After the Uruguay Round Agreements Act (URAA) (effective 8 June 1995), US patents have a patent term of 20 years measured from the filing date or the earliest-claimed priority date. The 20-year term, however, can be shortened if a terminal disclaimer is filed to overcome an obviousness-type double patenting (ODP) rejection issued by the U.S. Patent and Trademark Office (USPTO) during prosecution, or during litigation, if patent claims are later challenged under ODP.
ODP is a judicially created doctrine that is designed to prohibit a party from extending the duration of the right to exclude with claims in a later patent that are not "patentably distinct" from claims in an earlier patent. See, e.g., Eli Lilly & Co. v. Barr Labs., Inc.1 ODP may exist between a reference application/patent and a challenged application/patent where there is at least one common inventor, common applicant, and/ or a common assignee/owner. See MPEP §804. ODP may also exist where the inventions claimed in the conflicting patents/ applications were made as a result of activities undertaken within the scope of a joint research agreement.2
To overcome an ODP challenge, an applicant (pre-grant) or a patentee (post-grant) can either establish that the challenged claims are "patentably distinct" from the reference claims (i.e., show that the challenged claims are not anticipated by, or would not have been obvious over, the reference claims), or file a terminal disclaimer to disclaim any portion of the 20-year statutory term of the challenged patent/application that extends beyond the expiration date of the reference patent. To file a terminal disclaimer, the reference patent and the challenged patent/application must be commonly-owned at the time of filing of the terminal disclaimer, and throughout the term of both patents.3 As the Federal Circuit has explained, disclaiming patent term that extends beyond the expiration date of the reference patent prevents "unjustified timewise extension of the right to exclude granted by a patent," because all claims could have been granted in a single patent, and the requirement for common ownership prevents "multiple infringement suits by different assignees asserting essentially the same patented invention." In re Hubbell.4
While filing of a terminal disclaimer appears to be a quick solution to an ODP challenge, it has some drawbacks. A terminal disclaimer truncates the term of the entire patent based on an ODP challenge of a single claim. Moreover, while a terminal disclaimer can be filed during litigation after a finding that the challenged patent is invalid for ODP, a terminal disclaimer cannot be filed if the reference patent has already expired. Boehringer Ingelheim Int’l GmbH v. Barr Labs., Inc.5 Furthermore, because common ownership is not a requirement of a proper ODP challenge, e.g., overlap in inventorship can be sufficient for an ODP challenge, a terminal disclaimer cannot be properly filed if the underlying patent is not commonly owned, as was the case in Hubbell.
In Hubbell, the USPTO rejected the claims of a pending application claiming a genus for ODP over an issued patent, which claimed a species. On appeal, during prosecution, the Board affirmed the examiner and rejected Hubbell’s argument that common ownership is a requirement for ODP, reasoning that ODP applied because the issued patent and the pending application had two common inventors. On appeal to the Federal Circuit, Hubbell argued that ODP rejection should not apply where an application and a reference patent do not have identical inventive entities, were never commonly owned, and are not subject to a joint research agreement. The Federal Circuit disagreed. The Court reasoned that there was no basis for barring application of ODP in instances where the conflicting claims share only common inventors, rather than common ownership, and that implementing such an exception would create the potential for harassment of a potential infringer by multiple assignees.6 Thus, under Hubbell, conflicting patents that have at least one common inventor can be at risk for an ODP challenge, and a terminal disclaimer may not be feasible because the underlying patent is not commonly owned, and Hubbell serves as a caution to patent owners. For example, assignees should monitor the patent filings of the assignor, because unassigned patents and applications with common inventors may present unexpected ODP challenges. Additionally, ODP issues may arise if inventors move between employers.
Soon after Hubbell, the Federal Circuit decided two additional cases—Gilead Sciences, Inc. v. Natco Pharma Ltd7 and AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr.8—which significantly expanded the scope of ODP.
