Case: 19-1133    Document: 90     Page: 1   Filed: 09/28/2020




   United States Court of Appeals
       for the Federal Circuit
                  ______________________

                    BIOGEN MA INC.,
                     Plaintiff -Appellee

                             v.

          EMD SERONO, INC., PFIZER INC.,
               Defendants-Appellants

 BAYER HEALTHCARE PHARMACEUTICALS INC.,
 NOVARTIS PHARMACEUTICALS CORPORATION,
                  Defendants
            ______________________

                        2019-1133
                  ______________________

     Appeal from the United States District Court for the
 District of New Jersey in No. 2:10-cv-02734-CCC-MF,
 United States District Judge Claire C. Cecchi.
                 ______________________

                Decided: September 28, 2020
                  ______________________

      NICHOLAS P. GROOMBRIDGE, Paul, Weiss, Rifkind,
 Wharton & Garrison LLP, New York, NY, argued for plain-
 tiff-appellee. Also represented by PETER SANDEL, ERIC
 ALAN STONE, JENNY CHIA CHENG WU, JOSEPHINE YOUNG;
 DAVID J. BALL, JR., Washington, DC; JOHN D. TORTORELLA,
 KEVIN H. MARINO, Marino Tortorella & Boyle, PC, Chat-
 ham, NJ.
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 2                         BIOGEN MA INC.   v. EMD SERONO, INC.



      MARK ANDREW PERRY, Gibson, Dunn & Crutcher LLP,
 Washington, DC, argued for defendants-appellants. Also
 represented by CHRISTINE RANNEY, Denver, CO; WAYNE M.
 BARSKY, TIMOTHY P. BEST, Los Angeles, CA; JAYSEN
 CHUNG, San Francisco, CA.

     BRUCE GENDERSON, Williams & Connolly LLP, Wash-
 ington, DC, for amicus curiae Bayer Healthcare Pharma-
 ceuticals Inc. Also represented by DAVID I. BERL, SETH
 BOWERS, DAVID M. KRINSKY.
                  ______________________

     Before NEWMAN, LINN, and HUGHES, Circuit Judges.

 LINN, Circuit Judge.
     This appeal arises from a suit filed by Biogen MA, Inc.
 (“Biogen”) against EMD Serono, Inc. and Pfizer, Inc. (col-
 lectively “Serono”) in the District of New Jersey. 1 The suit
 alleged contributory and induced infringement of Biogen’s
 U.S. Patent Number 7,588,755 (“’755 patent”) by the sale
 and marketing in the United States of Rebif, a recombinant
 interferon-β (“IFN-β”) product used for the treatment of
 Multiple Sclerosis (“MS”). After a five-week trial, a jury
 found that the ’755 patent claims were anticipated by two
 references teaching the use of native IFN-β to treat viral
 diseases: Kingham et al., Treatment of HBsAg-positive
 Chronic Active Hepatitis with Human Fibroblast Inter-
 feron, 19(2) Gut 91 (1978) (“Kingham”) and Sundmacher et



     1   Biogen also asserted infringement claims against
 Bayer Healthcare Pharmaceuticals Inc. (“Bayer”) and No-
 vartis Pharmaceuticals Corp. (“Novartis”). The actions
 against Bayer and Novartis were severed from those giving
 rise to this appeal. Order Granting Bayer’s Motion to
 Sever, Oct. 27, 2017, ECF No. 743. Bayer filed an amicus
 brief here.
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 BIOGEN MA INC.   v. EMD SERONO, INC.                       3



 al., Human Leukocyte and Fibroblast Interferon in a Com-
 bination Therapy of Dendritic Keratitis, 208(4) Albrecht
 von Graefes Archiv für Klinische & Experimentelle Opthal-
 mologie 229 (1978) (“Sundmacher”). The jury also held the
 asserted claims not invalid for lack of enablement or writ-
 ten description, or for obviousness. Finally, the jury held
 that patients and prescribers directly infringed the as-
 serted claims and that Serono contributorily infringed the
 claims but did not induce infringement thereof.
     On cross-motions, the district court granted judgment
 as a matter of law (“JMOL”) of no anticipation in favor of
 Biogen and conditionally granted a new trial on anticipa-
 tion. In re Biogen ’755 Patent Litig., 

 (D.N.J. 2018) (“Biogen I”). The district court also ruled in
 favor of Biogen: sustaining the jury’s verdict of no invalid-
 ity based on written description or enablement; overturn-
 ing the verdict of no induced infringement; sustaining the
 verdict of contributory infringement; and holding that the
 ’755 patent claims were not patent ineligible.

