December 2017
CIPA Journal
By Jeffrey M. Jacobstein; Rhianna L. Lindop; Erin M. Sommers, Ph.D.
We began the year by reporting on U.S. case law that may significantly expand the scope of obviousness-type double patenting (ODP) challenges both before the USPTO and U.S. federal courts.1 Here, we cap off 2017 with yet another wrinkle in the ODP saga.
ODP is a judicially-created doctrine designed to prohibit a party from unjustly extending patent term with later patent claims that are not "patentably distinct" from claims in an earlier patent.2 As we previously reported, the United States Court of Appeals for the Federal Circuit upended seemingly established rules governing ODP, holding in Gilead Sciences, Inc. v. Natco Pharma Ltd. that a later-issuing but earlier-expiring patent could serve as an ODP reference.3 Since then, patent applicants and patentees may have found themselves facing many more ODP challenges, including instances where the ODP reference is another patent from the same family as the challenged patent.4 Indeed, the Federal Circuit has explained (in dicta) that patents sharing a common priority chain "still can have different patent terms due to examination delays at the USPTO," raising the specter of ODP for patents that have patent term adjustment (PTA).5 A district court turned that dicta into reality, holding a PTA-extended patent invalid over a family member patent that lacked PTA.6
As a result, divisional applications and their potential statutory safe harbor protection against ODP challenges under 35 U.S.C. §121 have assumed a sudden new importance. Generally, the Federal Circuit has allowed divisional applications to escape ODP in many scenarios, as long as the subject application was formally labeled a divisional and the claims that issued were consonant with those withdrawn from an earlier case pursuant to a restriction requirement. But a Patent Trial and Appeal Board (PTAB) decision from earlier this year called that protection for divisional applications into question when intervening continuations are thrown into the mix.7 Here is what practitioners need to know.
U.S. patent law exempts divisional applications filed as a result of a restriction requirement from ODP challenges both before the USPTO and in federal courts:
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.8
A divisional application is a type of continuing application presenting claims for an independent or distinct invention carved out of the disclosure in an original application.9 Typically, a divisional application is filed as a result of a restriction requirement issued by the USPTO.
A restriction requirement is an administrative tool that allows a patent examiner to streamline prosecution by requiring an applicant to limit the claims presented in a patent application to a single "invention".10 Examiners have wide latitude in defining what constitutes separately patentable inventions. In fact, although an applicant can challenge a requirement for restriction by petitioning the director of the USPTO, a restriction requirement itself cannot be appealed to the PTAB or Federal Circuit.11 In other words, the USPTO has discretion to issue a restriction requirement. Ironically, however, such discretionary—and potentially even incorrect—action has the ability to offer patent applicants and patentees added safe harbor protection in the face of subsequent ODP challenges under 35 U.S.C. §121.
The Federal Circuit has repeatedly addressed the scope of this “safe harbor” protection, explaining that a reference patent must comply with certain formal and substantive features to qualify for the protection that §121 offers. First, the patent must be designated a divisional and not a continuation or continuation-in-part.12 An applicant must claim divisional status during original examination and generally may not be able to correct this status later by reissue.13 In addition to formally identifying a patent as a divisional application, the issued claims must also be consonant with an independent and distinct invention withdrawn from examination by the examiner in a parent application pursuant to a restriction requirement.14 Protection may be lost if intervening applications present inconsistent claims, claims outside the scope of the original restriction, or claims inconsistent with irreconcilable restriction requirements issued in the intervening applications.15
Typically, the Federal Circuit has tended to treat patent applicants leniently when they generally complied with these formal and substantive requirements. For instance, the court has explained that applicants need not immediately cover all inventions restricted out of a parent case in one single divisional. Rather, an applicant may file a series of divisional applications directed to different subsets of the inventive groups identified in an original restriction requirement while retaining safe harbor protection for the subsequently-filed divisional applications.16 Likewise, the court has held that continuations descending from divisional applications can retain safe harbor protection, at least over the original parent case that received the restriction requirement.17
Given this Federal Circuit precedent, the patent applicants in Ex Parte Sauerberg,18 must have felt confident that their divisional application, filed after a series of continuation applications, would find safe harbor protection for any ODP rejections. After all, the Federal Circuit had previously confirmed that a patent could retain safe harbor protection even when separated from the case that received an original restriction requirement by a chain of intervening divisional applications. The court had even extended protection to continuations filed from those divisional applications. But despite this body of case law, the PTAB held in Sauerberg that a divisional application filed from a continuation (rather than a divisional filed from another divisional, or a continuation filed from a divisional) was an entirely different scenario and denied safe harbor protection.
