ACLU Gene Patents Challenge - Bilski Preview
Inherently Sarnoff Blog
Professor Josh Sarnoff
August 27, 2009
Lori Andrews and I today
filed a motion and an
amicus brief on
behalf of the American Medical Association, the American Society of Human
Genetics, the American College of Obstetricians and Gynecologists, the American
College of Embryology, and the Medical Society of the State of New York in Association for Molecular Pathology et al. v. U.S.
Patent and Trademark Office, et al., No. 09 Civ. 4515 (RWS) -- the
lawsuit filed by the ACLU and the Public Patent Foundation challenging
the BRCA1 and BRCA2 gene patents owned by Myriad Genetics. (I discussed the case earlier this summer on the Kojo Nnamde Show, with Hans Sauer of the Biotechnology Industry Organization and Shobita Parthasarathy of the U. of Michigan.) The case will provide a good
opportunity for the courts to resolve whether isolated natural materials and
discovered medical phenomena are patentable subject matter. We argued that in a
series of cases over the past 150 years, the Supreme Court has held that one
cannot patent (1) products of nature, or materials isolated from products of
nature if those materials behave in the same way they would in nature, or (2)
discovered laws of nature or mathematics, or applications of those laws lacking
significant (i.e., creative) “post-solution activity.” We also explained how
some of the claims at issue (the sequence claims) cover the natural materials
and being "isolated" does not change them nor give them new properties, and how
other claims (the correlation claims) cover the mental act of recognizing or
comparing information, however obtained. Finally, we explained how these patents
have interfered with our clients' research and have prevented proper medical
care, and why they violate both medical and scientific ethical
tenets.
The brief is a good preview for my forthcoming Supreme Court
amicus brief in Bilski v. Doll, as it
demonstrates in the contexts of products of nature and natural phenomena the
relevant patentable subject matter requirement that there must be invention
in the application of scientific
principles, naturally occuring materials, and abstract ideas. Historic ethical
obligations required treating previously known or newly discovered science,
nature, and ideas as not only "free for all to use" but also as if they were
already in the prior art (once disclosed, e.g., in a patent application). Thus,
in order for there to be any patent-eligible "invention" there must necessarily
be some other "inventive concept" (using the terminology of Parker v. Flook) in the application itself of
the discovered science, nature, and ideas, even if the application is novel.
Simply isolating the natural genetic material is not sufficient to be called
"invention," given that the discovery of the natural material must be treated as
if it were already known. Similarly, claiming the isolated genetic sequence
information or variants of it (in mutations) is not an invention once that
information is requiredto be treated as public domain information (as natural
phenomena). And claiming the acts of comparing the actual genetic sequence
disclosed in the patent to another (potentially mutated) sequence is not an
invention, given that there is no creativity in doing so once the sequence
information is treated as in the public domain -- recognizing that one of these
things is not like the others is trivial even if highly useful. (It also
destroys the quid pro quo of the patent system -- an enabling disclosure where
people can use the information -- if not the physical implementation -- in
exchange for patent rights. Note that this is different from but the mirror
image of the bargain-destroying problem caused by the lack of a meaningful
research exception, when people can't use the information disclosed in the
patent to sequentially innovate because they can't use physical embodiments that
are necessary to research. Although combinatorial chemistry and biology may
minimize that problem, some of the patents at issue in the AMP v. PTO case
actually prohibit "analyzing" sequence information, however it might be
obtained.)
Chris
Holman (a friend and a colleague on a recent paper entitled Recent Developments Affecting the Enforcement,
Procurement, and Licensing of Research Tool Patents, the draft of which
is on SSRN
and the final is published at 23 Berkeley Tech. L. J. 1299 (2008)) has
provided a good
short summary of the ACLU's motion for summary judgment that our amicus
brief supports on his Holman's Biotech IP Blog.
Chris appears to recognize that the Supreme Court precedents before Diamond v.
Chakrabarty (which as discussed in our amicus brief did not change the law in
this regard) require more than "mere isolation" in order to claim a
patent-eligible application of a product of nature. Chris also correctly notes
that the Patent Office has for a long time treated mere isolation as sufficient
human creativity and difference from the natural material to constitute a
patent-eligible invention. So we will have to see if the District Court (and
ultimately perhaps the Supreme Court) is willing to disregard various appellate
court decisions (pre-dating and of the Federal Circuit) and the PTO policies
that contravene the Supreme Court precedents, when the consequence is to
eliminate thousands of claims in a very important industry. For the reasons
explained in the medical association amicus brief, there are good policy reasons
to do so because these patents cause real harm.
This case also reflects
another "industry battle," this time not IT or generics against pioneering
PhRMA, but the medical treatment/scientific research community (and the patient
and consumer community as the ultimate beneficiaries) against the
biotech/scientific research community. And it is precisely the tension in the
scientific community (which spans both industries) that makes this so
fascinating. As the amicus brief discusses, scientists had an ethical duty
(deriving from the morality of religion) not to subject to private property
rights their discoveries of nature -- which duty remains reflected in the patent
law requirement that such discoveries must be treated as prior art if disclosed.
As William Robinson stated over a century ago in his celebrated Patent Law
treatise, "To benefit by the discoveries of his fellow-men is thus not only a
natural right, it is also the natural duty which every man owes to himself and
to society; and the mutual universal progress thence resulting is the
fulfillment of the earthly destiny of the human race.” As Lord Camden said a
century earlier, scientists are "entrusted by Providence with the delegated
power of imparting to their fellow creatures that instruction which heaven meant
for universal benefit; they must not be niggards to the world, or hoard up for
themselves the common stock." Are scientists who seek to (and often successfully) patent their natural discoveries bad people?
