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Vol.
XXVI No. 31
August
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Patenting Our
Genes
Amit Sen Gupta
THE battle on Patent rights is now poised to spill out of
laboratories dealing with chemical substances to human bodies. Biotech companies
are involved in a furious scramble to patent every bit of the human genetic
structure. What was merely a trickle a few years back has become a virtual
deluge. Drugs companies are applying for patents on genes and their functions
with unprecedented speed. And some
of these patents are so far-reaching that, if granted, they could prevent anyone
else from touching those genes to create drugs that act on them or even to test
the genes for mutations in a patient.
GENE PATENTS
GENERATE
CONTROVERSY
A recent controversy has erupted over a Patent
granted to an US company (New Scientist,
July 13, 2002) – Myriad Genetics – for a genetic test to assess the risk of
breast cancer or cancer of the ovaries. The
patent granted to Myriad allows it exclusive rights over the use of two genes
BRC41 and BRC42 for diagnostic or therapeutic purposes. Myriad is using this to
prevent other research institutions and scientists from carrying out tests for
ovarian and breast cancers.
The patent that
Myriad is armed with allows it to stifle research by potential competitors. The
floodgates are beginning to open and other companies are following in Myriads
footsteps. Athena Diagnostics, a Massachusetts subsidiary of Irelands Elan
Pharmaceuticals has exclusive patent rights to several genetic diagnostic tests
for neurological diseases like Alzheimers disease. The New Scientist in its report on the issue quotes a letter from Athena
that was sent to an university laboratory, which states that it is only by using
Athenas facilities that other laboratories can offer this patented diagnostic
test without infringing the patent.
WARNING
SIGNALS
The story of Myriad is a warning of sorts for future
trends in research and the effect of patents. Soon after being granted the US
patents in the mid-1990s, Myriad successfully halted most testing being done by
laboratories in the US. The company
allows only laboratories to conduct limited tests on the patented genes when
they are ready to pay a fee to Myriad. However if researchers want to conduct
tests that involve a full sequencing of the patented genes, Myriad insists that
all samples are sent to its headquarters in Salt Lake City, US.
While, in
keeping with the liberal acceptance of absolute patent rights in the US, Myriad
faced little opposition in the US, controversies erupted when it tried to extend
its exclusive right to other parts of the globe.
The company is being boycotted in Canada, Netherlands, Belgium and Germany. The
Curie Institute in Paris with support from the French government has challenged
Myriads patents with the European Patent Office (EPO), arguing that
Myriads unwillingness to let anyone else do full testing would establish a
monopoly, damaging scientific research and the welfare of patients. The patents
have also been challenged in Germany, the Netherlands, Belgium and Denmark.
Research facilities in universities are particularly
upset because, hitherto, they have been used to operating without restrictions.
For years, whenever a gene for a disease was published in a scientific journal,
researchers running university laboratories felt free to devise their own
diagnostic test for it. Since many
of the first gene discoveries that led to diagnostic tests were not patented,
labs could offer their homemade test without fear of infringing anyones
intellectual property rights. Things started changing when, in the 1980s, the US
passed the Bayh Dole Act to encourage universities to patent their research
results. Labs were now required to
pay for their in-house tests. This still allowed laboratories to perform the
tests themselves. The entry of companies
like Myriad has changed the whole scenario, and laboratories are now being asked
to stop doing all tests that involve patented genes.
IMPLICATIONS FOR
DRUG
DEVELOPMENT
The present situation has other frightening
implications. It is entirely conceivable that pharmaceutical companies shall try
to duplicate the methods used by Myriad and Athena. What we are looking at is, thus,
not just restriction on doing research on genetic material but also on creation
of huge monopolies in drug development. A large number of patent
applications are pending in patent offices across the globe that involve
different genetic sequences. The next generation of drugs are likely to target
specific genetic sequences, and this is what pharmaceutical companies are
targeting. These sequences will be vital in development of drugs that can
revolutionise medical treatment. In a sense patent holders will hold the key to
the gateway to developing new drugs.
At the heart of the whole controversy lies a core
issue – what is patentable matter. Many have argued that genes should never be
allowed to be patented in the first place as they already exist in nature and
therefore do not satisfy the basic criteria of involving an inventive
step. Till recently the US had led attempts to enlarge the definition of what
constitutes an invention. This had resulted in a virtual frenzy of patenting in
the 1990s when companies filed thousands of patent applications for genetic
sequences, even though they frequently had no idea what the genes did.
In January 2001, the US Patent and Trademark Office (USPTO)
has tried to be less liberal by stating that applicants must prove that they
have a unique, non-obvious use for a claimed gene, such as a diagnostic tool for
a specific disease. This still is a liberal interpretation of what constitutes
an inventive step, as even if new uses are discovered for genes they still
remain discoveries and not inventions. Classically discoveries were
not supposed to have been patentable – or else Columbus could have patented
America when he discovered it! Unfortunately
there has been a gradual blurring of the line between discoveries and
inventions. We may be looking at a situation soon where companies not only have
a 20 year monopoly over a drug they have developed but also complete monopoly
over all research in that area.
EFFECT ON RESEARCH
It is important to understand that the effects of
gene patenting on research are not limited only to raising the costs. There is a
real possibility that such patenting can harm research in many ways. Evidence is
available that once someone patents a gene, researchers interested in finding
diagnostic tests or therapies based on that gene will shy away from it for fear
of infringing the patent. Tactics, as used by Myriad can also harm clinical
studies because of the monopoly it would have on research data. It is widely
known that, often, different trials conducted on human subjects for the same
therapy can come up with differing results. Incremental progress is made
regarding the usefulness of therapies once data from a large number of trials
can be compared. But if a company like Myriad has complete control over data
because no body else is allowed to do research, the possibility of conducting
different trials is negated. Even more
dangerous is the possibility that a company that has monopoly over data will be
tempted to suppress data that is inimical to the commercial interests of the
company – viz. data that shows that a companys product has unacceptable
side-effects.
Even in the US such concerns are beginning to be
voiced. A bill to modify patent policy has just been introduced in Congress,
which stipulates that any scientist doing non-commercial research that involves
patented genes should be exempt from a patent.
The Bill also says that medical researchers would be free to create their
own tests for a patented gene without having to pay royalties on that gene.
Corporates are opposing the passage of the Bill and may well succeed. The other
problem about allowing non-commercial use is the fact that Universities across
the world are increasingly tying up with Industry to conduct research. Soon, it
may become difficult to categorise research in terms of its commercial use.
The bottom line is obvious. Today there is no
evidence that suggests that patents promote innovation and increase the pace of
scientific and technological advances. If anything, evidence exists to the
contrary. Yet we have a situation where hitherto untouched areas are being
opened for patenting. It is
necessary today, than ever before, to question the whole concept of patents.
