The U.S. Patent and Trademark Office has now filed its response brief in In re: Janssen Biotech, Inc., New York University, No. 2017-1257 (Fed. Cir.), the Federal Circuit appeal involving U.S. Patent No. 6,284,471/Reexamination Control No. 90/012,851 ("Reexam appeal"). This is a parallel appeal to Janssen's appeal from its District Court action against Celltrion involving the '471 patent, Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd., No. 2017-1120 (Fed. Cir.) ("Janssen v. Celltrion"). Notably, however, Janssen (and New York University) previously argued in the parallel Janssen v. Celltrion appeal that this PTO appeal controlled: "Because the '471 Patent was amended in reexamination, a decision favorable to Janssen in the co-pending appeal would supersede the district court's ruling, which was based on the un-amended form of the '471 Patent." As such, this Reexam appeal is the one to watch.
Both this appeal and the Janssen v. Celltrion appeal involve obviousness-type double patenting (or "ODP"), an issue which presents real risks for pharmaceutical manufacturers who have sought to broaden their patent estates to cover all possible uses of patented compositions. The ODP doctrine is an attempt to enforce the quid pro quo that is at the core of the patent system: that, in exchange for a patent, an inventor must fully disclose his invention and promise to permit free use of it at the end of his patent term. Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F. 3d 1208, 1212 (Fed. Cir. 2014). The ODP doctrine prevents an applicant from obtaining several sequential patents on the same invention, including obvious modifications of the invention. In such cases, a terminal disclaimer should be used to preserve the validity of the later-expiring patent by aligning its expiration date with that of the earlier-expiring patent. Id. at 1217
At issue in both of these appeals is (1) whether the claims of the '471 patent (as amended in the reexamination) are subject to the "safe harbor" of 35 U.S.C. § 121 to avoid the ODP issue altogether, and (2) if not, how the test for ODP should be applied, either under a "one-way test," or a "two-way test."
Under the "safe harbor" provision of 35 U.S.C. § 121, a restriction requirement from the PTO acts as a sort of estoppel with respect to a divisional application filed in response to that requirement: neither of the patents that result directly from the restriction requirement can be used as an ODP reference against the other patent.
If the safe harbor does not apply, then the PTO and courts must apply either a one-way test or two-way test for ODP. In the one-way test, the only question is whether the claimed subject matter in the later-expiring patent is obvious over that of the earlier-expiring patent. In the two-way test, the examiner (or patent challenger) must show that the subject matter of the claims of both patents would be obvious over the other, and thus is a much more difficult obstacle for the examiner (or patent challenger) to overcome. Although there are a number of pitfalls, the two-way test applies if (i) the later-expiring patent was filed before the earlier-expiring patent and (ii) the applicant could not avoid separate filings (by filing conflicting claims in the earlier-filed application) and (iii) the PTO was solely responsible for the delay in prosecution of the later-expiring patent. If all three are true, the two-way test applies; if any one is false, then the one-way test applies.
In its briefs in both appeals, Janssen made many of the same arguments supporting reversal of the District Court and the PTO decisions. There are two significant differences in the two appeals, however. First, the PTO has argued an alternative ground for rejecting the § 121 safe harbor, specifically the lack of "consonance." Second, and perhaps more damning, Janssen has to contend in this Reexam appeal with the PTO's finding that the PTO was not solely responsible for the delay in prosecution of the '471 patent. In the District Court decision on appeal in Janssen v. Celltrion, Judge Wolf did not rule on this last issue, finding a potential issue of fact.
The PTO's brief relied heavily on three facts, the first two of which are undisputed: (1) that the applicant filed the '093 application, which issued as the '471 patent, as a CIP application, not a divisional application (although they tried to fix this retroactively); (2) that claim 1 of the '471 patent is not patentably distinct from the claims of appellees' '272 and '195 reference patents; and (3) that the PTO had found that Janssen was partially responsible for the delay caused in the '903 application prosecution which caused the '471 patent to issue after its siblings, the '272 and '195 patents. PTO Response Brief, Slip op. at 18-19, 23 (note that the page numbering used here is the court's page numbering at the top of the page in the slip opinion, rather than the brief's page numbering at the bottom).