district court’s JMOL rulings on anticipation,
 written description, enablement, contributory infringe-
 ment, induced infringement and patent eligibility. We
 have jurisdiction under 28 U.S.C. § 1295(a).
     Because a reasonable jury could find the claims of the
 ’755 patent anticipated on the record presented in this
 case, we reverse the district court’s JMOL of no anticipa-
 tion and its conditional grant of new trial on that ground.
 We remand with instructions to reinstate the jury verdict
 of anticipation. We need not and do not address the other
 grounds asserted on appeal.
                                I
     The ’755 patent is directed to a method of treating a
 viral condition, a viral disease, cancers or tumors, by ad-
 ministration of a pharmaceutically effective amount of a
 recombinant polypeptide related to human interferon-β
 (“IFN-β”). The human immune system naturally produces
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 4                         BIOGEN MA INC.   v. EMD SERONO, INC.



 IFN-β in small amounts, and it is undisputed that IFN-β
 harvested from human cells (“native IFN-β”) was used in
 the prior art to treat viral conditions. See ’755 patent, col.
 2, l. 53–col. 4, l. 22.
     Representative claim 1 of the ’755 patent reads:
     1. A method for immunomodulation or treating a
        viral condition[ ], a viral disease, cancers or tu-
        mors comprising the step of administering to a
        patient in need of such treatment a therapeuti-
        cally effective amount of a composition compris-
        ing:
         a recombinant polypeptide produced by a
         non-human host transformed by a recombi-
         nant DNA molecule comprising a DNA se-
         quence selected from the group consisting
         of:
             (a) DNA sequences which are capa-
             ble of hybridizing to any of the DNA
             inserts of G-pBR322(Pst)/HFIF1,
             G-pBR322(Pst)/HFIF3             (DSM
             1791),       G-pBR322(Pst)/HFIF6
             (DSM        1792),       and       G-
             pBR322(Pst)/HFIF7 (DSM 1793)
             under hybridizing conditions of
             0.75 M NaCl at 68° C. and washing
             conditions of 0.3 M NaCl at 68° C.,
             and which code for a polypeptide
             displaying antiviral activity, and
             (b) DNA sequences which are de-
             generate as a result of the genetic
             code to the DNA sequences defined
             in (a);
         said DNA sequence being operatively
         linked to an expression control sequence in
         the recombinant DNA molecule.
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 BIOGEN MA INC.   v. EMD SERONO, INC.                       5



 ’755 patent, col. 49, l. 59–col. 50, l. 12. Dependent claim 2
 replaces the “capable of hybridizing” limitation with a se-
 lection from two particular DNA sequences, one of which is
 the DNA sequence of human interferon-beta.

col. 50,
 ll. 13–52. Claims 1 and 2 thus define the claimed polypep-
 tide by reference to the DNA sequence inserted into the
 host during the recombinant manufacture of the polypep-
 tide. Claim 3, dependent from claim 1, limits the polypep-
 tide to a particular linear polypeptide sequence. Because
 the claimed IFN-β DNA and polypeptide sequences are de-
 rived from human IFN-β, it is indisputable that native hu-
 man IFN-β is capable of hybridizing with the DNA
 sequences in claim 1, is produced by one of the DNA se-
 quences laid out in claim 2, and comprises the amino acid
 sequence set out in claim 3. See J.A. 47784 (Fiers Aff. to
 the Canadian Patent Office, indicating that the recombi-
 nant IFN-β was derived from human IFN-β cDNA);
 J.A. 77897 (Dr. Green Test., testifying that the sequences
 claimed in claim 1 are “DNA that will hybridize to one of
 the four human beta interferon clones”); J.A. 77904 (Dr.
 Green Test., testifying that accused-product Rebif is capa-
 ble of hybridizing to one or more of the DNA inserts be-
 cause the DNA sequence it used is identical to the
 published sequence of human IFN-β). For purposes of this
 opinion, we refer to “recombinant IFN-β” as shorthand for
 the recombinant protein that meets these claim limita-
 tions.
     During Markman, the district court held that claim 1
 covers a “one-step method of ‘administering’ to a patient in
 need the specified recombinant HuIFN-β.” Markman
 Opinion at 17, Mar. 28, 2016, ECF No. 403. The district
 court considered the claimed “produced” and “transformed”
 steps “merely descriptive of the recombinant polypeptide to
 be administered,” i.e. merely source limitations.

15.
 The district court also held that it was “unclear that [the]
 method of treatment claim can be treated as a product-by-
 process claim,” and that it was “aware of no binding
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 6                         BIOGEN MA INC.   v. EMD SERONO, INC.



 precedent requiring method of treatment claims to be
 treated as product-by-process claims in the claim construc-
 tion context.”

