Case: 20-1373    Document: 41     Page: 1   Filed: 04/21/2020




   United States Court of Appeals
       for the Federal Circuit
                  ______________________

          BIOGEN INTERNATIONAL GMBH,
                 Plaintiff-Appellant

                             v.

            BANNER LIFE SCIENCES LLC,
                 Defendant-Appellee
               ______________________

                        2020-1373
                  ______________________

     Appeal from the United States District Court for the
 District of Delaware in No. 1:18-cv-02054-LPS, Chief Judge
 Leonard P. Stark.
                   ______________________

                  Decided: April 21, 2020
                  ______________________

     JAMES B. MONROE, Finnegan, Henderson, Farabow,
 Garrett & Dunner, LLP, Washington, DC, for plaintiff-ap-
 pellant. Also represented by PAUL WILLIAM BROWNING, J.
 MICHAEL JAKES, LAURA POLLARD MASUROVSKY, JASON LEE
 ROMRELL.

    KYLE MUSGROVE, Parker Poe Adams & Bernstein LLP,
 Charlotte, NC, for defendant-appellee. Also represented by
 JOHN WORTHINGTON BATEMAN, ELIZABETH CROMPTON,
 SCOTT A. CUNNING, II, Washington, DC.
                  ______________________
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 2   BIOGEN INTERNATIONAL GMBH    v. BANNER LIFE SCIENCES LLC



     Before LOURIE, MOORE, and CHEN, Circuit Judges.
 LOURIE, Circuit Judge.
      Biogen International GmbH (“Biogen”) appeals from a
 judgment of the United States District Court for the Dis-
 trict of Delaware that Banner Life Sciences LLC (“Banner”)
 does not infringe the extended portion of U.S. Patent
 7,619,001 (the “’001 patent”), extended under the patent
 term restoration provisions of the Hatch-Waxman Act,
 Pub. L. No. 98-417, § 201, 98 Stat. 1585, 1598 (as codified
 at 35 U.S.C. § 156 (2018)). Biogen Int’l GmbH v. Banner
 Life Scis. LLC, No. 18-2054-LPS, 

(D. Del.
 Jan. 7, 2020) (“Decision”).
     Because the scope of a patent term extension under 35
 U.S.C. § 156 only includes the active ingredient of an ap-
 proved product, or an ester or salt of that active ingredient,
 and the product at issue does not fall within one of those
 categories, we affirm the judgment of the district court.
                        BACKGROUND
     Biogen holds the New Drug Application (“NDA”) for the
 active ingredient dimethyl fumarate (“DMF”), which was
 approved by the Food and Drug Administration (“FDA”) in
 2013 as Tecfidera®, a twice-daily pill indicated “for the
 treatment of patients with relapsing forms of multiple scle-
 rosis” at a daily dose of 480 mg. J.A. 1123. DMF is the
 dimethyl ester of fumaric acid. An ester is a compound de-
 rived from the combination of a carboxylic acid and an al-
 cohol, minus a molecule of water.
     DMF, a double ester, is the approved product in this
 appeal. Upon administration to a patient, one of DMF’s
 methyl ester groups is readily metabolized to a carboxylic
 acid group, becoming monomethyl fumarate (“MMF”) be-
 fore the compound reaches its pharmacological site of ac-
 tion. J.A. 1131.
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 BIOGEN INTERNATIONAL GMBH     v. BANNER LIFE SCIENCES LLC    3



     DMF and MMF are represented below. DMF contains
 two methyl groups (in red), which are part of the ester func-
 tional groups. MMF is virtually identical, except that it
 has only one methyl ester group; the other group is simply
 a carboxylic acid.




