,v,l;..o Wt1son Sonsini Goodrich & Rosati
`W'(r-'- PllOfliSSIONAL CORPOllATlON
`
`900Sauth upail olTcxas Highway
`LtsOmas rv, rum Roar
`AuJon, 1X 78746 5546
`1laa::r NIIJNF;512J3854Q2
`
`,,.-x 512.338.5499 ~-
`
`March I 8, 2021
`
`HIGHLY CONffDENTIAL
`
`VIA FEDERAL EXPRESS
`~TURN RE_!:EIPT REQUESTED.
`
`Salix Pharmaceuticals, Inc.
`400 Somerset Corporate Blvd.
`Bridgewater, NJ 08807
`
`Synergy Phannaceuticals Inc.
`420 Lexington Avenue
`Suite 2012
`New York, NY 10170
`
`Bausch Health Ireland Limited
`3013 Lake Drive
`Citywest Business Campus
`Dublin 24, Ireland
`
`Re: Plecanatide Tablets, 3mg (Trulance•, chronic idiopathic constipation (CIC)
`and irritable bowel syndrome with constipation (fflS-C))
`Dosage Form: Tablet
`Dosage Strength: 3mg
`Route of Administration: Oral
`United States Patent No. 7,041,786; United States Patent No. 9,610,321;
`United States Patent No. 9,616,097; United States Patent No. 9,919,024;
`United States Patent No. 9,925.231; United States Patent No. 10,011,637
`
`.Notice of Paraannh IV Certification.
`
`To Whom It May Concern:
`
`This is a notice-of-certification Jetter en behalf of Mylan Pharmaceuticals Inc., a Viatris
`Company ("Mylan"), pursuant to§ 505G)(2)(B)(ii) of the Federal Food, Drug and Cosmetic Act
`("the Act") and §§ 314.94 and 314.95 of Title 21 of the Code of Federal Regulations.
`
`Bausch Health Ireland Exhibit 2007, Page 1 of 97
`Mylan v. Bausch Health Ireland - IPR2022-00722
`
`

`

`CONFIDENTIAL
`PJecanatide Notice Letter
`March 18, 2021
`Page 2
`
`To obtain approval for Plecanatide Tablets; 3 mg, Mylan submitted to the Food
`1.
`and Drug Administration ("FDA'') an Abbreviated New Drug Application ("ANDA"), which
`under § 5050) of the Act contains any required bioavailability or bioequivalence data or
`infonnation.
`
`2.
`
`The ANDA number is 215686.
`
`3.
`215686.
`
`Mylan has received FDA's Paragraph IV acknowledgment letter for ANDA No.
`
`4.
`The established name ofMylan's proposed drug is Plecanatide Tablets, 3mg.
`Salix Phannaceulicals Inc. {"Salix'') holds an NDA on marketed products that contain the active
`ingredient plecanatide in 3mg dosage strength intended for oral administration under the brand
`name Trulance®.
`
`The ANDA indicates that Mylan seeks to obtain approval for the drug product
`5.
`before the expiration dates for United States Patent Nos. 7,041,786 {the "'786 Patent");
`9,610,321 (the "'321 Patent"); 9,616,097 (the "'097Patent"); 9,919,024 (the "'024 Patent");
`9,925,231 (the m231 Patent"); and 10,011,637 (the "'637 Patent") which are listed in the FDA's
`Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") for
`Plecanatide (Trulance®) Tablet 3mg.
`
`I
`
`Patent Number
`7,041,786 (the "'786 Patent")
`9,610,321 (the "'321 Patent';)
`9,616,097 (the "'097 Patent")
`9,919,024 (the "'024 Patent")
`9,925,231 (the "'231 Patent")
`I
`10,011,637 (the '"637 Patent")
`
`I
`I
`6.
`A detailed statement of the present factual and legal bases ofMylan's belief that
`the '786 Patent; the '321 Patent; the '097 Patent; the '024 Patent; the '231 Patent; and the '637
`
`I
`
`-
`
`Oran1e Book Exl!iration Date1
`January 30. 2028
`September 15, 2031
`August 20, 2032
`September 15, 2031
`September 15, 203 I
`June 5, 2034
`
`1 The expiration dates of the patents are based upon infonnation available in the FDA Orange
`Book. See FDA Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations at http://www.acccssdata.fda.gov/scripts/cder/ob/defau1t.cfin.