14. The district court did not construe
 “polypeptide,” “therapeutically effective amount,” or “anti-
 viral activity,” and neither party asked the court to con-
 sider whether the claims covered the linear sequence of
 amino acids or the three-dimensional structure of the pro-
 tein.
     Biogen, Serono, and Bayer all moved for summary
 judgment. Before Bayer was severed, Bayer argued that it
 was entitled to summary judgment of anticipation because
 the claimed recombinant IFN-β and the prior art native
 IFN-β shared the same linear amino acid sequence. The
 district court denied Bayer’s motion, holding, inter alia,
 that the claims require the polypeptide to have “antiviral
 activity” and be administered in a “therapeutically effec-
 tive amount.” Summary Judgment Opinion at 28, Jan. 9,
 2018, ECF No. 892. The district court concluded that those
 requirements necessitate that the polypeptide “be folded
 into its appropriate three-dimensional structure,” and that
 Bayer was therefore not entitled to summary judgment of
 anticipation by merely showing that the amino acid se-
 quence of recombinant IFN-β and the amino acid sequence
 of native IFN-β were identical.

trial, Biogen and Serono both moved
 for JMOL under Federal Rule of Civil Procedure 50(a). The
 district court deferred ruling until the jury verdict. Among
 other issues, the court submitted anticipation, obvious-
 ness, enablement, written description, and contributory
 and induced infringement to the jury. In its charge on an-
 ticipation, the district court told the jury that “[t]he term
 ‘polypeptide’ means ‘a linear array of amino acids con-
 nected one to the other by peptide bonds between the α-
 amino and carboxy groups of adjacent amino acids,’” and
 that the jury “must accept my definition of these words in
 the claims as correct.” Final Jury Instructions at 17, Feb.
 21, 2018, ECF No. 968. Biogen did not object to these
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 BIOGEN MA INC.   v. EMD SERONO, INC.                         7



 instructions and did not request any instruction defining
 the polypeptide in terms of its three-dimensional structure
 or requiring identity of the three-dimensional structures of
 native IFN-β and recombinant IFN-β proteins to establish
 anticipation.
      The jury held, inter alia, that all claims in the ’755 pa-
 tent were invalid as anticipated by native IFN-β; not inva-
 lid for obviousness, lack of enablement or lack of written
 description; and that Serono was liable for contributory in-
 fringement but not induced infringement. Jury Verdict
 Form at 1–6, Feb. 23, 2018, ECF No. 977.
     Both parties renewed their JMOL motions. As rele-
 vant here, the district court granted Biogen’s motion of no
 anticipation as a matter of law. Biogen 

. In a comprehensive opinion, the district court held
 that no reasonable jury could find anticipation under Ser-
 ono’s reading of the claims. First, applying a structural
 reading of the recombinant limitations, the district court
 held that Serono had not identified any prior art that dis-
 closed “treatment with a ‘therapeutically effective amount’
 of a composition comprising a ‘recombinant’ interferon-β
 polypeptide produced in a ‘non-human host’ that had been
 ‘transformed by a recombinant DNA molecule.’”

704.
 [JA21]. The district court reasoned that because treat-
 ment in the prior art entailed administration of native
 IFN-β, which was undisputedly not recombinantly pro-
 duced, no reasonable jury could find anticipation.
 Id. at
 705. The district court cited but did not distinguish Amgen
 Inc. v. Hoffman-La Roche Ltd., 
580 F.3d 1340 
(Fed. Cir.
 2009), which analyzed anticipation of a claimed recombi-
 nant erythropoietin (“EPO”) by prior art urinary (i.e. natu-
 ral) EPO. Biogen 
I, 335 F. Supp. 3d at 1367
. The district
 court declined to apply a product-by-process analysis to a
 product-by-process limitation contained within a method of
 treatment claim, concluding that no precedent required
 such an analysis and that the policy informing product-by-
 process claims—to enable an inventor to claim an
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 8                         BIOGEN MA INC.   v. EMD SERONO, INC.



 otherwise difficult-to-define product—was inapplicable to
 the instant method of treatment claims.
 Id. at 
712–13.
     In the alternative, the district court held that no rea-
 sonable jury could have found anticipation even applying a
 product-by-process analysis.
 Id. at 
705–11. The district
 court explained that because the claims required admin-
 istration of a “therapeutically effective amount” of a recom-
 binant polypeptide that “displays antiviral activity,” the
 product resulting from the claimed recombinant process is
 defined by the folded three-dimensional structure of the
 protein.
 Id. at 
705 (discussing Summary Judgment Opin-
 ion at 28, Jan. 9, 2018, ECF No. 892). The district court
 held that the jury lacked substantial evidence that the na-
 tive IFN-β protein as disclosed in Kingham and
 Sundmacher was structurally or functionally identical to
 the claimed three-dimensional recombinant IFN-β protein.

