Department of Commerce
                          Patent and Trademark Office

           Determination of New Expiration Dates of Certain Patents

Agency: Patent and Trademark Office, Commerce
Action: Final Determination
Summary: The Patent and Trademark Office (PTO) has determined the
expiration dates of patents that:
        1) Are in force on June 8, 1995, and, therefore, are entitled to the
greater of a term of 20 years from their relevant filing date, or 17 years
from grant, and
        2) have received a term extension under section 155 or 156 of title 35,
United States Code, or will receive a term extension under section 156 in
the future.
   All patents falling in this category are entitled to the longer term of
either a) 17 years from grant, supplemented by the period of extension
obtained under section 155 or 156, or b) 20 years from their relevant
filing date.
For Further Information Contact: H. Dieter Hoinkes, by telephone at (703)
305-9300, by facsimile at (703) 305-8885, or by mail marked to his
attention addressed to the Commissioner of Patents and Trademarks, Box 4,
Washington, D.C., 20231
Supplementary Information: Under section 156 of title 35, United States
Code, 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 Uruguay Round Agreements Act
("URAA"), Pub. L. 103-465, patents in force on June 8, 1995, are entitled
to a patent term of 17 years from grant or 20 years from their earliest
filing date, whichever is greater (See 35 U.S.C. 154(c)(1)).
   On February 16, 1995, the PTO held a public hearing to elicit comments
on what action it should take regarding patents that are entitled to a
longer patent term under the URAA and that had previously been extended
under section 156. (See 60 Fed. Reg. 3398 (Jan. 17, 1995)). After having
considered all the comments, both written and oral, the PTO requested
public comments on its intent to publish the new expiration date of all
patents that fall into the category mentioned above (See 60 Fed. Reg.
15748 (March 27, 1995)), using the following three criteria:
        (1) A patent that would have expired under the original 17-year patent
term before June 8, 1995, but that has received a patent term extension
for a period beyond June 8, 1995, is a patent "in force" on June 8, 1995,
even though the rights derived from that patent are circumscribed by
section 156(b) of title 35.
        (2) The "original expiration date of the patent" referred to in section
156(a) of title 35 is the date on which the patent would have expired if
it had not been extended under section 156 to expire at a later date.
Therefore, the "original expiration date" of the patents under
consideration is the date on which the 20-year term from filing expires.
        (3) The extension already issued on the basis of the 17-year term is added
to the 20-year term, subject to the limitation imposed by section
156(c)(3) of title 35. That provision limits the period remaining in the
term of an extended patent to fourteen years counted from the date on
which the product under review received approval for commercial marketing
by the relevant regulatory authority.
   After analyzing the written comments received regarding the PTO's
proposed intent to determine the expiration dates of the relevant patents,
taking into account the three criteria noted above, it has been concluded
that criterion (2) is in error and that, therefore, the steps outlined in
criterion (3) are not an appropriate course of action. The provisions of
section 156 cannot be applied in vacuo without obtaining results that
could not have been intended by the URAA or that are inconsistent with
section 156 itself.
   The entire argument in favor of adding an extension obtained under
section 156 to a 20-year term obtained under the URAA, was the manner of
interpreting the provision in section 156(a), requiring that the term of a
patent be extended from its "original expiration date". The term "original
expiration date" was proposed to be the date of a patent's expiration
without the aid of an extension period, which was proposed to be the end
of the 20-year term for those patents entitled to such term.
   This narrow interpretation of section 156, however, did not take into
account that the term "original" has several meanings, all of which must
be taken into consideration to avoid an improper interpretation of the
relationship between section 154(c)(1), added to title 35 by the URAA, and
section 156, enacted in 1984. To that end, considering the expiration of
the longer 20-year term to be the original expiration date, ignores the
fact that when the patent was issued, it originally had an expiration date
of 17 years from grant. That date must continue to be considered
"original" for two reasons.
   One is, that this was the date on which the patent, when granted, was
set to expire. Accordingly, if a patent is now entitled to a longer
20-year term, such is merely an added time period beyond the original
expiration date. The other reason is the impossibility of having more than
one "original expiration date" without having to refer to one as the first
"original" and to the other as the second or new "original", the latter
being a contradiction in terms.
   Had criteria (2) and (3) been adopted, additional anomalies would have
arisen. For example, the term "original expiration date" means the date on
which a patent would have expired without the extension added by section
156. In the case of many patents in question, their being in force on June
8, 1995, and their entitlement, therefore, to the longer term of 20 years
from filing, was solely due to an extension of the original patent term
under section 156. In other words, their entitlement to a 20-year term
rests on a patent term extension. It is not reasonable, therefore, to
ascribe to the end of such 20-year term the appellation "original
expiration" which under the provisions of section 156(a) was supposed to
have been achieved without the aid of an extended term.
   Moreover, in cases where the 17-year term expires before June 8, 1995,
and the patent is kept in force on that date by virtue of an extension
under section 156, transposing such extension to the end of the 20-year
term would have resulted in applying at least some of the extended period
twice to the term of the patent. This result would have been especially
curious in instances where both the original 17 and the 20-year terms
expired before June 8, 1995.
   Another vexing problem that would have arisen had the PTO proposal been
adopted, concerns the question of the rights that a patent holder derives
during the period of extension under section 156. If this period had been
added to the 20-year term, a patentee would have had full exclusionary
rights until the end of the 17-year term, followed by rights only to
equitable remuneration with respect to a certain class of infringers
during the period from the end of the 17 year term to the end of the
20-year term, and followed by a restoration of full exclusionary rights
with respect to the approved product during the continuing period of
extension under section 156. A more reasonable solution, such as a
continuation of limited patent rights during the period of extension, has
no statutory foundation, because section 154(c)(2) added by the URAA does
not address extensions under section 156, which itself contains an
explicit provision regarding a patentee's rights during the period of
extension.
   In analyzing section 156(a), it must be remembered that at the time of
its enactment in 1984, only one patent term -- seventeen years from grant
-- was available and that all extensions granted under section 156 until
now were added to that patent term. Because the URAA does not address the
question of patent term extension under section 156, the extensions of all
patents issued before June 8, 1995, must continue to be calculated by the
PTO on the basis of the 17-year term from grant and added to that term.
This is necessitated by the fact that all patents in that category have an
original expiration of 17 years from grant, even though they may be
entitled to a term of 20 years from filing under the URAA. Further, where
the 20-year term from filing exceeds the original term of 17 years from
grant, the provisions of the URAA are satisfied in cases where the
extension under section 156, added to the 17-year term, expires later than
20 years from the filing date.
   All patents in force on June 8, 1995, were originally issued with a
term of 17 years from grant. The fact that on June 8, 1995, these patents
are entitled to a term of 20 years from filing, if that term exceeds the
17-year term, does not move the original expiration date from which a
period of extension continues, if granted under section 156. It only
provides a new -- albeit not original -- expiration date. Accordingly, all
patents in this category are entitled either to the 17-year term, as
augmented by an extension under section 156, or to a 20-year term from the
relevant filing date, whichever is longer. This determination is fully
consistent with section 154(c)(1) of title 35, as added by the URAA,
because extensions under section 156 are not addressed by section
154(c)(1) and are, therefore, left untouched.
   Of course, all patents issued after June 8, 1995, on applications filed
before that date, are also entitled to a term that is the greater of 17
years from grant or 20 years from their relevant filing date. Extensions
under section 156 granted to these patents must be calculated with
reference to whatever term is applicable at their time of issue and will
then be added to that term. As these patents have only one term at issue,
there is no question regarding their original expiration date.
   Further, under the provisions of section 155 of title 35, 33 patents
were extended, each for a length of time to be measured from the date a
"stay of regulation of approval was imposed" (December 5, 1975) to the
date commercial marketing was permitted (October 22, 1981). This time
period mounts to 2,148 days. One of these 33 patents expired in 1992,
leaving 32 in force on June 8, 1995.
   Section 155 differs from section 156 in providing that "the term of a
patent . . . shall be extended . . . by a length of time...", rather than
that the term of a patent shall be extended "from the original expiration
date." This difference, however, has no practical effect because the 33
patents that originally were eligible for extension under section 155
already have been extended, as required by that provision. The provisions
of section 154(c)(1), therefore, would only have had an effect, if the
20-year term to which 21 patents are entitled, exceeded the 17-year patent
term, as extended by 2,148 days. Applying the provisions of section
154(c)(1) to these patents, however, reveals that its requirements are
already satisfied, because all previously extended terms exceed a term of
20 years from the patents' relevant filing dates. Accordingly, section
154(c)(1) does not benefit any of the patents already extended under
section 155.

