Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 1 of 830 PageID #:
`48581
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`Exhibit H
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`Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 2 of 830 PageID #:
`48582
`HIGHLY CONFIDENTIAL—SUBJECT TO OCA
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`
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`Highly Confidential Detailed Factual and Legal Basis for Mylan’s Opinion That
`U.S. Patent No. 11,084,865 B2 Is Invalid, Unenforceable, and/or Will Not Be Infringed
`
`I.
`
`Introduction.
`
`Pursuant to 42 U.S.C. § 262(l)(3)(B)(ii)(I), this document is the detailed factual and
`legal basis for Mylan’s1 opinion that U.S. Patent No. 11,084,865 B2 (“865 patent”) is invalid,
`unenforceable, and/or will not be infringed by the commercial marketing of the biological product
`described in Mylan’s BLA No. 761274. Mylan specifically reserves all rights to raise any
`additional defenses should litigation ensue.
`II. Mylan’s BLA Product.
`
`Mylan’s product, M710, 2 mg, Solution for Intravitreal Injection, as described in
`Mylan’s BLA No. 761274, is a proposed biosimilar product to EYLEA®, 40 mg/ml Injection for
`IV Use (aflibercept, BLA No. 125387, Regeneron Pharmaceuticals, United States) (hereinafter
`“BLA Product”).
`III. Legal Standards.
`
`
`
`Patent Non-Infringement.
`
`A patent infringement analysis consists of two steps: (1) determining the scope of
`the claims, a legal issue for the court; and (2) comparing the accused product to the claims, a
`factual question. Carroll Touch, Inc. v. Electro Mech. Sys., Inc., 15 F.3d 1573, 1576-78 (Fed. Cir.
`1993). A claim may be infringed either: (1) literally; or (2) under the judicially-created doctrine
`of equivalents. See id. Moreover, because a dependent claim incorporates all of the elements and
`limitations of the independent claim on which it depends, a dependent claim cannot be infringed
`unless each and every element of the underlying independent claim is also infringed. Forest Labs.,
`Inc. v. Abbott Labs., 239 F.3d 1305, 1310-11 & n.3 (Fed. Cir. 2001).
`1.
`
`Claim Construction.
`
`“It is axiomatic that the claims mark the outer boundaries of the patent right to
`exclude.” Astrazeneca AB v. Mut. Pharm. Co., Inc., 384 F.3d 1333, 1336 (Fed. Cir. 2004). The
`“goal of claim construction is to determine what an ordinary artisan would deem the invention
`claimed by the patent, taking the claims together with the rest of the specification.” Id. at 1337;
`see also DeMarini Sports, Inc. v. Worth, Inc., 239 F.3d 1314, 1322 (Fed. Cir. 2001) (noting that
`claim construction “is simply a way of elaborating the normally terse claim language in order to
`understand and explain, but not to change, the scope of the claims” (internal quotation marks and
`citation omitted)).
`
`The intrinsic evidence, including the claims, the specification, and the prosecution
`history, is the primary source for determining claim meaning. See Phillips v. AWH Corp., 415
`F.3d 1303, 1315-18 (Fed. Cir. 2005) (en banc); Astrazeneca, 384 F.3d at 1336; Markman v.
`Westview Instruments, Inc., 52 F.3d 967, 979-80 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370
`
`1 As used herein, “Mylan” refers to Mylan Pharmaceuticals Inc., the applicant of BLA No. 761274.
`
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`

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`Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 3 of 830 PageID #:
`48583
`Highly Confidential Detailed Factual and Legal Basis for
`Mylan’s Opinion That U.S. Patent No. 11,084,865 B2 Is
`Invalid, Unenforceable, and/or Will Not Be Infringed.
`
`
`(1996). The claim construction inquiry begins with the plain and ordinary meaning of the claims,
`which define the scope of the right to exclude. See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
`1576, 1582 (Fed. Cir. 1996). “When construing patent claims, there is a heavy presumption that
`the language in the claim carries its ordinary and customary meaning amongst artisans of ordinary
`skill in the relevant art at the time of the invention.” Housey Pharm., Inc. v. Astrazeneca UK Ltd.,
`366 F.3d 1348, 1352 (Fed. Cir. 2004) (citation and internal quotation marks omitted).