 Id.
      With respect to 
structural identity, the district court
 emphasized that whereas the attached carbohydrate
 groups in native IFN-β protein were glycosolated, the at-
 tached carbohydrate groups in recombinant IFN-β were not
 glycosolated, and that this change affected the three-di-
 mensional structure of the protein.
 

—
 relying on expert testimony by Serono’s expert, Dr. Lodish,
 and statements found in a post-priority date reference cre-
 ated by InterPharm Laboratories Ltd. entitled “Compara-
 tive Biochemical Analysis of Native Human Fibroblast
 lnterferon and Recombinant Beta Interferon Expressed by
 Chinese Hamster Ovary Cells” (“InterPharm”)—concluded
 that native and recombinant IFN-β were not identical but
 merely very similar.
 

706–07. 
The district court
 opined that the structural differences alone preclude antic-
 ipation.
 Id. at 
710–11 (relying primarily on this court’s de-
 cision in 
Amgen, 580 F.3d at 1367
–69, in which we affirmed
 a holding of no anticipation based on structural differ-
 ences). Finally, the district court discounted the conclusion
 in the InterPharm study that recombinant IFN-β and
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 BIOGEN MA INC.   v. EMD SERONO, INC.                        9



 native IFN-β were identical. It held that there was no sub-
 stantial evidence that the generic “native IFN-β” analyzed
 in the InterPharm study and found to be identical to re-
 combinant IFN-β was the same native IFN-β taught in the
 prior art.
 Id. at 
708.
     As for functional identity, the district court held that
 the relative ease of manufacture of recombinant IFN-β in
 large quantities functionally distinguished it from native
 IFN-β.
 Id. at 
709–10.
     For these reasons, the district court granted JMOL of
 no anticipation.
 Id. at 
713. The district court also condi-
 tionally granted Biogen’s motion for a new trial on antici-
 pation “[f]or the same reasons the Court grants Biogen’s
 JMOL motion.”
 Id. The district court 
added that the trial
 was complex and was “noticeably focused on issues other
 than anticipation,” such that that the jury verdict deserved
 close scrutiny.
 Id.
     Serono appeals. We 
have jurisdiction under 28 U.S.C.
 § 1295.
                               II
      We review the grant of JMOL and the grant of new trial
 under the law of the regional circuit. Uniloc USA, Inc. v.
 Microsoft Corp., 
632 F.3d 1292
, 1301, 1309 (Fed. Cir. 2011).
 The Third Circuit reviews the grant of JMOL for a fact
 question de novo, affirming “only if, viewing the evidence
 in the light most favorable to the nonmovant and giving it
 the advantage of every fair and reasonable inference, there
 is insufficient evidence from which a jury reasonably could
 find liability.” Lightning Lube, Inc. v. Witco Corp., 
4 F.3d
 1153
, 1166–67 (3d Cir. 1993); Garzier ex rel. White v. City
 of Phila., 
328 F.3d 120
, 123 (3d Cir. 2003) (“A district court
 should grant such a motion only if, viewing all the evidence
 in favor of the nonmoving party, no reasonable jury could
 find liability on a particular point.”). The Third Circuit re-
 views the conditional grant of a new trial against the
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 10                        BIOGEN MA INC.   v. EMD SERONO, INC.



 weight of the evidence for an abuse of discretion, “unless
 the court’s denial is based on the application of a legal pre-
 cept, in which case the standard of review is plenary.”
 Lightning 
Lube, 4 F.3d at 1167
.
                              III
     A claim is anticipated only if “each and every [limita-
 tion] is found within a single prior art reference.” Summit
 6, LLC v. Samsung Elecs. Co., 
802 F.3d 1283
, 1294 (Fed.
 Cir. 2015). Anticipation is a factual question and thus
 within the ordinary provenance of the jury. Lighting Bal-
 last Control LLC v. Phillips Elecs. N. Am. Corp., 
790 F.3d
 1329
, 1340 (Fed. Cir. 2015).
      In evaluating the evidentiary record presented to the
 jury on the question of anticipation, the district court:
 (1) declined to apply a product-by-process analysis to the
 claimed recombinant IFN-β source limitation; and (2) in its
 alternative ground analysis, required identity of three-di-
 mensional structures not specifically recited in the claims
 rather than the claimed and lexicographically defined “pol-
 ypeptide.” Both of these determinations led to an errone-
 ous conclusion on anticipation.
       A. The Recombinant Source of the Polypeptide
      The district court, focusing on the process of making
 recombinant IFN-β, concluded that it need not analyze
 whether native IFN-β and recombinantly produced IFN-β
 were identical because neither Kingham nor Sundmacher
 prior art reference taught a method of treatment using re-
 combinant IFN-β. Biogen 
I, 335 F. Supp. 3d at 704
. It cat-
 egorized the “produced” and “transformed” limitations as
 meaningful “source limitations.”
 