 Banner Opening Br. at 6, Biogen Int’l GmbH v. Banner Life
 Scis. LLC, No. 18-2054-LPS (D. Del. Feb. 1, 2019), ECF
 No. 10.
      The ’001 patent, entitled “Utilization of Dial-
 kylfumarates,” ultimately claims priority from a German
 application filed in 1998.        It discloses that dialkyl-
 fumarates may have therapeutic uses “in transplantation
 medicine and for the therapy of autoimmune diseases,”
 ’001 patent col. 3 ll. 44–45, including multiple sclerosis,

l. 57. Claim 1 is representative:
     1. A method of treating multiple sclerosis compris-
     ing administering, to a patient in need of treatment
     for multiple sclerosis, an amount of a pharmaceu-
     tical preparation effective for treating multiple
     sclerosis, the pharmaceutical preparation compris-
     ing
     at least one excipient or at least one carrier or at
     least one combination thereof; and
     dimethyl fumarate, methyl hydrogen fumarate, or
     a combination thereof.
 Both the dimethyl ester and monomethyl ester forms are
 covered by this claim, monomethyl ester being an
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 4   BIOGEN INTERNATIONAL GMBH   v. BANNER LIFE SCIENCES LLC



 alternative way to describe the claimed methyl hydrogen
 fumarate. The ’001 patent was originally set to expire on
 April 1, 2018, but its term was extended by 811 days under
 the provisions of § 156 to compensate Biogen for the period
 during which the FDA reviewed its Tecfidera® NDA. The
 ’001 patent is now set to expire on June 20, 2020. The ques-
 tion in this appeal is whether the monomethyl ester, cov-
 ered by the claim, is covered by the extension. We
 conclude, consistent with the district court, that it is not.
     In 2018, after the five-year data exclusivity period for
 Tecfidera® had expired, Banner submitted an application
 under 21 U.S.C. § 355(b)(2) (a § 505(b)(2) application or a
 “paper NDA”) to market a twice-daily MMF pill at a daily
 dose of 380 mg. A paper NDA is a form of generic applica-
 tion used before the enactment of the Hatch-Waxman Act.
 Banner performed clinical studies to assess whether its
 proposed product was bioequivalent to Tecfidera®, see 21
 C.F.R. § 314.3(b), but it relied on the clinical data Biogen
 submitted to the FDA in its Tecfidera® NDA to satisfy the
 safety and efficacy requirements.
     In December 2018, Biogen asserted the ’001 patent in
 an infringement action against Banner in the District of
 Delaware. Banner immediately moved for a judgment of
 noninfringement, arguing that § 156(b)(2) limits the scope
 of the ’001 patent’s extension to methods of using the ap-
 proved product as defined in § 156(f)—in this case, DMF,
 its salts, or its esters—and that MMF is none of those
 things. Biogen responded that § 156(b)(2) does not limit
 extension of a method of treatment patent to uses of the
 approved product, but instead only to uses of any product
 within the original scope of the claims. Biogen further ar-
 gued that, in any event, “product” in § 156 has a broader
 meaning encompassing any compound that shares with the
 approved product an “active moiety.” See 21 C.F.R.
 § 314.3(b) (defining “active moiety” as “the molecule or ion,
 excluding those appended portions of the molecule that
 cause the drug to be an ester, salt[], or other noncovalent
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 BIOGEN INTERNATIONAL GMBH    v. BANNER LIFE SCIENCES LLC   5



 derivative[] of the molecule, responsible for the physiologi-
 cal or pharmacological action of the drug substance”).
 Since DMF and MMF share an active moiety (MMF), Bio-
 gen contended that Banner’s proposed MMF product in-
 fringes the ’001 patent even as extended.
     The district court agreed with Banner’s interpretation
 of § 156 in both respects and rendered a judgment of non-
 infringement. It rejected Biogen’s argument that extension
 of a method of treatment patent under § 156(b)(2) is not
 limited to uses of the approved product. Decision, 

, at *4–5. The district court also reasoned that this
 court’s interpretation of “product” in § 156 forecloses Bio-
 gen’s argument that MMF is the same product as Tecfid-
 era®.

