[Federal Register Volume 61, Number 50 (Wednesday, March 13, 1996)]
[Notices]
[Pages 10320-10323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5895]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Notice of Hearings and Request for Comments on Issues Relating to
Patent Protection for Therapeutic and Diagnostic Methods
AGENCY: Patent and Trademark Office, Commerce.
ACTION: Notice of Hearings and Request for Comments.
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SUMMARY: The Patent and Trademark Office (PTO) will hold public
hearings, and it requests comments, on issues relating to patent
protection for therapeutic and diagnostic methods. Interested members
of the public are invited to testify at public hearings and to present
written comments on any of the topics outlined in the supplementary
information section of this notice.
DATES: A public hearing will be held on Thursday, May 2, 1996, starting
at 9:00 a.m. and ending no later than 5:00 p.m.
Those wishing to present oral testimony at the hearing must request
an opportunity to do so no later than Friday, April 26, 1996.
Written comments on the topics presented in the supplementary
information section of this notice will be accepted by the PTO until
Friday, May 17, 1996.
Written comments and transcripts of the hearing will be available
for public inspection on or about June 14, 1996. They will be
maintained for public inspection in Room 902 of Crystal Park Two, 2121
Crystal Drive, Arlington, Virginia.
ADDRESSES: The hearing will be held from 9:00 a.m. to 5:00 p.m. in
Suite 912, Commissioner's Conference Room, Crystal Park Two, 2121
Crystal Drive, Arlington, Virginia.
Requests to testify should be sent to Richard Wilder by telephone
at (703) 305-9300, by facsimile transmission at (703) 305-8885, or by
mail marked to his attention addressed to the U.S. Patent and Trademark
Office, Office of Legislative and International Affairs, Box 4,
Washington, D.C. 20231.
Written comments should be addressed to Richard Wilder, U.S. patent
and Trademark Office, of Legislative and International Affairs, Box 4,
Washington, D.C. 20231. Comments may also be submitted by facsimile
transmission at (703) 305-8885, with a confirmation copy mailed to the
above address.
FOR FURTHER INFORMATION CONTACT: Richard Wilder by telephone at (703)
305-9300, by facsimile transmission to (703) 305-8885, or by mail
marked to his attention addressed to the Office of Legislative and
International Affairs, Box 4, Washington, D.C. 20231.
SUPPLEMENTARY INFORMATION:
I. Background
On March 3, 1995, H.R. 1127, the ``Medical Procedures Innovation
and Affordability Act,'' was introduced. H.R. 1127 would exclude from
patentability any technique, method, or process for performing a
surgical or medical procedure, administering a surgical or medical
therapy, or making a medical diagnosis. In this notice, the foregoing
subject matter is referred to collectively as ``therapeutic and
diagnostic methods.'' The bill would, however, allow claims to such
techniques, methods, or processes that are performed by or as a
necessary component of a machine, manufacture, or composition of matter
that is otherwise patentable. On October 19, 1995, the Subcommittee on
Courts and Intellectual Property, Committee on the Judiciary, U.S.
House of Representatives (``Congressional Hearing'') held a hearing on
H.R. 1127.
On October 18, 1995, S. 1334, the ``Medical Procedures Innovation
and Affordability Act'', was introduced. While S. 1334 would not
exclude subject matter from patentability, as would H.R. 1127, it would
grant limited immunity from patent infringement to certain persons. S.
1334 provides that a patient, physician, or other licensed health care
practitioner, or a health care entity with which a physician or
licensed health care practitioner is professionally affiliated, would
be free to use or induce others to use a patented technique, method, or
process for performing a surgical or medical procedure, administering a
surgical or medical therapy, or making a medical diagnosis. This
immunity would not extend, however, to the ``use of, or inducement to
use, such a patented technique, method, or process by any person
engaged in the commercial manufacture, sale, or offer for sale of a
drug, medical device, process, or other product that is subject to
regulation under the Federal Food, Drug, and Cosmetic Act or the Public
Health Service Act.''
The critics of the patenting and/or enforcement of surgical and
medical procedure patents believe that ``it is unethical for physicians
to seek, secure or enforce patents on medical procedures.'' ``Report 1
of the Council on Ethical and Judicial Affairs (A-95), Patenting of
Medical Procedures,'' p. 9, the American Medical Association (1995)
(``AMA Report''). The bases for this belief are that such patents
restrict access to patented procedures, increase costs of medical care,
and interfere with patient confidentiality. See, AMA Report, pp. 3-6.