Before Gilead, analyzing an ODP challenge focused on the issue dates of the respective patents and applications—i.e., an earlier-issued patent was used as the ODP reference for rejecting or invalidating the claims of a later-issued patent or pending application. See Eli Lilly.9 In Gilead, however, the Federal Circuit held, in a split decision, that an ODP challenge must focus on the expiration date, not the issue date—i.e., a patent that issues after but expires before can qualify as an ODP reference for an earlier-issued, later-expiring patent. Gilead.10
In Gilead, the patents at issue, U.S. Patent Nos. 5,763,483 ("the '483 patent") and 5,952,375 ("the '375 patent"), were issued to the same inventors and were commonly owned by Gilead, but they were not part of the same patent family and had different expiration dates.11 The '483 patent was filed after the application was filed for the '375 patent, but it issued first and had a later expiration date (due to its later filing date).12 (The timeline is reproduced below). The '483 patent issued during prosecution of the application for the '375 patent and Gilead filed a terminal disclaimer to overcome an ODP rejection based on the '483 patent disclaiming any portion of the '375 patent term that would extend beyond the expiration date of the '483 patent (even though the '483 patent had a later expiration date).13 The application that led to the '375 patent was not used as part of an ODP rejection with respect to the '483 patent or its underlying application.
During litigation, however, the '375 patent was the basis of an ODP challenge. Thus, the question presented in Gilead was: whether the later-issued, but earlier-expiring '375 patent could serve as an ODP reference for the earlier-issued, later-expiring '483 patent? The panel majority found that it could. The fact that the reference patent (i.e., the '375 patent) issued later than the conflicting patent (i.e., the '483 patent) was of little import to the Court. Instead, the Court concluded that expiration date (rather than issue date) was key to determining which patent is the "earlier" patent for ODP analysis. That is, the "earlier" patent is the patent that expires earlier, not the patent that was filed earlier or issued earlier, and that a later-issued patent can serve as an ODP reference for an earlier-issued but later-expiring patent.14
In the U.S., ODP arose when patents were granted a term of 17 years from issuance, instead of the current 20 years from filing term.15 In Gilead, the Court reasoned that focusing on issue date for 20-year term patents post the Uruguay Agreement (URAA) could lead to "gamesmanship during prosecution," i.e., inventors could potentially obtain additional patent term for obvious modifications of an invention by filing multiple applications for the obvious variants, claiming priority to different applications in each, and then arranging for the application with the latest filing date to issue first.16 The Court also noted the possibility for significant yet arbitrary differences in inventors’ period of exclusivity over their inventions based on prosecution delays leading to different patent issuance dates.17 The Court concluded that: "[p]ermitting any earlier expiring patent to serve as a double patenting reference for a patent subject to the [20-year patent term of the] URAA guarantees a stable benchmark that preserves the public’s right to use the invention (and its obvious variants) that are claimed in a patent when that patent expires" and further, it "preserves the ability of inventors to use a terminal disclaimer of later-expiring patents to create one expiration date for their term of exclusivity over their inventions and obvious variants."18
As the dissent in Gilead explained, ODP was judicially created to curtail the practice of filing successive continuations on obvious modifications, and receiving 17 years of staggered patent term for each continuation.19 The dissent in Gilead further argued that the expansion of ODP to invalidate earlier-issued but later-expiring patents was unwarranted because, among other things, successive continuations do not result in any additional patent term for post-URAA patents (because patent term is based on filing date), and thus a primary motivation behind ODP is largely no longer applicable, i.e., successive patents, each with later issue dates and thus later expiration dates (as was the term for pre-URAA patents).20 Any difference in term for successive continuations results from the statutorily prescribed patent term adjustment (PTA) for USPTO delays.21 To have patents with different terms, an applicant must file separate, staggered applications (not continuations) with different priority dates.
