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In re Biogen '755 PA Tent Litigation

United States District Court, D. New Jersey

September 28, 2018

IN RE BIOGEN '755 PA TENT LITIGATION

          OPINION

          HON. CLAIRE C. CECCHI UNITED STATES DISTRICT JUDGE

         The Court held a five-week jury trial in this patent infringement action beginning on January 18, 2018. On February 23, 2018, the jury returned a verdict finding that healthcare professionals and/or patients directly infringe claims 1 and 2 of United States Patent No. 7, 588, 755 (the "'755 patent") when they administer or self-administer the product Rebif® for the treatment of multiple sclerosis ("MS"), that Defendants EMD Serono, Inc. ("Serono") and Pfizer Inc . ("Pfizer") (collectively, "Defendants") have contributed to the infringement of claims 1 and 2 by selling or offering to sell Rebif®, that neither Serono nor Pfizer has actively induced the infringement of claims 1 or 2, that claims 1, 2, and 3 of the '755 patent are not invalid for obviousness, lack of adequate written description, or lack of enablement, and that claims 1, 2, and 3 are invalid for anticipation. ECF No. 977 ("Verdict Form").

         Now pending before the Court are renewed motions for judgment as a matter of law ("JMOL") pursuant to Federal Rule of Civil Procedure 50(b) by Plaintiff Biogen MA Inc. ("Biogen") and Defendants. ECF Nos. 980, 982. Specifically, Biogen moves for JMOL on the issues of anticipation, induced infringement by Serono and Pfizer, certain defenses that were not litigated at trial, and certain subsidiary damages-related issues. Biogen also moves conditionally and in the alternative for a new trial as to certain issues pursuant to Federal Rules of Civil Procedure 50(c) and 59, respectively. Defendants move for JMOL on the issues of patent eligibility, obviousness, enablement, written description, contributory infringement by Pfizer, and lost profits damages.

         The Court heard oral argument on June 6, 2018. The parties also submitted letters following oral argument. ECF Nos. 1010, 1011, 1012, 1014, 1015, 1017, 1018. Having considered the parties' written submissions and oral presentations, and for the reasons discussed below, Biogen's JMOL motions with respect to anticipation, induced infringement against Serono and Pfizer, and certain non-litigated defenses are hereby GRANTED. The Court also conditionally orders a new trial on anticipation and induced infringement against Serono and Pfizer pursuant to Rule 50(c), and orders a new trial on all damages issues pursuant to Rule 59. Biogen's remaining JMOL motions and each of Defendants' JMOL motions are hereby DENIED.

         I. BACKGROUND

         On May 28, 2010, Biogen filed this patent infringement suit asserting claims of the '755 patent against Defendants, Bayer HealthCare Pharmaceuticals Inc. ("Bayer"), and Novartis Pharmaceuticals Corp. ("Novartis"). C.A. No. 10-2760, ECF No. 1 ("Compl."). Prior to trial, Biogen's infringement claims against Serono and Pfizer were severed from Biogen's infringement claims against Bayer and Novartis.[1] ECF No. 743. Thus, only Biogen's claims against Serono and Pfizer (and Serono and Pfizer's defenses thereto) were tried before the jury and are the subject of the instant motions.

         The '755 patent claims a method for immunomodulation, or treating viral diseases, cancers, or tumors, by administering to a patient a recombinant polypeptide-human interferon beta[2]-that is produced by a non-human host transformed by a recombinant DNA molecule. The '755 patent includes three claims, of which only claim 1 is independent.[3]

         Claim 1 of the '755 patent recites:

1. A method for immunomodulation or treating a viral conditions [sic], a viral disease, cancers or tumors comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition comprising:
a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of:
(a) DNA sequences which are capable 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 degenerate 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.

         The Court previously construed claim 1 of the '755 patent as reciting a "one-step method of 'administering' to a patient in need the specified recombinant HuJFN-β." ECF No. 403 ("Markman Op.") at 17. The Court also determined that the "produced" and "transformed" limitations of claim 1 are "merely descriptive of the recombinant polypeptide to be administered" as opposed to separate steps that must be shown to prove infringement. Id. at 14-15.

         Biogen's infringement claims against Serono and Pfizer are based on the sale of recombinant interferon-β product Rebif® in the United States for the treatment of MS. Compl. ¶¶ 32-49; Am. Compl. ¶¶ 42-59. In their Answers, Defendants assert that the '755 patent claims are invalid, not infringed, and/or unenforceable. C.A. No. 10-2760, ECF Nos. 56, 57, 75; ECF Nos. 44, 71. The issues of infringement, validity, and damages were tried to a jury for a number of weeks in January and February of 2018.[4] With respect to infringement, the jury was asked to decide whether Serono and Pfizer were each liable for induced and contributory infringement of claims 1 and 2 of the '755 patent (the "asserted claims"). With respect to validity, the jury was asked to decide whether claims 1, 2, and 3 were invalid for obviousness, lack of adequate written description, lack of enablement, or anticipation. Before the case was submitted to the jury, Biogen and Defendants each moved for JMOL on a number of issues pursuant to Federal Rule of Civil Procedure 50(a).[5] 2/9/18 Tr. at 168:21-169:15, 170:18-171:8, 172:4-18, 179:7-23; 2/21/18 Tr. at 20:23-22:3, 52:9-53:24, 62:23-64:5, 67:19-69:16. The Court reserved decision on all of the parties' Rule 50(a) motions. 2/9/18 Tr. at 183:11-12; 2/21/18 Tr. at 75:26-77:4.

         On February 23, 2018, the jury returned a verdict finding that healthcare professionals and/or patients directly infringe the asserted claims of the '755 patent when they administer or self-administer Rebif® for the treatment of MS. Verdict Form at 1, Q. 1. The jury also found that neither Serono nor Pfizer has actively induced the direct infringement of the asserted claims. Id. at 2-3, Qs. 2, 6. The jury further found that both Serono and Pfizer have contributed to the direct infringement of the asserted claims by selling or offering to sell Rebif® in the United States. Id. at 3, Qs. 7, 8. With respect to validity, although the jury found that the '755 patent claims were not invalid for obviousness, lack of adequate written description, or lack of enablement, (id. at 3-4, Qs. 9-11), it found that the claims were anticipated by prior-art uses of naturally-occurring (or native), human interferon-β (id. at 4, Q. 12). Accordingly, the jury did not reach the issue of damages, leaving the damages questions on the Verdict Form blank. Id. at 5-6, Qs. 13-18.

