Blog March 31, 2023
Federal Circuit to Consider the Relevance of an Alleged Infringer’s “Intent” in a Hatch-Waxman Safe Harbor Analysis
This article appeared on Law360 on July 25, 2016 and is reprinted with permission.
In Amgen Inc. v. Apotex Inc., the Federal Circuit addressed the 180-day notice provision of the Biologics Price Competition and Innovation Act of 2009 where the parties had engaged in the so-called "patent dance." In explaining the consequences for failing to identify a patent in the initial stages of the patent exchange process, the court, in dicta, stated:
If a patent that the reference product sponsor should have included in its (3)(A) list or its (7) supplement "was not timely included" then the owner of that patent may not sue for infringement under 35 U.S.C. § 271 with respect to the biological product at issue. 35 U.S.C. § 271(e)(6)(C).
Simply put, if a reference product sponsor ("RPS") fails to identify a patent in its initial list of patents that could reasonably be asserted (or in the supplemental list allowed with later issued or licensed-in patents), is the RPS (and the patent owner) precluded from asserting infringement of the nonlisted patent(s) under all subsections of section 271, or just subsection 271(e)(2)?
Before addressing this issue, a brief review of the BPCIA is instructive.
An applicant for a license under a biologic reference product ("biosimilar applicant") must demonstrate, inter alia, that its proposed product is "biosimilar" to the reference product. Subsection 262(l) of the act outlines the procedure required to obtain that license.
Under § 262(l)(2)(A),  the biosimilar applicant gives notice to the RPS within 20 days after being informed that its application has been accepted by the U.S. Food and Drug Administration for review. Under § 262(l)(3)(A) ("(3)(A)"), within 60 days of receipt of that notice, the RPS provides the biosimilar applicant a list of patents that could reasonably be asserted against its biosimilar product. The biosimilar applicant then has 60 days under § 226(l)(3)(B) ("(3)(B)") to respond and explain why each identified patent is invalid, unenforceable or not infringed. The biosimilar applicant may also list any patents that it believes that the RPS could have reasonably asserted. Under § 363(l)(3)(C), the RPS has 60 days to respond.
The Federal Circuit has noted that the § (3)(A) and § (3)(B) lists "form the basis of the next steps in the process leading to litigation under paragraph (6)."  The § (3)(A) list can be supplemented under § 262 (l)(7), but only with patents issued to or exclusively licensed by the RPS after the date that the RPS provided its § (3)(A) list. This does not excuse the RPS who omits an existing patent from its § (3)(A) list.
One could contend that an RPS is forever barred from asserting any existing patents that were not included in its § (3)(A) list. This harsh result — "list it or lose it" — stems from one interpretation of subsection 271(e)(6)(C), which reads:
The owner of a patent that should have been included in the list described in section 351(l)(3)(A) of the [BPCIA], including as provided under section 351(l)(7) of such Act for a biological product, but was not timely included in such list, may not bring an action under this section for infringement of the patent with respect to the biological product.
In Amgen v. Apotex, supra, the Federal Circuit cited 35 U.S.C. § 271(e)(6)(C), but stated that an RPS could not sue for infringement "under 35 U.S.C. § 271." Accordingly, this article explores whether an RPS is forever barred from asserting infringement of an unlisted patent under all sections of § 271 — i.e., §§ 271(a), (b), (c), et al. — or only under § 271(e)(2), the section that creates an "artificial act of infringement" for FDA filings under the BPCIA.
The possibility of complete forfeiture is questionable given the patent listing and exchange procedures of the BPCIA as well as the specific context in which the term "this section" is used in subsection 271(e).
Is the term “this section” ambiguous?
The first step in interpreting a statute is to determine whether the language at issue has a plain and unambiguous meaning by examining the language itself, the specific context in which it is used, and the broader context of the statute as a whole. The inquiry ends if the statutory language is unambiguous, and the statutory scheme is coherent and consistent.
