Ensuring Section 121 Safe Harbor Applies to Patent
The last few days of a patent are often its most valuable. Maximizing patent term is therefore a chief goal for many patent applicants. The need to file a terminal disclaimer in order to obviate obviousness-type double patenting, however, may result in a shortened patent term. This is especially a concern in the post-Gilead world, where a later-issued patent can be used as a double patenting reference against an earlier-issued patent.1
The 1952 Patent Act included a provision (35 U.S.C. §121) shielding a child patent from double patenting over a parent patent (and vice versa).2 When applicable, this provision obviates the need to file a terminal disclaimer due to obviousness-type double patenting. This can result in a patent having a longer term, for instance, due to patent term adjustment under 35 U.S.C. §154(b).
The importance of the safe harbor provision is illustrated in the recent decision In re Janssen Biotech, Inc. involving a patent covering the blockbuster drug infliximab (Remicade).3 The patent, which does not expire until September 2018, did not receive the benefits of the safe harbor provision and was found to be unpatentable for obviousness-type double patenting over a related patent that expired in 2014.
Patent prosecutors seeking the benefits of this provision should be careful to meet the requirements of §121 as construed by the courts and Patent Trial and Appeal Board. In this article, we discuss the importance of filing a divisional application during the pendency of the parent patent application in which a restriction requirement is issued.
The safe harbor provision of 35 U.S.C. §121 states:
A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.
The courts “apply ‘a strict test’ for application of §121, ‘[g]iven the potential windfall [a] patent term extension could provide to a patentee.’”4
A formal restriction requirement must have been issued by the U.S. Patent and Trademark Office for Section 121 to apply.5 Furthermore, consonance must exist between the divided groups of claims and the restriction requirement. “Consonance requires that the line of demarcation between the ‘independent and distinct inventions’ that prompted the restriction requirement be maintained. ... Where that line is crossed[,] the prohibition of  of Section 121 does not apply.”6
The construction of the patent family is also important for ensuring that the safe harbor provision is available. This includes the characterization of a child patent as a divisional, continuation, or continuation-in-part,7 as well as the timing of the first divisional application in the family.
The protection afforded by §121 is limited to divisional applications and does not apply to continuation-in-part applications or continuation applications.8,9 The Federal Circuit found in Pfizer v. Teva that the safe harbor does not apply to continuation-in-part applications:
[t]here is no suggestion … in the legislative history of section 121 that the safe-harbor provision was, or needed to be, directed at anything but divisional applications. The commentary and materials published since section 121’s enactment similarly contain no suggestion that section 121 was meant to cover any applications other than divisionals. … We conclude that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.10
Similarly, the court held that the safe harbor does not apply to continuation applications in Amgen Inc. v. F. Hoffman-La-Roche Ltd.:
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.11
The Amgen court, however, pointed out that continuation applications that depend from divisional applications filed as a result of a restriction requirement may receive the benefit of the safe harbor provision.
In both [the Applied Materials and Symbol Technologies] cases … the continuation applications, from which the protected patents issued, descended from divisional applications that were filed as a result of restriction requirements. … [These] decisions thus establish that a patent need not have issued directly from a divisional application to receive § 121 protection. In other words, intervening continuation applications do not render a patent ineligible for § 121 protection so long as they descended from a divisional application filed as a result of a restriction requirement.12
Additionally, the safe harbor provision only applies “if the divisional application is filed before the issuance of the patent on the other application.”13 According to at least two PTAB decisions, the filing date referred to here is the actual filing date of the divisional, not its effective filing date under 35 U.S.C. §120.14 In other words, the first divisional application in the lineage must be filed before issuance of the patent in which the restriction requirement was issued.
While many errors during patent prosecution can be corrected by reissue, it has been found difficult to recharacterize a patent to retroactively obtain the benefit of the safe harbor provision. Following the decision in Pfizer v. Teva, Pfizer reissued its patent to change the characterization of the patent from a continuation-in-part to a divisional.15 Nonetheless, the Federal Circuit found that the patent was not entitled to the benefits of Section 121.