711–12. 
The dis-
 trict court was convinced that because the recombinant
 source limitations here overcame the shortcoming of the
 prior art—namely, the unavailability of native IFN-β in
 sufficient quantity to facilitate practical treatment—the
 recombinant nature of the claimed IFN-β “lies at the heart
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 BIOGEN MA INC.   v. EMD SERONO, INC.                       11



 of the benefit of this invention” [and] should be given “force
 and effect in the anticipation analysis.’”
 Id. (quoting Bio-
 gen’s 
statements at JMOL hearing, Trial Tr. 6/6/18 at 12:7–
 10). The district court reasoned that no binding precedent
 required it to apply a product-by-process analysis to a lim-
 itation contained in a method of treatment claim, and held
 that the rationale underlying the use of product-by-process
 claims—to allow claiming of an otherwise difficult-to-de-
 fine invention, see 
SmithKline, 439 F.3d at 1315
—did not
 apply to the claims here because the “product” itself was
 sufficiently described. Biogen I, 
335 F. Supp. 3d
. at 713.
 The district court thus concluded there could be no antici-
 pation, regardless of whether Serono had shown the iden-
 tity of native IFN-β and recombinant INF-β.
     Serono contends that Biogen has waived any argument
 that the recombinant source of the IFN-β can alone confer
 novelty because Biogen’s pre-verdict JMOL motion only ar-
 gued that native IFN-β and recombinant IFN-β were not
 identical. We find no waiver. The source limitation was
 one of the bases for Biogen’s argument of non-identity and
 was considered by the district court at Summary Judgment
 and in its opinion on JMOL.
     On the merits, Serono asserts that a source limitation
 alone cannot confer novelty unless the product itself is
 novel. Serono argues that the district court erred by hold-
 ing that the lack of a recombinantly produced IFN-β prod-
 uct in the prior art compelled a finding of no anticipation.
 Biogen argues that the source of the IFN-β matters is an
 independent limitation.
     We agree with Serono. The district court’s refusal to
 consider the identity of recombinant and native IFN-β runs
 afoul of the longstanding rule that “an old product is not
 patentable even if it is made by a new process.” 
Amgen,
 580 F.3d at 1366
. See also Gen. Elec. Co. v. Wabash Appli-
 ance Corp., 
304 U.S. 364
, 373 (1938) (“[A] patentee who
 does not distinguish his product from what is old except by
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 12                        BIOGEN MA INC.   v. EMD SERONO, INC.



 reference, express or constructive, to the process by which
 he produced it, cannot secure a monopoly on the product by
 whatever means produced.”); Cochrane v. Badische Anilin
 & Soda Fabrik, 
111 U.S. 293
, 311 (1884) (“While a new pro-
 cess for producing [an old product] was patentable, the
 product itself could not be patented, even though it was a
 product made artificially for the first time.”); SmithKline
 Beecham Corp. v. Apotex Corp., 
439 F.3d 1312
, 1317 (Fed.
 Cir. 2006) (“It has long been established that one cannot
 avoid anticipation by an earlier product disclosure by
 claiming the same product . . . as produced by a particular
 process.”).
     In Amgen, we explained that a claim to a recombinant
 EPO composition must be analyzed for novelty by compar-
 ing the recombinant EPO to the prior art urinary EPO. We
 further explained that simply because prior art urinary
 EPO was not made recombinantly was not enough to avoid
 anticipation as a matter of law. 
2 580 F.3d at 1370 
(“To
 prove invalidity, Roche had to show that recombinant EPO
 was the same as urinary EPO, even though urinary EPO
 was not made recombinantly.”) (emphasis added). The key



      2  The key claim in Amgen read: “A pharmaceutical
 composition comprising a therapeutically effective amount
 of human erythropoietin and a pharmaceutically accepta-
 ble diluent, adjuvant or carrier, wherein said erythropoi-
 etin is purified from mammalian cells grown in 
culture.”
 580 F.3d at 1364
. An additional independent claim in a
 related patent read: “A non-naturally occurring glycopro-
 tein product of the expression in a mammalian host cell of
 an exogenous DNA sequence comprising a DNA sequence
 encoding human erythropoietin said product possessing
 the in vivo biological property of causing bone marrow cells
 to increase production of reticulocytes and red blood cells.”