`
`A patentee may assign a claim term a meaning “other than its ordinary and
`accustomed meaning . . . if the patentee has chosen to be his or her own lexicographer by clearly
`setting forth an explicit definition for a claim term.” Johnson Worldwide Assocs., Inc. v. Zebco
`Corp., 175 F.3d 985, 990-91 (Fed. Cir. 1999) (examining the scope of the term “heading” through
`its use by the patentee throughout the specification); see also Markman, 52 F.3d at 979-80;
`Schering Corp. v. Amgen Inc., 222 F.3d 1347, 1353 (Fed. Cir. 2000). The Federal Circuit has
`made clear that rigid formalism in this regard is not required. See Astrazeneca, 384 F.3d at 1339
`(rejecting argument that lexicography requires rigid formalism and explicit statements of
`definition). Lexicography does not require a “statement in the form ‘I define _____ to mean
`____,’” but rather can be accomplished in a more subtle manner or even by implication. Id. at
`1349-1350; see also Bell Atl. Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d 1258,
`1268 (Fed. Cir. 2001) (“[A] claim term may be clearly redefined without an explicit statement of
`redefinition. . . . [T]he specification may define claim terms ‘by implication’ such that the meaning
`may be ‘found in or ascertained by a reading of the patent documents.’”).
`
`The specification also should be consulted to determine whether the patentee has
`disavowed or relinquished claim scope. See SciMed Life Sys., Inc. v. Advanced Cardiovascular
`Sys., Inc., 242 F.3d 1337, 1340-41 (Fed. Cir. 2001) (“Where the specification makes clear that the
`invention does not include a particular feature, that feature is deemed to be outside the reach of the
`claims of the patent, even though the language of the claims . . . might be considered broad enough
`to encompass the feature in question.”).
`
`In addition, a patentee cannot recapture in litigation a claim scope surrendered
`during the prosecution of the patent, either by amendment or argument. See Pharmacia & Upjohn
`Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1376-77 (Fed. Cir. 1999). “Claims may not be
`construed one way in order to obtain their allowance and in a different way against accused
`infringers.” Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed. Cir. 1995).
`
`Further, the Federal Circuit has approved reliance upon statements in foreign
`prosecutions where the statements constituted “blatant admission[s]” directed at the claim scope,
`see Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1374 (Fed. Cir. 2005), and where the
`statements proved otherwise “consistent with the claims and the invention described in the
`specification” at issue. Apple Inc. v. Motorola, Inc., 757 F.3d 1286, 1313 (Fed. Cir. 2014),
`overruled on other grounds by Williamson v. Citrix Online, LLC, 729 F.3d 1339 (Fed. Cir. 2015).
`2.
`
`Comparison of the Accused Product to the Properly Construed Claims.
`a.
`
`Literal Infringement.
`
`2
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`Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 4 of 830 PageID #:
`48584
`Highly Confidential Detailed Factual and Legal Basis for
`Mylan’s Opinion That U.S. Patent No. 11,084,865 B2 Is
`Invalid, Unenforceable, and/or Will Not Be Infringed.
`
`
`
`Under 35 U.S.C. § 271(a),2 “whoever without authority makes, uses, offers to sell,
`or sells any patented invention, within the United States or imports into the United States any
`patented invention during the term of the patent therefor, infringes the patent.” Literal
`infringement requires a patentee to prove “that every limitation of the asserted claim is literally
`met by the accused device.” Enercon GmbH v. Int’l Trade Comm’n, 151 F.3d 1376, 1384 (Fed.
`Cir. 1998); see also Amhil Enters. Ltd. v. Wawa, Inc., 81 F.3d 1554, 1562 (Fed. Cir. 1996) (literal
`infringement occurs “when the properly construed claim reads on the accused device exactly”).