`
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`

`

`CONFIDENTIAL
`Plecanatide Notice Letter
`March 18, 2021
`Page 3
`
`Patent are inv!11id, unenforceable, and/or will not be infringed is attached, made pursuant to 21
`U.S.C. ·§ 355(j)(2)(B)(iv)(ll) and 21 C.F.R. § 314.95(c)(6).
`
`7.
`
`An Offer of Confidential Access is enclosed.
`
`Wilson Sonsini Goodrich & Ro�ati P.C. is authorized to accept service of process
`8.
`for Mylan, solely relating to ANDA No. 215686. Please direct any correspondence in this regard
`to my at!;ention.
`
`Anticompetitive Behavior Warning. It is an antitrust violation to assert any
`9.
`patent lmown not to be infringed, or lmown not to be valid. See Loctite Corp. v. Ultrasea/ Ltd,
`781 F.2d 861 (Fed. Cir. 1985); Ham:lgards, Inc. v. Ethicon, Inc., 601 F.2d 986 (9th Cir. 1979). If
`Salix launches any patent infringement lawsuit, either now or later, Mylan may pursue the
`appropriate remedies against Salix. including seeking fees, costs, and sanctions for potential
`violations of Rule 11 of the Federal Rules of Civil Procedure, exceptional case and frivolous suit
`statutes under the patent laws, and fqr violations of the antitrust laws and/or other laws, plus any
`remedy the court deems fit to award.
`
`The information in this letter and its attachmen� is supplied for the sole purpose of
`complying with the above-referenced statutes and regulations. Neither Mylan nor its attorneys
`waive any attorney-client privilege or work-product immunity concerning the subjeci matter of
`this communication.
`
`Reservation of Legal Right
`
`Mylan reserves the right to assert the same, similar, different or new theories of non­
`infringement, invalidity and/or unenforceability and nothing in this Notice Letter or Detailed
`Statement shall be construed as to limit Mylan's right to make any allegation in any litigation
`regarding any issue.
`
`Sincerely,
`
`WILSON SONSINI GOODRICH & ROSA TI
`Professional Corporation
`
`�W.�
`
`Nicole W. Stafford
`
`Encl.: Detailed Statement of the Factual and Legal Bases for Mylan's Paragraph IV
`Certification Concerning with respect to United States Patent Nos. 7,041,786; 9,610,321;
`9,616,097; 9,919,024; 9,925,231; and 10,011,637.
`
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`

`

`CONFIDENTIAL
`Plecwiatide Notice Letter
`March 18, 2021
`Page 4
`
`Offer of Confidential Access
`Duplicate with enclosure via Federal Express
`
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`
`

`

`CONFIDENTIAL
`Plecanatide Notice Letter
`March 18, 2021
`Page I
`
`DETAILED STATEMENT OF THE FACTUAL AND LEGAL BASES FOR
`MYLAN'S PARAGRAPH IV CERTIFICATION WITH RESPECT TO
`U.S. PATENT NOS. 7,041,786; 9,610,321; 9,616,097; 9,919,024; 9,925,231; AND 10,0ll,637
`The manufacture, use, offer to sell, or sale of Mylan' s proposed Plecanatide Tablets, 3mg
`will not infringe any valid and enforceable claim of U.S. Patent Nos. 7,041,786 (the "'786
`Patent"); 9,610,321 (the .. '321 Patent"); 9,616,097 (the '"097 Patent"); 9,919,024 (the "'024
`Patent"); 9,925,231 (the "'231 Patent"); and 10,01 1,637 (the "'637 Patent").
`
`I.
`
`APPLICABLE LEGAL PRINCIPLES
`
`Burdens and Presumption
`A.
`Each claim ofa patent issued by the U.S. Patent and Trademark Office ("USPTO") is
`presumed to be valid; this presumption is independent of the validity of other claims. See
`Microsoft Corp. v. i4i Ltd. Partnership, 564 U.S. 91, 95 (2011) (citing 35 U.S.C. § 282 (2000)).
`A party may overcome this presumption by presenting clear and convincing evidence. Id.
`Although prior art not presented during prosecution "may facilitate meeting the
`challenger's ability to meet the burden of proof on invalidity," the burden of presenting clear and
`convincing evidence by the challenger remains intact and does not change. Atlas Powder Co. v.
