[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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