`The failure to meet even a single element within a claim mandates a finding that the accused
`product does not literally infringe the patent. Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1535
`(Fed. Cir. 1991). A prior commercial use of claimed “subject matter consisting of a process, or
`consisting of a machine, manufacture, or composition of matter used in a manufacturing or other
`commercial process” may provide an infringement defense if the “commercial use occurred at
`least 1 year before the earlier of either . . . the effective filing date of the claimed invention; or . . .
`the date on which the claimed invention was disclosed to the public in a manner that qualified for
`the exception from prior art under [AIA] section 102(b).” AIA 35 U.S.C. § 273.
`
`35 U.S.C. § 271(f) contains two subsections. Section 271(f)(1) addresses exporting
`a substantial portion of an invention’s components:
`
`Whoever without authority supplies or causes to be supplied in or
`from the United States all or a substantial portion of the components
`of a patented invention, where such components are uncombined in
`whole or in part, in such manner as to actively induce the
`combination of such components outside of the United States in a
`manner that would infringe the patent if such combination occurred
`within the United States, shall be liable as an infringer.
`
`WesternGeco LLC v. ION Geophysical Corp., 138 S. Ct. 2129, 2134 (2018). “[S]ubstantial
`portion” has a “quantitative, not a qualitative meaning” and “a single component does not
`constitute a substantial portion of the components that can give rise to liability under § 271(f)(1).”
`Life Techs. Corp. v. Promega Corp., 137 S. Ct. 734, 737, 743 (2017). Section 271(f)(2) addresses
`exporting components that are specially adapted for an invention:
`
`Whoever without authority supplies or causes to be supplied in or
`from the United States any component of a patented invention that
`is especially made or especially adapted for use in the invention and
`not a staple article or commodity of commerce suitable for
`substantial noninfringing use, where
`such component
`is
`uncombined in whole or in part, knowing that such component is so
`made or adapted and intending that such component will be
`combined outside of the United States in a manner that would
`infringe the patent if such combination occurred within the United
`
`
`2 Unless otherwise indicated, citations to Title 35 of the U.S. Code refer to statutes in force prior
`to the effective date of the America Invents Act (“AIA”).
`
`3
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`Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 5 of 830 PageID #:
`48585
`Highly Confidential Detailed Factual and Legal Basis for
`Mylan’s Opinion That U.S. Patent No. 11,084,865 B2 Is
`Invalid, Unenforceable, and/or Will Not Be Infringed.
`
`
`
`States, shall be liable as an infringer.
`
`WesternGeco, 138 S. Ct. at 2135.
`
`Under 35 U.S.C. § 271(g):
`
`Whoever without authority imports into the United States or offers to
`sell, sells, or uses within the United States a product which is made by
`a process patented in the United States shall be liable as an infringer, if
`the importation, offer to sell, sale, or use of the product occurs during
`the term of such process patent. In an action for infringement of a
`process patent, no remedy may be granted for infringement on account
`of the noncommercial use or retail sale of a product unless there is no
`adequate remedy under this title for infringement on account of the
`importation or other use, offer to sell, or sale of that product. A product
`which is made by a patented process will, for purposes of this title, not
`be considered to be so made after (1) it is materially changed by
`subsequent processes; or (2) it becomes a trivial and nonessential
`component of another product.
`
`“[W]hen read as a whole, the two parts of section 271(g) require the plaintiff to demonstrate (1)
`that a product is produced pursuant to a patented process, (2) that the product is then imported into
`this country, and (3) that the product made by the patented process is neither materially changed
`by subsequent processes nor a trivial and nonessential component of another product.” Eli Lilly
`& Co. v. Am. Cyanamid Co., 896 F. Supp. 851, 855-56 (S.D. Ind. 1995), aff’d, 82 F.3d 1568 (Fed.
`Cir. 1996); see also Bayer AG v. Housey Pharm., Inc., 340 F.3d 1367, 1377 (Fed. Cir. 2003).