`EI Du Pont De Nemours & Co., 750 F. 2d 1569, 1573 (Fed. Cir. 1984); see also i4i, 564 U.S. at
`110-12 (rejecting a fluctuating standard of proof, propounded by the patent owner, by which a
`preponderance of the evidence standard would apply for prior art not considered by the USPTO
`during prosecution of the patent application); Stratojlex, Inc. v. Aeroquip Corp., 713 F.2d 1530,
`1535 (Fed. Cir. 1983). Proving invalidity, however, is not limited to prior art not presented
`during prosecution, and a patent may also be found invalid based upon prior art considered by
`the examiner. Deference to the examiner is provided through the presumption of validity that is
`accorded to issued patents under 35 U.S.C. § 282. E.g., Purdue Pharma L.P. v. Fau/ding, Inc.,
`230 F.3d 1320, 1329 (Fed. Cir. 2000). Thus, a trial court is free to come to a different
`conclusion of patentability from the US PTO on the basis of clear and convincing evidence
`presented to the court. Id.; AK Steel Corp. v. So/lac & Ugine, 344 F.3d 1234, 1245 (Fed. Cir.
`2003).
`
`Invalidity-Obviousness
`B.
`Even if no single reference discloses the claimed invention, a claim may still be found
`invalid by reason of obviousness. Panduit Corp. v. Dennison Mfg. Co., 774 F .2d 1082, 1084
`(Fed. Cir. 1985).
`"Obviousness under 35 U.S.C. § 103 is a mixed question offact and law." ABT Systems,
`LLC v. Emerson Elec. Co., 797 F.3d 1350, 1354 (Fed. Cir. 2015). "While a jury may render a
`decision on � question of obviousness when it is considering any underlying fact questions,
`obviousness is ultimately a question oflaw." Boston Scientific Scimed, Inc. v. Cordis Corp., 5 5 4
`
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`

`CONFIDENTIAL
`Plecanatide Notice Letter
`March 18, 2021
`Page 2
`
`F.3d 982, 990 (Fed. Cir. 2009). Thus, even though a district court can give the legal issue of
`obviousness to an advisory jury to decide, "the ultimate detennination is reserved for the court."
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F. 3d 1342, 1358-S9 (Fed. Cir. 2012).
`In general, a claim is invalid for obviousness if "a skilled artisan would have been
`motivated to combine the teachings of the prior art references to achieve the claimed invention, ..
`and "would have had a reasonable expectation of success in doing so." Pfizer, Inc. "· Apotex,
`Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007). "When the prior art does not expressly disclose a
`claim limitation, 'inherency may supply a missing claim limitation in an obviousness analysis."'
`Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329 (Fed. Cir. 2020), "lnherency is
`established in the context of obviousness when 'the limitation at issue necessarily must be
`present, or the natural result of the combination of elements explicitly disclosed by the prior
`art."' Id. "Extrinsic evidence can be used to demonstrate what is 'necessarily present' in a prior
`art embodiment even if the extrinsic evidence is not itself prior art. Moreover, the work of the
`inventor or the patentee can be used as the evidence of inherency." Id at 1329-30 ( citations
`omitted).
`The motivation to combine need not come from the references themselves nor must it be
`explicitly stat�d, but may reside in the knowledge generally known to one of ordinary skill in the
`art. Takeda Chem. Indus. Ltd v. Alphapharm Pty., Ltd, 492 F.3d 1350, 1357 (Fed. Cir. 2007)
`(citing KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398, 401 (2007)). Additionally, the reasonable
`expectation of success need not be guaranteed or amount to absolute predictability:
`Obviousness does not require absolute predictability of success. Indeed, for many
`inventions that seem quite obvious, there is not absolute predictability of success
`until the invention is reduced to practice. There is always at least a possibility of
`unexpected results that would then provide an objective basis for showing that the
`invention, although ·apparently obvious, was in law nonobvious. For obviousness
`under § l 03, all that is required is a reasonable expectation of success.
`In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988) (citations omitted).
`Furthennore, "[i]f a property of a composition is in fact inherent, there is no question of a
`reasonable expectation of success in achieving it." Hospira, 946 F.3d at 1332.
`"The factual detenninations underpinning the legal conclusion of obviousness include I)
`the scope and content of the prior art, 2) the level of ordinary skill in the art, 3) the differences
`between the claimed invention and the prior art, and 4) evidence of secondary factors, also
`known as objective indicia of non-obviousness." Id. (citing Graham"· John Deere Co., 383 U.S.
`1, 17 (1966)).
`
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`

`CONFIDENTIAL
`Plecanatide Notice Letter
`March 18, 2021
`Page 3
`
`1.