Comments

   Nine written comments were received in response to PTO's request for
comments mentioned above. Responses to significant comments follow.

1. Comment: One comment urged that any period of patent term extension
used to keep a patent in force on June 8, 1995, not be added to the
20-year term and that only the portion of the extended patent term past
June 8, 1995, be added.
Response: The suggestion has not been adopted because neither section 156
of title 35, nor section 154(c)(1), as added by the URAA, contains a
provision that would permit apportioning a term of patent extension in the
manner suggested.
2. Comment: Two comments suggested that all patents that received an
extension under section 156 prior to June 8, 1995, were extended from an
"original expiration date" and that neither the URAA nor section 156
authorizes any alteration. It was suggested, therefore, that any patent in
force on June 8, 1995, should expire either at the end of the term
extension under section 156 as added to the 17-year term, or at the end of
20 years from filing, whichever is longer.
Response: The suggestion has been adopted for the reasons given above.
3. Comment: Four comments endorsed the PTO's proposal to move the term of
extension from the original expiration date of the patent to its new
expiration date, although two of the comments took issue with the proposal
that the period of extension comply with the limitation proposed by
section 156(c)(3).
Response: In light of the fact that the original PTO proposal has not been
followed, the question of the applicability of section 156(c)(3) is moot.
Nevertheless, it appears anomalous that some supporters of the original
PTO proposal would have looked to section 156 for support of transposing
the period of extension, while disclaiming the validity of other
provisions in section 156 that materially affect that extension.
4. Comment: One comment suggested that the PTO certify the new patent
expiration date upon the patentee's request.
Response: The suggestion has not been adopted, as this final determination
of the expiration dates of the relevant patents makes certification
unnecessary.
   It should be noted that any patent in force on June 8, 1995, and any
patent issued on the basis of an application filed before June 8, 1995,
are entitled to the longer term of 17 years from grant or 20 years from
the relevant filing date. Because patents issued before June 8, 1995, were
initially given a term of 17 years from grant, any extension under section
156 must begin from the original expiration date, which is the end of the
17-year term. If the term of 20 years from the relevant filing date
exceeds the expiration of the extended term, the patent is entitled to
such later expiration date. Patents issued after June 8, 1995, on the
basis of applications filed before such date, are also entitled to the
greater one of the two terms mentioned above. However, as this term
attaches at the time of issue, the question of what term is extended under
section 156 does not arise.
   As the information to determine the applicable expiration dates of all
these patents is readily available from relevant patent documents,
publication of their expiration dates is not necessary for the purpose of
clarification.

June 1, 1995                                                    BRUCE A. LEHMAN
                                            Assistant Secretary of Commerce and
                                         Commissioner of Patents and Trademarks