`
`A determination of what “products will be considered to have been ‘made by’ the
`patented process” is determined on a case-by-case basis. Bio-Tech. Gen. Corp. v. Genentech, Inc.,
`80 F.3d 1553, 1561 (Fed. Cir. 1996). Courts have held “the ordinary meaning of ‘made’ as used
`in § 271(g) means ‘manufacture,’” and thus “extends to the creation or transformation of a product,
`such as by synthesizing, combining components, or giving raw materials new properties.”
`Momenta Pharm., Inc. v. Teva Pharm. USA Inc., 809 F.3d 610, 616 (Fed. Cir. 2015). The process
`must not be “too far removed from the actual making of the product.” Id. at 617.
`
`When examining whether a product has been “materially changed” courts “look []
`to the substantiality of the change between the product of the patented process and the product that
`is being imported.” Eli Lilly, 82 F.3d at 1573. “The ‘materially changed’ exception of § 271(g)
`requires, at a minimum, that there be a real difference between the product imported, offered for
`sale, sold, or used in the United States and the products produced by the patented process.” Bio-
`Tech., 80 F.3d at 1560. Courts will also examine whether the differences are material where
`“[m]ateriality is context-dependent.” Amgen Inc. v. F. Hoffman-La Roche Ltd, 580 F.3d 1340,
`1379 (Fed. Cir. 2009). “Whether a change in a product is material is a factual determination, and
`is properly for the trier of fact.” Biotec Biologische Naturverpackungen GmbH & Co. v. Biocorp,
`Inc., 249 F.3d 1341, 1352 (Fed. Cir. 2001).
`
`4
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`Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 6 of 830 PageID #:
`48586
`Highly Confidential Detailed Factual and Legal Basis for
`Mylan’s Opinion That U.S. Patent No. 11,084,865 B2 Is
`Invalid, Unenforceable, and/or Will Not Be Infringed.
`
`
`
`“In the chemical context, a ‘material’ change in a compound is most naturally
`viewed as a significant change in the compound’s structure and properties.” Eli Lilly, 82 F.3d at
`1573. “[A] change in the physical or chemical properties of a product, even though minor, may
`be ‘material’ if the change relates to a physical or chemical property which is an important feature
`of the product produced by the patented process.” Id. at 1577. “In the biotechnology context, a
`significant change in a protein’s structure and/or properties would constitute a material change.”
`Amgen, 580 F.3d at 1379. Additionally, the determination of whether a “product of a patented
`process is a ‘trivial and nonessential component’ of another product is necessarily a question of
`degree.” Eli Lilly, 82 F.3d at 1572.
`
`Certain activity is exempt from infringement under the “safe harbor” provision. 35
`U.S.C. § 271(e)(1) states: “[i]t shall not be an act of infringement to make, use, offer to sell, or sell
`within the United States or import into the United States a patented invention . . . solely for uses
`reasonably related to the development and submission of information under a Federal law which
`regulates the manufacture, use, or sale of drugs.” The Supreme Court has stated that “§ 271(e)(1)’s
`exemption from infringement extends to all uses of patented inventions that are reasonably related
`to the development and submission of any information under the [Federal Food, Drug, and
`Cosmetic Act].” Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005).
`b.
`
`Doctrine of Equivalents.
`
`Infringement under the doctrine of equivalents requires the patentee to show, for
`each claim asserted, the presence of each and every claim element or its substantial equivalent in
`the accused device. See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722,
`732-33 (2002); Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 40 (1997);
`Wolverine World Wide, Inc. v. Nike, Inc., 38 F.3d 1192, 1199 (Fed. Cir. 1994). An equivalent of
`a missing claim element or limitation is found only if “‘insubstantial differences’ distinguish the
`missing claim element from the corresponding aspects of the accused [product].” Abbott Labs. v.
`Novopharm Ltd., 323 F.3d 1324, 1329 (Fed. Cir. 2003) (alteration in original) (quoting Sage
`Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1423 (Fed. Cir. 1997)).