         Following the verdict, on March 16, 2018 the Court held a telephone conference with the parties to discuss a schedule for filing post-trial motions pursuant to Rule 50(b). In its Rule 50(b) JMOL motions, Biogen asks the Court to enter judgment that the '755 patent claim? are not anticipated by prior-art uses of native, human interferon-β and that Serono and Pfizer have each induced infringement of the asserted claims. ECF No. 980-1 ("Biogen Br."). Biogen also seeks a judgment in its favor on certain damages-related issues and as to certain non-litigated defenses. Biogen further asks the Court to conditionally grant a new trial under Rule 50(c) for each of those issues except for the non-litigated defenses, and alternatively moves for a new trial under Rule 59 for any of those issues on which the Court does not grant JMOL. Defendants oppose each of Biogen's motions. ECF No. 991 ("Defs. Opp."). In their Rule 50(b) JMOL motions, Defendants ask the Court to enter judgment that Pfizer has not contributed to the infringement of the asserted claims, that the '755 patent claims are patent ineligible, that the '755 patent claims are invalid on the grounds of obviousness, lack of enablement, and lack of adequate written description, and that Biogen is not entitled to lost profits damages. ECF No. 983 ("Defs. Br."). Biogen opposes each of Defendants' motions. ECF No. 989 ("Biogen Opp."). The Court heard oral argument on June 6, 2018 ("6/6/18 Tr.").

         II. LEGAL STANDARDS

         A. Motion for Judgment as a Matter of Law

         Judgment as a matter of law is appropriate if "the court finds that a reasonable jury would not have a legally sufficient evidentiary basis to find for [a] party" on an issue. Fed.R.Civ.P. 50(a)(1). "If the court does not grant a motion for judgment as a matter of law made under Rule 50(a), the court is considered to have submitted the action to the jury subject to the court's later deciding the legal questions raised by the motion." Fed.R.Civ.P. 50(b). In ruling on a Rule 50(b) motion, "the court may: (1) allow judgment on the verdict, if the jury returned a verdict; (2) order a new trial; or (3) direct the entry of judgment as a matter of law." Id.

         To prevail on a renewed motion for JMOL under Rule 50(b) following a jury trial and verdict, the moving party "must show that the jury's findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusion(s) implied by the jury's verdict cannot in law be supported by those findings." Power Integrations, Inc. v. Fairchild Semiconductor Int'l, Inc., 843 F.3d 1315, 1326 (Fed. Cir. 2016) (quoting Pannu v. Iolab Corp., 155 F.3d 1344, 1348 (Fed. Cir. 1998)). "Substantial evidence" is defined as "such relevant evidence from the record taken as a whole as might be accepted by a reasonable mind as adequate to support the finding under review." Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed. Cir. 1984) (citations omitted).

         In the Third Circuit, JMOL "should be granted 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" for the nonmovant. Lightning Lube, Inc. v. Witco Corp., 4 F.3d 1153, 1166 (3d Cir. 1993) (citing Wittekamp v. Gulf & Western Inc., 991 F.2d 1137, 1141 (3d Cir. 1993)). "The question is not whether there is literally no evidence supporting the party against whom the motion is directed but whether there is evidence upon which the jury could properly find a verdict for that party." Id. (quoting Patzig v. O'Neil, 577 F.2d 841, 846 (3d Cir. 1978)). The district court "may not weigh the evidence, determine the credibility of witnesses, or substitute its version of the facts for the jury's version." Id. (citation omitted). While JMOL motions should be granted sparingly, "a scintilla of evidence is not enough to sustain a verdict of liability." Id. (citing Walter v. Holiday Inns, Inc., 985 F.2d 1232, 1238 (3d Cir. 1993)). Moreover, "although the court should review the record as a whole, it must disregard all evidence favorable to the moving party that the jury is not required to believe." Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 151 (2000) (citing 9A C. Wright & A. Miller, Federal Practice and Procedure § 2529, p. 299 (2d ed. 1995)); Integra Lifesciences I, Ltd. v. Merck KGaA, 496 F.3d 1334, 1345. (Fed. Cir. 2007). "That is, the court should give credence to the evidence favoring the nonmovant as well as that evidence supporting the moving party that is uncontradicted and unimpeached, at least to the extent that that evidence comes from disinterested witnesses." Reeves, 530 U.S. at 151 (internal quotation marks and citation omitted).

         B. Motion for a New Trial

         Rule 59(a) provides, in pertinent part, "[t]he court may, on motion, grant a new trial on all or some of the issues-and to any party-as follows:... after a jury trial, for any reason for which a new trial has heretofore been granted in an action at law in federal court." Fed.R.Civ.P. 59(a)(1)(A). The most common reasons for granting a new trial include: (1) the verdict is against the clear weight of the evidence, and a new trial must be granted to prevent a miscarriage of justice; (2) newly discovered evidence exists that would likely alter the outcome of the trial; (3) improper conduct by an attorney or the court unfairly influenced the verdict; or (4) the verdict was facially inconsistent. See Zarow-Smith v. N.J. Transit Rail Operations, Inc., 953 F.Supp. 581, 584-85 (D.N.J. 1997) (internal citations omitted). The decision to grant or deny a new trial is committed to the sound discretion of the district court. See Allied Chem. Corp. v. Daiflon, Inc., 449 U.S. 33, 36 (1980). In the Third Circuit, "new trials because the verdict is against the weight of the evidence are proper only when the record shows that the jury's verdict resulted in a miscarriage of justice or where the verdict, on the record, cries out to be overturned or shocks [the] conscience." Williamson v. Consol. Rail Corp., 926 F.2d 1344, 1353 (3d Cir. 1991).