`
`Level of Ordinary Skill in the Art
`
`The hypothetical person of ordinary skill in the art is not an extraordinarily innovative
`person, nor a researcher of inexhaustible patience, but is a person who thinks conventionally in
`matters affecting the art in which he or she is skilled. Standard Oil Co. v. Am. Cyanamid Co.,
`774 F.2d 448, 454 (Fed. Cir. 1985). "Ordinary skill means at least the ability to understand the
`technology and make modest adaptations or advances." See In re Mahurkar Patent Litig., 831 F.
`Supp. 1354, 1374 (N.O. Ill. 1993). Factors that may be considered for determining the level of a
`skilled practitioner include:
`
`1) the educational level of the inventor;
`2) types of problems encountered in the art;
`3) prior art solutions to these problems;
`4) rapidity with which innovations are made;
`5) sophistication of the technology; and
`6) educational level of active workers in the feld.
`
`Daiichi Sankyo, Ltd v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007) (citation omitted}.
`The hypothetical person of ordinary skill in the art is assumed to be aware of all pertinent prior
`art. See, e.g., Standard Oil Co., 774 F.2d at 454.
`
`2.
`
`Scope and Content of the Prior Art
`
`As an initial inquiry under Graham, the scope and content of the prior art must be
`considered. See, e.g., Eolas Techs. Inc. v. Microsoft Corp., 399 F.3d 1325, 1335 (Fed. Cir. 2005)
`(citation omitted); see also MPEP § 2144.08. To be considered within the prior art for purposes
`of the obviousness analysis, a reference must be analogous (i.e., if it is from the same field of
`endeavor or if it is reasonably pertinent to the particular problem the inventor is trying to solve).
`Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331 (Fed. Cir. 2015) (citation omitted}; see also In re
`ICON Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) ("A reference is
`reasonably pertinent if, even though it may be in a different field from that of the inventor's
`endeavor, it is one which, because of the matter with which it deals, logically would have
`commended itself to an inventor's attention in considering his problem." (quoting In re Clay, 966
`.
`F .2d 656, 659 (Fed. Cir. 1992)). A party's admissions may also create valid prior art. See, e.g.,
`In re Font, 675 F.2d 297, 300 (C.C.P.A. l 982) (citation omitted).
`Furthermore, in determining obviousness, pri_or art references, the general knowledge in
`the art, and common sense can be considered. See, e.g., Leapfrog Enterprise Inc. v. Fisher-Price
`Inc., 485 F.3d 1157, 1161 (Fed. Cir. 2007) (affirming district court's invalidation of a claim in
`
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`CONFIDENTIAL
`Plecanatide Notice Letter
`March 18, 2021
`Page 4
`
`view of a combination of prior art references and the knowledge of one of ordinary skill in the
`art); see also KSR, 550 U.S. at 421 ("Rigid preventative rules that deny fact finders recourse to
`common sense, however, arc neither necessary under our case law nor consistent with it."}.
`
`Differences between the Prior Art and the Claimed Invention
`3.
`The differences between the prior art and the scope of the claimed invention must aJso be
`ascertained to detennine those aspects of the claimed subject matter that may be obvious or
`nonobvious against the prior art and the knowledge of a skilled artisan. Graham, 383 U.S. at
`22-23; see also Dystar Textilfarben GmbH & Co. v. Deutsch/and KG v. C.H. Patrick Co., 464
`F.3d 1356, 1369 (Fed. Cir. 2006).
`
`4.
`
`Objective Indicia of Nonobviousness
`
`The strength of the primafacie case of obviousness is weighed against the objective
`indicia of non-obviousness in order to reach the ultimate conclusion of obviousness. Par Phann,
`v. TWi Pharms., Inc., 773 F.3d 1186, 1199 (Fed. Cir. 2014). "Objective evidence of
`nonobviousness can include copying, long felt but unsolved need, failure of others, commercial
`success, unexpected results created by the claimed invention, unexpected properties of the
`claimed invention, licenses showing industry respect for the invention, and skepticism of skilled
`artisans before the invention." Power Integrations, Inc. v. Fairchild Semiconductor
`International, Inc., 711 F. 3d 1348, 1368 (Fed. Cir. 2013) (citing In re Rouffet, 149 F.3d 1350,
`1355 (Fed. Cir. 1998) (collecting cases)). No one factor is dispositive: it is the totality of the
`evidence that must be considered. Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, .1483--
`84 (Fed, Cir. 1997).