It is not the purpose of the PTO hearing to discuss the ethics of
patenting therapeutic and diagnostic method patents. Nor is it the
purpose of the hearing to consider economic analyses of patenting
therapeutic and diagnostic method patents. Rather, the purpose of the
hearing is to consider whether the problems identified by the
proponents of H.R. 1127 and S. 1334, some of which are discussed above,
can be solved administratively, rather than legislatively. In this
regard, the AMA Report draws a distinction between inventions in the
field of therapeutic and diagnostic methods that are ``worthy'' of
patent protection and those that are not. The Report states, at p. 8,
that
rigorous application of the standard [of obviousness] would not only
remove the procedures which are currently causing an uproar in the
medical community from patent protection but would ensure that
procedures worthy of patent protection could come into existence. It
seems reasonable to assert that generally the producers which were
non-obvious would be the ones that required additional incentives
and economic investment.
The requirement of non-obviousness, along with novelty, is one of the
basic requirements to be met prior to a patent being granted. The
novelty requirement ensures that a patent is not granted when the
claimed invention is identical to an invention found in the ``prior
art.'' The purpose of the obviousness standard is to ensure that an
invention, even though novel, is not granted patent protection if it
would have been obvious at the time the invention was made to a person
of ordinary skill in the art or technology to which the invention
pertains.
Accordingly, at the Congressional Hearing, the Administration
offered to hold hearings at the PTO to determine the extent to which
and how the problems presented by the patenting of therapeutic and
diagnostic methods can be solved by changes in standards and practices
within the PTO. In a letter from The Honorable Carlos J. Moorhead,
Chairman of the Subcommittee on Courts and Intellectual Property, House
Committee on the Judiciary, to PTO Commissioner Bruce Lehman, Chairman
Moorhead requested the PTO to convene hearings ``to determine
[[Page 10321]]
whether the problems identified by the proponents of H.R. 1127 could be
solved administratively, rather than legislatively.'' Chairman Moorhead
suggested several areas of inquiry for such PTO hearings and those
areas of inquiry are identified in the following section.
II. Issues for Public Comment
Interested members of the public are invited to testify and/or
present written comments on issues they believe to be relevant to the
discussion topics outlined below. Questions following each topic are
included to identify specific issues upon which the PTO is interested
in obtaining public input.
Information that is provided pursuant to this notice will be made
part of a public record. In view of this, parties should not provide
information that they do not wish to be publicly disclosed. Parties who
would like to rely on confidential information to illustrate a point
being made are requested to summarize or otherwise provide the
information in a way that will permit its public disclosure.
Individuals with questions regarding submission of such information may
contact Richard Wilder at the numbers listed above for further
information.
A. Application of the Standards of Patentability, PTO Resources, and
Reexamination
Chairman Moorhead, in his letter to Commissioner Lehman, stated the
following:
(At the Congressional Hearing) there appeared to be a great deal
of concern that the PTO has issued patents in the field of
therapeutic and diagnostic methods that fail to meet current
patentability standards. This concern implies a need to inquire into
the standards applied by the PTO, including obviousness, in
determining whether or not to issue a patent. It also implies a need
to examine the resources available to the PTO to be used in the
examination process, including the prior art available to examiners.
It may also be worthwhile to consider whether changes to the patent
reexamination process may be useful.
1. Application of Patentability Standards by the PTO
In the field of therapeutic and diagnostic methods, as in any other
technical field, the PTO applies the statutory standards for
patentability, which include novelty, 35 U.S.C. 102, and non-
obviousness, 35 U.S.C. 103. To receive a patent, an invention for which
patent protection is sought must comply with all statutory requirements
of patentability. The PTO examines each patent application on its own
merits and does not apply per se rules regarding novelty, obviousness,
or any other statutory requirement of patentability. Furthermore, the
PTO strives to ensure that its examining practices reflect appropriate
scientific and technological standards. The PTO thus seeks public input
to help ensure that it is properly construing and applying the
statutory requirements of patentability in the field of surgical and
medical methods.