         Moreover, "[w]here the subject matter of the litigation is simple and within a layman's understanding, the district court is given less freedom to scrutinize the jury's verdict than in a case that deals with complex factual determinations." Id. at 1352 (citing Lind v. Schenley Indus., Inc., 27'8 F.2d 79, 90-91 (3d Cir. I960)); see also Comcast Cable Commc'ns, LLC v. Sprint Commc'ns Co., 262 F.Supp.3d 118, 139 (E.D. Pa. 2017) ("Where a trial is long and complicated and deals with a subject matter not lying within the ordinary knowledge of jurors a verdict should be scrutinized more closely by the trial judge, [in ruling on a motion for new trial], than is necessary where the litigation deals with material which is familiar and simple." (quoting Lind, 278 F.2d at 90-91)).

         Pursuant to Rule 50(c), "[i]f the court grants a renewed motion for judgment as a matter of law, it must also conditionally rule on any motion for a new trial by determining whether a new trial should be granted if the judgment is later vacated or reversed." Fed.R.Civ.P. 50(c)(1). In addition, the court "must state the grounds for conditionally granting or denying the motion for a new trial." Id.

         III. DISCUSSION

         A. Biogen's Post-Trial Motions

         Biogen moves for JMOL under Rule 50(b) as to (1) anticipation; (2) induced infringement by Pfizer; (3) induced infringement by Serono; (4) certain non-litigated defenses; and (5) certain subsidiary damages-related issues. Biogen also moves conditionally for a new trial under Rule 50(c), and alternatively for a new trial under Rule 59, on anticipation, induced infringement by Pfizer and Serono, and the subsidiary damages issues. The Court addresses each of Biogen's motions in turn with the exception of Biogen's JMOL motion as to Defendants' patent-ineligibility defense, which the Court addresses with Defendants' JMOL motion on that defense in Section III. B.1 below.

         1. Anticipation

         (a) Applicable Legal Principles for Anticipation

         A patent claim is invalid by reason of anticipation if "the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent." 35 U.S.C. § 102(a). "A prior art reference anticipates a patent's claim when the four corners of the document 'describe every element of the claimed invention, either expressly or inherently, such that a person of ordinary skill in the art could practice the invention without undue experimentation.'" In re Hodges, 882 F.3d 1107, 1111 (Fed. Cir. 2018) (quoting Spansion, Inc. v. Int'l Trade Comm'n, 629 F.3d 1331, 1356 (Fed. Cir. 2010)); see also Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1294 (Fed. Cir. 2015) ("A claim is anticipated only if each and every element is found within a single prior art reference, arranged as claimed."). The party asserting the defense bears the burden of demonstrating anticipation by clear and convincing evidence. See Summit 6, 802 F.3d at 1294 (citing Microsoft Corp. v. i4i Ltd. P'ship, 564 U.S. 91, 95 (2011)). Anticipation is a question of fact. In re Hodges, 882 F.3d at 1111 (citing Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1341 (Fed. Cir. 2016)).

         Moreover, anticipation "requires the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim. A prior art disclosure that 'almost' meets that standard may render the claim invalid under [35 U.S.C.] § 103; it does not 'anticipate.'" Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (internal citation omitted); see also TF3 Ltd. v. Tre Milano, LLC, 894 F.3d 1366, 1374 (Fed. Cir. 2018) ("Claims cannot be 'anticipated' by devices that are not the same. Invalidity for anticipation requires that '[t]he identical invention must be shown in as complete detail as contained in the patent claim.'" (citation omitted)); Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) ("[Differences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation."); Trintec Indus., Inc. v. Top-U.SA. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002) (noting that the "test for novelty" requires "strict identity"); Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) ("[Anticipation is not, shown by a prior art disclosure which is only 'substantially the same' as the claimed invention."), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc); 1 Donald S. Chisum, Chisum on Patents § 3.02[1] (2018) (noting that the anticipation standard "is one of strict identity" and that "Federal Circuit decisions, explicitly or implicitly, reject any standard of 'substantial identity'" (citations omitted)).

         The jury was instructed that "[f]or a claim to be invalid because it is not new" Defendants "must show by clear and convincing evidence that all of the requirements of that claim were present in a single previous device or method that was known of, used, or described in a single previous printed publication or patent." ECF No. 968 ("Final Jury Instructions") at 29. The jury instructions also provide that "[t]o anticipate the invention, the prior art does not need [to] use the same words as the claim, but all the requirements of the claim must have been disclosed, either stated expressly or implied to a person of ordinary skill in the art in the technology of the invention, so that looking at that one reference, that person could make and use the claimed invention." Id.

         (b) Parties' Contentions

         The jury found that the '755 patent claims were anticipated by prior-art uses of native, human interferon-β. Verdict Form at 4, Q. 12 ("Do you find, by clear and convincing evidence, that the claims of the '755 patent are invalid as anticipated by prior art uses of native human interferon-β"). Biogen contends that the verdict cannot stand because no reasonable jury could have found by clear and convincing evidence that the '755 patent claims were anticipated by the prior art. According to Biogen, JMOL of no anticipation under Rule 50(b) is appropriate because Defendants failed to identify a single prior-art reference that discloses all of the elements of the '755 patent claims. Biogen Br. at 13. Specifically, Biogen asserts that no reference discloses treatment with a "therapeutically effective amount" (or any amount) of a composition comprising "recombinant" interferon-β made in a "non-human host" that had been "transformed by a recombinant DNA molecule." Id. at 13-14. Instead, all therapeutic uses of interferon-β before the priority date of June 6, 1980 employed the native protein.[6] Biogen further observes that, in stark contrast to Defendants' trial presentation of their obviousness defense, Defendants did not bring a Rule 50(a) motion on anticipation at trial, "barely alluded to anticipation at trial," and did not raise anticipation in their summation. Id. at 5; see also 6/6/18 Tr. at 168:17-169:8. In Biogen's view, because the jury "did not focus on, and did not understand, the anticipation question," as evidenced by a jury question asked only one hour before the jury returned its verdict, the verdict represents a "miscarriage of justice" warranting a new trial under Rule 59.[7] Biogen Br. at 6.