(citing Glaxo Ops. UK Ltd. v. Quigg, 

, 395 (Fed. Cir. 1990)).
     Biogen appealed to this court. We have jurisdiction un-
 der 28 U.S.C. § 1295(a)(1).
                         DISCUSSION
      We review a district court’s judgment on the pleadings
 under Federal Rule of Civil Procedure Rule 12(c) according
 to the law of the regional circuit. Koninklijke KPN N.V. v.
 Gemalto M2M GmbH, 

, 1149 (Fed. Cir. 2019)
 (citing Allergan, Inc. v. Athena Cosmetics, Inc., 

, 1380 (Fed. Cir. 2011)). In the Third Circuit, judg-
 ment under Rule 12(c) is reviewed de novo and is appropri-
 ate when “no material issue of fact remains to be resolved,”
 and the movant “is entitled to judgment as a matter of law.”
 Jablonski v. Pan Am. World Airways, Inc., 

,
 290–91 (3d Cir. 1988) (quoting Society Hill Civic Ass’n v.
 Harris, 

, 1054 (3d Cir. 1980)).
    Infringement is a question of fact. Amgen Inc. v.
 Sandoz Inc., 

, 1027 (Fed. Cir. 2019), reh’g
 granted, opinion modified, 776 F. App’x 707 (Fed. Cir.
 2019) (citing Lucent Techs., Inc. v. Gateway, Inc., 

, 1309 (Fed. Cir. 2009)). Statutory interpretation is a
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 6   BIOGEN INTERNATIONAL GMBH     v. BANNER LIFE SCIENCES LLC



 question of law that we review de novo. Power Integrations,
 Inc. v. Semiconductor Components Indus., LLC, 

, 1313–14 (Fed. Cir. 2019) (citing Unwired Planet,
 LLC v. Google Inc., 

, 1379 (Fed. Cir. 2016)).
     Section 156 was enacted as part of the Hatch-Waxman
 Act, otherwise intended to provide for approval of generic
 products, to restore part of a patent’s term consumed dur-
 ing clinical testing and FDA review of an NDA relating to
 a compound covered by the patent. As the Supreme Court
 has noted, the ordinary term of a pharmaceutical patent is
 diminished by the time spent in the FDA approval process.
 See Eli Lilly & Co. v. Medtronic, Inc., 

, 669–71
 (1990). While the patent’s term is running, the NDA appli-
 cant may not commercialize its product until it receives
 FDA approval. The Hatch-Waxman Act provided for pa-
 tent term extensions in § 156 to partially compensate NDA
 applicants for this loss of patent life.

156, an NDA holder is entitled to extend the
 term of only one patent for the corresponding approved
 product.

Subsection (a) places several con-
 ditions on term extension for an NDA holder, including
 that the applicant’s approved NDA must be “the first per-
 mitted commercial marketing or use of the product.”
 § 156(a)(5)(A). Subsection (b) limits the scope of the patent
 extension to “any use approved for the product,” and fur-
 ther, for method of treatment patents, to uses also “claimed
 by the patent.” § 156(b)(2). Critically, for the purposes of
 this appeal, subsection (f) defines “product” as “the active
 ingredient of . . . a new drug . . . including any salt or ester
 of the active ingredient.” § 156(f)(2)(A).
     Biogen primarily argues that the district court misin-
 terpreted “product” in § 156(f) as not encompassing a de-
 esterified form of an approved product. Biogen maintains
 that this court decided in Pfizer Inc. v. Dr. Reddy’s Labs.,
 Ltd., 

(Fed. Cir. 2004), that “product” has a
 different meaning under § 156(b), encompassing the de-
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 BIOGEN INTERNATIONAL GMBH     v. BANNER LIFE SCIENCES LLC    7



 esterified form, particularly where “a later applicant’s pa-
 tentably indistinct drug product . . . relies on the patentee’s
 clinical data.” Appellant Br. 17. In that circumstance, Bi-
 ogen contends, “active ingredient” means “active moiety,”
 and our holdings in Glaxo and PhotoCure ASA v. Kappos,
 

