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...