This practice of staggering patent filings was specifically addressed by the Federal Circuit in AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr.22 The question presented in AbbVie was whether an applicant can choose to file separate applications for overlapping subject-matter and claim different priority dates without running afoul of ODP. The Court found it cannot. In AbbVie, the patentee, Kennedy Institute, had two separate patents. A first patent with claims to a method of treating rheumatoid arthritis (a "broad genus") and a second patent with claims to a method of treating rheumatoid arthritis of a specific class of patients (a "narrower species").23 The two patents had different priority dates, resulting in a six-year difference in patent term between them, with the broad genus claims expiring before the narrow genus claims.24 AbbVie sought a declaratory judgment that claims of the '442 patent were invalid over the '766 patent for ODP. During litigation, Kennedy argued that the species of the '442 patent was patentably distinct from the genus of the '766 patent.25 Kennedy’s claim of non-obviousness, however, rested on its theory of unexpected results for the "narrower species," which was derived from the same study reported in the first patent directed to the "broad genus."26 The court found that the claims of the second patent (directed to the "narrower species") were obvious in view of the reference patent, thus rendering them invalid for ODP.27 In determining the question of obviousness, the court looked to the reference patent’s disclosures of utility, and specifically stated that:
"[w]e have repeatedly approved examination of the disclosed utility of the invention claimed in an earlier patent to address the question of obviousness."28
The court further explained that it was making explicit what was implicit in Gilead: that ODP continues to apply, even to post-URAA patents, whenever two patents that claim the same invention have different expiration dates.29 In the court’s view, a patentee is not entitled to extra years of monopoly simply because it filed separate applications unless the claimed inventions are patentably distinct.30
Given the significant shift following Gilead, it is likely that the validity and patent term of many existing patents may be affected, particularly if the reference patent has already expired and therefore a terminal disclaimer cannot be filed to overcome the ODP challenge.
But even if terminal disclaimer is available as an option to overcome an ODP challenge, patent owners should consider the potential impact on any PTA of the terminally disclaimed patent. In a recent district court case, Magna Electronics, Inc. v. TRW Automotive Holdings Corp.31, the principle of ODP set out in Gilead was applied to override the statutory grant of PTA. In that case, the reference and the challenged patents belonged to the same family and had the same priority date, but the expiration dates differed because one of the patents accrued PTA while the other did not. Both patents were post-URAA and were entitled to a 20-year term plus any statutory PTA. Without any PTA, both patents would have otherwise expired on the same date. The district court used the earlier-expiring patent (the patent without PTA) as an underlying ODP reference to invalidate the claims of the later-expiring patent (the patent with PTA).32 This, in effect, eliminated the statutory PTA of the "later-expiring" patent.
Because this is a district court case, it is still an open question whether filing of a terminal disclaimer can override the statutory grant of PTA of the disclaimed patent. The parties in Magna Electronics subsequently settled and the ODP issue was not appealed to the Federal Circuit. We will continue to monitor this topic to see if other district courts will similarly apply ODP to PTA-adjusted term of a patent, and whether the Federal Circuit will further extend the reach of ODP to allow a judicially created doctrine to supersede the statutory grant of PTA.
