January 25, 2018
In re Janssen Biotech, decided by the Federal Circuit on January 23, 2018, provides new insight into availability of the safe harbor for divisional applications under 35 U.S.C. § 121. It also provides excellent perspective on CIP practice, divisional practice, reexaminations, and double patenting rejections. The case presented the question of whether several years after a challenged patent issued on a CIP application, a patent owner could retroactively bring the challenged patent within the scope of the § 121 safe harbor by amending the CIP application during a reexamination proceeding to redesignate it as a divisional application.
Janssen Biotech, Inc., and New York University (collectively, “Janssen”) appealed a decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (USPTO PTAB) resulting from an ex parte reexamination of U.S. Patent No. 6,284,471 (“the ’471 patent”). The PTAB affirmed the rejection of claims 1–7 of the ’471 patent as unpatentable under the doctrine of obviousness-type double patenting.
The double patenting issue in this case turned on whether Janssen was entitled to invoke § 121 as a defense against a double patenting rejection. That issue depended, in turn, on an interpretation of the prosecution history of the ’471 patent and that patent’s relationship to its parent, Application No. 08/013,413 (“the ’413 application”).
On October 27, 1993, an examiner issued a five-way restriction requirement in the ’413 application. Group I was drawn to antibodies, pharmaceutical compositions, and assay methods, and Group IV was drawn to methods for treating an animal by administering a pharmaceutical composition containing an antibody. Rather than filing a response, Janssen expressly abandoned that application, and filed Application No. 08/192,093 (“the ’093 application”) and Application No. 08/192,102 (“the ’102 application”). The challenged patent, the ’471 patent, issued on the ’093 application. A reference patent, U.S. Patent No. 5,656,272 (“the ’272 patent”), issued on the ’102 application.
A diagram illustrating the relationships between relevant applications is below:
After receiving a double patenting rejection during reexamination, Janssen amended the ’471 patent to remove subject matter that was not present in the parent application and to designate the application as a divisional rather than a CIP. The USPTO nevertheless maintained the double patenting rejection. On appeal, the PTAB affirmed the rejection.
Federal Circuit Opinion
On January 23, 2018, the Federal Circuit affirmed the PTAB’s decision, stating that the Federal Circuit follows “a strict application of the plain language of § 121.” The court went on to say:
The § 121 safe harbor, “by its literal terms, protects only divisional applications (or the original application) and patents issued on such applications.” . . . Accordingly, patents issued on CIP applications are not within the scope of § 121. . . . Nor are patents issued on continuation applications. . . . Our precedent is clear: aside from the original application and the original patent, the protection afforded by § 121 is limited to divisional applications and patents issued on divisional applications.
The court further noted:
We recognize that this court has held that a patent need not have directly issued on a divisional application to receive § 121 protection. Any intervening continuing applications, however, must descend from a divisional application filed as a result of a restriction requirement.
The court discussed other considerations as well, including
The court did not foreclose the possibility that in other cases an application might be amended to become a divisional and thereby become entitled to the benefit of the § 121 safe harbor, but stated:
Janssen voluntar[il]y and deliberately filed an application properly designated as a CIP, having subject matter not disclosed in the original ’413 application. At no time during the pendency of the ’093 application did Janssen request, by submitting amendments or otherwise, that the relationship of the ’093 application to the ’413 application be changed to anything other than a CIP.
The Federal Circuit also considered whether the USPTO had improperly applied a one-way test rather than a two-way test for double patenting, and found that the one-way test was proper in view of delays in prosecution by Janssen.
In addition to being recommended reading on the boundaries of the safe harbor provisions of § 121, In re Janssen more generally provides valuable perspective on various issues that may arise in CIP practice, in divisional practice, and in responding to obviousness-type double patenting rejections.
For more information on this decision, please contact Fitch Even partner Joseph E. Shipley, author of this alert.
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