         By contrast, Defendants contend that the evidence presented at trial supports the jury's verdict of anticipation. Defendants rely on the legal principle that a new source or process (i.e., recombinant DNA technology) for making an old product (i.e., interferon-β) in and of itself is insufficient to confer novelty on the product, unless the new source or process confers both structural and functional differences distinguishing the product from the prior art. Defs. Opp. at 1. Product claims that define a product by a particular process are referred to as "product-by-process" claims.[8] Defendants contend that this principle applies to all types of claims having source limitations, including the method of treatment claims of the '755 patent. 6/6/18 Tr. at 63:7-64:2. Defendants further assert that evidence of either structural or functional identity between native and recombinant interferon-β can support the jury's anticipation verdict, and that there is more than sufficient evidence of both in the record. See Id. at 65:18-66:11.

         Defendants principally rely on, two allegedly-anticipatory publications, Kingham et al, Treatment of HBsAg-positive chronic active hepatitis with human fibroblast interferon, Gut. 19(2):91-4 (1978) ("Kingham") (STX-1596) and Sundmacher et al, Human Leukocyte and Fibroblast Interferon in a Combination Therapy of Dendritic Keratitis, Albrecht Von Graefes Arch Klin Exp Ophthalmol. 208(4):229-33 (1978) ("Sundmacher") (STX-1810). Defendants contend that these publications disclose all of the elements of claim 1, specifically, the administration of therapeutically effective amounts of native, human interferon-β proteins-which, in Defendants' view, are identical to the recombinant interferon-β proteins of claim 1-to treat viral diseases. Defs. Opp. at 7-8; 6/6/18 Tr. at 61:6-18.

         In addition, Defendants rely on two comparative studies that, while not prior art, allegedly demonstrate that the native interferon-β administered in Kingham and Sundmacher is structurally identical to interferon-β made recombinantly in Chinese Hamster Ovary ("CHO") cells: a study by InterPharm Laboratories Ltd. entitled "Comparative Biochemical Analysis of Native Human Fibroblast Interferon and Recombinant Beta Interferon Expressed by Chinese Hamster Ovary Cells" (the "InterPharm Study") (STX-1259), [9] and Kagawa et al, Comparative Study of the Asparaging-linked Sugar Chains of Natural Human interferon-β 1 and Recombinant Human interferon-β 1 Produced by Three Different Mammalian Cells, J Biol Chem. 263(33): 17508-15 (1988) ("Kagawa") (STX-1587). In support of their position that native and recombinant interferon-β are functionally identical, Defendants rely on the InterPharm Study, along with a publication co-authored by Michel Revel, M.D., Ph.D., Professor Emeritus retired from the Weizmann Institute of Science, entitled Chernajovsky et al, Efficient Constitutive Production of Human Fibroblast Interferon by Hamster Cells Transformed with the IFN-1 Gene Fused to An SV40 Early Promoter, DNA 3(4):297-308 (1984) ("Chernajovsky") (STX-1439), and Dr. Revel's United States Patent No. 4, 808, 523 (the "Revel '523 patent") (STX-1314). Defs. Opp. at 13. As with the InterPharm Study and Kagawa, neither Chernajovsky nor the Revel '523 patent is prior art.

         Finally, Defendants rely on the expert testimony of Harvey Lodish, Ph.D., a Professor of Biology and Biological Engineering at the Massachusetts Institute of Technology and member of the Whitehead Institute for Biomedical Research. 2/8/18 PM Tr. at 48:21-49:1. Defendants offered Dr. Lodish as an expert in the field of recombinant DNA technology and the production of recombinant therapeutic proteins. Id. at 57:9-16. In Defendants' view, JMOL is inappropriate because there was sufficient evidence in the record for the jury to conclude that native interferon-β administered before June 6, 1980 and recombinant interferon-β made in CHO cells are structurally identical, functionally identical, or both.

         (c) Biogen Is Entitled to JMOL of No. Anticipation

         In assessing the sufficiency of the evidence, the Court gives Defendants, as the verdict winners, "the benefit of all logical inferences that could be drawn from the evidence presented, resolve[s] all conflicts in the evidence in [Defendants'] favor and, in general, view[s] the record in the light most favorable to [Defendants]." Williamson, 926 F.2d at 1348. After reviewing the evidence presented at trial, the Court concludes that there is insufficient evidence to support the jury's verdict that the prior-art uses of native, human interferon-β anticipate the '755 patent claims.

         (1) Defendants Failed to Present as Evidence a Prior-Art Reference Disclosing Each and Every Element of the '755 Patent Claims

         The Court concludes that because Defendants failed to present as evidence a single prior-art reference that describes the therapeutic use of a recombinant interferon-β polypeptide made in a non-human host, the jury could not have reasonably reached its verdict of anticipation. As discussed above, the '755 patent claims are method claims that require therapeutic use of a recombinant interferon-β polypeptide made in a non-human host. The Court instructed the jury that a "recombinant polypeptide" is "a polypeptide produced by recombinant DNA engineering," that a "recombinant DNA molecule" must include "DNA from different genomes," and that "produced in a nonhuman host transformed by a recombinant DNA molecule" requires production within "a transformed cell line that is not a human cell line." Final Jury Instructions at 17. Defendants failed to identify a single prior-art reference that discloses all of the elements of the '755 patent claims. Specifically, no reference in the record discloses 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."

         Instead, the expert testimony presented to the jury, including testimony by Defendants' experts Dr. Lodish and Jordan Gutterman, M.D., the latter a Professor of Medicine at the University of Texas MD Anderson Cancer Center, showed that all therapeutic uses of interferon-β before the priority date of June 6, 1980 employed native, human interferon-β.[10] See 2/13/18 AM Tr. at 35:4-37:5 (Lodish) (explaining that before June 6, 1980, no one had made enough recombinant interferon-β to treat a patient); 2/7/18 PM Tr. at 85:7-86:7 (Gutterman) (explaining that studies of interferon-β in MS in the 1970s did not use "recombinant interferon" but instead used "the native interferon produced from fibroblasts"); 2/15/18 PM Tr. at 66:12-16 (Garcia) (agreeing that no prior-art publications "talked about the activity of recombinant beta interferon"). The '755 patent itself discloses that therapeutic use of native, human interferon-β was known in the prior art, and describes how compositions of the native protein had been prepared. PTX0001 ('755 patent) at 2:53-4:22, 4:49-5:3. Although Defendants cite prior-art publications disclosing therapeutic uses of interferon-β, those uses were limited to the native protein. See STX-1596 (Kingham) at 1 (disclosing use of native, human interferon-β for the treatment of hepatitis B virus); STX-1810 (Sundmacher) at 1 (disclosing use of native, human interferon-β for the treatment of dendritic keratitis virus). Defendants did not present any evidence or testimony as to the presence in the prior art of therapeutic uses of recombinant interferon-β.

