Robert Cook-Deegan directs the Center for Public Genomics, Duke University, which conducted eight case studies of the impact of patenting and licensing on genetic testing for ten clinical conditions commissioned by the US Secretary’s Advisory Committee for Genetics, Health and Society, published in April 2010.
A brief submitted by the DOJ on behalf of neither party is available here.
DOJ asks the court to reverse the district court’s invalidation of the composition claims that are limited to cDNAs and similar man-made constructs, but affirm the district court’s conclusion that the claims encompassing isolated human genomic DNA are invalid.
Here are Summaries of the Arguments:
In their zeal to address perceived public policy concerns associated with.
Myriad’s gene patents, and more particularly Myriad’s controversial business and
patent enforcement practices, plaintiffs have invoked the recently re-invigorated
patent eligibility doctrine in a manner that threatens to wreak substantial collateral
damage on future innovation in genetic diagnostic testing, personalized medicine,
and biotechnology in general. DNA patents have created incentives critical in
attracting the substantial investment necessary to fuel the discovery and
development of life-saving products produced by the biotechnology industry.
Although plaintiffs have identified numerous potential concerns with gene patents
in the context of some types of genetic diagnostic testing, to date there is
insufficient evidence that harms attributable to patents on genes justify broad,
subject matter-based invalidation of all patents made of or based on DNA. More
appropriate and targeted legal and policy solutions to problems associated with
some gene patents and patent enforcement practices are preferable to the blunt
doctrinal instrument of patent eligibility. The decision below should be reversed in
order to prevent substantial unintended negative consequences for innovation in
this increasingly important technology sector, and to enable adjudication of
patentability using other tools that are more appropriate to the task
Section 101 marks the “threshold” of the patent system. Bilski v.
Kappos, 130 S.Ct. 3218, 3225 (2010). It not only “defines the subject
matter that may be patented,” ibid., but simultaneously defines what
must remain in “‘the storehouse of knowledge of all men * * * free to all
men and reserved exclusively to none,’” ibid. (quoting Funk Brothers
Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)); see Bonito
Boats, Inc. v. Thundercraft Boats, Inc., 489 U.S. 141, 151 (1989) (the
patent laws “determine not only what is protected, but also what is free
for all to use”). The boundary between eligible and non-eligible subject
matter is defined, in significant part, by the settled principle that the
patent laws do not embrace laws of nature, physical phenomena, or
abstract ideas. See Bilski, 130 S.Ct. at 3225.
In attempting to apply that principle here, the district court
erroneously cast doubt on the patent-eligibility of a broad range of manmade
compositions of matter whose value derives from the informationencoding
capacity of DNA. Such compositions — e.g., cDNAs, vectors,
recombinant plasmids, and chimeric proteins, as well as countless
industrial products, such as vaccines and genetically modified crops,
created with the aid of such molecules — are in every meaningful sense
the fruits of human ingenuity and thus qualify as “‘human-made
inventions’” eligible for patent protection under section 101. J.E.M. Ag
Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124, 130 (2001)
(quoting Diamond v. Chakrabarty, 447 U.S. 303, 313 (1980)). The
district court therefore erred in invalidating the challenged composition
claims, such as claim 2 of the ‘282 patent, that are directed solely to
The district court correctly held, however, that genomic DNA that
has merely been isolated from the human body, without further
alteration or manipulation, is not patent-eligible. Unlike the
genetically engineered microorganism in Chakrabarty, the unique
chain of chemical base pairs that induces a human cell to express a
BRCA protein is not a “human-made invention.” Nor is the fact that
particular natural mutations in that unique chain increase a woman’s
chance of contracting breast or ovarian cancer. Indeed, the relationship
between a naturally occurring nucleotide sequence and the molecule it
expresses in a human cell — that is, the relationship between genotype
and phenotype — is simply a law of nature. The chemical structure of
native human genes is a product of nature, and it is no less a product of
nature when that structure is “isolated” from its natural environment
than are cotton fibers that have been separated from cotton seeds or
coal that has been extracted from the earth.
The scope of Section 101 is purposefully wide and its threshold is
not difficult to cross. See Bilski, 130 S.Ct. at 3225. New and useful
methods of identifying, isolating, extracting, or using genes and genetic
information may be patented (subject to the prohibition against
patenting abstract ideas), as may nearly any man-made transformation
or manipulation of the raw materials of the genome, such as cDNAs.
Thus, the patent laws embrace gene replacement therapies, engineered
biologic drugs, methods of modifying the properties of plants or
generating biofuels, and similar advanced applications of biotechnology.
Crossing the threshold of section 101, however, requires something
more than identifying and isolating what has always existed in nature,
no matter how difficult or useful that discovery may be.