Congress typically uses the term "this section" to refer to an entire statute when the same statute also uses the term "subsection" to refer to individual subsections. For example, in Hernandez v. CitiFinancial Services Inc., the court found that the term "this section" unambiguously referred to an entire section because the text consistently distinguished sections from subsections, which were demarcated by language such as "subsection (a)."
The term "this section" is seemingly ambiguous in section 271 because the terms "section" and "subsection" are not used consistently throughout the statute. Indeed, the term "this subsection" (as opposed to "this section") does not appear anywhere in the statute, while the term "subsection" refers to a different statute. The term "section" is used six times in section 271 to broadly refer to other statutes and 14 more times to pinpoint subsections within these other statutes. Notably, none of the five other subsections of section 271 that describe infringing acts — subsections 271(a), (b), (c), (f) and (g) — use the term "section." Section 271 therefore stands in stark contrast to statutes where Congress "carefully distinguished among the hierarchical divisions" by using the terms "this subsection" and "subsection" to refer to subsections within the same statute or statutes where "Congress was precise in its use of internal cross-references."
The term "this section" is also ambiguous given the broader context of Section 271. Subsection 271(e), which contains the critical subsection (e)(6)(C), is almost a stand-alone drug infringement statute. It twice uses the term "this section" to refer to infringing acts, remedies, and exceptions in the BPCIA context. In the first instance, subsection 271(e)(3) exempts activities carried out under the subsection 271(e)(1) safe harbor. In the second, subsection 271(e)(6)(C) precludes an infringement action when the RPS fails to list a patent under BCPIA § (3)(A). In contrast, the same term ("this section") is used twice more in subsections 271(h) and 271(i), respectively, to define the terms "whoever," "offer for sale," and "offer to sell." Congress clearly meant these definitions to apply to all of Section 271, because none of the defined terms are used in subsection 271(h) or 271(i). However, the marked difference between the definitional context of subsections 271(h) and (i) and the limited focus of subsection 271(e) further shows that the term "this section" in Section 271 is somewhat ambiguous.
This potential ambiguity could be resolved by construing the phrase "this section" to mean "this subsection" when it is used in subsection 271(e). Such an interpretation might also avoid rendering a complementary portion of the BPCIA the cross-listing by the biosimilar applicant under § (3)(B) meaningless.
A court examining ambiguous statutory language interprets the text so that "no clause, sentence or word is rendered superfluous, void or insignificant." Moreover, a statute should be construed together with other statutes addressing the same subject matter as if they were one law ("in pari materia"). This principle is a variation of the canon stating that all parts of a statute should be construed together.
Section 271 and the BPCIA are intimately related and should be in pari materia. Indeed, Section 271 contains several references to the BPCIA, including an explicit reference to § (3)(A) of the BPCIA in subsection 271(e)(6)(C). In pari materia applies here because the canon "makes the most sense when the statutes were enacted by the same legislative body at the same time."  This is the situation here.
Construing "this section" in subsection 271(e)(6) to refer to all of Section 271 would completely bar patents that should have been — but were not — on an RPS's initial list. But if an RPS forever forfeits its right to assert unlisted patents under all subsections of Section 271 — and not just Section 271(e)(6)(C) — the biosimilar applicant would never supplement the RPS's § (3)(A) list under § (3)(B). It seems unlikely that Congress intended to render § (3)(B) essentially meaningless by extending the reach of subsection 271(e)(6)(C) to cover all infringement actions described in Section 271. Thus, subsection 271(e)(C)(6) should not forever estop an RPS from asserting unlisted patents.
Additional support for this same conclusion is found in the other sections of the BPCIA. The act specifically envisions two waves of litigation. The first wave includes those patents listed under §§ (3)(A) and (3)(B). But the second wave of litigation also includes patents listed under these two sections, assuming that they were not litigated in the first wave. Again, if "list it or lose it" applies, a biosimilar applicant would not add patents under §(3)(B) and risk a second wave of litigation on patents that were not identified by the RPS in its § (3)(A) list.
