In view of the unprecedented uncertainty in patent law generated by counter-doctrinal Supreme Court decisions over the past decade or so and a cowed Federal Circuit relegated to complaining that their hands are tied on most matters (even when acknowledging that the decisions they are rendering do violence to the U.S. patent system; see now-Chief Judge Moore's dissent in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC), an occasional clear decision that establishes a bright line in the law (once the Court's stock in trade) is refreshing even if the clarity comes with unwanted consequences. The Court's recent In re Cellect is one of those decisions, which held (as "once-and-for-all" as can be expected for the Court in its current incarnation) that the primary concern when assessing the interplay between obviousness-type double patenting (ODP) and patent term adjustment (PTA) is whether a patentee can obtain claim term that extends past 20 years from its earliest priority date for any reason (other than patent term extension under 35 U.S.C. § 156 for FDA delay in approving a patented drug, a small and unique subset of all granted patents) in favor of the public's right to having the patented invention freely available upon expiration of the earliest to expire patent claiming patentably indistinguishable embodiments of the invention.
The issue, of course, is ODP and the extent to which terminal disclaimers are required under circumstances where a patent is entitled by statute to patent term adjustment (PTA) under circumstances where the claims in such a patent is deemed to be an obvious variant of claims in a related, earlier-expiring patent. To recap, the issue arose in a series of ex parte reexaminations over five patents owned by Cellect, U.S. Patent Nos. 6,424,369; 6,452,626; 6,982,742; and 7,002,621, that involve "solid state image sensors which are configured to be of a minimum size and used within communication devices specifically including video telephones" according to the '621 patent (only four of these patents were invalidated, the fifth, U.S. Patent No. 6,862,036 not having any PTA that raised the issue). The chronological situation is set forth in an exhibit from Cellect's Federal Circuit appeal brief and reproduced in modified form in the opinion:
There was no dispute that the claims in these applications were patentably indistinct. The Board issued four Decisions on Appeal affirming the reexamination division's invalidation of the '369, '626, '621, and '742 patents, all on the grounds that the provisions of 35 U.S.C. § 154(b)(2)(B) mandated that a terminal disclaimer be filed under circumstances where obviousness-type double patenting arose due to extension of patent term as PTA, i.e., that ODP must be determined after application of PTA. (The Federal Circuit reached a different conclusion with regard to patent term extension (PTE) under 35 U.S.C. § 156 in Novartis AG v. Ezra Ventures LLC, the Court expressly refusing to permit "a judge-made doctrine to cut off a statutorily-authorized time extension.") In its consolidated decision, the Board emphasized the potential inequities to the public due to the possibility of harassment by different parties owning patents to obvious variants of one another (in the absence of a terminal disclaimer preventing this potentiality) as representing an unjust extension of patent term to the public's detriment; see In re Fallaux, 564 F.3d 1313 (Fed. Cir. 2009)). The Board further held that under In re Longi, the public was entitled to the assumption that it is free to practice what is claimed in the patent and obvious modifications and variants thereof once the patent has expired. 759 F.2d 887 (Fed. Cir. 1985).
The Federal Circuit affirmed the Board's judgment in these re-examinations in an opinion by Judge Lourie joined by Judges Dyk and Reyna. The primary basis for the Court's decision was that it is inequitable to the public that a second, later-expiring patent should be obtained ("an unjustified timewise extension of patent term") on an obvious variant of a patented invention, based on AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1373 (Fed. Cir. 2014). The panel's opinion found support in the statute (as had the Board), wherein application of PTA was limited under circumstances where there was or should have been a terminal disclaimer filed, which stated that "no patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer." 35 U.S.C. § 154(b)(2)(B)* This conclusion was based in part by the Court's precedent, particularly AbbVie, and by the panel's determination that the overriding policy consideration is the need to "ensure that the applicant does not receive an unjust timewise extension of patent term" (as it has for over a decade; see "In re Janssen Biotech, Inc.; G.D. Searle LLC v. Lupin Pharmaceuticals, Inc."; "AbbVie Inc."; "Gilead Sciences, Inc. v. Natco Pharma Ltd."; "Eli Lilly & Co. v. Teva Parenteral Medicines, Inc."; and "Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co.").
