[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