[House Report 104-178]
[From the U.S. Government Publishing Office]
104th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 104-178
_______________________________________________________________________
BIOTECHNOLOGICAL PROCESS PATENTS
_______
July 11, 1995.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______________________________________________________________________
Mr. Moorhead, from the Committee on the Judiciary, submitted the
following
R E P O R T
[To accompany H.R. 587]
The Committee on the Judiciary, to whom was referred the
bill (H.R. 587) to amend title 35, United States Code, with
respect to patents on biotechnological processes, having
considered the same, report favorably thereon without amendment
and recommend that the bill do pass.
TABLE OF CONTENTS
Purpose and Summary.............................................. 1
Background and Need for Legislation.............................. 2
Hearings......................................................... 7
Committee Consideration.......................................... 7
Committee Oversight Findings..................................... 7
Committee on Government Reform and Oversight..................... 8
New Budget Authority and Tax Expenditures........................ 8
Congressional Budget Office Estimate............................. 8
Inflationary Impact Statement.................................... 8
Section-by-Section Analysis and Discussion....................... 9
Sec. 101..................................................... 9
Sec. 102..................................................... 9
Sec. 103..................................................... 10
Changes in Existing Law Made by the Bill, as Reported............ 10
Purpose and Summary
The purpose of H.R. 587 is to provide for a modified
examination of biotechnological process patents. Under the
provisions of H.R. 587 a biotechnological process will not have
to undergo a separate review of nonobviousness under certain
conditions. If the process uses or produces a patentable
composition of matter, the process will be determined
nonobvious for the purpose of examination of biotechnological
process claims. The expedited review will resolve the delays
and inconsistent determinations faced by biotechnological
process patent applicants under present PTO practices without
harm to the basic principles of patentability.
Background and Need for the Legislation
Patents can be granted on any invention that is included
within the statutory subject matter provisions, including
processes under 35 U.S.C. Sec. 101.\1\ A patent on an invention
gives the patent owner the right to exclude others from making,
using or selling that invention. A process patent may be
obtained for a new method of use or new method of making a
product. A process patent can be infringed if the process is
used in making any product or used in any manner covered by the
process patent. If a patent is obtained on a product, the owner
of the patent can prevent the manufacture, the sale or the
importation of that particular product in the United States.
The owner of a United States patent cannot prevent the
manufacture or sale of that patented product in another
country, unless a patent is obtained in that country.
\1\ 35 U.S.C. Sec. 101 states: ``Whoever invents of 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.''
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It is not uncommon to seek a product patent with process
claims relating to the same invention. A process can be
described in simple terms such as a new method of draining
swamps to more complex processes detailing the exact steps that
take place when a starting material is pasteurized,
pressurized, radiated or subjected to other procedures. Product
and process patents claims are each subject to examination
under the same principles of patent law, including examining
criteria such as novelty, nonobviousness, and usefulness.
If a patent containing process claims is granted on the
manufacturing process or development process of a particular
product, then the owner of the patent also can prevent the
manufacture or sale of a product made using that process. Under
the provisions of the Process Patent Amendments Act of 1988,
the process owner also can prevent importation of the product
if the product is made overseas using the patented process.\2\
A patent may be obtained on the starting materials or materials
used in a process but unless a patent on the process is
obtained (or a patent on the final product), the final product
could be produced overseas and imported back into the United
States for sale without infringing the patent on the materials
used in the process.
\2\ The Process Patent Amendments Act of 1988 was contained in The
Omnibus Trade and Competitiveness Act of 1988, Pub. L. No. 100-418
(1988) and is found at 35 U.S.C. Sec. 271(g): ``Whoever without
authority imports into the United States or sells or uses within the
United States a product which is made by a process 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 process
patent. In an action for infringement of a process patent no remedy may
be granted for infringement on account of the noncommercial use or
retail sale of a product unless there is no adequate remedy under this
title for infringement on account of the importation or other use or
sale of that product. A product which is made by a patented process
will, for purposes of this title, not be considered to be so made
after--(1) it is materially changed by subsequent processes; or (2) it
becomes a trivial and nonessential component of another product.''
A problem arises in those situations in which the final
product produced by a process may not be patentable. Without a
patent on the final product or a patent on the process, the
original developer of the product cannot take advantage either
of basic product patent protection or the process patent
protection permitted under the Process Patent Amendments Act of
1988.\3\
\3\ The amendments were intended to provide protection to domestic
U.S. process patent holders against foreign companies using the U.S.
patented process overseas and importing the resulting product into the
U.S. without any recourse by the process patent owner for infringement.