Are you aware of any problems related to the manner in which the
requirements under 35 U.S.C. 102 and 103 are administered by the PTO
for claims drawn to a therapeutic and diagnostic method? If so,
please identify those problems with particularity, citing, if
appropriate, specific situations or examples and providing steps
that may be taken to solve the problems.
In responding to this question, you may wish to draw a distinction
between problems caused by a lack of clarity of the legal standards
governing 35 U.S.C. 102 and 103, as developed and interpreted by the
Federal courts, and those caused by how those legal standards are
applied by the PTO.
2. PTO Resources for the Search and Examination of Applications
Directed to Therapeutic and Diagnostic Methods
In making a determination as to patentability under 35 U.S.C. 102
and 103, the examiner must compare the claimed invention with the prior
art. The prior art can, inter alia, comprise knowledge, use, offer for
sale, or a sale in the United States or U.S. or foreign patents or
publications. Proponents of H.R. 1127 and S. 1334 argue that the PTO
does not have access to all materials that comprise the prior art in
the field of therapeutic and diagnostic methods. This is particularly
so, they argue, in the case of prior uses of inventions that are not
reported in journals, patents, or other publications. In this regard,
testimony is solicited on the following points:
Do you believe that the prior art collection relating to
therapeutic and diagnostic methods to which examiners in the PTO
have access is deficient? If so, please suggest ways in which the
prior art collection may be improved.
In responding to this question you may wish to draw a
distinction between prior art that may not be included in a printed
publication (including, for example, prior uses, including
procedures performed in operating rooms and physicians' offices,
prior knowledge, and prior sales) and prior art that is embodied in
a printed publication. You may wish to comment on how the PTO can
obtain access to obscure papers and other hard-to-obtain technical
publications.
3. Reexamination of Patents in the Field of Therapeutic and Diagnostic
Methods
A person may conclude that a patent is invalid and want to
challenge its validity on the basis of a ``prior art'' reference that
was not considered by the PTO during the original examination.
Proponents of H.R. 1127 and S. 1334 argue that it can be costly to
challenge the validity of a patent in court. An alternative to
challenging such a patent in court is to request that the patent be
reexamined in the PTO on the basis of that newly discovered reference.
35 U.S.C. 301. The bases upon which reexamination may be sought and the
degree of participation of a person seeking reexamination are currently
quite limited. Proponents of H.R. 1127 and S. 1334 cite these
limitations as dissuading third parties from seeking reexamination and
relying on litigation instead when a patent they consider invalid is
asserted against them.
Another bill before Congress, H.R. 1732, would provide a more
effective reexamination procedure by permitting greater participation
by reexamination requestors throughout a reexamination proceeding, with
a right of appeal for the requester. The bill would also allow the PTO
to consider matters under 35 U.S.C. 112, first paragraph, except for
best mode affecting patent validity, in addition to those based on the
prior art. Some persons practicing in the field of therapeutic and
diagnostic methods suggest that the changes contemplated in H.R. 1732
are not sufficient. In particular, they suggest that the basis upon
which reexamination may be requested should be expanded to include
prior art consisting of unpublished prior use, including medical
procedures performed in operating rooms and physicians' offices. This
gives rise to the following question:
Do you think the current reexamination statute requires
modification to solve the concerns of persons practicing in the
field of therapeutic and diagnostic methods beyond those
contemplated in H.R. 1732? If so,
(a) please identify with specificity the modifications deemed
necessary to solve the concerns; and
(b) explain the implications of such modifications, not only for
patent owners, but for the PTO.
B. Publication of Patent Information
Chairman Moorhead, in his letter to Commissioner Lehman, stated the
following:
We also heard from witnesses that patent protection in the field
of therapeutic and diagnostic methods exercises a chilling effect on
the publication or dissemination of knowledge in the field. I
believe it would be worthwhile at the hearings you have
[[Page 10322]]
proposed to look into ways in which information contained in patent
documents could be made more easily and widely available to the
medical community. Perhaps a discussion on the role of early
publication of patent applications would be useful here.
