Practice Tips for Avoiding Terminal Disclaimers and Maintaining PTA

• Author: Leslie A. McDonell - Christina M. Rodrigo
• Position: Leslie A. McDonell is a partner at Finnegan. She specializes in intellectual property matters for the biotechnology and pharmaceutical industries. She can be reached at leslie.mcdonell@finnegan.com. Christina M. Rodrigo is an associate at Finnegan in Boston, Massachusetts. She focuses on patent prosecution and due diligence for innovative...
• Pages: 9-10

Published in Landslide® magazine, Volume 10, Number 2, a publication of the ABA Section of Intellectual Property Law (ABA-IPL), ©2017 by the American Bar Association. Reproduced with permission. All rights reserved. This

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Practice Tips for

Avoiding Terminal Disclaimers

and Maintaining PTA

By Leslie A. McDonell and Christina M. Rodrigo

The doctrine of obviousness-type double patent-

ing (OTDP) was developed when US patents had

a 17-year patent term. Because that patent term

ran from the patent issue date, the ling of con-

tinuation applications on obvious variants of a

previously claimed invention had the potential

to extend the patent monopoly for the invention.

The doctrine of OTDP was originally intended to

prevent this result by requiring terminal disclaimers of later,

commonly owned patents that did not claim patentably dis-

tinct subject matter over the earlier issued patents. Thus, in

theory at least, all commonly owned patents that relate to a

single invention or its obvious variants would have a single

expiration date. Because the patent term is now 20 years from

the rst nonprovisional ling date, later-led continuations

and divisionals will expire on the same date as a parent pat-

ent, unless a patent is awarded patent term adjustment (PTA)

from United States Patent and Trademark Ofce (USPTO)

delays. This article will discuss practice tips to avoid ling

terminal disclaimers that could reduce or eliminate PTA and

shorten the patent term.

Restriction requirements issued by the USPTO require

an applicant to divide independent and patentably distinct

claims into separate applications instead of pursuing all of

the claims in a single application.1 To address the potential

injustice created by inconsistent standards imposed by exam-

iners in restriction requirements and courts evaluating OTDP,

Congress enacted 35 U.S.C. §121 to provide a safe harbor

for claims that must be led in separate applications due to

restriction requirements issued by the USPTO. The safe har-

bor provision states:

A patent issuing on an application with respect to which a

requirement for restriction under this section has been made,

or on an application led as a result of such a requirement,

shall not be used as a reference either in the Patent and Trade-

mark Ofce or in the courts against a divisional application or

against the original application or any patent issued on either

of them, if the divisional application is led before the issu-

ance of the patent on the other application.2

Thus, if the USPTO issues a restriction between claims, patents

issuing on the restricted claim groups cannot be applied against

each other for OTDP. Making sure that the safe harbor provisions

of 35 U.S.C. §121 apply to your claims will avoid the necessity

of ling a terminal disclaimer and risking the loss of PTA to over-

come an OTDP problem. As you might expect, it is not always

simple to do so, and a few key requirements must be met.

First, it is important to ensure that all of the subject matter

that you may want to claim in an application is presented in

the original claims subject to restriction by the USPTO. The

Federal Circuit has held that an application claiming subject

matter that was not part of the claims subject to restriction

may not be protected by the safe harbor of §121.3 For exam-

ple, if you receive a restriction requirement between claims

to compositions and claims to methods of treatment, but

later pursue claims to diagnostic assays involving the com-

positions, you are very likely to be required to le a terminal

disclaimer unless you can establish that the diagnostic claims

are patentably distinct from the composition claims and/or

method of treatment claims. On the other hand, if the diag-

nostic claims had been present in the originally restricted

claims, this subject matter would very likely have been

Leslie A. McDonell is a partner at Finnegan. She specializes in intellectual property matters for the biotechnology and pharmaceutical industries.

She can be reached at leslie.mcdonell@nnegan.com. Christina M. Rodrigo is an associate at Finnegan in Boston, Massachusetts. She focuses on

patent prosecution and due diligence for innovative pharmaceutical clients. She can be reached at christina.rodrigo@nnegan.com.