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Under present patent law, an owner of a product patent can
prevent others in the United States from using or making a
patented product even in the absence of a process patent. The
value of the process patent is the ability to prevent others
from importing a non-patentable product that was made by use of
a protected process. The value of the process patent is the
ability to prevent others from importing a non-patentable
product that was made by use of a protected process.
H.R. 587 and related predecessor bills were developed as a
result of two conflicting and irreconcilable decisions issued
by the Court of Appeals for the Federal Circuit, In re Durden,
763 F. 2d 1406 (Fed. Cir. 1985) and In re Pleuddemann, 910 F.
2d 823 (Fed. Cir. 1990).
In re Durden concerned a process patent claim which had
been rejected by the PTO. The case involved a chemical process.
The applicants for the patent argued on appeal that while
individual process steps were obvious, the use of a novel and
nonobvious starting material and the production of a new and
nonobvious product meant that the process should be patentable.
The Court concluded that the use of a new starting material
and/or the development of a patented product did not
automatically ensure the nonobviousness of a process or the
grant of a process patent. The Court noted that if every
process using a new or novel material was granted a patent,
then simple processes such as dissolving or heating would be
patentable when using a new compound.\4\
\4\ In re Durden, 763 F. 2d 1406, 1410 (Fed. Cir. 1985)
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Following this case, there were complaints from various
industry groups that the PTO was automatically rejecting
process claims under circumstances similar to In re Durden. In
the subsequent case of In re Pleuddemann, the Court emphasized
that In re Durden was not to be read as a ``per se'' rule
against patenting old processes using new starting materials or
producing new products. The Court stated that each invention
had to be viewed as a whole and considered on its individual
facts.\5\
\5\ In re Pleuddeman, 910 F. 2d 823, 828 (Fed. Cir. 1990).
In holding of In re Pleuddemann, the Court distinguished In
re Durden on the grounds that the fact situation there involved
a process of ``making'', and In re Pleuddemann involved a
process of ``using.'' \6\ The Court did not specifically
overrule In re Durden but relied on the distinction of
``using'' versus ``making.'' The distinction between the two
types of processes was lost on many and caused others to
manipulate phrasing in developing patent applications to ensure
that processes were ``using'' instead of ``making.'' At two
different hearings during the 103d Congress of the then
Subcommittee on Intellectual Property and Judicial
Administration, testimony was provided which indicated that in
several cases the patent applicant had originally written a
claim as a ``making'' process. After the examiner rejected the
claims on the basis of In re Durden, the claims were rewritten
as a ``using'' claim and were approved by the examiner.\7\
\6\ Id., at 827.
\7\ Legislative Hearing during 103d Congress on H.R. 4307, before
the Subcommittee on Intellectual Property and Judicial Administration
of the House Committee on the Judiciary, 103d Cong., 2d Sess. (May 5,
1994) (Testimony of Lisa J. Raines); Amending Title 35, United States
Code, With Respect to Patents on Certain Processes, Hearing on H.R.
760, before the Subcommittee on Intellectual Property and Judicial
Administration of the House Committee On The Judiciary, 103d Cong., 1st
Sess., Serial No. 32 (June 9, 1993) (Testimony of George W. Enbright,
p. 42; Testimony of Steven M. Odre, p. 51).
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The holdings in In re Durden and In re Pleuddemann have led
to inconsistent practices by the PTO in the examination of
applications for process patents. The result has been that some
process patents have been granted without any delay or
controversy while other applications, similar in nature, have
been rejected or required to be defended at length with the
patent examiner.\8\
\8\ Legislative Hearing during 103d Congress on H.R. 4307, supra
(Testimony of Lisa J. Raines); Amending Title 35, United States Code,
With Respect To Patents On Certain Processes, Hearing on H.R. 760,
supra (Testimony of George W. Enbright, p. 42).
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Legislation was developed as a response to a perceived
failure on the part of PTO to grant process patents based on
the In re Durden decision and the resulting importation problem
due to the inability of inventors to obtain process patents.\9\
While the holdings of In re Durden and In re Pleuddemann have
been applied generally, the resulting problems were considered
to affect particularly biotechnology applications because of
the nature of the products produced. In the case of
biotechnology products, the final product is a naturally
occurring substance despite the fact that it has never been
able to be produced before in commercially viable
quantities.\10\
\9\ Legislative Hearing during 103d Congress on H.R. 4307, supra
(Testimony of Lisa J. Raines); Amending Title 35, United States Code,
With Respect To Patents on Certain Processes, Hearing on H.R. 760,
supra (Testimony of George W. Enbright, p. 42).
