Determination of New Expiration Dates of Certain Patents

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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