 Id. In relevant part, 
we applied the same analysis to both
 claims.
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 BIOGEN MA INC.   v. EMD SERONO, INC.                           13



 question was “whether the production of EPO by recombi-
 nant technology resulted in a new product,”
 id. at 1367, 
or,
 “[i]n other words, does the source limitation ‘purified from
 mammalian cells grown in culture’ distinguish recombi-
 nant EPO from [prior art] urinary EPO?”
 Id.
      The nature of 
the origin or source of the composition
 recited in the claims at issue in this case is, in all relevant
 respects, identical to that considered in Amgen. As in
 Amgen, the recombinant origin of the recited composition
 cannot alone confer novelty on that composition if the prod-
 uct itself is identical to the prior art non-recombinant prod-
 uct. The requirements that the claimed polypeptide is
 “recombinant” and “produced by a non-human host trans-
 formed by a recombinant DNA molecule” (in the case of
 Claim 1 of the ’755 patent) describe the process by which
 the product, i.e. the “polypeptide,” is formed. These are not
 additional structural limitations. See Purdue Pharma L.P.
 v. Epic Pharma, LLC, 
811 F.3d 1345
, 1353 (Fed. Cir. 2016)
 (holding that because a source limitation of a composition
 “has no effect on its structure . . . [that] limitation . . . can-
 not be a structural limitation”). The key question for an-
 ticipation here, as in Amgen, is thus whether the
 recombinant product is identical to the prior art product—
 not whether the prior art product was made recombinantly.
     Biogen argues that Amgen is limited to composition
 claims and is not applicable to the method of treatment
 claims at issue here. To support this proposition, Biogen
 relies on general statements in product-by-process cases
 such as In re Thorpe, 
777 F.2d 695
, 697 (Fed. Cir. 1985)
 (applying product-by-process analysis for “an otherwise pa-
 tentable product”) (emphasis added), and the well-recog-
 nized distinction patent law draws between the scope of
 composition and method of treatment claims. See, e.g.,
 Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 
569
 U.S. 576
, 595 (2013) (recognizing the distinct scope for com-
 position and method of treatment claims in the context of
 35 U.S.C. § 101).
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 14                        BIOGEN MA INC.   v. EMD SERONO, INC.



      Biogen’s only basis for novelty of the method of treat-
 ment claims at issue here is the novelty of the recombinant
 IFN-β composition that is administered. That composition
 is claimed in terms of the process by which it is manufac-
 tured. If the novelty of the recombinant IFN-β composition
 requires comparing its structure to the structure of native
 IFN-β, as Amgen requires, it would defy all reason to ex-
 cuse that analysis for a method of administration claim us-
 ing that composition. Such a rule could have the absurd
 result that a recombinant composition could be non-novel,
 the method of administration could be non-novel, but the
 method of administration of the composition defined by the
 process of its manufacture would be novel as a matter of
 law.
      There is no logical reason why the nesting of a product-
 by-process limitation within a method of treatment claim
 should change how novelty of that limitation is evaluated.
 Indeed, we have previously applied product-by-process
 analysis to a nested limitation. In Purdue Pharma, we in-
 terpreted a claim to “an oral dosage form compris-
 ing . . . oxycodone hydrochloride active pharmaceutical
 ingredient having less than 25 ppm 14-hydroxy[ ], wherein
 at least a portion of the 14-hydroxy [ ] is derived from 8α[ ]
 during conversion of oxycodone free base to oxycodone hy-
 drochloride” as including a product-by-process limitation;
 namely, the 14-hydroxy as derived. Purdue 
Pharma, 811
 F.3d at 1353 
(emphasis omitted). Similar to our analysis
 here, the court in Purdue Pharma held that it was appro-
 priate to focus on the identity of the products of the claimed
 and prior art processes, and not on the source limitation, in
 analyzing obviousness. See
 id. at 1353–54. 
The nesting of
 the product-by-process limitation within a method of treat-
 ment claim does not change the proper construction of the
 product-by-process limitation itself.
     We are also unpersuaded by the district court’s and Bi-
 ogen’s reasoning that a product-by-process-type analysis is
 inappropriate here because the composition was otherwise
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 BIOGEN MA INC.   v. EMD SERONO, INC.                       15