\10\ Legislative Hearing during 103d Congress on H.R. 4307, supra
(Testimony of Lisa J. Raines); Amending Title 35, United States Code,
With Respect To Patents On Certain Processes, Hearing on H.R. 760,
supra (Testimony of Michael Kirk, p. 22; Testimony of George W.
Enbright, p. 41).
The final unpatentable product is often developed or
synthesized through the use of a ``host cell'' that has been
genetically altered in a way to produce the final product in
large quantities. The host cell is usually patentable. The
issue is whether the process, by which the final product is
produced, also can be patented.
Since the host cell is patented, the host cell cannot be
used in the United States without the patent owner's permission
and no products can be produced in the United States from that
host cell. Without a United States process patent, however, the
host cell can be taken offshore and used to make the final
product. The final product produced from the host cell can be
imported back into the United States for commercial sale. The
owner of the patented host cell has no recourse because there
is no ``use'' of the patented host cell in the United States
and thus no infringement. Since there is no patent on the
process by which the final product was produced, the
importation of the product cannot be challenged.
Clearly, obtaining a process patent could solve the
importation problem for the biotechnology industry. H.R. 587 is
necessitated by the difficulty of obtaining timely and adequate
process patent protection under present court rulings and PTO
interpretation.
The approach taken in H.R. 587 is industry specific, as
were some prior bills designed to take care of the problem.
Although industry specific legislation, particularly in the
context of patent law, is generally not favored, considerable
opposition to a more comprehensive solution proposed by other
predecessor bills, such as H.R. 4307, made their enactment
unlikely. As a result of concerns raised by certain industries
as to the impact of a broad change in patent law, the
applicability of H.R. 587 has been limited to biotechnological
processes only. The computer industry, the electronics industry
and others previously raised questions as to the ability of
certain patent owners to secure patents that would have such
extensive coverage that public domain processes would be
combined with new products to obtain patent coverage to the
detriment of the industry.\11\ The chemical industry also
raised questions as to the scope and potential infringement of
patents issued under the revised examination process proposed
in H.R. 4307, as introduced, and as amended.
\11\ Legislative Hearing during 103rd Congress on H.R. 4307, supra
(Testimony of Roger S. Smith; testimony of Richard G. Waterman);
Amending Title 35, United States Code, With Respect To Patents On
Certain Processes, Hearing on H.R. 760, supra (Testimony of Robert A.
Armitage, p. 70).
The legislation impacts only one element of patentability
of biotechnological processes--the element of nonobviousness.
There is no guarantee of patentability if the process claim
satisfies the special nonobviousness provisions of the revised
Sec. 103. The process must still satisfy all other requirements
of patentability, including the utility requirement under 35
U.S.C. Sec. 101 and the enabling provisions of 35 U.S.C.
Sec. 112 which require sufficient description provisions of the
invention and claims, described in ``full, clear and concise,
and exact terms,'' so that other skilled in the art can use the
process. Process claims patented pursuant to the proposed
revisions of Sec. 103 would not enjoy greater protection than
process claims granted under present law.
Resolution of this problem will provide both certainty for
patent applicants in the field of biotechnology and protection
against foreign competition. Once process patents are awarded,
foreign companies will not be able to take advantage of the
inability of the United States manufacturer to obtain a product
patent. There is no question, as some opponents have argued,
that, in many cases, a product patent provides better
protection than a process patent against foreign manufacture
and importation of the product into the United States. However,
if a product patent is unobtainable because of the nature of
the final product, it is essential that some other protection
be afforded. In the opinion of the Committee, the appropriate
protection is a process patent and the infringement protection
pursuant to 35 U.S.C. Sec. 271(g) against importation of
products resulting from foreign use of the patented process.
The unpredictability of the patent examination process has
become a critical problem for development of new technologies,
such as biotechnology. With a mitigation of uncertainty, that
industry can now better assess the chances and risks associated
with the patent application process. The granting of a process
patent will no longer depend on the chance of the wording of a
claim or the preference of an examiner in applying the holding
of In re Durden versus the holding of In re Pleuddemann.
H.R. 587 is in no way intended to reduce or eliminate any
requirements of the patent laws of the United States other than
providing, upon election of an applicant, that a
biotechnological process using or resulting in a composition of
matter found upon examination to be novel and nonobvious, shall
likewise be found nonobvious.