Having spoken plainly (and seeing that the likelihood the Supreme Court will weigh in is substantially zero), the question is what prosecution stratagems can be devised to permit maximizing patent term by (at a minimum) having a patent receive its statutory PTA without running afoul of concerns over public expectations. Some have argued that filing "preemptive" terminal disclaimers would at least prevent patents from being invalidated on ODP grounds after the exclusivity of such patents has been relied upon to protect investment in drugs and other inventions requiring exclusivity terms that provide a sufficiently robust return on investment (see, for example, Mitra et al., 2023, In re Cellect: The Federal Circuit Alters Terminal Disclaimer Strategy; Huis et al., 2023, Patent Owners Must Consider New Terminal Disclaimer Strategies in View of the Federal Circuit's Decision in In re Cellect). The drawback of these strategies is that by definition they relinquish PTA even before entitlement to such PTA has been challenged and thus such terminally disclaimed patents may not provide the requisite exclusivity to support investment in the claimed technology.
There are, however, several alternative approaches. The most direct is to take advantage of the safe harbor provisions of 35 U.S.C. § 121 for claims subject to a restriction requirement. Particularly for inventions having claims encompassing several statutory categories under 35 U.S.C. § 101 (compositions, methods of making, methods of using, etc.) having a restriction requirement issued can provide a basis to avoid having to file a terminal disclaimer because the various claim groupings have been judged by the patent examiner to be patentably distinct. While not immune from later challenge, the presumption is that the Office's determination was correct and thus will be subject to the clear and convincing standard for invalidating patents for ODP. This tactic carries the responsibility to make certain that claims in the various groups are kept within their patentably distinct "silos" to maintain the safe harbor (see Boehringer Ingelheim Int'l. v. Barr Laboratories, Inc. (Fed. Cir. 2010); Obviousness-type Double Patenting after Amgen v. F. Hoffmann-LaRoche), a concept termed "consonance" in this regard. And it can also be prudent to avoid taking the opportunity to request rejoinder under M.P.E.P. § 821.04 of certain otherwise patentably distinct groups of claims (such as method claims being rejoined to allowed composition claims) which has the effect of having these patentably distinct claims issued in the same granted patent and thus having the same expiration date (which could in some instances be less than could be obtained under the PTA statute).
Substantively, assertion of ODP can be addressed as with any other obviousness rejection, by challenging motivation-to-combine disclosure of related applications with other prior art references, or whether species encompassed by ODP-rejected claims have features (like unexpected results) not shared with earlier claimed embodiments. Other objective indicia (like commercial success) may be available for species claims to the eventual commercial embodiment. Such strategies will require more careful consideration of what claims are pursued and in what order, which in turn will benefit from close coordination between business development actors and patent prosecutors that, while always recognized as being beneficial has not always been pursued with sufficient diligence. In this regard, it is important to remember that "the patent disclosure [of an earlier related patent asserted in an ODP rejection] is not 'prior art' and cannot be looked to for what it teaches," In re Baird, 348 F.2d 974, 979 (C.C.P.A. 1965), which renders such patents much more limited than prior art to another (which can be considered for obviousness purposes for all that it teaches and is not limited to whether the reference is enabling, see Amgen Inc. v. Hoechst Marion Roussel Inc., 314 F.3d 1313, 1357 (Fed. Cir. 2003) ("Under [§]103, however, a reference need not be enabled; it qualifies as a prior art, regardless, for whatever is disclosed therein) (emphasis added). Moreover, a species claim is not necessarily obvious over an earlier genus claim and can be found to be patentably distinct using the analytical rubrics contemplated herein. In re Sarett, 327 F.2d 1004 (C.C.P.A. 1964); an illustrative example is In re Vogel, where the Court of Customs and Patent Appeals held that claims to a method of preparing a beef product in a later application was patentably distinct from claims to a similar but not identical method for preparing a pork product but claims to a similar method for making a meat product were not patentably distinct. 422 F.2d 438 (C.C.P.A. 1970). This is also true for distinguishing claims to compositions and methods for using them. In re Boylan, 392 F.2d 1017, 1022-23 (C.C.P.A. 1968).
Implementing these various ways of avoiding ODP rejections and the need for PTA-destroying terminal disclaimers takes intentional planning when drafting claims and assessments that heretofore have not had compelling reasons to be performed for time-saving and drafting-efficiency reasons. In view of the Federal Circuit's decisions precluding any consideration of what is fair to the patentee (as opposed to the public), making the effort to avoid the need for filing a terminal disclaimer seems worth doing to the broadest extent possible.
* There is no such limitation in 35 U.S.C. § 156, even though both statutes recite that an extension of the term shall be granted.
[View source.]