`"Unexpected results that arc probative of nonobviousness are those that are 'different in
`kind and not merely in degree from the results of the prior art.,., Galderma -Labs., LP v. To/mar,
`Inc., 737 F.3d 731, 739 (Fed. Cir. 2,013) (quoting Iron Grip Barbell Co. v. USA Sports, Inc., 392
`F.3d 1317, 1322 (Fed.Cir.2004)). "Results which differ by percentages are differences in degree
`rather than kind, where the modification of the percentage is within the capabilities of one skilled
`in the art at the time." Id. For example, increased efficacy, measured by per�entages, have been
`found to be a difference of degree and not of kind. See In re Harris, 409 F.3d 1339, P44
`(Fed.Cir.2005). Likewise, no unexpected results have been found where ranges of reaction time
`and temperature constituted only a difference in degree rather than in kind, In re Budde, 319 F.2d
`242, 246 (C.C.P.A. 1963) or where improved yields over the prior art, measured, by percentages,
`reflect a difference in degree, not in kind. In re Aller, 220 F.2d 454, 456-57 (C.C.P.A. 1955).
`When presented, objective evidence of nonobviousness must always be considered. See,
`e.g., Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 617 F.3d
`1296, 1305 (Fed. Cir. 2010) ("[A] district court must always consider any objective evidence of
`
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`Plecanatide Notice Letter
`March 1 8, 2021
`Page 5
`
`nonobviousness presented in a case.") (emphasis added). But see KSR, 550 U.S. at 415 ("To this
`end, Graham set orth a broad inquiry and invited courts, where appropriate, to look at any
`secondary considerations that would prove instructive.") (emphasis added). Any evidence,
`however, of secondary considerations must have a sufficient "nexus" with the claimed invention.
`See, e.g., Stratojlex, 713 F .2d at 1539 (no nexus between secondary considerations and the
`product of the patent-at issue). The patentee ultimately bears th.is burden of demonstrating a
`nexus between the secondary considerations and the claimed invention. See, e.g., In re GPAC,
`57 F.3d 1573, 1580 (Fed. Cir. 1995).
`
`C.
`
`Invaliditv - lndefmiteness under 35 U.S.C. § 112, Second Paragraph
`-
`·---
`-
`A claim that is indefinite is invalid under 35 U .. S.C. § 112, second paragraph. A claim is
`indefinite if one of ordinary skill in the art is unable to determine its meaning with reasonable
`certainty. Nautilus, 134 S. Ct. at 2123 ("A patent is invalid for indefiniteness if its claims, read
`in light of the patent's specification and prosecution history, fail to inform, with reasonable
`certainty, those skilled in the art about the scope of the invention."). A claim may be indefinite if
`a claim term lacks antecedent basis in the claim or a claim from which it depends. In re
`Packard, 751 F.3d 1307, 1314 (Fed. Cir. 2014). However, antecedent basis is not lacking where
`the claim term refers to structure inherent in a recited claim clement. Bose Corp. v. JBL, Inc.,
`274 F.3d 1354, 1359 (Fed. Cir. 2001) (holding that recftation of "an ellipse" provided antecedent
`basis for "an ellipse having a major diameter" because "[tJhere can be no dispute that
`mathematically an inherent characteristic of an ellipse is a major diameter.")
`
`Non-Infringement
`
`D.
`Proof of direct infringement is necessary for any patent infringement action. For direct
`infringement, 35 U.S.C. § 27J(a) provides that " . . . 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 therefore, infringes the patent."
`
`Determining direct infringement is a two-step process. First, the claim must be properly
`construed to determine its scope and meaning. Markman l 5 2 F.3d at 976. See also, e.g.,
`Rapoport, 254 F.3d at 1 058 (Fed. Cir. 2001). Second, the accused device or process must be
`compared to the claim as properly construed. Id. The patentee bears the burden of proving
`infringement and must demonstrate infringement by a preponderance of the evidence. SRI Int '[,
`775 F .2d at 1123. "Infringement, whether literal or under the doctrine of equivalents, is a
`question of fact." Id; NTP, 418 F .3d at 131 1 . A court generally examines literal infringement
`first. Absent literal infringement, the court would then examine the possibility of infringement
`under the doctrine of.equivalents (assuming such arguments were advanced by the patentee).
`
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`March 18, 2021
`Page 6
`
`Federal Circuit law makes clear that infringement of dependent claims cannot lie where
`non-infringement is found for the corresponding independent claim. See, e.g. , Monsanto Co. v.
