Department of Commerce
                          Patent and Trademark Office
             Notice of Hearing and Request for Comments on Changes
            to a Twenty-Year Patent Term and Its Effects on Patent
                  Expiration Dates and Patent Term Extensions

Agency: Patent and Trademark Office, Commerce

Action: Notice of public hearing and request for comments

Summary: In a Notice published on December 12, 1994 [59 FR 63951], the
Patent and Trademark Office ("PTO") announced a public hearing on proposed
changes related to the 20-year patent term contained in the Uruguay Round
Agreements Act ("URAA"), Pub. L. 103-465.

   Concurrently with the hearing scheduled for February 16, 1995, PTO also
seeks comments on several additional issues that are relevant to the Food
and Drug Administration's interpretation and application of current
provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA") and its
implementing regulations in light of the changes to title 35, United
States Code, effected by passage of the URAA. The specific provisions of
the FDCA that would be affected govern the submission of patent
information related to new drug applications ("NDAs") and the submission
and approval of abbreviated new drug applications ("ANDAs") for generic
equivalents of listed drugs in anticipation of the expiration of patent
protection for the listed drugs. (See 21 U.S.C. 321; 21 CFR Part 314,
Subparts C and D.) Similarly affected may be FDCA provisions related to
the submission of new animal drug applications ("NADAs") and the
submission and approval of abbreviated new animal drug applications
("ANADAs"). (See 21 U.S.C. 360b). Because the changes to title 35 may
affect the effective date of ANDA and ANADA approval under the FDCA and
are relevant to the issues that will be discussed at the public hearing to
be held on February 16, 1995, PTO will set aside a portion of the meeting
to address these issues.
   In addition, PTO seeks comments on the URAA's effect on existing patent
term extensions under 35 U.S.C. 156.

Dates: The public hearing will be held on February 16, 1995, at 9:30 a.m.
in the Commissioner's Conference Room 912, Crystal Park 2, 2121 Crystal
Drive, Arlington, Virginia. Oral testimony on issues addressed in this
notice will begin at 1:00 p.m. Requests to present oral testimony should
be received on or before February 14, 1995. Written comments must be
submitted on or before February 17, 1995.

Addresses: Address written comments and requests to present oral testimony
to the Commissioner of Patents and Trademarks, Washington, D.C. 20231,
Attention: Stephen G. Kunin, Deputy Assistant Commissioner for Patent
Policy and Projects, Crystal Park 2, Suite 919, or by fax to (703)
305-8825. Persons with comments on the issues raised in this notice should
also forward copies of those comments to the Food and Drug Administration,

Attention: Dockets Management Branch (HFA-305), Room 1-23, 12420 Parklawn
Dr., Rockville, Md. 20857, identified with docket number 95N-0005.

For Further Information Contact: H. Dieter Hoinkes by telephone at (703)
305-9300, by fax at (703) 305-8885, through electronic mail to
hoinkes@uspto.gov, or by mail marked to his attention addressed to the
Commissioner of Patents and Trademarks, Box 4, Washington, D.C. 20231.
Persons may also contact Brian Malkin by phone at (301) 443-1382, by fax
at (301) 443-0232 or by mail marked to his attention and addressed to the
Food and Drug Administration, Office of Health Affairs, HFY-20, 5600
Fishers Lane, Rockville, Md. 20857.

Supplementary Information:

I. The Effect of URAA on the FDCA's ANDA Approval Process

Background

   As described in detail in the Federal Register Notice published on
December 12, 1994, the URAA was signed into law on December 8, 1994 (Pub.
L. 103-465). The amendments to title 35, United States Code, in the URAA
that relate to patent terms will become effective June 8, 1995. Certain
provisions of the URAA patent amendments will change the term of existing
patents from 17 years from the date of patent grant to 20 years from the
date of filing of the patent application. If the patent application
contains a specific reference to an earlier application under 35 U.S.C.
120, 121 or 365(c), the patent term will end 20 years from the date on
which the earliest application relied on was filed. Patents that are in
force on, or applied for by, June 8, 1995, will be entitled to the longer
of 17 years from the date of the grant of the patent, or 20 years from the
date of filing of the application. In addition, the URAA patent amendments
provide for the extension of patents (up to a maximum of five years) in
certain specified instances where there was delay in the issuance of the
patent. This extension is separate from, and in addition to, the patent
term extension available under 35 U.S.C. 156.
   Section 532(c)(2) of the URAA patent amendments also limits the
remedies available to a patent holder for patent infringement under
certain circumstances. Specifically, a patent holder may not obtain an
injunction or monetary damages, currently provided under title 35, for
"acts which (A) were commenced or for which substantial investment was
made before [June 8, 1995] and (B) became infringing by reason of [any
amendment to a patent term resulting from the new 20-year provision]."
Instead, the patent holder may only collect an "equitable remuneration"
under such circumstances.
   These amendments to title 35 may affect the drug approval process.
Under the FDCA, pharmaceutical companies seeking to market pioneer drugs
must first obtain FDA approval through the filing of an NDA (see, 21
U.S.C. 355(a) and (b)). In addition to data demonstrating the safety and
effectiveness of the drug, an NDA applicant is required to submit to FDA
information on any patent which claims the drug or a method of using such
drug for which a claim of patent infringement could reasonably be asserted
against an unauthorized party (see, 21 U.S.C. 355(b)(1) and (c)(2)). The
patent information must include the patent number and date of expiration.
FDA publishes this required information in its official publication,
Approved Drug Products with Therapeutic Equivalence Evaluations (commonly
referred to as the "Orange Book").
   Under section 505(j)(2)(A)(vii) of the FDCA (21 U.S.C.
355(j)(2)(A)(vii)), an ANDA must include a certification, in the opinion
of the applicant and to the best of the applicant's knowledge with respect
to each patent which claims the listed drug, (I) that such patent
information has not been filed, (II) that such patent has expired, (III)
of the date on which such patent will expire, or (IV) that such patent is
invalid or will not be infringed by the manufacture, use, or sale of the
new drug for which the application is submitted. In addition, an ANDA
applicant, who certifies that a patent is either invalid or will not be
infringed, must provide notice of this filing to each owner of the patent
as well as to the holder of the approved NDA for the listed drug which is
claimed by the patent (see 21 U.S.C. 355(j)(2)(B)(i)). This notice must
contain a statement of the legal and factual grounds that support the
applicant's opinion that the patent is not valid, unenforceable, or will
not be infringed (see 21 U.S.C. 355(j)(2)(B)(ii); 21 CFR 314.52(c)(6)).
   Under the FDCA, an ANDA approval shall be made effective on the date
certified by the ANDA applicant to be the date on which a patent expires
(see 21 U.S.C. 355(j)(4)(B)(ii)), or immediately if certified by the ANDA
applicant (1) that patent information has not been filed or that the
patent has expired (see 21 U.S.C. 355(j)(4)(B)(i)); or (2) that the patent
is invalid or will not be infringed, unless an action is brought within 45
days after the ANDA applicant gives notice to the patent holder under
section 505(j)(2)(B)(i) of the FDCA (see 21 U.S.C. 355(j)(4)(B)(iii)). The
FDCA and implementing regulations provide no other mechanism by which to
stay the effective date of an ANDA approval.
   Under the FDCA, similar provisions apply to NADAs and ANADAs. Upon the
approval of an NADA, FDA publishes required NADA patent information in its
official publication, FDA Approved Animal Drug Products (referred to as
the "Green Book"). (See 21 U.S.C. 360b(b)(1)). ANADAs are subject to
patent certification requirements (see 21 U.S.C. 360b(n)(1)(H)) and to
approval effective dates (see 21 U.S.C. 360b(c)(2)(D)), similar to the
ANDA provisions described above. The effective approval date of an ANADA,
similar to an ANDA, is stayed only if an action is brought within 45 days
after the ANADA applicant gives notice to the patent holder under 21
U.S.C. 360b(n)(2)(B)(i), that the patent is not valid or will not be
infringed. The FDCA provides no other mechanism by which to stay the
effective date of an ANADA.