         Accordingly, since Defendants failed to present as evidence a single prior-art reference that discloses each and every element of the '755 patent claims, no reasonable jury could have found by clear and convincing evidence that the claims were anticipated by the prior art. See Summit 6, 802 F.3d at 1294 ("A claim is anticipated only if each and every element is found within a single prior art reference, arranged as claimed.").

         (2) JMOL of No. Anticipation Is Appropriate Even Applying Product-By-Process Law

         Even if the Court were to agree with Defendants that method of treatment claims having source limitations should be analyzed in the same way as product-by-process claims for purposes of anticipation, or that the Court should at least be guided by product-by-process law, the jury's verdict of anticipation still cannot stand. Giving Defendants the benefit of every fair and reasonable inference that can be drawn from the record, as discussed below, there is insufficient evidence to support a finding that the product of the '755 patent claims (i.e., recombinant interferon-β made, for example, in CHO cells) is the same as the product known and used in the prior art (i.e., native interferon-β).

         (i) Native and Recombinant interferon-β Are Not Structurally Identical

         The evidence presented at trial demonstrates that native interferon-β and recombinant interferon-β are not structurally identical. As discussed above, "strict identity" is a requirement for anticipation; that the prior art is "substantially identical," "extremely similar," or "very similar" to the claimed invention is not enough. See Trintec, 295 F.3d at 1296 (noting that the "test for novelty" requires "strict identity"); Jamesbury, 756 F.2d at 1560 ("[A]nticipation is not shown by a prior art disclosure which is only 'substantially the same' as the claimed invention."); Connell, 722 F.2d at 1548 (rejecting argument that "it is sufficient for an anticipation if the general aspects are the same and the differences in minor matters is only such as would suggest itself to one of ordinary skill in the art" as "[t]hose statements relate to obviousness, not anticipation" (internal quotation marks omitted)).

         Although Defendants contend that the "most basic and obvious identicality between [native and recombinant interferon-β] proteins is in the DNA," (6/6/18 Tr. at 74:23-24), and that the "amino acid sequence of both proteins is identical," (id. at 75:20-21), the record evidence shows that the proteins differ structurally in terms of their attached carbohydrate (or sugar) groups, also referred to as glycosylation patterns. In denying Bayer's Motion for Summary Judgment of Invalidity No. 2 (Anticipation by the Treatment References), which Defendants joined, the Court declined to find as a matter of law that "their shared amino acid sequence renders native interferon-β and recombinant interferon-β the same for purposes of anticipation." ECF No. 892 ("Summ. J. Op.") at 28. In reading the term "polypeptide" in the context of claim 1, the Court determined that claim 1 requires the recombinant polypeptide to display "antiviral activity" and be administered in a "therapeutically effective amount." Id. The Court concluded that "for a polypeptide to display biological activity, it must be folded into its appropriate three-dimensional structure." Id. That the native and recombinant interferon-β proteins share the same linear amino acid sequence is not enough for purposes of anticipation. Rather, the appropriate analysis is to compare the three-dimensional structure of the prior-art native interferon-β with the recombinant interferon-β of claim 1, which include the structures of any attached carbohydrate groups.

         Moreover, Defendants' expert, Dr. Lodish, testified during his direct examination that the native and recombinant proteins' structures are not identical with respect to their carbohydrate groups. Among the several opinions Dr. Lodish discussed during the three days on which he testified was the brief statement that, in his view, native interferon-β and recombinant interferon-β are, at best, "substantially identical." 2/8/18 PM Tr. at 50:11-12. Specifically, during a short portion of one afternoon session at trial, he testified that, based on his reading of the InterPharm Study, "[t]here were minor differences in the structures of the sugars" of native and recombinant interferon-β, "but I wouldn't call them identical, I would call the sugars extremely similar."[11]2/9/18 Tr. at 87:24-88:7; see also Id. at 87:3-9 (explaining that although he did not perform a comparison of native interferon-β in the prior art with recombinant interferon-β made in CHO cells, he would characterize the amino acid sequences as "exactly" the same but the carbohydrates as "virtually identical"); STX-1259 (InterPharm Study) at 94 (concluding that the sugar structures of native and recombinant interferon-β are merely "very similar"). Additional expert testimony in the record offered a consistent interpretation of the InterPharm Study. See 2/15/18 PM Tr. at 101:9-102:15 (Garcia) (stating that with respect to the glycosylation patterns of the native and recombinant proteins, "[i]n some cases they're close, but they're never identical," and that it is "pretty clear that the[] glycans have some significant differences"). Dr. Lodish also testified that Kagawa showed that the sugar groups of the native and recombinant proteins in the study had "small differences" that made them "extremely similar." 2/9/18 Tr. at 88:9-25. These "minor" and "small" differences matter for purposes of anticipation. See Net MoneyIN, 545 F.3d at 1371 ("[Differences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation." (emphasis added)).