 capable of definition other than by the process. That argu-
 ment is precluded by Amgen, where the product was also
 well-defined in the claims: “human erythropoi-
 etin . . . wherein said erythropoietin is purified from mam-
 malian cells grown in 
culture.”          580 F.3d at 1364
.
 Furthermore, as 
noted supra
, the rule in Amgen is a neces-
 sary outgrowth of the black-letter legal principle that an
 old product made by a new process is not novel and cannot
 be patented. Logic compels extending that rule to the pre-
 sent case; an old method of administration of an old prod-
 uct made by a new process is not novel and cannot be
 patented.
      Biogen is certainly correct that the scope of composition
 and method of treatment claims is generally subject to dis-
 tinctly different analyses. But where, as here, the novelty
 of the method of administration rests wholly on the novelty
 of the composition administered, which in turn rests on the
 novelty of the source limitation, the Amgen analysis will
 necessarily result in the same conclusion on anticipation
 for both forms of claims.
     Finally, the district court erred in considering the ad-
 vantages of the recombinant process—the new capability of
 manufacturing sufficient quantities of IFN-β through re-
 combinant technology—as a reason not to apply a product-
 by-process analysis. See Biogen 
I, 335 F. Supp. 3d at 713
.
 That consideration may well be relevant in considering the
 novelty of the recombinant process, but, a new process, re-
 gardless of its novelty, does not make an old product cre-
 ated by that process novel. This does not fail to give “force
 and effect” to the heart of the claimed invention; it protects
 the public from attempts to excise old products from the
 public domain.
     Because a proper anticipation analysis of the claims in
 the ’755 patent turns not on the source of the claimed pol-
 ypeptide but on a comparison of the claimed recombinant
 polypeptide and the prior art native polypeptide, the
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 16                        BIOGEN MA INC.   v. EMD SERONO, INC.



 district court erred in concluding that the mere absence of
 recombinantly produced IFN-β in the prior art was suffi-
 cient to grant JMOL of no anticipation.
   B. The Three-Dimensional Structure of the Polypeptide
      The district court also held that even applying a prod-
 uct-by-process type analysis, no reasonable jury could have
 found anticipation because the jury lacked sufficient evi-
 dence of identity between the claimed recombinant “poly-
 peptide” and the native IFN-β. In particular, the district
 court concluded that just because recombinant and native
 IFN-β “share the same linear amino acid sequence is not
 enough for purposes of anticipation.”
 Id. at 
705. The dis-
 trict court took the position that native polypeptide antici-
 pates the “recombinant polypeptide” only if their respective
 folded three-dimensional proteins share identical structure
 and function.
 Id. The district court 
reasoned that without
 a disclosure in the prior art of such three-dimensional pro-
 tein, a showing of the native polypeptide alone would not
 necessarily produce “antiviral activity” when administered
 in a “therapeutically effective amount” as recited in the
 claims.
 Id. (citing Summary Judgment 
Opinion at 28, ECF
 No. 892). This was error.
     The “product” administered in the claimed method is
 the “polypeptide.” See ’755 patent, col. 49, ll. 59–64 (“A
 method . . . comprising the step of administering . . . a
 therapeutically effective amount of a composition compris-
 ing: a recombinant polypeptide produced by a non-human
 host . . . .”). As 
noted supra
, the key question for anticipa-
 tion is whether the native “polypeptide” is identical to the
 “polypeptide” “produced by” the recited recombinant pro-
 cess.
     Biogen explicitly defined “polypeptide” in the ’755 pa-
 tent:
      Polypeptide—A linear array of amino acids con-
      nected one to the other by peptide bonds between
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 BIOGEN MA INC.   v. EMD SERONO, INC.                        17



     the α-amino and carboxy groups of adjacent amino
     acids.
 ’755 patent, col. 8, ll. 62–64. The “polypeptide” structure is
 thus defined by reference to its “linear” array, without re-
 gard to its folded protein structure. The district court
 charged the jury with this definition, adding that the jury
 “must accept my definition of these words in the claims as
 correct.” Final Jury Instructions at 17, ECF No. 968. Bio-
 gen did not object to this charge and did not ask the court
 for a jury instruction requiring identity of the folded pro-
 tein structures.
     As the district court recognized on summary judgment,
 “Biogen does not dispute that ‘[t]he sequential order of the
 amino acid residues for native IFN-β is the same as the se-
 quential order of the amino acid residues for recombinant
 IFN-β.’” Summary Judgment Opinion at 27, ECF No. 892.
 See also Biogen Brief at 19. Thus, the native IFN-β poly-
 peptide and the claimed recombinant IFN-β polypeptide
 are identical for purposes of the instant claim.
     Biogen argues that the district court was correct in re-
 quiring identity not just of the polypeptide, but also of the
 folded proteins, because the claims require the administra-
 tion of “a therapeutically effective amount of a composition”
 and that the DNA sequences in the claims must “code for a
 polypeptide displaying antiviral activity.” Biogen asserts
 that only three-dimensional proteins can be therapeuti-
 cally effective and have antiviral activity, and therefore
 that the “product” to be analyzed for novelty is the folded
 three-dimensional protein, not just the amino acid se-
 quence.
     Biogen is incorrect. First, Biogen’s argument fails to
 give effect to Biogen’s explicit definition of “polypeptide” in
 the specification. We must respect this lexicographic
 choice. See Edward Lifesciences LLC v. Cook Inc., 
582 F.3d
 1322
, 1329 (Fed. Cir. 2009) (“[W]e will adopt a definition
 that is different from the ordinary meaning when ‘the
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 18                         BIOGEN MA INC.   v. EMD SERONO, INC.