With respect to the § 121 safe harbor issue, the PTO followed a long line of cases -- Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008); Amgen Inc. v. F. Hoffman-LaRoche Ltd., 580 F.3d 1340 (Fed. Cir. 2009); Amgen v. HLR, and G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015) (id. at 29-34), and a long-standing PTO practice (id. at 34-38), in holding that because the applicants filed the '093 application as a CIP application, not a divisional application, the '471 patent was not entitled to § 121's safe harbor. Indeed, the single largest chunk of the PTO's argument is directed to reminding the Federal Circuit of what exactly it held in those three decisions. That is, under these prior decisions, applicants' belated attempt to re-cast the filing as a divisional is too little, too late. As Searle made clear, "Janssen cannot 'retroactively alter the nature' of the original '093 CIP application" to make it a divisional application after-the fact. Id. at 20. Because Janssen filed the '093 application as a CIP of two applications, and included subject matter and claims not supported by the disclosure of the '413 application where the restriction requirement was made, "there is no way that the '093 application can be considered a divisional of the '413 application in 'form' or in 'substance.'" Id. at 20.
A second, alternative argument that the PTO made for denying appellees the § 121 safe harbor was that the claims at issue in the ODP rejection did not maintain "consonance." That is, issued claims in the three patents involved in the ODP rejection are not consonant with the restricted claims in the '413 application because they did not maintain the independent and distinct inventions that prompted the restriction requirement. The PTO provided several reasons, including: (a) the issued claims in the '195 patent and '272 patent are not limited to TNF-α, whereas claims that were the subject of the restriction requirement were limited to TNF-α; and (b) claims 1 and 9 of the '471 patent are not only broader than the original Group I claims of the restriction requirement but they are also directed to subject matter not disclosed in the '413 application where the restriction was made.
Notably, for Janssen to prevail on the § 121 safe harbor issue it must establish that the PTO erred on both of these two grounds. It appears unlikely to succeed with either.
Regarding the § 121 safe harbor argument, Janssen argued a number of equities that the PTO's brief dismissed. With respect to Janssen's argument that its added disclosure -- disclosed but not eventually claimed -- in the '093 application benefited the public, for example, the PTO noted that Janssen could have filed both a CIP and a divisional application and given the same benefit without losing its divisional designation. With respect to Janssen's argument that it relied to its detriment on the Examiner's withdrawal of an ODP objection, because it could have filed a divisional while the parent application was still pending, the PTO argued that the timing is unlikely because Janssen did not file a divisional application during the two years that the examiner's ODP objection was pending. And with respect to Janssen's argument that it relied on a non-precedential decision in a reexamination, the PTO noted that the decision was both not binding and in any event preceded Searle. Id. at 45-47.
With respect to the second issue on appeal, the PTO argued that Janssen was not entitled to the two-way ODP test because (a) the application that led to the '471 and '272 patents were filed on the same day, and the MPEP clearly states that where "both applications are filed on the same day, only a one-way determination of distinctness is needed" and (b) Janssen was partially responsible for the "delay" that caused the '471 patent to issue after the '272 and '195 reference patents. These examples of delay cited by the PTO included (i) the applicant waited ten months to file a preliminary amendment that included immunoreceptor claims from the other parent application (not supported by the '413 application where the original restriction requirement was made) -- which then prompted a further restriction requirement; (ii) that, by contrast, Janssen took specific steps in the '195 and '272 applications explicitly designed to expedite prosecution; (iii) after receiving a final rejection in May, 1996, Janssen waited six months, until October, 1996 to file a Notice of Appeal; and then (iv) Janssen waited another six months, until May, 1997 to reopen prosecution by filing a 37 C.F.R. § 1.129(a) amendment. Id. at 52-54.
If there are points for brevity, the PTO got all this done in only 10,627 of the 14,000 words allotted.