The Federal Circuit recently clarified the limits of the safe harbor provision of 35 USC §121. In In re: Janssen Biotech, Inc., New York University, No. 2017-1257 (Fed. Cir. Jan. 23, 2018), the Federal Circuit upheld a Patent Trial and Appeal Board (PTAB) decision affirming invalidity of claims of US Patent 6,284,471 under the doctrine of obviousness-type double patenting.
If two or more independent and distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions. If the other invention is made the subject of a divisional application which complies with the requirements of section 120 it shall be entitled to the benefit of the filing date of the original application. . .
The ’471 patent issued from a continuation-in-part (CIP) patent application, no. 08/192,093. The ’093 application claimed priority to multiple other applications, and was part of a somewhat complicated family of applications and patents, whose relationships are diagramed below.
The ’471 patent was challenged in an ex parte reexamination under the doctrine of obviousness-type double patenting over US Patent 5,656,272 During the reexamination, and to overcome an obviousness-type double patenting rejection, Janssen, owner of the ’471 patent, sought protection of the safe-harbor provision of § 121 by requesting amendment of the ’471 patent to remove any matter not present in its parent application no. 08/013,413. Janssen further sought designation of the ’471 patent as a divisional of the ’413 application. The PTO entered the requested amendments for the purposes of the reexamination, but did not confirm the status of the ’471 patent as a divisional. The PTO ultimately found the ’471 patent could not take advantage of the safe harbor provision of § 121, and was invalid under the doctrine of obviousness-type double patenting. The PTAB and the Federal Circuit affirmed.
Reviewing de novo the issue of whether the ’093 application could be amended to a divisional application during reexamination to take advantage of the safe harbor provision of §121, the Federal Circuit first cited G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349 (Fed. Cir. 2015) which established that a reissue proceeding may not be used to convert a continuation-in-part application to a divisional application. In Searle, the Federal Circuit reasoned that the nature of a patent could not be changed retroactively in a reissue proceeding by deleting subject matter, because the applicant had already enjoyed years of patent protection based on such matter.
Janssen argued that the reexamination of the ’471 patent was distinguishable from the reissue of Searle, because the claims of the ’471 patent were not directed to matter in the ’093 application which was not included in the ’413 application. Accordingly, Janssen argued, there was no benefit from the matter sought to be removed. The Federal Circuit disagreed, citing 30+ patents that claimed priority of the ’093 application, and identifying such patents as providing benefit to Janssen based on the matter sought to be removed from the ’093 application.
The Federal Circuit further looked to the plain language of § 121 which states the safe harbor is available to challenged patents “issuing on” a divisional application. The ’471 patent “issued on” a continuation-in-part application. No amendment or re-designation would change the status of the ’093 application at the time of issuance of the ’471 patent.
Finally, the Federal Circuit discussed Janssen’s various decisions leading up to issue of the ’471 patent. Specifically, Janssen “voluntary and deliberately” filed as a continuation-in-part (not as a divisional), and at no time during pendency of the ’093 application did Janssen try to amend to change the status to a divisional application.
Lessons for Practice
It is good to keep in mind the limits of the § 121 safe harbor. Specifically, the explicit scope of the safe harbor is to protect patents that issue on a divisional filed in response to a restriction requirement. With this scope in mind, a filing and prosecution strategy may be crafted to take advantage of the §121 safe harbor. For example, in the present case, Janssen could have originally filed a divisional application and then filed one or more continuations-in-part claiming priority to such divisional. Alternately, it appears that Janssen may have been able to convert the ‘093 application to a divisional application prior to issue of the ‘471 patent, and prior to filing additional applications which claimed priority to the ‘093 application.