Negating "list it or lose it" through different constructions of the term — "this section" — is reasonable because identical words may have different meanings when they are used to describe different subject matter within a statute. This principle applies here because of the marked difference between the broad definitional context of subsections 271(h) and (i) and the specific context of subsection 271(e), which describes artificial acts of infringement and the related remedies. Thus, the phrase "this section" likely has a different meaning in subsections 271(h) and (i) versus the meaning in subsection 271(e).
During the legislative debate for the BPCIA, commentators seemingly agreed that the proposed "list or lose it" provision resulted in a complete forfeiture of the RPS' patent rights. This provision was first introduced in a 2007 bill, and the BPCIA as enacted tracks the language of this early section. Later, in 2009, representatives of key patent stakeholders testified before Congress and acknowledged the total forfeiture aspect of a then pending bill. For example, one witness stated that the provision "[took] the unprecedented step of entirely nullifying the patent property right to enforce the administrative notification provisions of the bill." Another seemingly accepted the "list it or lose it" provision, but was concerned about the potentially "harsh consequences for third-party patent owners who license their patents to others developing commercial products." These comments show that the dire consequences of the provision were clearly recognized — yet the provision was not altered in the enacted statute. The weight given to these contemporaneous observations awaits further analysis as courts are wary of relying on such testimony, as it does not necessarily reflect the intent of the legislation's drafters.
The term "this section" may have been employed in different parts of Section 271 with a different intent and effect. Thus, the term "this section" in subsection 271(e)(6)(C) may only apply to actions under subsection (e)(2). If so, "list it or lose it," would not apply. However, the precise consequences for failing to list a relevant patent under § (3)(A) will remain unclear until the Federal Circuit addresses this issue. Until then, an RPS should be over inclusive in deciding what patents it could reasonably assert against the biosimilar product. Otherwise "list it or lose it" may come into play.
Brian Coggio is of counsel and Ron Vogel is an associate in Fish & Richardson’s New York office.
 ___F.3d___, 2016 WL 3606770 (Fed. Cir. 2016). Earlier, in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed Cir. 2015), the court addressed the same issue where the parties had not engaged in the "patent dance."
 Apotex, 2016 WL 3606770at *4.
 In this article, "§" is used to note subsections of the BPCIA, the term "section" is used when discussing 35 U.S.C. § 271, and the term "subsection" is used to refer to subsections, paragraphs and clauses within Section 271.
 42 U.S.C. § 262(l)(2)(A).
 § 262(l)(3)(A).
 § 262(l)(3)(B)(ii).
 § 262(l)(3)(B)(i).
 § 262(l)(3)(C).
 Apotex, 2016 WL 3606770 at *2.
 42 U.S.C. § 262(l)(7).
 If the biosimilar applicant fails to provide its FDA application to the RPS, the latter is not required or indeed able to list all potentially infringed patents under § (3)(A). Accordingly, there is no possible forfeiture under subsection 271(e)(6)(C).
 35 U.S.C. § 271(e)(6)(C) (emphasis added).
 Apotex, 2016 WL 3606770 at *4.
 Robinson v. Shell Oil Co., 519 U.S. 337, 340-41 (1997).
 Id. at 340.
 See, e.g., Hooks v. Remington Lodging & Hosp., LLC, 8 F. Supp. 3d 1178, 1188 (D. Alaska 2014); Hernandez v. Citifinancial Servs., Inc., No. 05 C 2263, 2005 WL 3430858, at *4 (N.D. Ill. Dec. 9, 2005).
 Hernandez, 2005 WL 3430858, at *4.
 35 U.S.C. § 271(e)(5).
 E.g. "section § 351(l)(3)(A) of the Public Health Service Act" and "section § 2201 of Title 28".
