In re Janssen and NYU (Johnson & Johnson) (Fed. Cir. 2018).
In an ex parte reexamination of U.S. Patent No. 6,284,471, the Patent Trial and Appeal Board affirmed the examiner’s conclusions that NYU’s claims unpatentable under the judicial doctrine of obviousness-type double patenting. NYU and J&J have played a few games with this particular patent family of 30+ patents. The claims relate to antibodies and assay methods associated with a tumor necrosis factor (TNF) and is said to cover J&J’s blockbuster drug Remicade used to treat so-called autoimmune diseases.
The Patent Act text appears to allow a patentee to obtain multiple patents covering similar inventions. However, the judicially created doctrine blocking double-patenting limits that approach. The most poignant need for the OTDP doctrine arose pre-GATT when a patent’s term extended for 17 years beyond its issue date. In that legal framework, a patentee could seemingly file a series of continuation applications that included obvious modifications to claim scope but in order to continually refresh the patent term. Thus, the Federal Circuit has explained:
The doctrine of obviousness-type double patenting is intended to prevent the extension of the term of a patent by prohibiting the issuance of the claims of a second patent that are not patentably distinct from the claims of the first patent.”
G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349, 1351 (Fed. Cir. 2015) (citing Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 689 F.3d 1368, 1376 (Fed. Cir. 2012)). This concern has largely been eliminated since patent terms are now calculated based upon priority filing dates. In addition, it is unclear the extent that the doctrine survives the modifications of the America Invents Act. These concerns though are irrelevant to this case since it is a pre-GATT case.
A twist on the OTDP doctrine comes from 35 U.S.C 121 which has been interpreted to prohibit claims in a divisional application (filed following a restriction requirement) from being cancelled or rejected based upon the parent application.
Here indeed, the parent application was subject to a 5-way restriction requirement. However, rather than limiting the claims and filing a divisional, NYU abandoned the original application and filed two separate continuation-in-part applications — in both cases adding new matter. According to the Federal Circuit, without a divisional, Section 121 safe harbor does not apply.
The § 121 safe harbor, “by its literal terms, protects only divisional applications (or the original application) and patents issued on such applications.” Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1360 (Fed. Cir. 2008) (internal quotation marks omitted). Accordingly, patents issued on CIP applications are not within the scope of § 121. Nor are patents issued on continuation applications. Amgen. 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 precedent above is not new and was well known to the patentee here by the time of this dispute. Thus, during the reexamination the patentee attempted to retroactively amend its filing to transform the application from a continuation-in-part into a divisional application. The Federal Circuit has rejected that approach:
In Searle we answered this question in the reissue context, holding that the patent owner could not take advantage of the safe-harbor provision simply by designating the CIP as a divisional application in a reissue application years after the fact. . . . We are persuaded by the reasoning in Searle that a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding.
Obviousness-type double patenting AFFIRMED.