[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Notices]
[Pages 30069-30071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13848]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Determination of New Expiration Dates of Certain Patents
AGENCY: Patent and Trademark Office, Commerce.
ACTION: final Determination.
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SUMMARY: The Patent and Trademark Office (PTO) has determined the
expiration date of patents that:
(1) Are in force on June 8, 1995, and, therefore, are entered 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, DC 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''), Public Law 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 previsouly
been extended under section 156. (See 60 FR 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 FR 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 by 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 [[Page 30070]] 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 amounts 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 [[Page 30071]] 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.
Dated: June 1, 1995.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
[FR Doc. 95-13848 Filed 6-2-95; 1:42 pm]
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