It is intended that biotechnological processes using or
resulting in a composition of matter, otherwise patentable to
the applicant, be entitled to full patent protection including
the benefits of enforcement, specifically of 35 U.S.C.
Sec. 271(g). It is not intended by this bill that applicants be
given the right to extend patent claims to all upstream or
downstream processes leading to or resulting from use of the
patented composition of matter in a way that would create
infringement liability on parties not making or using the
patented composition of matter, except as is already provided
under existing law for infringement.
There are presently two cases being considered by the U.S.
Court of Appeals for the Federal Circuit which may have a
bearing on the matter considered in H.R. 587.\12\ The Court
still has not issued opinions in these cases which might
resolve the perceived inconsistencies of the two previous
opinions of the Court, In re Durden and In re Pleuddemann. The
two cases were argued in November 1992. There has been no
indication when the Court might issue the decisions. In any
event, it is by no means certain that the two cases will
resolve the underlying issues. On the other hand, because H.R.
587 is restricted to biotechnological processes, its enactment
would not moot these cases, as they involve chemical processes.
\12\ In re Ochiai, No. 92-1446 (Fed. Cir. filed July 22, 1992); In
re Brouwer, No. 92-1225 (Fed. Cir. filed March 11, 1992).
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The PTO testified before the Subcommittee that it does not
believe it can resolve the problem administratively because of
the two seemingly conflicting Court opinions.\13\
\13\ Legislative Hearing on H.R. 587, before the Subcommittee on
Courts and Intellectual Property of the House Committee on the
Judiciary, 104th Cong., 1st Session (March 29, 1995).
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Conclusion
The extended history of H.R. 587 and related legislation
speaks to the need to have the inconsistency existing in case
law and in PTO examination procedures resolved. Testimony over
several Congresses has amply illustrated the difficulties faced
by patent applicants in satisfying the dictates of two
seemingly inconsistent Court opinions, In re Durden and In re
Pleuddemann. The inability of the PTO to make changes
administratively and the lack of direction from the Court makes
Congress the appropriate forum to address this matter.
The award of patent protection ensures a greater degree of
protection for businesses in the United States. Biotechnology
companies are faced with competition form overseas companies
who derive the benefits from the innovations and investments of
American companies without any of the risks. A resolution of
the examination practices for biotechnological processes that
are linked to patentable compositions of matter would ensure
that United States manufacturers can better protect the
extensive investment made in research and development.
Hearings
The Committees' Subcommittees on Courts and Intellectual
Property held one day of hearings related to the issues
contained in H.R. 587. The hearing was held on March 29, 1995.
Testimony was received from the following four witnesses: Mr.
H. Dieter Hoinkes, Senior Counsel, Office of Legislative and
International Affairs, Patent and Trademark Office, United
States Department of Commerce; Mr. Henry Linsert, Chairman and
Chief Executive Officer, Martek Biosciences Corporation,
Columbia, Maryland; Michele Cimbala, Ph.D. and J.D., Partner,
Sterne, Kessler, Goldstein and Fox; and Mr. Steven Odre, Senior
Vice President, Amgen Incorporated, Thousand Oaks, California
with additional material submitted by Biotechnology Industry
Organization (Bio).
The Subcommittee on Intellectual Property and Judicial
Administration held a hearing on a related bill, H.R. 4307 on
May 5, 1994. The witnesses at the hearing were Mr. Michael
Kirk, Administrator for Legislation and International Affairs,
Patent and Trademark Office, United States Department of
Commerce; Mr. Gerald Mossinghoff, President, Pharmaceutical
Research and Manufacturers of America (formerly known as
Pharmaceutical Manufacturers Association); Ms. Lisa Raines,
Vice President, Government Relations, Genzyme Corporation;
testifying on behalf of the Biotechnology Industry
Organization; Mr. Roger Smith, Assistant General Counsel, IBM
Corporation; and Mr. Richard Waterman, General Patent Counsel,
Dow Chemical Company.
A hearing on related legislation, H.R. 760 was held by the
Subcommittee on Intellectual Property and Judicial
Administration on June 9, 1993. The witnesses at the hearing
were The Honorable Rick Boucher, Congressman, 9th District,
Virginia; The Honorable Dennis DeConcini, Senator, Arizona; Mr.
Michael Kirk, Acting Commissioner, United States Patent and
Trademark Office, United States Department of Commerce; Mr. G.