`
`The scope and application of this doctrine, however, are limited. The Supreme
`Court has warned that “[i]t is important to ensure that the application of the doctrine, even as to an
`individual element, is not allowed such broad play as to effectively eliminate that element in its
`entirety.” Warner-Jenkinson, 520 U.S. at 29. Under this “all elements rule, there can be no
`infringement under the doctrine of equivalents if even one limitation of a claim or its equivalent is
`not present in the accused device.” Lockheed Martin Corp. v. Space Sys./Loral, Inc., 324 F.3d
`1308, 1321 (Fed. Cir. 2003). Furthermore, “if a theory of equivalence would entirely vitiate a
`particular claim element, partial or complete judgment should be rendered by the court, as there
`would be no further material issue for the jury.” Warner-Jenkinson, 520 U.S. at 39 n.8.
`In addition, the scope of permissible equivalents cannot encompass or ensnare what is already in
`the prior art. See, e.g., Jang v. Boston Sci. Corp., 872 F.3d 1275, 1285 (Fed. Cir. 2017); Marquip,
`Inc. v. Fosber Am., Inc., 198 F.3d 1363, 1367 (Fed. Cir. 1999).
`
`Likewise, under the doctrine of prosecution history estoppel, an equivalent cannot
`be extended to include subject matter surrendered by the patentee either in amendments to
`
`5
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`Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 7 of 830 PageID #:
`48587
`Highly Confidential Detailed Factual and Legal Basis for
`Mylan’s Opinion That U.S. Patent No. 11,084,865 B2 Is
`Invalid, Unenforceable, and/or Will Not Be Infringed.
`
`
`overcome patentability rejections or in arguments to secure allowance of a claim. See Warner-
`Jenkinson, 520 U.S. at 33; Wang Labs., Inc. v. Mitsubishi Elecs. Am., Inc., 103 F.3d 1571, 1577-
`78 (Fed. Cir. 1997); Haynes Int’l, Inc. v. Jessop Steel Co., 8 F.3d 1573, 1577-78 (Fed. Cir. 1993),
`reh’g granted on other grounds, 15 F.3d 1076 (Fed. Cir. 1994). Pursuant to the disclosure-
`dedication rule, a patentee can disclaim an equivalent by disclosing subject matter in the
`specification without claiming it. SanDisk Corp. v. Kingston Tech. Co., 695 F.3d 1348, 1363 (Fed.
`Cir. 2012); Johnson & Johnston Assocs., Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1054 (Fed. Cir.
`2002) (en banc).
`
`In addition, a patentee’s arguments during the prosecution of a patent regarding a
`“critical feature” of an invention used to overcome a prior art rejection can give rise to argument-
`based prosecution history estoppel. See, e.g., Pharmacia & Upjohn, 170 F.3d at 1377-78 (finding
`that “key feature of the present invention” statement during prosecution surrendered claim scope).
`Further, a patentee’s “failure to challenge the Examiner’s understanding amounts to a disclaimer.”
`Sandbox Logistics v. Proppant Express, No. 19-1684, 2020 WL 2517113, at *4 (Fed. Cir. 2020).
`c.
`
`Indirect Infringement.