Proponents of H.R. 1127 and S. 1334 contend that patenting
therapeutic and diagnostic methods may have a chilling effect on the
development of new medical knowledge by creating an atmosphere of
secrecy among physicians to protect their proprietary interests. One of
the basic requirements of the patent law is that an applicant must
disclose his or her invention in a manner sufficiently clear so that
others skilled in the art are taught how to make and use it. Once
issued, a patent is published, and thus, the public can read the
information and learn from it. Another bill before Congress, H.R. 1733,
would improve the information-dissemination function of patent
documents. H.R. 1733 would require the PTO to publish patent
applications no later than 18 months after the earliest effective
filing date claimed by the patent applicant.
1. Does the medical community use information in granted U.S.
patents or published foreign applications or patents, in particular
such information concerning therapeutic and diagnostic methods?
(a) if not why not? if so, in what way is that information used?
(b) In either case, are there ways in which the dissemination of
such information can be improved, both in terms of the form in which
it is presented and its channels of distribution? For example, would
the publication of patent applications as contemplated by H.R. 1733
improve the information-dissemination function of patent documents?
2. Would the absence of patent protection for inventions of
therapeutic and diagnostic methods lead to a reduction in the
dissemination of information in that field due to a desire to protect
such inventions as trade secrets?
3. Does the availability of patent protection for inventions in the
field of therapeutic and diagnostic methods inhibit the publication or
dissemination of knowledge in the field? If so, in what way and to what
extent?
C. Experimental Use
Chairman Moorhead, in his letter to Commissioner Lehman, stated the
following:
The medical community has expressed concern that patent
protection for therapeutic and diagnostic methods will have a
chilling effect on the ``peer review'' of such procedures. Some of
the proponents of H.R. 1127 have suggested that this concern may be
overcome through a more expansive application of the ``experimental
use doctrine.'' An inquiry into this matter may be useful at the
hearings that the Administration has proposed.
Note: The PTO has solicited written comments on the experimental
use defense to patent infringement. See, Public Hearings and Request
for Comments on Economic Aspects of the U.S. Patent System, 58 FR
68394 (December 27, 1993); Cancellation of Public Hearings on
Economic Aspects of the U.S. Patent System, 59 FR 1935 (January 12,
1994); and Notice of Public Hearings and Request for Comments on
Patent Protection for Biotechnological Inventions, 59 FR 45267,
(September 1, 1994).
A concern among medical professionals is that the existence of
patents on therapeutic and diagnostic methods has a chilling effect on
the study of such procedures. In particular, there is concern that the
need to seek and obtain a license to practice a patented procedure will
restrict ``peer review'' whereby experimentation and testing of such
procedures are carried out to assess their quality and safety. It has
been suggested that some of these concerns could be avoided by
expansion of the ``experimental use doctrine.'' See, AMA Report, p. 5.
This doctrine would exempt from infringement certain acts considered
purely experimental, unrelated to any commercial use of the patented
invention. Yet, other than limited provisions allowing for testing of
patented pharmaceutical products for purposes of regulatory approval
(e.g., section 271 (e)(1) of title 35, United States Code), existing
law does not provide a general, statutory defense against a charge of
infringement for experimental use of patented technology.
Despite this, the Federal courts have recognized a limited defense
to a charge of patent infringement based on use of the patented
technology for experimental purposes. This defense, referred to as the
experimental use defense, has been raised infrequently, and when
considered has been construed very narrowly. There are few cases
elaborating the nature of the defense, primarily because patent rights
are not frequently enforced against members of the public that use the
patented technology for purely experimental purposes. In these cases,
the courts have not recognized the defense where the accused infringer
has engaged in use of the patented invention for purposes of
commercially exploiting the invention, rather than for increasing his
or her understanding of the invention. In cases in which the defense
has been raised successfully, the experimental use in question was to
ascertain how the invention functioned or for purely philosophical or
academic reasons.
Proponents of H.R. 1127 and S. 1334 contend that the need for an
experimental use exception in the field of therapeutic and diagnostic
methods is greater than in other fields of technology, including the
fields of pharmaceuticals or medical devices. They argue first that,
while the Food and Drug Administration has responsibility for
regulating pharmaceuticals or medical devices, peer review serves as
the primary regulatory mechanism for therapeutic and diagnostic
methods. Second, they argue that a patent on a surgical or medical
procedure acts as a barrier to peer review that could lead to a
decrease in the quality and safety of such procedures. Given these two
postulates, proponents of H.R. 1127 and 1334 conclude that an expanded
form of the experimental use doctrine is needed.