Simply deleting the new matter from the reissue patent does not retroactively alter the nature of the [patent as a continuation-in-part]. …
For years , the public was not free to practice that new matter …. Pfizer cannot now identify [the patent] as a divisional … (for purposes of section 121) and retroactively relinquish the new matter in the [patent], after having enjoyed years of patent protection from it. … Fairness to the public does not permit Pfizer to convert the [patent] into a division[al], and thereby take advantage of the safe harbor provision …16
More recently, in Janssen Biotech, the Federal Circuit refused to permit a patentee to amend a continuation-in-part application during a re-examination proceeding to redesignate it as a divisional and obtain the benefits of the safe harbor provision. Here, unlike in Pfizer, the patent did not claim any of the new matter added by the continuation-in-part application.17 According to the court, “[f]or a challenged patent to receive safe-harbor protections, the application must be properly designated as a divisional application, at the very latest by the time the challenged patent issues on that application.”18
Patent prosecutors should be cognizant of the requirements of the safe harbor provision. Under the existing case law, it is prudent to file a divisional application based on an original application in which a restriction requirement has been issued before the patent issues from the original application in order to preserve the ability to invoke the safe harbor provision of 35 U.S.C. §121.
1 Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1217 (Fed. Cir. 2014).
2 At the time of the 1952 Patent Act, terminal disclaimers were not accepted by the USPTO to obviate non-statutory double patenting. That did not occur until 1964. In re Robeson, 331 F.2d 610 (CCPA 1964).
3 In re: Janssen Biotech, Inc., slip no. 2017-1257 (Fed. Cir. Jan. 23, 2018).
4 G.D. Searle LLC v. Lupin Pharmaceuticals Inc., 790 F.3d 1349, 1354 (Fed. Cir. 2015) (citing Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382 (Fed. Cir. 2003); Amgen Inc. v. F. Hoffman-La-Roche Ltd., 580 F.3d 1340, 1353 (Fed. Cir. 2009)).
5 Geneva, 349 F.3d at 1382 (“Specifically, § 121 only applies to a restriction requirement that is documented by the PTO in enough clarity and detail to show consonance. The restriction documentation must identify the scope of the distinct inventions that the PTO has restricted, and must do so with sufficient clarity to show that a particular claim falls within the scope of the distinct inventions. In other words, § 121 requires a record that shows a discernable consonance.”).
6 Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1579 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 687 (Fed. Cir. 1990) (“The prohibition against use of a parent application ‘as a reference’ against a divisional application applies only to the divisional applications that are ‘filed as a result of a restriction requirement. Plain common sense dictates that a divisional application filed as a result of a restriction requirement may not contain claims drawn to the invention set forth in the claims elected and prosecuted to patent in the parent application.”).
7 “A continuation-in-part is an application filed during the lifetime of an earlier nonprovisional application, repeating some substantial portion or all of the earlier nonprovisional application and adding matter not disclosed in the said earlier nonprovisional application.” Manual of Patent Examining Procedure §201.08 (9th ed., Rev. 07.2015, 2015) (emphasis added).
8 Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1361-1362 (Fed. Cir. 2008) (finding that section 121 does not apply to continuation-in-part applications); Amgen at 1353 (“the § 121 safe harbor provision does not protect continuation applications”); Ex parte Jordan, Appeal 2011-007291 (Aug. 26, 2013 Decision on Request for Rehearing) (finding no safe harbor for a continuation application).
9 See 35 U.S.C. §121; Amgen at 1354 (“intervening continuation applications do not render a patent ineligible for §121 protection so long as they descended from a divisional application filed as a result of a restriction requirement”) (emphasis added); Symbol Techs. at 1580 (Fed. Cir. 1991) (extending the protection of § 121 to a patent issuing from a continuation application that descended from a divisional application filed as a result of a restriction requirement); Boehringer Inhelheim Intern. GmbH v. Barr Laboratories, Inc., 592 F.3d 1340, 1351-52 (Fed. Cir. 2010) (finding the safe harbor applicable to a patent issued from an application that was a divisional of a divisional).
10 Pfizer at 1361-1362.
11 Amgen at 1353 (footnote and internal cites omitted).
12 Amgen at 1353-1353 (citing Applied Materials, Inc. v. Advanced Semiconductor Materials America, Inc., 98 F.3d 1563, 1568-69 (Fed. Cir. 1996), and Symbol Technologies, 935 F.2d at 1579-81).
13 35 U.S.C. §121.
14 See Ex parte Sauerberg, Appeal 2015-007064 (Jan. 12, 2017) at 7-8 (“Appellants’ interpretation [that the filing date is the effective filing date] would render meaningless the requirement to file the divisional application ‘before the issuance of the patent on the other application.’”); Ex parte Jordan, Appeal 2011-007291 at 17 (Mar. 21, 2013) (“The instant application .. was not filed until … two months after the issuance [of the earlier patent having a restriction requirement]. Thus, it was impossible for [the present application] to have been filed prior to issuance of [the earlier patent], and therefore impossible for this application to satisfy the divisional requirements of 35 U.S.C. §121”).
15 G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015).
16 Id. at 1355.
17 Janssen Biotech, supra.
18 Janssen Biotech at *12-13.