PATENT LAW RELATING TO GENETIC ENGINEERING:
IT REALLY IS A BRAVE NEW WORLD
By: Gordon Kit, Kenneth Burchfiel and Mary Goulet
In the past decade, there have been great advancements in genetic engineering, and patent issues
relating to this field have also evolved. Recent legislative activity in Congress and decisions by
the Federal Circuit concerning patent protection of recombinant DNA and related biotechnology
are summarized below.
A. Legislative Matters
Proposed legislation relating to patent protection for biotechnological processes and materials is
before the U.S. Congress. The Senate version, DeConcici Bill S 298, passed in 1993. The House
version, Boucher Bill HR 760, is being considered. The Senate and House versions are
substantially identical.
(1) Biotechnological Processes
Title I of the Boucher bill proposes changes to Title 35 concerning biotechnological process
patents of the United States Code. The Boucher bill would add a new subsection to 35 U.S.C. §
103, so that "a claimed process of making or using a machine, manufacture, or composition of
matter is not obvious" where the following three conditions are met:
First , the machine, manufacture, or composition of matter must be both novel under §
102 and nonobvious under § 103.
Second , the claimed process must be a "biotechnological process". The proposed
legislation defines "biotechnological process" as "any method of making or using living
organisms, or parts thereof, for the purpose of making or modifying products."
"Recombinant DNA, recombinant RNA, cell fusion including hybridoma techniques, and
other processes involving site specific manipulation of genetic material" are specifically
included in the statutory definition.
Third , a series of common ownership and effective filing date requirements would have
to be met. A person seeking patent protection would have to show that at the time "the
machine, manufacture, or composition of matter" and the claimed process invention were
made, they were "owned by the same person or subject to an obligation of assignment to
the person". In addition, claims to the process and to the machine, manufacture, or
composition would have to be entitled to the same effective filing date and would have to
"appear in the same patent application, different patent applications, or patent which is
owned by the same person and which expires or is set to expire on the same date."
A related amendment is proposed to 35 U.S.C. § 282, to provide that a claim issued under the
proposed biotechnological process subsection of 35 U.S.C. § 103 shall not be held invalid under
§ 103 solely because the machine, manufacture, or composition of matter lacks novelty (under 35
U.S.C. § 102) or is obvious (under 35 U.S.C. § 103).
The House version provides for the proposed amendments to the process patent statutes to apply
to patents granted on or after the Act is enacted, as well as to all applications (including for
reissue) pending on, or filed after, the enactment date.
(2) Biotechnological Materials
Title II of the Boucher bill relates to biotechnological material patents. The proposed amendment
would add a subsection concerning infringement under 35 U.S.C. § 271, and provides that
anyone who without authority imports into the United States "a product which is made by using
a biotechnological material ... which is patented in the United States shall be liable as an
infringer if the importation, sale, or use of the product occurs during the term of such patent."
"Biotechnological material" is defined in the proposed statute as "any material (including a host
cell, DNA sequence, or vector) that is used in a biotechnological process" as defined in the
proposed definition of that term in § 103.
The proposed amendment concerning biotechnological materials would go into effect six months
after the enactment of the Act, and would apply only with respect to products made or imported
after the effective date of the proposed amendments.
The proposed statute contains an "exceptions" section grandfathering in certain business
activities already in progress before its enactment. Particularly, the proposed statute would not
remove the right of any person to continue to use, sell, or import products which were "in
substantial and continuous sale or use by such person in the United States on the date of the
enactment of this Act" or products "for which substantial preparation by such person for such
sale or use was made" before the enactment date, "to the extent equitable for the protection of
commercial investment made or business commenced in the United States" before the enactment
date.
B. Cases
In addition to the evolution of proposed amendments to the U.S. patent statutes concerning
recombinant DNA and related genetic engineering matters, several recent decisions of the
Federal Circuit are quite relevant.
In Amgen Inc. v. Chugai Pharmaceutical Co. , 18 U.S.P.Q. 2d 1016 (Fed. Cir. 1991), the Federal
Circuit set forth the requirements necessary to establish conception of a purified DNA sequence
coding for a specific protein. In Amgen , the Federal Circuit explained that for conception to
occur, the scientist must have "a mental picture of the structure of the chemical," or be "able to
define it by its method of preparation, its physical or chemical properties, or whatever
characteristics sufficiently distinguish it." 927 F.2d at 1206. The Federal Circuit stated that
defining the chemical "solely by its principal biological property, e.g. , encoding human
erythropoietin" was insufficient . The Court indicated that such a definition was no more than a
"wish to know the identity of any material with that biological property." Specifically, the Court
held that "when an inventor is unable to envision the detailed chemical structure of the gene so as
to distinguish it from other materials, as well as a method for obtaining it, conception has not
been achieved until reduction to practice has occurred, i.e. , until after the gene has been
isolated." 927 F.2d at 1206. Under Amgen , the complexity or simplicity of the isolation method
was irrelevant.
In Fiers v. Sugano , 25 U.S.P.Q.2d 1601 (Fed. Cir. 1993), the Federal Circuit expanded on the
Amgen principles in an interference case relating to DNA sequences. Particularly, the Court
considered a product, a DNA sequence coding for a protein (called fibroblast beta interferon
(beta IF)) that promotes viral resistance in human tissue. The Federal Circuit rejected an
argument that the existence of a workable method for preparing a DNA sequence establishes its
conception. 25 U.S.P.Q.2d at 1604. The Court explained that its "statement in Amgen that
conception may occur, inter alia , when one is able to define a chemical by its method of
preparation requires that the DNA be claimed by its method of preparation." 25 U.S.P.Q.2d at
1604 05. The Court noted that chemical materials may be claimed by structure or physical
properties, or also through a product by process claim.
However, the Court in Fiers explained that typically a product by process claim was an after the
fact definition constructed after a scientist has obtained a material by a particular process. The
Court noted that, before reduction to practice occurs, conception only of a process for making a
material, without having conceived the structure or equivalent definition of the material, at most
constituted conception of the material claimed as a process. Thus, when alleging conception of a
substance without referring to a process, the substance's "structure, name, formula, or definitive
chemical or physical properties" must be known. 25 U.S.P.Q.2d at 1605.
In Fiers , the Federal Circuit also addressed enablement issues as to recombinant DNA
inventions. The Court held that an adequate written description by an inventor of a DNA
sequence "requires more than a mere statement that it is part of the invention and reference to a
potential method for isolating it". 25 U.S.P.Q.2d at 1606. Rather, the inventor must provide a
description of the DNA itself. An application which fails to demonstrate that the disclosed
method actually leads to the DNA (such as one that only discloses a clone that might be used to
obtain mRNA coding for beta IF) is insufficient. Also, referring to a DNA sequence and stating
that it can be obtained by reverse transcription is insufficient. The inventor must show that he or
she was in possession of the DNA. 25 U.S.P.Q.2d at 1606. A wish or plan for obtaining the DNA
is not enough.
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With the new proposed biotechnological amendments to the U.S. patent statutes, and with
interference and infringement litigation likely as research and development proceeds, further
developments in U.S. patent protection for such recombinant DNA-related inventions should
follow.