Comments from Wayne R. Eberhardt

NAME:               WAYNE R. EBERHARDT, REG NBR 22,804

ADDR-1:             107 GREY BRIDGE ROW



The following is submitted in response to the notice published in the
Federal Register, Vol. 60, No. 10, January 17, 1995.


Section I 1. Yes, the FDA should revise the patent term expiration
dates listed in the Orange Book and   Green Book.

2. The PTO should be required to certify new patent expiration dates
only upon request by an   interested party in the event of a dispute
over the correct dates.

3. NDA and NADA holders should be required to submit revised patent
expiration dates to the   FDA by June 8, 1995.

4. The FDA should require certification by the NDA/NADA holder which
includes, in addition   to the patent number and new expiration date,
the original expiration date, the first U. S. filing   date on which
the 20 year term is based, and, if the patent is subject to a
terminal disclaimer,   the patent number, first U.S. filing date and
new expiration date ofthe patent on which the   terminal disclaimer
is based

5. Applicants with pending ANDAs or ANADAs should be required to
revise their patent   certifications within 30 days of the date of
publication of the revised Orange/Green book.   Any applicant
claiming a substantial investment under Section 532(c)(2) should be
required to   make that claim within the above 30 day period and
provide detailed substantiation thereof to the FDA and NDA/ANDA
holder within a further period of 60 days.

Section II

Option 1. If the section 156 extension already issued by the PTO is
simply added to the longer of the 17 or 20 year patent term, this
could result in an extended patent term which exceeds 14 vears from
date of market approval. Accordingly, this is not considered a viable


Option 3, which limits the extension of Option 1 to the maximum 14
year term from date of market approval, presents a problem to the
ANDA/ANADA applicant claiming a right under Section 532(c)(2) since
this right would commence on the original 17 year expiration date,
but would not continue during the Section 156 extension following
expiration of the 20 year term. Thus the right under Section
532(c)(2) would be a temporary right of little practical value.


To accommodate the different scope of rights granted under the URAA
term extension and the Section 156 extension to both the patent
holder and the ANDA applicant, the Section 156 extension should be
calculated from the original 17 year expiration date for patents
granted prior to June 8, 1995, and from the (original) 20 year
expiration date for patents granted after June 8, 1995, and limited
in each case to a maximum patent term of 14 years from date of
market approval unless the current law is otherwise amended.


The preceding comments and opinions are personal and not to be
attributed to my employer or any organization of which I am a member.

Last Modified: March 1995