The foregoing discussion raises the following questions:
1. Does the grant of patent protection for therapeutic and
diagnostic methods impose a ``chilling'' effect on the peer review
of such procedures?
2. If the answer to question 1 is ``yes,'' explain how such
patents have such a ``chilling'' effect.
3. If the answer to question 1 is ``yes,'' do you think
modification of the present experimental use exception would reduce
or eliminate such a ``chilling'' effect?
4. If the answer to question 3 is ``yes,'' how should the
experimental use exception be modified to reduce or eliminate such a
``chilling'' effect? In particular,
(a) What activities involving a patented invention should be
exempted from infringement under the experimental use exception?
(b) Which entities should be able to take advantage of such an
experimental use exception? That is, should it be limited to
physicians or health care providers or should it extend to legal
entities with which physicians or health care providers are
affiliated?
(c) What gains or losses to levels of basic research, inventive
activity, and investment in research-intensive industries, if any,
would you expect to occur if the nature of the present experimental
use defense to infringement was modified as you suggest?
D. Foreign and International Experience
Chairman Moorhead, in his letter to Commissioner Lehman, stated the
following:
As you know, many countries, including developed industrialized
countries, exclude therapeutic and diagnostic methods from
patentability. I think it would be useful to invite testimony on the
way in which exceptions from patentability of therapeutic and
diagnostic methods are provided for in the laws of other countries,
the ways in which those exclusions are implemented,
[[Page 10323]]
and the effect such exclusions have on the medical community and
industry.
The proponents of H.R. 1127 and S. 1334 have argued that many
countries exclude therapeutic and diagnostic methods from patent
protection and that the United States should follow their lead and
``harmonize'' our law with theirs. Testimony is invited in this regard
in response to the following questions:
1. Identify countries that exclude therapeutic and diagnostic
methods from patentability. As to such exclusions, identify:
(a) the way in which exceptions from patentability of
therapeutic and diagnostic methods are provided for in the laws of
other countries (for example, whether they are specifically excluded
or defined as not being industrially applicable);
(b) the ways in which those exclusions are implemented (for
example, whether they are strictly or liberally construed by offices
in those countries that grant patents);
(c) the effect such exclusions have on the medical community and
industry in countries that maintain them;
(d) any international obligations that would prevent such
countries from continuing such exclusions; and
(e) the rationale for providing such exclusions.
2. Identify countries that grant limited immunity from patent
infringement to certain persons that practice therapeutic and
diagnostic methods. As to such limited immunity, identify:
(a) the way in which such limited immunity is provided for in
the laws of other countries (for example, whether it is part of such
countries' patent law or general tort law);
(b) the ways in which such limited immunity is implemented in
practice;
(c) the effect such limited immunity has on the medical
community and industry in countries that provide for such immunity;
(d) any international obligations that would prevent such
countries from continuing such limited immunity; and
(e) the rationale for providing such limited immunity from
patent infringement.
III. Guidelines for Oral Testimony
Individuals wishing to testify must adhere to the following
guidelines:
1. Anyone wishing to testify at the hearings must request an
opportunity to do so no later than Friday, April 26, 1996. Requests to
testify may be accepted on the date of the hearing if sufficient time
is available on the schedule. No one will be permitted to testify
without prior approval.
2. Requests to testify must include the speaker's name,
affiliation, and title, phone number, fax number, and mailing address.
3. Speakers will be provided between 5 and 15 minutes to present
their remarks. The exact amount of time allocated per speaker will be
determined after the final number of parties testifying has been
determined. All efforts will be made to accommodate requests for
additional time for testimony presented before the day of the hearing.
4. Speakers may provide a written copy of their testimony for
inclusion in the record of the proceedings. These remarks should be
provided no later than Friday, May 17, 1996.
5. Speakers must adhere to guidelines established for testimony.
These guidelines will be provided to all speakers on or before
Wednesday, May 1, 1996. A schedule providing approximate times for
testimony will be provided to each speaker prior to the hearing.
Speakers are advised that the schedule for testimony will be subject to
change during the course of the hearings.
(Authority: 35 U.S.C. 6(a))
Dated: March 7, 1996.
Bruce Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
[FR Doc. 96-5895 Filed 3-12-96; 8:45 am]
BILLING CODE 3510-16-M