`
`Where a particular entity has not directly committed an act of infringement but has
`acted in a manner leading to the direct infringement by another, that entity may be held liable for
`“indirect infringement” for inducement of infringement under 35 U.S.C. § 271(b) and/or for
`contributory infringement under 35 U.S.C. § 271(c). See, e.g., Joy Techs., Inc. v. Flakt, Inc., 6
`F.3d 770, 774 (Fed. Cir. 1993). Liability for either inducement of infringement or contributory
`infringement requires direct infringement by another as a prerequisite. See, e.g., Deepsouth
`Packing Co. v. Laitram Corp., 406 U.S. 518, 526 (1972) (“[I]f there is no (direct) infringement of
`a patent there can be no contributory infringer.”), superseded by statute on other grounds by 35
`U.S.C. § 271(f); Aro Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336, 341 (1961)
`(“Aro I”); DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1303 (Fed. Cir. 2006); Joy Techs., 6 F.3d
`at 774 (“Liability for either active inducement of infringement or for contributory infringement is
`dependent upon the existence of direct infringement.”); C.R. Bard, Inc. v. Advanced
`Cardiovascular Sys., Inc., 911 F.2d 670, 673 (Fed. Cir. 1990) (“[A] finding of induced or
`contributory infringement must be predicated on a direct infringement of [the asserted] claim.”);
`Limelight Networks, Inc. v. Akamai Techs., Inc., 134 S. Ct. 2111, 2117 (2014) (“[A]s both the
`Federal Circuit and respondents admit, where there has been no direct infringement, there can be
`no inducement of infringement under § 271(b).”). Direct infringement of a method claim “occurs
`where all steps of a claimed method are performed by or attributable to a single entity.” Akamai
`Techs., Inc. v. Limelight Networks, Inc., 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc). An entity
`is responsible for others’ performance of method steps “where that entity directs or controls others’
`performance” and/or “where the actors form a joint enterprise.” Id. Courts rely on general
`principles of vicarious liability to determine if a single entity controls the acts of another. Id.
`However, according to the Federal Circuit, indirect infringement based on direction and control
`requires that customers do more than merely take a vendor’s guidance and act independently on
`their own. Id. at 1025.
`
`Moreover, inducing infringement under 35 U.S.C. § 271(b) requires “actively and
`knowingly aiding and abetting another’s direct infringement.” C.R. Bard, 911 F.2d at 675; accord
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`Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 8 of 830 PageID #:
`48588
`Highly Confidential Detailed Factual and Legal Basis for
`Mylan’s Opinion That U.S. Patent No. 11,084,865 B2 Is
`Invalid, Unenforceable, and/or Will Not Be Infringed.
`
`
`Rodime PLC v. Seagate Tech., Inc., 174 F.3d 1294, 1306 (Fed. Cir. 1999). The patentee must
`prove that the defendant’s “actions induced infringing acts and that [it] knew or should have known
`[its] actions would induce actual infringements.” Manville Sales Corp. v. Paramount Sys., Inc.,
`917 F.2d 544, 553 (Fed. Cir. 1990). Proof of mere knowledge of the acts alleged to constitute
`infringement is insufficient; rather, the plaintiff must prove specific intent and action to induce
`infringement. See, e.g., DSU, 471 F.3d at 1305; Hewlett-Packard Co. v. Bausch & Lomb Inc., 909
`F.2d 1464, 1469 (Fed. Cir. 1990) (holding that “proof of actual intent to cause the acts which
`constitute the infringement is a necessary prerequisite to finding active inducement”); Metro-
`Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 937 (2005) (the inducement rule in
`the copyright context “premises liability on purposeful, culpable expression and conduct”).
`Furthermore, the patentee or patent owner also must prove that the defendant was responsible for
`the “commission of an affirmative act” in furtherance of the direct infringement of another.
`Beverly Hills Fan Co. v. Royal Sovereign Corp., 21 F.3d 1558, 1569 & n.25 (Fed. Cir. 1994). In
`general, “inducement has connotations of active steps knowingly taken—knowingly at least in the
`sense of purposeful, intentional as distinguished from accidental or inadvertent.” Tegal Corp. v.
`Tokyo Electron Co., 248 F.3d 1376, 1378 (Fed. Cir. 2001).
`
`The Federal Circuit has made clear that the patentee must prove that an applicant
`(here, a BLA applicant) will actually promote or encourage others, such as pharmacists,
`physicians, nurses or other end users, to infringe the patent by using the drug for the patented use.
`Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1364-65 (Fed. Cir. 2003); Takeda Pharm.
`U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015) (“The label must
`encourage, recommend, or promote infringement.”). The “mere existence of direct infringement
`. . . is not sufficient for inducement”; the inquiry instead focuses on whether “the instructions
`reflect an ‘affirmative’ or ‘specific intent to encourage infringement.’” HZNP Meds. LLC v.