Issues Upon Which Comments Are Sought

   Comments are requested regarding the effect of the URAA patent
amendments upon the filing and approval of ANDAs and ANADAs. Specifically,
comments are requested on the following questions:

1. Should FDA revise the patent term expiration dates currently listed in
the Orange Book and Green Book for those patents entitled to a longer term
under the URAA, because they are in force on June 8, 1995?

2. Should PTO, at the request of NDA or NADA holders, certify (or
alternatively, verify) new patent expiration dates under the URAA for
patents currently listed in the Orange Book and the Green Book?

3. Should NDA and NADA holders be required to submit to FDA revised patent
expiration dates for those patents currently listed in the Orange Book and
Green Book that will have a longer term under URAA? If so, should such
submissions be required to be made (1) by June 8, 1995, (2) only after PTO
certifies or verifies the claimed patent term expiration date, or (3)
within some other specified time period?

4. If revised patent term expiration dates are published in the Orange
Book and the Green Book, then if PTO does not certify or verify the patent
term expiration date identified by the NDA or NADA holder, what
submission, if any, should FDA require to verify the date? Should FDA
publish the revised patent term expiration date submitted by the NDA or
NADA holder without verification?

5. If revised patent term expiration dates are published in the Orange
Book and the Green Book, what revisions to patent certifications, if any,
should applicants with pending ANDAs or ANADAs be required to make? When
should such revisions to patent certifications be made? What type of
information related to substantial investment, if any, should ANDA and
ANADA applicants be required to make with such revisions?

II. The Effect of URAA on Existing Patent Term Extensions under 35 U.S.C.
156

   Under 35 U.S.C. 156, patent term extensions are issued for eligible
patents from the original expiration date of the patent. Since this
provision was enacted in 1984, the PTO has issued 195 certificates of
patent term extension in accordance with section 156. Under the URAA,
patents in force on June 8, 1995, are entitled to a patent term of 17
years from grant or 20 years from filing, whichever is longer. The PTO
estimates that 93 patents whose terms were extended under section 156
would be entitled to such longer patent term. The PTO has assumed, for the
purpose of evaluating the number of extended patents that may be affected
by the 20-year patent term, that a patent that would have expired (under
the original 17-year patent term) before June 8, 1995, but has received a
patent term extension for a period beyond June 8, 1995 (with the rights
prescribed in 35 U.S.C. 156(b)), is a patent "in force" on June 8, 1995.
   There are several ways to interpret the provision of the URAA that
grants the longer of a 17 or 20-year patent term to patents in force on
June 8, 1995, and that have been or will be extended under section 156.
First, the extension already issued by the PTO could simply be added to
the longer of the 17 or 20-year patent term. No action would be required
by the PTO. Second, the extension already issued by the PTO could be
interpreted to operate from "the original expiration date of the patent"
(35 U.S.C. 156(a)), which could be interpreted as the expiration date of
the 17-year patent term. Again, no action would be required by the PTO. A
third interpretation could be that the appropriate extension under section
156 would be added to the longer of the 17 or 20-year patent term. This
third interpretation would require the PTO to revise the extension granted
in some cases, as the 14-year limitation of a patent term counted from the
date of market approval (35 U.S.C. 156(c)(3)) would be applicable to the
extended patent term regardless of whether the original expiration date of
the patent was 17 years from grant or 20 years from the filing date. The
PTO seeks comments from the public on the appropriate course of action
with respect to patents that have been or will be issued term extensions
under section 156 of title 35, United States Code.

Questions:

1. Should PTO take any action with respect to existing patent term
extensions under section 156?

2. What approach should PTO take with respect to the calculation of new
patent term extensions under section 156 where the patent is entitled to
the longer of the 17 or 20-year patent term under the URAA?

   Comments on any other issues relevant to the relationship between the
URAA and the FDCA or existing patent term extensions under 35 U.S.C. 156
are also invited.

January 11, 1995                                                MICHAEL K. KIRK
                                                     Deputy Assistant Secretary
                                                         of Commerce and Deputy
                                                        Commissioner of Patents
                                                                 and Trademarks