In another recent district court case, Janssen Biotech Inc. et al. v. Celltrion Healthcare Co. Ltd. et al.33, the district court granted defendant Celltrion’s "Gilead Motion," finding a pre-URAA patent invalid for ODP based on a post-URAA patent. There, both the reference and the challenged patents belonged to the same family and claimed the same earliest priority date in 1991. The challenged patent was filed in 1994, pre-URAA, and issued in 2001. Standing alone, the challenged patent would have expired in 2018 (17 years from the date of issuance). The reference patent, was filed in 2001, post-URAA, and expired in 2011 (20 years from the 1991 priority date). Patent owner Janssen did not dispute that the claims of the challenged patent were not "patentably distinct" from the claims of the reference patent.34 Thus, the only question before the court was whether Gilead (using expiration dates to analyze ODP challenges for post-URAA patents) can be applied to a pre-URAA patent.35 The court found that the reasoning in Gilead did apply to pre-URAA patents, and that URAA neither intended to alter the ODP doctrine nor statutorily guaranteed at least 17 years of patent term.36 Citing Gilead, the court explained that if the pre-URAA patent is not invalidated, it would violate the "bedrock principle" that "when a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention."37 The court further explained that the patent owner knowingly took a risk when it applied for and obtained the (later-filed) reference patent because the ODP doctrine was well-established at that time.38
Given the Magna Electronics decision and the possibility that other district courts may follow the same approach, patent owners should carefully consider how best to address an ODP challenge, whether during prosecution or litigation, i.e., distinguish the conflicting claims on the merits or file terminal disclaimer. Indeed, additional consideration should be given if one (or more) patents at risk for an ODP challenge has significant PTA. Patent owners should also weigh the pros and cons of pursuing narrower claims (e.g., to species or specific embodiments) and broader claims (e.g., to a genus) in separate applications. This is a relatively familiar practice,39 but the broader claims may be at risk for an ODP challenge based on the narrower claims. Because it is likely that the narrower claims may be granted before the broader claims and the narrower claims are likely to receive less (or no PTA) compared to the broader claims, application of the narrower claims against the broader claims may eliminate any PTA available to the broader claims. Two strategies might help. First, applicants should consider filing multiple claims in a single application in the likely event that the USPTO will issue a restriction requirement identifying different embodiments as patentably distinct from others. If so, applicants can take advantage of the "safe harbor" provision of 35 U.S.C. §121. This provides that a patent issued on a divisional application that was filed as a result of a restriction requirement in the parent application is immune from ODP challenge based on the patent. But see Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.40 (finding that the safe harbor protection of §121 applies only to a divisional application filed as a result of a restriction requirement, and not to other types of continuing applications). Second, applicants should consider filing strategies for pursing narrow and broad claims in separate applications. One possibility is to file narrow claims in the first patent of a family, and pursue broader claims in a subsequent continuation. The first filed application in a family, usually receives the largest PTA of any patent in that family. Pursuing narrow claims in the first (parent) application may safeguard any PTA-extended term of the parent, because the second (continuation) application may not be applicable as an ODP reference against the parent because those broader claims may not anticipate or render obvious the narrower claims.
The growing body of precedent described here holds many lessons regarding ODP for both patent challengers and patent owners. We will continue to monitor this area of patent law and watch how the Federal Circuit will apply its recent holdings in Gilead and AbbVie to other cases, in particular, those ODP challenges directly dealing with PTA.
1 251 F.3d 955, 967 (Fed. Cir. 2001)
3 37 C.F.R. §1.321(c)(3)
4 709 F.3d 1140, 1145 (Fed. Cir. 2013)
5 592 F.3d 1340, 1347 (Fed. Cir. 2010)
6 Id. at 1146-47
7 753 F.3d 1208 (Fed. Cir. 2014)
8 764 F.3d 1366 (Fed. Cir. 2014)
9 251 F.3d at 968, 974-75
10 753 F.3d at 1215, 1217.
11 Id. at 1210.
14 Id. at 1215
15 See id. at 1217-18 (Rader, C.J., dissenting)
17 Id. at 1215-16
18 Id. at 1216
19 See Id. at 1217-18 (Rader, C.J., dissenting)
20 Id. at 1218
21 PTA is a statutory grant of additional patent term due to USPTO delays in prosecution. 37 C.F.R. § 1.703.
22 764 F.3d 1366 (Fed. Cir. 2014)
23 AbbVie, 764 F.3d at 1371-72
24 Id. at 1370-71
25 Id. at 1379
26 Id. at 1380
29 Id. at 1374
31 No. 1:12-cv-654 (W.D. Mich., 10 December 2015)
32 Id., slip op., at *5
33 No. 1:15-cv-10698 (D. Mass. 28 September 2016)
34 Id., slip op., at *2
35 Id., slip op., at *3
36 Id., slip op., at **3-4
38 Id., slip op., at *7
39 See AbbVie, 764 F.3d at 1371-72
40 518 F.3d 1353, 1362 (Fed. Cir. 2008)
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