`Actavis Labs. UT, Inc., 940 F.3d 680, 702 (Fed. Cir. 2019) (alteration in original); Takeda, 785
`F.3d at 633 (finding insufficient evidence that instructions would inevitably lead doctors to
`practice claimed method); see also United Therapeutics Corp. v. Sandoz, Inc., Nos. 12-1617, 13-
`316, 2014 WL 4259153, at *19-21 (D.N.J. Aug. 29, 2014). Moreover, intent to induce
`infringement cannot be inferred when there are substantial non-infringing uses for the drug.
`Warner-Lambert, 316 F.3d at 1365; see also Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322,
`1332-33 (Fed. Cir. 2003).
`
`In addition, contributory infringement arises when there is a sale or offer for sale
`of a component of a patented apparatus or a material for use in a patented process if the material
`or apparatus constitutes a material part of the invention and the person supplying it knows that it
`is especially made or adapted for use in the infringement of a patent. 35 U.S.C. § 271(c). The
`Supreme Court in Aro Manufacturing Co. v. Convertible Top Replacement Co., 377 U.S. 476
`(1964) (“Aro II”) addressed the knowledge requirement of § 271(c). The Court held that § 271(c)
`requires a showing that the alleged contributory infringer knew that the combination for which his
`component was especially designed was both patented and infringing. Aro II, 377 U.S. at 488; see
`also Golden Blount, Inc. v. Robert H. Peterson Co., 365 F.3d 1054, 1061 (Fed. Cir. 2004).
`
`Furthermore, a party is liable for contributory infringement only if its product is not
`a “staple article . . . of commerce suitable for substantial noninfringing use.” 35 U.S.C. § 271(c).
`If a product is “suitable for substantial noninfringing use,” it would be, by definition, a “staple
`7
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`Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 9 of 830 PageID #:
`48589
`Highly Confidential Detailed Factual and Legal Basis for
`Mylan’s Opinion That U.S. Patent No. 11,084,865 B2 Is
`Invalid, Unenforceable, and/or Will Not Be Infringed.
`
`
`article” of commerce, the sale of which would not create liability for contributory infringement.
`C.R. Bard, 911 F.2d at 673-74 (determining whether product was “staple article” by examining
`whether it had substantial non-infringing uses). The threshold for what constitutes a “substantial
`noninfringing use” is not high. Indeed, “[u]nless a commodity ‘has no use except through practice
`of the patented method,’ the patentee has no right to claim that its distribution constitutes
`contributory infringement.” Sony Corp. of Am. v. Universal City Studios, Inc., 464 U.S. 417, 441
`(1984) (citation omitted) (quoting Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176, 199
`(1980)); see also Fina Research, S.A. v. Baroid Ltd., 141 F.3d 1479, 1481-82 (Fed. Cir. 1998)
`(finding that “suit may not be brought . . . for contributory infringement, because . . . [the product
`at issue] is a ‘staple article or commodity of commerce suitable for substantial noninfringing
`use’”).
`
`Thus, judgment of non-infringement on a claim of contributory infringement is
`proper where the defendant proffers competent evidence that the product is used in a non-
`infringing manner. See Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361, 1374 (Fed. Cir. 2003)
`(affirming judgment of no contributory infringement where evidence was introduced that accused
`product could be installed without infringing the claim); Warner-Lambert, 316 F.3d at 1365
`(concluding that product used in non-infringing manner had substantial non-infringing uses);
`Universal Elecs., Inc. v. Zenith Elecs. Corp., 846 F. Supp. 641, 652 (N.D. Ill. 1994) (granting
`summary judgment in favor of alleged contributory infringer based on evidence that accused
`remote control was sold to owners of devices, which when used with the remote control, would
`not directly infringe the patent).
`
`
`
`Patent Invalidity.