 §§ 271(a), (b), (c), (f), (g).
 Pietras v. Curfin Oldsmobile, Inc., No. CIV.A. 05 C 4624, 2005 WL 2897386, at *3 (N.D. Ill. Nov. 1, 2005). See also Bruce v. Wells Fargo Bank, N.A., No. 2:05 CV 243 PS, 2006 WL 1195210, at *4 (N.D. Ind. May 2, 2006).
 SW General, Inc. v. N.L.R.B., 796 F.3d 67, 74 (D.C. Cir. 2015).
 § 271(e)(3).
 § 271(e)(6)(C).
 35 U.S.C. § 271(h)-(i). Subsection (h) address governmental liability, whereas subsection (i) makes an "offer for sale" an act of infringement.
 TRW Inc. v. Andrews, 534 U.S. 19, 31 (2001).
 Erlenbaugh v. United States, 409 U.S. 239, 243 (2007).
 Id. at 244.
 Congress added section 271(e)(6)(C) as part of the BPCIA.
A biosimilar applicant could conceivably supplement or augment the RPS's § (3)(A) list under § (3)(B) if it wanted to avoid any possible uncertainty (e.g., potential litigation) over what patents the RPS "should" have listed.
 It is worth noting that the Hatch Waxman Act does not have a "list it or lose it" provision. A patentee can choose to assert any patents listed in the Orange Book, but it does not forfeit the right to later assert patents that were not part of the original litigation.
 § 262(l)(4).
 § 262(l)(8).
 Atlantic Cleaners & Dyers, Inc. v. United States, 286 U.S. 427, 433 (1932). This rule is an exception to the presumption that "identical words used in different parts of the same statute" have the same meaning. IBP, Inc. v. Alvarez, 546 U.S. 21, 34 (2005).
 The presumption that the term "this section" should be given the same meaning in subsection 271(e) as in subsections 271(h) and (i) is furthered weakened because this presumption is most applicable when the identical words were inserted into the statute at the same time — which is not the case here. See Powerex Corp. v. Reliant Energy Servs., Inc., 551 U.S. 224, 232 (2007). Subsection 271(e)(3) was part of the 1984 Hatch-Waxman amendments and subsection 271(e)(6)(C) was part of the 2010 BPCIA. To the contrary, subsections 271(h) and 271(i) were added to section 271 in 1992 and 1994, respectively.
 The Biologics Price Competition and Innovation Act of 2007, S. 1695 110th Cong. (2007) § 2(c)(1)(C). The drafters also considered a provision requiring the FDA to appoint a special master to review the RPS's initial list, "to ensure that the patents listed were included in good faith in lieu of the list it or lose it provision." Erika Lietzan et al., An Unofficial Legislative History of the Biologics Price Competition and Innovation Act of 2009, 65 Food & Drug L.J. 671, 761 (2010).
 Lietzan, supra n.37 at 746, 757; see also S. 1695 § 2(a)(2). The 2007 bill included sections similar to § (3)(A) and § (3)(B) of the BPICA.
 Promoting Innovation and Access to Life Savvy Medicine Act, H.R. 1427 111th Cong. (2009). The pending bill contained a more limited patent listing and exchange process than the BCPIA.
 Biologics and Biosimilars: Balancing Incentives for Innovation, Hearing Before the Subcomm. on Courts and Competition Policy of the H. Comm. on the Judiciary, 111th Cong. 69 n.26 (statement of Mr. Kushan on behalf of The Biotechnology Industry Organization).
 See, e.g., id. at 207 (statement of Ms. Rea on behalf of The American Intellectual Property Law Association).
 Exxon Mobil Corp. v. Allapattah Servs., Inc., 545 U.S. 546, 568 (2005) (expressing concern that unelected staffers and lobbyists can "attempt strategic manipulations of legislative history to secure results they were unable to achieve through the statutory text").
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
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