[Federal Register Volume 60, Number 10 (Tuesday, January 17, 1995)]
[Notices]
[Pages 3398-3399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1073]



[[Page 3398]]

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.

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SUMMARY: In a Notice published on December 21, 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 
[email protected], or by mail marked to his attention addressed to the 
Commissioner of Patents and Trademarks, Box 4, Washington, DC 20231. 
Persons may also contact Brain 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 
[[Page 3399]] (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 ``Greek 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. 360(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 revised 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 extending 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.

    Dated: January 11, 1995.
Michael K. Kirk,
Deputy Assistant Secretary of Commerce and Deputy Commissioner of 
Patents and Trademarks.
[FR Doc. 95-1073 Filed 1-13-95; 8:45 am]
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