(Fed. Cir. 2004), are thus inapposite because
 they ultimately concerned the availability of separate ex-
 tension under § 156(a).
      Banner responds that § 156(f) provides a consistent
 definition of “product” for the entire statute, a definition
 that this court expressly held in Glaxo excludes a de-ester-
 ified form of the active ingredient. It further argues that
 Biogen has misinterpreted the holding of Pfizer.
    We agree with Banner that the extended portion of Bi-
 ogen’s patent does not encompass its MMF product.
      The parties here argue that either Glaxo or Pfizer helps
 their case. But this case is neither a Glaxo case nor a Pfizer
 case. It is governed by the statute. Glaxo involved the
 question whether a separate ester compound, not the same
 active ingredient as its previously approved carboxylic
 acid, was entitled to its own extension under § 156(a). We
 held that it was so entitled because the ester compound
 was not the same product as the previously approved car-
 boxylic acid within the meaning of § 156(f). “Active ingre-
 dient” is a term of art, defined by the FDA as “any
 component that is intended to furnish pharmacological ac-
 tivity or other direct effect,” 21 C.F.R. § 210.3(b)(7), and it
 “must be present in the drug product when administered.”
 Hoechst-Roussel Pharm., Inc. v. Lehman, 

, 759
 n.3 (Fed. Cir. 1997) (citation omitted). The active ingredi-
 ent of a given drug product is defined by what is approved
 and is specified on the drug’s label. See 21 U.S.C.
 § 352(e)(1)(A)(ii); 21 C.F.R. § 201.100(b)(4). MMF is not the
 approved product, nor is it specified as the active ingredi-
 ent on the Tecfidera® label. Esters are included in the stat-
 utory definition of what can be extended, but MMF is the
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 8   BIOGEN INTERNATIONAL GMBH    v. BANNER LIFE SCIENCES LLC



 de-esterified form of DMF, not an ester of DMF. Thus, it is
 not the same product under § 156(f) and does not fall
 within the scope of the ’001 patent’s term extension under
 § 156(b)(2).
     As this court held in Glaxo, “product” is plainly defined
 in § 156(f)—not as the active moiety—but as the active in-
 gredient or an ester or salt of the active ingredient. We
 concluded in that case that a product whose active ingredi-
 ent, cerufoxime axetil, was an ester of a previously ap-
 proved active ingredient, cerufoxime, was eligible for its
 own separate extension under § 156(a) because neither ce-
 rufoxime axetil, nor salts or esters of that compound, had
 previously been 

–96. This case
 is not directly governed by Glaxo, as it does not involve an
 issue of a separate extension.
      This case is also not a Pfizer case. In Pfizer, we consid-
 ered whether an extension for amlodipine encompassed a
 § 505(b)(2) applicant’s amlodipine maleate product under
 § 156(b)(2). We held that it did because amlodipine male-
 ate is a salt of the active ingredient, amlodipine, and was
 therefore the same product under § 156(f). 

(“We conclude that the active ingredient is amlodi-
 pine . . . .”). Pfizer does not govern this case because MMF
 is not a salt of DMF. Biogen’s assertion that Pfizer en-
 dorsed an “active moiety” interpretation of § 156(f) finds
 little support in our opinion. Instead, Pfizer noted the fol-
 low-on applicant’s reliance on the patentee’s clinical data
 in its own application and the FDA’s construction of similar
 phrases in the Hatch-Waxman Act. But these statements
 simply illuminated the purpose of the statute and gave con-
 text to our holding that amlodipine maleate is a salt of am-
 lodipine and therefore the same product under § 156(f), as
 expressly provided by the language of the statute.

any salt or ester of the active ingredient”); see Pho-
 toCure ASA v. Kappos, 

, 1376 (Fed. Cir.
 2010).
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 BIOGEN INTERNATIONAL GMBH     v. BANNER LIFE SCIENCES LLC    9



     While Biogen highlights a dictum of PhotoCure, our ob-
 servation that the new ester in that case was separately
 

, PhotoCure presented a situ-
 ation virtually identical to that in Glaxo—a new ester’s el-
 igibility for term extension under § 156(a)—and was thus
 decided according to the holding of Glaxo,