Kirk Raab, Chief Executive Officer, Genentech, Inc., testifying
on behalf of the Biotechnology Industry Organization (formerly
known as the Industrial Biotechnology Association and the
Association of Biotechnology Companies); Mr. Steven M. Odre,
Vice-President for Intellectual Property, Amgen, Inc.; Mr.
William L. LaFuze, President, American Intellectual Property
Law Association; and Mr. Robert Armitage, testifying on behalf
of the Intellectual Property Owners, Inc. and on behalf of the
National Association of Manufacturers.
Committee Consideration
On May 16, 1995 the Subcommittee on Courts and Intellectual
Property met in open session and ordered reported the bill H.R.
587, by a voice vote, a quorum being present. On June 7, 1995
the Committee met in open session and ordered reported the bill
H.R. 587 without amendment by a voice vote, a quorum being
present.
Committee Oversight Findings
In compliance with clause 2(l)(3)(A) of rule XI of the
Rules of the House of Representatives, the Committee reports
that the finding and recommendations of the Committee, based on
oversight activities under clause 2(b)(1) of rule X of the
Rules of the House of Representatives, are incorporated in the
descriptive portions of this report.
Committee on Government Reform and Oversight Hearings
No findings or recommendations of the Committee on
Government Reform and Oversight were received as referred to in
clause 2(l)(3)(D) of rule XI of the Rules of the House of
Representatives.
New Budget Authority and Tax Expenditures
Clause 2(l)(3)(B) of House Rule XI is inapplicable because
this legislation does not provide new budgetary authority or
increased tax expenditures.
Congressional Budget Office Cost Estimate
In compliance with clause 2(l)(3)(C) of rule XI of the
Rules of the House of Representatives, the Committee sets
forth, with respect to the bill, H.R. 587, the following
estimate and comparison prepared by the Director of the
Congressional Budget Office under section 403 of the
Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, June 15, 1995.
Hon. Henry J. Hyde,
Chairman, Committee on the Judiciary,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
reviewed H.R. 587, a bill to amend title 35, United States
Code, with respect to applications for process patents, as
ordered reported by the House Committee on the Judiciary on
June 7, 1995. CBO estimates that enactment of H.R. 587 would
result in no significant costs to the federal government and in
no costs to state and local governments. Enacting H.R. 587
would not affect direct spending or receipts. Therefore, pay-
as-you-go procedures would not apply to the bill.
H.R. 587 would expand the definition of a non-obvious
process for purposes of considering the patentability of
biotechnological processes. The bill also would remove the
presumption of validity for a biotechnological process patent
if its approval was based on a product patent that was later
said to be invalid.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is John Webb.
Sincerely,
James L. Blum
(For June E. O'Neill, Director).
Inflationary Impact Statement
Pursuant to clause 2(l)(4) of rule XI of the Rules of the
House of Representatives, the Committee estimates that H.R. 587
will have no significant impact on prices and costs in the
national economy.
Section-by-Section Analysis
sec. 101. conditions for patentability; nonobvious subject matter
Section 101 adds a clarifying standard to 35 U.S.C.
Sec. 103. Section 103 requires that for a patent to be
obtained, the subject matter must be nonobvious. Under
Sec. 103, if the ``subject matter as a whole would have been
obvious at the time the invention was made * * *.'' a patent
cannot be granted.
The section provides that an application with a
biotechnological process claim which is linked to a patentable
composition of matter will be considered nonobvious under
Sec. 103. If a patentable composition of matter is either
produced by a biotechnological process or used as part of that
process, the process claims will be considered nonobvious.
The examination of the process claims will proceed under
the revised provisions of Sec. 103 if the applicant for a
patent elects in a timely fashion to proceed under the new
subsection.
For a biotechnological patent application to be considered
nonobvious under the proposed revision of Sec. 103, there are
several conditions which must be met. First, the claims to the
process and the patentable composition of matter, to which the
process is linked, must be contained in the same application or
have the same effective filing date. Second, the patentable
composition of matter and the process must be owned by the same
person or be subject to an obligation of assignment to the same
person. Third, the composition of matter used or resulting from
the process sought to be patented must be novel under Sec. 102,
must be nonobvious on its own merits and must, in all other
ways, be patentable.
If process claims are granted under this standard, they
must appear in the same patent containing the claims to the
patentable composition of matter used or made by the process.