 patentee acted as his own lexicographer and clearly set
 forth a definition of the disputed claim term in . . . the spec-
 ification’” (quoting CCS Fitness, Inc. v. Brunswick Corp.,
 
288 F.3d 1359
, 1366–67 (Fed. Cir. 2002))). Biogen does not
 attempt to square its theory with the definition in the spec-
 ification.
      Second, Biogen draws the wrong conclusion from the
 claimed antiviral activity limitation. The claims, in calling
 for antiviral activity, do not recite any specific folded three-
 dimensional structure that gives rise to that activity.
 While it is indisputable that an amino acid sequence alone
 cannot give rise to antiviral activity, it is also indisputable
 that every linear sequence of proteins will fold into some
 three-dimensional configuration. The claimed antiviral ac-
 tivity can arise from the administration of any three-di-
 mensional protein with a linear amino acid sequence
 identical to the claimed recombinant “polypeptide.”
      Finally, and importantly, Biogen did not ask for a jury
 instruction on anticipation that required comparing the
 three-dimensional protein structures of prior art IFN-β and
 the claimed recombinant IFN-β. Neither Biogen nor the
 district court can reframe the anticipation inquiry on
 JMOL to focus on the unclaimed three-dimensional protein
 structure, where the jury was instructed, without objec-
 tion, to decide anticipation based on the linear amino acid
 sequence. See Finjan, Inc. v. Blue Coat Sys., Inc., 
879 F.3d
 1299
, 1306 (Fed. Cir. 2018) (“[I]t is too late at the JMOL
 stage to . . . adopt a new and more detailed interpretation
 of the claim language and test the jury verdict by that new
 and more detailed interpretation.” (quoting Hewlett-Pack-
 ard Co. v. Mustek Sys., Inc., 
340 F.3d 1314
, 1321 (Fed. Cir.
 2003))).
      The jury was correctly instructed that “to be entitled to
 a patent, the invention must actually be ‘new.’” J.A. 81262.
 It is undisputed that the prior art here teaches the admin-
 istration of native IFN-β that has a linear amino acid
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 BIOGEN MA INC.   v. EMD SERONO, INC.                       19



 sequence identical to the linear amino acid sequence of the
 recited recombinant IFN-β and that shows antiviral activ-
 ity. See ’755 patent, col. 3, ll. 4–14. The jury thus had suf-
 ficient evidence to find that native IFN-β polypeptide is
 identical to recombinant IFN-β polypeptide, was adminis-
 tered in therapeutically effective amounts, and showed an-
 tiviral activity in the prior art. The district court thus
 erred in granting JMOL of no anticipation. 3
             IV. Conditional Grant of New Trial
     The district court also conditionally granted a new trial
 on anticipation. The district court’s grant of a new trial
 was based on the same legal errors supporting its grant of
 JMOL. Biogen 
I, 335 F. Supp. 3d at 713 
(“For the same
 reasons the Court grants Biogen’s JMOL motion, the Court
 conditionally orders a new trial on anticipation.”). None of
 the additional considerations noted by the district court in
 support of its conditional grant of a new trial are inde-
 pendently sufficient to support its decision. We therefore
 reverse the district court’s grant of a conditional new trial
 on anticipation.
                          CONCLUSION
     For the reasons discussed above, we reverse the district
 court’s grant of judgment as a matter of law of no anticipa-
 tion and the conditional grant of a new trial on anticipa-
 tion. We remand with instructions to reinstate the jury
 verdict on anticipation. We need not and do not address
 the several other issues raised by the parties on appeal.



     3    Because the proper construction of the claims does
 not require comparison of the three-dimensional structure
 of prior art native IFN-β and recombinant IFN-β, we need
 not consider the parties’ contested readings of the Inter-
 Pharm study or the evidence or lack thereof of structural
 identity.
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 20                       BIOGEN MA INC.   v. EMD SERONO, INC.




                REVERSED AND REMANDED