GENETIC TECHNOLOGIES AND THE LAW: CASES AND MATERIALS

Chapter 6 Commercialization of Genetic Tests and Products All the research and insights developed in genetics labs will remain
as purely scientific enlightenment without a means to translate them into
practical, commercially available applications. At the same time, there
are ongoing debates as to how such commercialization should take place, who
should control and profit from it, and whether certain innovations should
be placed into the public domain instead. Some of these issues were raised
in Chapter 5; others will be addressed in this Chapter. A subset of these
issues focused on developments in agricultural biotechnology will be
further discussed in Chapter 8. This Chapter follows the commercialization
chain beginning with identifying patentable inventions, including
allocation of ownership and other rights. Next it turns to the technology
transfer system by which research that primarily occurs in university or
other non-profit labs is packaged and made available for commercial
development. It then considers the issues facing biotech start-ups and
spin-off companies as they perform the actual commercialization activities
that will lead to a saleable genetic diagnostic or therapeutic product or
service. Finally, the chapter concludes with an overview of the procedure
for obtaining regulatory approval for the marketing and sale of these
products and services. A. Identifying Patents in the Research Environment Patents are not the only way to assert ownership over scientific or
technological innovation, but they are perhaps the most potent and concrete
means of protecting such assets. While there is some controversy over
whether the USPTO should issue "gene patents"-patents on DNA fragments
identified by researchers as constituting a gene-the final "kit" version of
a genetic diagnostic or therapeutic product should be less objectionable.
This Part considers the general elements of patentability under the U.S.
patent laws by focusing on the particular issues raised for each element by
genetic product and services. In the U.S., inventors have a right to have a patent issued by the
USPTO so long as their inventions meet a statutory set of criteria
including: subject matter, utility, novelty, and nonobviousness. Thus,
these criteria can guide anyone who is trying to determine whether they
have a patentable invention. If an inventor believes that her invention
meets these criteria, then she can file a patent application with the
USPTO, but that application must contain a written description of the
invention such that it is clear that the inventor actually is in possession
of the invention and which enables one of ordinary skill in the relevant
art to "practice" or use the invention without undue experimentation. The
following sections consider each of these requirements particularly as they
apply broadly in the life sciences and biotechnology and narrowly, where
guidance is available, in the subfield of genetic diagnostic or therapeutic
inventions. 1. Subject Matter The case of Diamond v. Chakrabarty effectively illustrates both the
general issues of defining patentable subject matter as well as the
specific issues of including living things in that definition. Diamond v. Chakrabarty
447 U.S. 303 (1980) C.J. Burger delivered the opinion of the Court We granted certiorari to determine whether a live, human-made micro-
organism is patentable subject matter under 35 U.S.C. § 101. I In 1972, respondent Chakrabarty, a microbiologist, filed a patent
application assigned to the General Electric Co. The application asserted
36 claims related to Chakrabarty's invention of "a bacterium from the genus
Pseudomonas containing therein at least two stable energy-generating
plasmids, each of said plasmids providing a separate hydrocarbon
degradative pathway."[1] This human-made, genetically engineered bacterium
is capable of breaking down multiple components of crude oil. Because of
this property, which is possessed by no naturally occurring bacteria,
Chakrabarty's invention is believed to have significant value for the
treatment of oil spills.[2] Chakrabarty's patent claims were of three types: first, process
claims for the method of producing the bacteria; second, claims for an
inoculum comprised of a carrier material floating on water, such as straw,
and the new bacteria; and third, claims to the bacteria themselves. The
patent examiner allowed the claims falling into the first two categories,
but rejected claims for the bacteria. His decision rested on two grounds:
(1) that micro-organisms are "products of nature," and (2) that as living
things they are not patentable subject matter under 35 U.S.C. § 101. Chakrabarty appealed the rejection of these claims to the Patent
Office Board of Appeals, and the Board affirmed the examiner on the second
ground.[3] Relying on the legislative history of the 1930 Plant Patent
Act, in which Congress extended patent protection to certain asexually
reproduced plants, the Board concluded that § 101 was not intended to cover
living things such as these laboratory created micro-organisms. The Court of Customs and Patent Appeals, by a divided vote, reversed .
. . . The Commissioner of Patents and Trademarks . . . sought certiorari .
. . . II The Constitution grants Congress broad power to legislate to "promote
the Progress of Science and useful Arts, by securing for limited Times to
Authors and Inventors the exclusive Right to their respective Writings and
Discoveries." Art. I, § 8, cl. 8. The patent laws promote this progress
by offering inventors exclusive rights for a limited period as an incentive
for their inventiveness and research efforts. The authority of Congress is
exercised in the hope that "[t]he productive effort thereby fostered will
have a positive effect on society through the introduction of new products
and processes of manufacture into the economy, and the emanations by way of
increased employment and better lives for our citizens." The question before us in this case is a narrow one of statutory
interpretation requiring us to construe 35 U.S.C. § 101, which provides: "Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefor, subject to the
conditions and requirements of this title." Specifically, we must determine whether respondent's micro-organism
constitutes a "manufacture" or "composition of matter" within the meaning
of the statute. III In cases of statutory construction we begin, of course, with the
language of the statute. And "unless otherwise defined, words will be
interpreted as taking their ordinary, contemporary, common meaning." We
have also cautioned that courts "should not read into the patent laws
limitations and conditions which the legislature has not expressed." Guided by these canons of construction, this Court has read the term
"manufacture" in § 101 in accordance with its dictionary definition to mean
"the production of articles for use from raw or prepared materials by
giving to these materials new forms, qualities, properties, or
combinations, whether by hand-labor or by machinery." Similarly,
"composition of matter" has been construed consistent with its common usage
to include "all compositions of two or more substances and . . . all
composite articles, whether they be the results of chemical union, or of
mechanical mixture, or whether they be gases, fluids, powders or solids."
In choosing such expansive terms as "manufacture" and "composition of
matter," modified by the comprehensive "any," Congress plainly contemplated
that the patent laws would be given wide scope. The relevant legislative history also supports a broad construction.
The Patent Act of 1793, authored by Thomas Jefferson, defined statutory
subject matter as "any new and useful art, machine, manufacture, or
composition of matter, or any new or useful improvement [thereof]." Act of
Feb. 21, 1793, § 1, 1 Stat. 319. The Act embodied Jefferson's philosophy
that "ingenuity should receive a liberal encouragement." Subsequent patent
statutes in 1836, 1870 and 1874 employed this same broad language. In
1952, when the patent laws were recodified, Congress replaced the word
"art" with "process," but otherwise left Jefferson's language intact. The
Committee Reports accompanying the 1952 Act inform us that Congress
intended statutory subject matter to "include anything under the sun that
is made by man." S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952); H. R.
Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952). This is not to suggest that § 101 has no limits or that it embraces
every discovery. The laws of nature, physical phenomena, and abstract
ideas have been held not patentable. Thus, a new mineral discovered in the
earth or a new plant found in the wild is not patentable subject matter.
Likewise, Einstein could not patent his celebrated law that E=mc2.; nor
could Newton have patented the law of gravity. Such discoveries are
"manifestations of . . . nature, free to all men and reserved exclusively
to none." Judged in this light, respondent's micro-organism plainly qualifies as
patentable subject matter. His claim is not to a hitherto unknown natural
phenomenon, but to a nonnaturally occurring manufacture or composition of
matter--a product of human ingenuity "having a distinctive name, character
[and] use." The point is underscored dramatically by comparison of the
invention here with that in [Funk Brothers Seed Co. v. Kalo Inoculant Co.,
333 U.S. 127 (1948)]. There, the patentee had discovered that t