`
`Patent invalidity is a complete defense to a charge of infringement. See, e.g., 35
`U.S.C. § 282 (stating that invalidity and unenforceability are defenses to any action involving
`infringement of a patent); TypeRight Keyboard Corp. v. Microsoft Corp., 374 F.3d 1151, 1157
`(Fed. Cir. 2004); Viskase Corp. v. Am. Nat’l Can Co., 261 F.3d 1316, 1323 (Fed. Cir. 2001);
`Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d 1326, 1335 (Fed. Cir. 1998) (“[I]nvalidity
`operates as a complete defense to infringement for any product, forever . . . .”). A patent is invalid
`if it fails to satisfy any of the conditions for patentability found in 35 U.S.C. § 101 et seq.
`Furthermore, a patent claim may be invalid for being an obvious variation of a patented claim
`under the judicially-created doctrine of obviousness-type double patenting. Georgia-Pacific Corp.
`v. U.S. Gypsum Co., 195 F.3d 1322, 1326 (Fed. Cir. 1999).
`1.
`
`Burden of Proof and Presumption of Validity.
`
`The burden of proving invalidity rests with the party asserting it.
`
`A patent, though presumed valid, 35 U.S.C. § 282 (1988),
`is actually a fragile entity, and must be propped up by a myriad of
`supports, each representative of one of the legal requirements of
`validity. If even a single one of these supports is removed, the patent
`will fall. For example, a patent may be declared invalid . . . if it is
`found to be anticipated by a prior art reference, see id.
`§ 102; if it is rendered obvious by a combination of the prior art, see
`8
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`HIGHLY CONFIDENTIAL—SUBJECT TO OCA
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`

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`Case 1:22-cv-00061-TSK-JPM Document 627 Filed 09/01/23 Page 10 of 830 PageID #:
`48590
`Highly Confidential Detailed Factual and Legal Basis for
`Mylan’s Opinion That U.S. Patent No. 11,084,865 B2 Is
`Invalid, Unenforceable, and/or Will Not Be Infringed.
`
`
`
`id. § 103; or if it fails to satisfy any one of a variety of other
`conditions.
`
`Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1471-72 (Fed. Cir. 1993) (Mayer, J.,
`concurring).
`
`The statutory presumption of validity merely assumes the U.S. Patent and
`Trademark Office (“PTO”) properly did its job by considering all prior art or other evidence
`material to patentability. See Lannom Mfg. Co. v. U.S. Int’l Trade Comm’n, 799 F.2d 1572, 1575
`(Fed. Cir. 1986). “[W]here the PTO has not considered facts relevant to an issue in suit, there is
`no reason to give deference to its action in issuing the patent and a court may find those facts
`controlling in determining whether the burden of proof has been sustained.” Kalman v. Kimberly-
`Clark Corp., 713 F.2d 760, 773 n.3 (Fed. Cir. 1983), overruled in part on other grounds by SRI
`Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107 (Fed. Cir. 1985) (en banc). Thus, “[t]he
`courts are the final arbiter of patent validity and, although courts may take cognizance of, and
`benefit from, the proceedings before the patent examiner, the question is ultimately for the courts
`to decide, without deference to the rulings of the patent examiner.” Quad Envtl. Techs. Corp. v.
`Union Sanitary Dist., 946 F.2d 870, 876 (Fed. Cir. 1991).
`2.
`
`35 U.S.C. § 101—Lack of Utility.
`
`35 U.S.C. § 101 provides that “[w]hoever invents . . . any new and useful
`process . . . or composition of matter . . . may obtain a patent therefor.” A patent claim is invalid
`if no substantial or practical utility for the invention claimed is disclosed. Cross v. Iizuka, 753
`F.2d 1040, 1044 (Fed. Cir. 1985). As noted by the Supreme Court:
`
`The basic quid pro quo contemplated by the Constitution and the
`Congress for granting a patent monopoly is the benefit derived by
`the public from an invention with substantial utility. Unless and
`until a process is refined and developed to this point—where
`specific benefit exists in currently available form—there is
`insufficient justification for permitting an applicant to engross what
`may prove to be a broad field.
`
`Brenner v. Manson, 38