If there are two different patents issued for the composition
of matter and for the biotechnological process claims relating
to the composition of matter, the process patent must expire on
the same date as the patent on the composition of matter,
notwithstanding the statutory patent term set pursuant to 35
U.S.C. Sec. 154.
To ensure that the term ``biotechnological process'' is not
misinterpreted, a definition is provided that specifies these
processes as being methods of using a product produced either
by organisms that were genetically altered or otherwise induced
to express characteristics not naturally associated with them,
by cell fusion procedures, or by a composition of both.
sec. 102. presumption of validity; defenses
This section amends 35 U.S.C. Sec. 282 which elaborates on
the validity of each patent and patent claim. Since a
biotechnological process claim examined under the terms of
Sec. 103(b)(1) is linked to a patentable composition of matter
for a determination of nonobviousness, if a claim for such
composition of matter is held invalid, the process to which it
is linked, shall no longer be entitled to rely on the claim for
a presumption of nonobviousness.
sec. 103. effective date
The Act and the amendments made by the Act shall take
effect on the date of enactment and will apply to any patent
application filed on or after the date of enactment and any
patent applications pending on the date of enactment.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3 of rule XIII of the Rules of the
House of Representatives, changes in existing law made by the
bill, as reported, are shown as follows (existing law proposed
to be omitted is enclosed in black brackets, new matter is
printed in italics, existing law in which no change is proposed
is shown in roman):
TITLE 35, UNITED STATES CODE
* * * * * * *
PART II--PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS
* * * * * * *
CHAPTER 10--PATENTABILITY OF INVENTIONS
* * * * * * *
Sec. 103. Conditions for patentability; non-obvious subject matter
(a) A patent may not be obtained though the invention is not
identically disclosed or described as set forth in section 102
of this title, if the differences between the subject matter
sought to be patented and the prior art are such that the
subject matter as a whole would have been obvious at the time
the invention was made to a person having ordinary skill in the
art to which said subject matter pertains. Patentability shall
not be negatived by the manner in which the invention was made.
(b)(1) Notwithstanding subsection (a), and upon timely
election by the applicant for patent to proceed under this
subsection, a ``biotechnological process'' using or resulting
in a composition of matter that is novel under section 102 and
nonobvious under subsection (a) of this section shall be
considered nonobvious if--
(A) claims to the process and the composition of
matter are contained in either the same application for
patent or in separate applications having the same
effective filing date; and
(B) the composition of matter, and the process at the
time it was invented, were owned by the same person or
subject to an obligation of assignment to the same
person.
(2) A patent issued on a process under paragraph (1)--
(A) shall also contain the claims to the composition
of matter used in or made by that process, or
(B) shall, if such composition of matter is claimed
in another patent, be set to expire on the same date as
such other patent, notwithstanding section 154.
(3) For purposes of paragraph (1), the term
``biotechnological process'' means--
(A) a process of genetically altering or otherwise
inducing a single- or multi-celled organism to--
(i) express an exogenous nucleotide sequence,
(ii) inhibit, eliminate, augment, or alter
expression of an endogenous nucleotide
sequence, or
(iii) express a specific physiological
characteristic not naturally associated with
said organism;
(B) cell fusion procedures yielding a cell line that
expresses a specific protein, such as a monoclonal
antibody; and
(C) a method of using a product produced by a process
defined by (A) or (B), or a combination of (A) and (B).
(c) Subject matter developed by another person, which
qualifies as prior art only under subsection (f) or (g) of
section 102 of this title, shall not preclude patentability
under this section where the subject matter and the claimed
invention were, at the time the invention was made, owned by
the same person or subject to an obligation of assignment to
the same person.
* * * * * * *
PART III--PATENTS AND PROTECTION OF PATENT RIGHTS
* * * * * * *
CHAPTER 29--REMEDIES FOR INFRINGEMENT OF PATENT, AND OTHER ACTIONS
* * * * * * *
Sec. 282. Presumption of validity; defenses
A patent shall be presumed valid. Each claim of a patent
(whether in independent, dependent, or multiple dependent form)
shall be presumed valid independently of the validity of other
claims; dependent or multiple dependent claims shall be
presumed valid even though dependent upon an invalid claim. The
burden of establishing invalidity of a patent or any claim
thereof shall rest on the party asserting such invalidity.
Notwithstanding the preceding sentence, if a claim to a
composition of matter is held invalid and that claim was the
basis of a determination of nonobviousness under section
103(b)(1), the process shall no longer be considered nonobvious
solely on the basis of section 103(b)(1).
* * * * * * *