinary skill in the art in
order to determine the function of a molecule are likely to be rejected.
The motivation for the requirement is to reduce claims that expand
the scope of the invention beyond the functions and utility described
in the specifications. In its most simplified interpretation, the
utility rule demands that each claim pertain to products that have
a clear use and benefit to human society.
The challenges to pharmacogenomics patents are still evolving. Because
of their direct application to biological life on earth, pharmacogenomics
and genomics patents are subject to intense scrutiny by the various
patent offices. As the technology develops, however, one impedance
to the biotech patent process, namely the need for more cross-technically
educated patent examiners and counsel, will eventually become less
of a burden. Knowledge of the challenges to the pharmacogenomics
patent process will lead to more skillful prosecution and more rapid
innovation overall.
Nusrat Khaleeli
and Dennis Fernandez are with Fernandez & Associates, LLP (www.iploft.com).
Go to the
Biotechnology
section of Larta Institute's Research Archives
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