         In their opposition brief, Defendants explain that Dr. Lodish's testimony was "not that the individual polypeptides differed, but instead that the proportions of polypeptides containing identical sugar structures in IFN-β made naturally and recombinantly were 'extremely similar.'" Defs. Opp. at 14 (quoting 2/9/18 Tr. at 87:14-88:25, 103:6-10 (Lodish)) (emphasis in original). Defendants assert that the "prior art mixtures" of native interferon-β proteins encompass species of proteins that are identical to species of recombinant interferon-β proteins covered by the '755 patent claims. See Id. Defendants rely on Kagawa's purported teaching that "IFN-β made naturally is actually a mixture of proteins having distinct structures, and the same is true of IFN-β made in CHO cells with recombinant DNA technology," and that two such distinct structures (Structures I and V) disclosed in Kagawa are "common to both native and CHO IFN-β." Id. at 12-13 (citing STX-1587 (Kagawa) at 4 (Table HI)). In Defendants' view, Kagawa shows that the "overwhelming majority of IFN-β made in CHO cells (95%) is structurally identical to specific protein molecules found in IFN-β made naturally," and the prior-art treatments disclosed in Kingham and Sundmacher "therefore necessarily included the administration of specific IFN-β polypeptides (Structures I and V) that are structurally identical to IFN-β polypeptides made in CHO cells and within the scope of the '755 patent claims." Id. at 13 (emphasis in original). Defendants contend that Biogen improperly focuses on Dr. Lodish's testimony regarding structural differences between the "mixtures" or "populations" of native and recombinant proteins as groups, and that the "pertinent question is whether the prior art disclosed the administration of a composition including any polypeptide with the same structure as any polypeptide whose use that '755 patent claims cover." Id. at 14. In other words, in Defendants' view, it is sufficient for anticipation purposes if within a population of native interferon-β proteins there are some molecules that are the same as (i.e., atomically identical to) some molecules within a population of recombinant interferon-β proteins even if the populations themselves are not identical.[12] See 6/6/18 Tr. at 116:10-117:11, 138:2-22.

         Even if the Court were to accept Defendants' anticipation theory, the anticipation evidence remains critically deficient. Defendants have not cited any testimony, from Dr. Lodish or otherwise, stating that as between two populations-native interferon-β proteins in the prior art and recombinant interferon-β proteins-there is a molecule or subset of molecules that is identical between them. See Id. at 120:7-23, 123:7-22, 130:9-132:23, 133:7-136:13, 139:4-140:24, 143:25-145:16. The few lines of trial testimony from Dr. Lodish upon which Defendants rely neither expressly nor implicitly elucidate this theory for the jury. Based on a review of the record, it does not appear that the particular arguments that Defendants have raised post-trial to uphold the anticipation verdict were, in fact, presented to the jury either through expert testimony, during summation, or otherwise. Although Defendants assert that "the InterPharm report and the Kingham or Sundmacher papers... would be sufficient in and of itself to support this jury verdict," (id. at 77:3-8), neither Dr. Lodish nor any other witness at trial testified as to the presence in the prior art of the particular protein structures identified in the InterPharm Study or any of, the other post-June 6, 1980 references. In other words, there was no evidence presented to the jury "linking" the prior-art use of native, human interferon-β as disclosed in Kingham, Sundmacher, or any other prior-art reference with the InterPharm Study, Kagawa, Chernajovsky, or the Revel '523 patent. See Id. at 22:12-23:3. Without any evidence or testimony in the record mentioning, let alone explaining, that there is a molecule that exists in both the prior-art native interferon-β population and the recombinant interferon-β population, it cannot fairly be concluded that the jury drew such an inference in reaching its verdict.

         The evidence Defendants cite in support of their anticipation theory is deficient in other respects as well. For instance, there appears to be no evidence or testimony that the native interferon-β proteins used in the prior art are the same as the native proteins studied in the post-June 6, 1980 publications. Absent from the record is any evidence of the carbohydrate structure of a single native interferon-β protein used for treatment in the prior art. Sundmacher does not disclose the structure of the native interferon-β material, including its glycosylation pattern, nor is it clear what cell lines were used in the study. Kingham similarly does not disclose the glycosylation pattern of the native interferon-β produced from the human fetal lung fibroblast cells used in the study. Moreover, there was no testimony from any witness regarding the structures of the native proteins discussed in either of those prior-art publications. Also absent from the record is any testimony that all native, human interferon-β proteins are structurally identical. Indeed, the InterPharm Study and Kagawa disclose different compositions for native, human interferon-β proteins. See 6/6/18 Tr. at 104:14-106:9; STX-1587 (Kagawa) at 4; STX-1259 (InterPharm Study) at 67 (stating that "[a]n analysis of oligosaccharide [or carbohydrate] structures on the same protein from different species and even different tissues reveals that major variations frequently exist" and that "a homogeneous cell population" produces "an astonishing array of different oligosaccharide structures"). Furthermore, the InterPharm Study offers almost no information about the precise native, human interferon-β proteins used in the study, whether those proteins pre-dated the priority date, or whether the study used the same cell line or cell type as that used in either Kingham or Sundmacher.

         In sum, Defendants bore the burden of proving by clear and convincing evidence that the native, human interferon-β in the prior art was in fact identical to the recombinant interferon-β of the '755 patent claims. Given the above-mentioned deficiencies in the evidence, no reasonable jury could find that Defendants met their burden.

         (ii) Native and Recombinant interferon-β Are Not Functionally Identical

         The evidence presented at trial also demonstrates that native, human interferon-β and recombinant interferon-β are not functionally identical. Although Dr. Lodish testified that the functional characteristics of native interferon-β and recombinant interferon-β made in CHO cells are "very similar, if not identical," (2/9/18 Tr. at 87:10-13), as discussed above, "strict identity" is required for anticipation. Defendants rely on the InterPharm Study, Chernajovksy, and the Revel '523 patent as evidence of functional identity. See Defs. Opp. at 13; STX-1439 (Chernajovsky) at 2 (stating that recombinant interferon-β "appears identical in size, activity, and immunospecificity to the native human IFN-β1 glycoprotein"); STX-1314 (Revel '523 patent) at 10 (stating that "expression of the DNA coding for pre-IFN-βi in hamster cells leads to the secretion of a protein which is electrophoretically identical to the natural glycoprotein and which gives, upon purification by immunoaffinity on monoclonal antibodies, the same specific activity as the IFN- β1 purified from human fibroblasts"). As discussed above, however, there was no evidence presented to the jury "linking" the prior-art use of native, human interferon-β disclosed in Kingham and Sundmacher with the InterPharm Study, Chernajovsky, or the Revel '523 patent.

         Moreover, the jury heard fact and expert testimony regarding the different biological effects that native interferon-β and recombinant interferon-β have on the human body. Biogen's expert, Revere Kinkel, M.D., a neurologist at the University of California San Diego, testified regarding the role of neutralizing antibodies in interferon-β treatment. 1/29/18 PM Tr. at 12:16-15:18. Dr. Kinkel explained that neutralizing antibodies are proteins that bind to interferon and prevent it from binding to its receptor and having its intended effect. Id. at 14:3-8. Dr. Kinkel opined that the closer a recombinant protein resembles the native protein, the lower the development of neutralizing antibodies. Id. at 13:1-10. Dr. Kinkel also testified about the differences among the various recombinant interferon-β drug products Betaseron®, Extavia®, Rebif®, Avonex®, and Plegridy® in terms of the incidence of neutralizing antibodies. Id. at 14:9-15:18.