 (rejecting argument for an “active moiety” interpretation of
 § 156(f) as contrary to the holding of Glaxo).
      All these precedents, and now this case, rest on the
 same holding: the term “product,” defined in § 156(f) as the
 “active ingredient . . . including any salt or ester of the ac-
 tive ingredient,” has a plain and ordinary meaning that is
 not coextensive with “active moiety.” It encompasses the
 active ingredient that exists in the product as administered
 and as approved—as specified by the FDA and designated
 on the product’s label—or changes to that active ingredient
 which serve only to make it a salt or an ester. It does not
 encompass a metabolite of the active ingredient or its de-
 esterified form. This case is unlike Glaxo or Pfizer in that
 it concerns a de-esterified compound, not an ester or salt.
     Biogen makes two other arguments, neither of which
 has merit. Biogen first contends that, unlike the provision
 for product patents under § 156(b)(1), § 156(b)(2) does not
 limit extension for method of treatment patents to ap-
 proved uses of the approved product, but only to approved
 uses of any approved product. Otherwise, Biogen main-
 tains, the additional clause in subsection (b)(2), further
 limiting extension to “any use claimed by the patent,”
 would be superfluous. 1 Banner responds that the relevant


     1   As Biogen points out, this clause in § 156(b)(2) is
 somewhat redundant because a method of treatment claim
 is already limited by its own terms to the uses it claims.
 Nevertheless, this slight redundancy certainly does not re-
 verse the limitation imposed by the “any use . . . approved
 for the product” clause.
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 10 BIOGEN INTERNATIONAL GMBH v. BANNER LIFE SCIENCES LLC



 language of § 156(b) is identical for product patents and
 method of treatment patents, limiting extension for each to
 “any use approved for the product.”

we see no basis for Biogen’s interpreta-
 tion of § 156(b)(2). As an initial matter, subsection (b)(2) is
 limited to “use[s] approved for the product,”

which is defined in § 156(f), and an indication of
 use is obviously inseparable from a specific product. See,
 e.g., 21 C.F.R. § 201.57(a)(6) (requiring “[a] concise state-
 ment of each of the product’s indications” (emphasis
 added)). The approved product here is DMF, not MMF.
 And the statute uses the word “limited,” which runs contra
 to Biogen’s argument for extension. Patent term extension
 exists to compensate an NDA holder for time consumed
 during regulatory review of the product. But it would make
 little sense for an extension—whether for a product patent
 or a method of treatment patent—to apply to a different
 product for which the NDA holder was never subjected to a
 regulatory review period. See Merck & Co., Inc. v. Kessler,
 

, 1547 (Fed. Cir. 1996) (concluding for product
 patents that “the restoration period of the patent does not
 extend to all products protected by the patent but only to
 the product on which the extension was based”).
     Finally, Biogen argues that the district court erred in
 rejecting its claim for infringement under the doctrine of
 equivalents because “all provisions of the patent law apply
 to the patent during the period of extension.” Appellant
 Br. 28 (quoting Genetics Inst., LLC v. Novartis Vaccines &
 Diagnostics, Inc., 

(Fed. Cir. 2011) (emphasis
 in Biogen’s brief)).
      We disagree. To infringe a patent claim extended un-
 der § 156, an accused product or process must meet, either
 literally or through equivalence, each individual element of
 the claim. See Johnson & Johnston Assocs. Inc. v. R.E.
 Serv. Co., 

, 1052 (Fed. Cir. 2002) (en banc).
 But such a product or process cannot logically infringe an
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 BIOGEN INTERNATIONAL GMBH   v. BANNER LIFE SCIENCES LLC 11



 extended patent claim under equivalence if it is statutorily
 not included in the extension under § 156. That would
 make judge-made law prevail over statute.
                        CONCLUSION
     We have considered Biogen’s further arguments but
 find them unpersuasive. For the foregoing reasons, the
 judgment of the district court is
                        AFFIRMED