Will I lose my dignity?
Will someone care?
Will I wake tomorrow
From this nightmare?
"Will I," Rent
By Kevin E. Noonan —
The Supreme Court's grant of certiorari over the question "Are human genes patentable"
had raised for many the specter of an uninformed generalist court rendering a
decision containing dicta that would negatively affect biotechnology. This possibility is real, in view of the
voices raised against patenting human genes based on moral, policy, or
ideological grounds. While strongly
felt, these sentiments are based, in large part, on a misunderstanding or
mischaracterization of either the facts or the law, specifically patent
law. These misstatements include
arguments based on patent claims somehow exerting an ownership interest in
individual's DNA, or that isolated human nucleic acid claims preempt future
research (in the face of thousands of published scientific journal articles
published since the BRCA gene patents were granted), or that isolated DNA
patents inhibit future technologies like personalized medicine.
This is an argument that might have been relevant
30 years ago, but at least two facts mitigate against resolving this issue
now. The first is that the day of the
DNA patent claim is rapidly coming to a close. These types of patents were first filed directed to specific genes
encoding biologically relevant proteins having therapeutic benefits. These include erythropoietin, tissue plasminogen
activator, interferon, blood clotting Factors VIII and IX, and others. (Indeed, one of the most compelling types of
evidence not considered by any court in the Myriad
case is the testimony of the tens or hundreds of thousands of patients whose lives
have been saved or bettered by biotechnology drugs protected, in part, by
so-called "gene patents.") Myriad's BRCA gene patent claims are in this form, one of the reasons
why these claims are not infringed by genetic diagnostic methods used
today.
The vast majority of gene patent applications,
however, were filled as the result of the Human Genome Project. These patents are limited in at least three
ways. First, the U.S. Patent and Trademark Office has established a
policy that patents will be granted only if an applicant provided on the filing date specific, substantial, and credible utility for the protein encoded by the claimed DNA. This provision prevents an applicant from
obtaining patent exclusivity unless the applicant shows that she establishes utility,
a requirement of the patent statute, of the encoded protein. (This requirement is related to the policy
enunciated in Brenner v. Manson,
where claims to methods for making steroid molecules were invalidated based on
failure to disclose a utility for the steroid molecules made using the
methods.) Second, certain researchers
(notably, Sir John Shulston in England) made certain that the sequence results
of the HGP were published in public databases as soon as possible; doing so
placed the sequences in the prior art and precluded patentability for any
application filed after the sequences were made public. Finally, because almost all of these patents
were filed at the turn of the century, and the term of these patents will expire
no later than 20 years after application filing, the "problem" of
gene patents will disappear no later than 2020 (and in many instances much
earlier even if a patent can be obtained under the enhanced utility
requirements).
Another reason why the ACLU's challenge is
anachronistic (except for those meaning to make an ideological point) is that present
and future technology, such as genetic diagnostic testing or personalized
medicine, is not prevented or inhibited by claims to isolated DNA molecules
encoding a specific human protein. This
is a consequence of the history of these type of claims for providing means for
producing biologically relevant proteins like EPO and TPA. The claims require that the DNA is isolated and that it encodes the full-length protein,
as defined by specific amino acid sequence. (For these reasons these claims are
exceedingly narrow, and do not broadly preempt: for example, such claims are
not literally infringed if the encoded protein differs by a single amino acid,
meaning that a difference of a single methylene group (the difference between a
valine and an isoleucine residue) is enough to take a species outside the scope
of the claim.) Modern gene sequencing methods used for
diagnostics neither isolate DNA nor produce a full-length DNA molecule
encoding the protein. Rather, sequencing
is performed in such a way that fragments of the DNA are produced in a reaction
mixture and sequenced without isolation; what is produced is the sequence, a
characteristic of the DNA molecule that is not
protected by the patent. (This is why
infringement of isolated DNA claims does not lie by using the sequence
information to, inter alia,
interrogate a DNA database.) And the Myriad
case has established that method claims directed to merely comparing an
individual's gene sequence with a reference sequence and disclosing mutations
identified as indicating a risk of disease, without more, are not patent
eligible (under either Bilski v Kappos
or Mayo v. Prometheus).
So there appears to be no sound policy reason for
having the Supreme Court render a decision on the patent eligibility of human
genes. Sadly, there is seemingly no
sound business reason for Myriad Genetics to have the Court decide this question
either. Myriad's counsel, Greg Castanias,
argued in the first Federal Circuit oral argument that the plaintiffs did not have
standing because there was no redressability to their claim. Specifically, Mr. Castanias argued that even
if the Court ruled in plaintiffs' favor, Myriad had other patent claims that
would prevent Dr. Harry Ostrer and other plaintiffs from providing BRCA gene
diagnostic tests. In addition, while
these patents were undoubtedly important when Myriad was establishing its
diagnostics business they are less important now. Fifteen years and thousands of genetic tests
(apparently without any failures) later, the company's reputation, experience and
extensive database is far more valuable than the claims at issue.
Under these circumstances, the question must be
asked whether the prudent thing for Myriad to do is grant Dr. Ostrer a covenant
not to sue on all the patents and claims involved in this litigation. The result would be to render the issues
before the Court moot; regardless of the perceived importance of the Question
Presented, even the Supreme Court is limited by Article III of the Constitution
and cannot render an advisory opinion on this issue. Such an action by Myriad would not only
prevent this case from being decided, it would preclude the Court from
including in its opinion dicta on the patent eligibility of isolated DNA from
other species (which may have importance in fields like agriculture or
biofuels) or other "products of nature" that may provide the basis
for biologic and other types of drugs. In view of the seemingly complete lack of any practical reason for
having the Supreme Court decide this issue, and the risks to the progress
provided for a generation by the biotechnology industry, nothing other than a
desire to be vindicated remains to support seeing this case through to its
conclusion. Frankly, in view of what is at stake, such vindication is simply not enough.