         The evidence presented at trial also showed that recombinant interferon-β can be made in much larger quantities and much more easily than native, human interferon-β can be obtained. See, e.g., PTX0001 ('755 patent) at 4:10-13, 4:49-61, 6:64-67. In particular, the '755 patent explains that interferon-β "produced by human cell lines grown in tissue culture" resulted in a "low yield, expensive process." Id. at 4:49-50; see also Id. at 4:11-13 (noting that "the antitumor and anticancer applications of IFN-β have been severely hampered by lack of an adequate supply of purified IFN-β"). This problem was eventually solved by

locating and separating DNA sequences that code for the expression of HuIFN-β in an appropriate host thereby providing DNA sequences, recombinant DNA molecule and methods by means of which a host is transferred to produce a polypeptide displaying an immunological or biological activity of human fibroblast interferon.

Id. at 6:48-53. By virtue of this discovery, it was "possible to obtain polypeptides displaying an immunological or biological activity of HuIFN-β for use in antiviral, antitumor or anticancer agents and methods," and the invention "allow[ed] the production of these polypeptides in amounts and by methods" that were not previously available "for use in antiviral and antitumor or anticancer agents and methods and immunomodulation." Id. at 6:54-7:7; see also Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1364 (Fed. Cir. 2009) (referring to functional differences between the prior-art native protein and claimed recombinant protein that formed the basis of the district court's finding of no anticipation, including the recombinant protein's "ability to be mass produced"). Defendants did not offer contrary evidence with respect to these particular functional differences. See Reeves, 530 U.S. at 151 (explaining that while the district court "must disregard all evidence favorable to the moving party that the jury is not required to believe" it should "give credence" to the "evidence supporting the moving party that is uncontradicted and unimpeached").

         Furthermore, although the evidence establishes functional differences, it appears that structural differences alone may suffice to impart novelty. This case is similar to Amgen, Inc. v. F. Hoffman-La Roche Ltd., 581 F.Supp.2d 160 (D. Mass. 2008), which involved patents related to the production of a protein called erythropoietin, also known as EPO, using recombinant DNA technology. The claims at issue covered EPO and pharmaceutical compositions thereof and included source limitations-i.e., the EPO was "purified from mammalian cells grown in culture" or was the "product of . . . expression in a mammalian host cell." Id. at 193, 206. The district court concluded, and the Federal Circuit affirmed, that the claims to recombinant EPO were not anticipated by the prior-art native EPO that had been isolated from human urine based on differences in carbohydrate structures between the recombinant protein and the native protein.[13] Id. at 195; Amgen, 580 F.3d at 1367-69. Those "structural distinctions," which were "attributable to recombinant EPO's source," meant that "no reasonable jury could find that the recombinant EPO described in the asserted claims ... was an old product." Amgen, 580 F.3d at 1368-69.

         Notably, the Federal Circuit made no mention of functional differences in affirming the anticipation rulings. After analyzing and finding sufficient bases to uphold those rulings, the Federal Circuit then addressed the defendant Roche's challenge to the district court's decision to construe the source limitations differently in the validity and infringement contexts. Id. at 1369-70. In so doing, the Federal Circuit noted that the district court had found, based on the record in the case, that "urinary EPO and recombinant EPO were structurally and functionally different." Id. at 1370. Although Defendants focus on this language from the decision, the holding of novelty in Amgen was based on structural differences, and at no point in its decision did the Federal Circuit state that functional differences were required.[14] See United Therapeutics Corp. v. Sandoz, Inc., Nos. 12-1617, 13-316, 2014 WL 4259153, at *52 (D.N.J. Aug. 29, 2014) ("Structural differences alone may distinguish the prior art." (citing Greenliant Sys., Inc. v. Xicor LLC, 692 F.3d 1261, 1269-71 (Fed. Cir. 2012))); Manual of Patent Examining Procedure § 2113 (9th ed. Rev. Aug. 2017) ("The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product." (emphasis added)); 3 Donald S. Chisum, Chisum on Patents § 8.05[3] (2018) ("Even though a product may be claimed in terms of the process of making it, the product still must be new in structural terms in order to meet the novelty requirement." (emphasis added) (citing Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293 (1884); SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312 (Fed. Cir. 2006))).[15]

         (3) Product-By-Process Law Should Not Apply in Analyzing the Validity of the '755 Patent Method of Treatment Claims

         The Court has addressed the issues raised in Biogen's JMOL motion under the framework proposed by Biogen. The Court has also addressed those issues under the framework proposed by Defendants. Under either approach, the Court has concluded that there is legally insufficient evidence to support the jury's verdict of anticipation. Nevertheless, for the following reasons, the Court concludes that Biogen's proposed framework is more appropriate in this case.

         As an initial matter, there appears to be no binding precedent supporting Defendants' position that the anticipation inquiry of product-by-process claims governs the analysis of method of treatment claims that include source limitations, such as claim 1 of the '755 patent. The parties agree that claim 1 includes a source limitation, i.e., the interferon-β protein is made by recombinant DNA technology. In its claim construction Opinion, this Court stated 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 precedent requiring method of treatment claims to be treated as product-by-process claims in the claim construction context." Markman Op. at 14. Since the Court's claim construction ruling, Defendants have not identified cases that would warrant this Court to apply the framework for assessing novelty of product-by-process claims to method of treatment claims.[16]

         Even beyond the absence of binding precedent, the Court is persuaded by Biogen's argument that given the particular principles underlying product-by-process law, the framework Defendants propose should not apply to assessing the validity of the '755 patent method of treatment claims.[17] The product-by-process doctrine allows patentees to draft claims to a product by reference to the process by which the product is made where the product's characteristics are unknown or otherwise cannot be described. See In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985). As the Federal Circuit explained:

Product-by-process claims are not specifically discussed in the patent statute. The practice and governing law have developed in response to the need to enable an applicant to claim an otherwise patentable product that resists definition by other than the process by which it is made. For this reason, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.