The Facts
In 2008, applicants filed a patent application directed to a genus of small molecule compounds and methods of treatment using those compounds (original application).19 The USPTO required restriction between the compounds and the methods of treatment. In response to that restriction requirement, the applicants elected to prosecute the compound claims in the original application.20 The applicants then filed two subsequent continuation applications (CON-1 and CON-2) directed to additional compound claims, before finally filing a divisional application from CON-2 with claims directed to methods of treatment.21 The original application, CON-1, and CON-2 all issued as patents.22 The examiner rejected the divisional application on the basis of ODP over all three earlier patents, and the applicants appealed that rejection to the PTAB.23
Before the PTAB
On appeal, the PTAB first addressed the ODP rejections over the two patents that issued as a result of CON-1 and CON-2. While agreeing that "there is no requirement under §121 that the divisional application being shielded by the safe harbor must immediately follow the parent," the PTAB explained that safe harbor only applied when the reference patents at issue were filed "as a result of a restriction requirement".24 Because the applicants could not show that they filed the two continuations, or the subsequent divisional, in response to a requirement from the examiner to restrict the claims, the PTAB reasoned that safe harbor did not apply.25 The PTAB did not explain how it reconciled that holding with the protection extended by the Federal Circuit to continuations filed from divisional applications.
Turning to the original application, the PTAB pointed to the Federal Circuit’s instructions in G.D. Searle to narrowly apply the safe harbor provisions using a "strict test" (albeit a test outlined in the very different context of an applicant attempting to switch a CIP application to a divisional during reissue).26 Based on that "strict test" expounded in a factually unrelated case and its narrow reading of §121, the PTAB concluded that an applicant must file a divisional application before the original application that received the restriction requirement grants as a patent, rather than at any time during the pendency of an application that claims priority back to that original application.27 Thus, according to the PTAB, the Sauerberg applicants missed their window of opportunity to rely on safe harbor protection because their divisional application was filed from CON-2, after the original application that received the restriction requirement had issued as a patent. Here again, this holding conflicts with Boehringer Ingelheim, where the original patent granted before the last divisional application was filed.28
The Sauerberg applicants have not appealed the PTAB’s decision. Thus, it remains to be seen whether U.S. federal courts will follow suit.
U.S. courts may not ultimately follow the PTAB’s interpretation of the safe harbor protection afforded by §121—especially where Federal Circuit precedent may counsel against it. Nevertheless, patent applicants may want to consider filing at least one divisional application during the pendency of any application that receives a restriction requirement to preserve an opportunity to argue for safe harbor protection. Applicants may also want to consider designing claims to maximize the likelihood of receiving a restriction requirement. Once the USPTO issues a restriction requirement, Applicants should endeavor to only pursue claims in subsequent applications that are consonant with the withdrawn invention groups identified by the examiner. Those later applications should also be properly identified as divisional applications. And, as always, these authors urge practitioners to continue to watch the case law develop in this area.
Endnotes
1 Double Patenting, Arpita Bhattacharyya, Ph.D. and Timothy P. McAnulty, January/February [2017] CIPA 22.
2 See, e.g., Eli Lilly & Co. v Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir. 2001).
3 753 F.3d 1208, 1210 (Fed. Cir. 2014).
4 See AbbVie Inc. v. Mathilda & Terence Kennedy Inst. Of Rheumatology Trust, 764 F.3d 1366, 1368 (Fed. Cir. 2014).
5 Id. at 1373.
6 Magna Electronics, Inc. v. TRW Automotive Holdings Corp., No. 1:12-cv-654, slip. op. 13-14 (W.D. Mich, Dec. 10, 2015).
7 Ex Parte Sauerberg, Appeal 2015-007064, 5-6 (PTAB Jan. 10, 2017).
8 35 U.S.C. §121 (emphasis added).
9 M.P.E.P. §201.06.
10 37 C.F.R. §1.142.
11 In re Weber, 580 F.2d 455, 460 (C.C.P.A. 1978) (citing 37 C.F.R. §1.144).
12 Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1362 (Fed. Cir. 2008); Amgen Inc. v. F. Hoff man-La Roche Ltd., 580 F.3d 1340, 1352 (Fed. Cir. 2009).
13 G.D. Searle LLC v. Lupin Pharm., Inc. 790 F.3d 1349, 1355 (Fed. Cir. 2015).
14 Geneva Pharms., Inc. v. GlaxoSmithKline Plc, 349 F.3d 1373, 1382 (Fed. Cir. 2003).
15 Bristol-Myers Squibb Co. v. Pharmachemie B.V., 361 F.3d 1343, 1349-50 (Fed. Cir. 2004).
16 Boehringer Ingelheim Int’l. GmbH v. Barr Labs., Inc., 592 F.3d 1340, 1359 (Fed. Cir. 2010).
17 Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1580 (Fed. Cir. 1991); see also Amgen Inc. v. F. Hoff man-La Roche Ltd, 580 F.3d 1340, 1351-52 (Fed. Cir. 2009).
18 Appeal 2015-007064 (PTAB Jan. 10, 2017).
19 Id. at 2-3.
20 Id. at 3.
21 Id.
22 Id.
23 Id.
24 Id. at 5-6.
25 Id. at 6.
26 Sauerberg, Appeal 2015-007064 at 7.
27 Id.
28 Boehringer Ingelheim Int’l GmbH, 592 F.3d 1340, 1344.
Originally printed in CIPA Journal in December 2017. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.
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