Id. (citations omitted). The purpose of the doctrine is to prevent foreclosing inventors "from the benefits of the patent system simply because a product is difficult to describe in words, or its structure is insufficiently understood." SmithKline, 439 F.3d at 1315. For purposes of infringement, the product-by-process claim will only cover products that are made by the claimed process, whereas for purposes of validity, the "focus is on the product and not on the process of making it." Amgen, 580 F.3d at 1369-70 (citations omitted); see also Id. at 1370 ("[A] product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim.").

         Claim 1 of the '755 patent, by contrast, is not directed to a product that the inventor, Dr. Walter Charles Fiers, was unable to describe in words or where the product's structure was not sufficiently understood. Rather, the purpose of the invention, consistent with the stated goal of the '755 patent, was to solve the problem in the prior art that the viability of certain medical treatments was hindered by insufficient supply. See PTX0001 ('755 patent) at 4:10-13; 6:54-7:7. The principles that inform product-by-process law as set forth in Thorpe, SmithKline, and Amgen do not apply in this context. See 6/6/18 Tr. at 12:10-11 (explaining that the '755 patent "is not taking advantage of a legal procedure to overcome a lack of information"). The Court agrees with Biogen that since the source limitation of claim 1 "lies at the heart of the benefit of this invention," it should be given "force and effect in the anticipation analysis." Id. at 12:7-10.

         The procedural posture dictates that the Court may only consider whether Defendants presented sufficient evidence to support the jury's conclusion. Even viewing the evidence in the light most favorable to Defendants, the Court concludes that there is insufficient evidence from which the jury reasonably could have found that the '755 patent claims were anticipated by the prior-art uses of native, human interferon-β. Accordingly, the Court grants Biogen's Rule 50(b) JMOL motion of no anticipation and vacates the jury's verdict in favor of Defendants.

         (d) Biogen Is Entitled to a Conditional New Trial on Anticipation

         For the same reasons the Court grants Biogen's JMOL motion, the Court conditionally orders a new trial on anticipation pursuant to Rule 50(c)(1). Additional considerations warrant granting Biogen's request for a new trial on the issue of anticipation. The Court recognizes that the five-week trial in this case was "long and complicated," required complex factual determinations on multiple infringement, validity, and damages issues, was noticeably focused on issues other than anticipation, and involved scientific concepts that are not the "subject matter... lying within the ordinary knowledge of jurors." Lind, 278 F.2d at 90-91. Thus, the jury verdict deserves close scrutiny. See Comcast, 262 F.Supp.3d at 139 (applying "close scrutiny" to the verdict and conditionally granting a new trial under Rule 50(c)(1) following a 14-day patent trial involving "the complexities of cellular networks"). The jury spent the vast majority of the trial hearing fact and expert testimony on issues other than anticipation; indeed, in contrast with their other invalidity theories, Defendants did not mention anticipation or Question 12 of the Verdict Form once in their summation. Moreover, although a jury is free to draw reasonable inferences from the evidence presented, here the verdict of anticipation appears to rest on a number of inferences that Defendants did not argue to the jury. See Roebuck v. Drexel Univ., 852 F.2d 715, 735-36 (3d Cir. 1988).

         Upon consideration of the overall setting of the trial, the character of the evidence, and the complexity of the legal principles that the jury was asked to apply to the facts, the Court concludes that the jury's determination that the '755 patent claims are invalid for anticipation is against the weight of the evidence and therefore warrants the conditional grant of a new trial on the issue of anticipation pursuant to Rule 50(c)(1). Biogen's alternative request for a new trial under Rule 59 is denied as moot.

         2. Induced Infringement By Pfizer and Serono

          Biogen seeks JMOL of induced infringement against Pfizer and Serono. As to the questions of direct infringement by healthcare professionals and/or patients and contributory infringement by Pfizer and Serono, the jury found in favor of Biogen. Defendants have not challenged the jury's finding of direct infringement or its finding of contributory infringement by Serono. Nevertheless, because the legal principles for, and specific elements of, each type of infringement are instructive to the following analysis regarding the issue of induced infringement, the Court discusses those principles and elements below.

         (a) Applicable Legal Principles for Direct, Induced, and Contributory Infringement

         Section 271(a) of the Patent Act governs direct infringement and provides that "whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States ... during the term of the patent therefor, infringes the patent." 35 U.S.C. § 271(a). Section 271(b) of the Patent Act governs induced infringement and provides that "[w]hoever actively induces infringement of a patent shall be liable as an infringer." 35 U.S.C. § 271(b). In order to prevail on an inducement claim, the patentee must establish "first that there has been direct infringement, and second that the alleged infringer knowingly induced infringement and possessed specific intent to encourage another's infringement." ACCO Brands, Inc. v. ABA Locks Mfrs. Co., 501 F.3d 1307, 1312 (Fed. Cir. 2007) (quoting Minn. Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1304-05 (Fed. Cir. 2002)). "To prove inducement of infringement, the patentee must []show that the accused inducer took an affirmative act to encourage infringement with the knowledge that the induced acts constitute patent infringement." Power Integrations, 843 F.3d at 1332 (quoting Astornet Techs. Inc. v. BAE Sys., Inc., 802 F.3d 1271, 1279 (Fed. Cir. 2015)).

         In addition, a reasonable, good-faith belief in noninfringement can negate the specific intent required for induced infringement. See Commil USA, LLC v. Cisco Sys., Inc., 720 F.3d 1361, 1367-68 (Fed. Cir. 2013) ("[I]t is clear that a good-faith belief of non-infringement is relevant evidence that tends to show that an accused inducer lacked the intent required to be held liable for induced infringement." (citations omitted)), vacated and remanded on other grounds, 135 S.Ct. 1920 (2015). This defense applies where such a belief is based on a reasonable reading of the patent claims, even if that reading is later found to be incorrect.[18] See Commil, 135 S.Ct. at 1928.

         Section 271(c) of the Patent Act governs contributory infringement and provides that:

[w]hoever offers to sell or sells within the United States or imports into the United States a component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or ...

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