`Syngenta Seeds, Inc., S03 F.3d 1352, 1359 (Fed. Cir. 2007), cert. dismissed, 129 S. Ct. 394
`(2008), quoting Wahpeton Canvas Co., Inc. v. Frontier, Inc., 810 F .2d 1546, 1552 (Fed. Cir.
`1989) ("One who does not infringe an independent claim cannot infringe a claim dependent on
`(and thus containing all the limitations of) that claim."). "It is axiomatic that dependent claims
`cannot be found infringed unless the ciaims from which they depend have been found to be
`infringed." Wahpeton, 870 F.2d at 1553. Thus, once an assessment that a product does not
`infringe an independent claim is made, the dependent claims, which include the limitations of the
`independent claims, would not be infringed for the same reasons.
`
`Literal Infringement Analysis
`l .
`To be liable for direct infringement, every limitation or its equivalent of the asserted
`claim must be present in the accused device or every step or its equivalent of the asserted claim
`must be practiced. See, e.g., Becton Dickinson & Co. v. C.R. Bard, Inc., 922 F.2d 792, 796 (Fed.
`Cir. 1 990); Monsanto Co. v. Syngenta Seeds, Inc. , 503 F.3d 1 352, J 359 (Fed. Cir. 2007).
`
`2.
`
`Infringement under the Doctrine of Equivalents
`
`To prove infringement under the doctrine of equivalents, the patentee must show that an
`accused product or process contains every element of the patented invention or its substantial
`equivalent. Warner-Jenkinson Co, Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 40 ( 1997).
`It is important to note that in applying the doctrine of equivalents, some meaning for each
`limitation in a claim must be maintained in order to preserve the boundaries of the invention's
`patent protection: Because "[e]ach element contained in a patent claim is deemed material to
`defining the scope of the patented invention, . . . . [t]he doc�e of equivalents must be applied to
`individual elements of the claim, not to the invention as a whole." Warner-Jenkinson, 520 U.S.
`at 29. Accordingly, there should be no infringement if a claim element is totally missing from
`the accused device. See, e.g., Novartis Pharms. Corp. v. Abbott Labs. , 375 F.3d 1328, I 338
`(Fed. Cir. 2004). There are a number of general principles related to the doctrine of equivalents
`that are discussed below: the tri-partite test, the all element rule, prior art limitation, unclaimed
`subject matter, and prosecution history estoppeJ.
`
`i. The Tri-Partite Test rr,-;,,/e Identitv Test)
`There are several ways of detennining whether an element in the accused device is
`substantially equivalent to a corresponding element in the patented invention. Equivalency is
`determined based on the interchangeability of the claimed element and the accused element at
`the time of the infringement. Warner-Jenkinson Co, Inc. at 37-38. Equivalency may also be
`
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`Page 7
`
`found indirectly by detennining if the accused element plays a role substantially different from
`the claimed element. Id at 40.
`The ''tri-partite test" or "triple identity test" is a commonly used test to detennine whether
`a patentee can receive protection under the doctrine of equivalents. Under the triple identity test,
`the patentee must establish by a preponderance of the evidence that the accused device perfonns
`substantially the same function in substantially the same way to obtain substantially the same
`result as the claimed invention. Warner-Jenkinson, 520 U.S� at 39-40. Depending on the
`underlying facts of the case, the patentee in certain circumstances may be able to meet its burden
`of proof by showing the known interchangeability of the accused and claimed elements to
`persons reasonably skilled in the art, or by a showing that the accused infringer copied the
`claimed device with only insubstantial changes. Id. at 40. Accordingly, a finding of a
`substantial difference precludes the possibility of infringement under the doctrine of equivalents.
`
`ii. The All ElemenJs Rule
`The "all-elements rule" acts as a limitation on the application of the doctrine of
`equivalents. It precludes reliance on the doctrine "if applying the doctrine·would vitiate an entire
`claim limitation." Asyst Techs., Inc. v. Emtrak, Inc. , 402 F.3d 1188, 1195 (Fed. Cir. 2005).
`There can be no infringement under the doctrine of equivalents if even a single limitation in the
`claim or its substantial equivalent is missing from the accused composition or device. See, e.g.,
`Lockheed Martin Corp. v. Space Systems/Loral, Inc., 324 F.3d 1308, 1321 (Fed. Cir. 2003); Bell
`Atl. NetworkServ., Inc., 262 F.3d at 1280; Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d
`931, 935 (Fed. Cir. 1987) (en bane), overruled in part on other grounds, 508 U.S. 83 (1993).
`The "substantially the same way'' prong of the Triple Identity Test cannot be satisfied if
`an equivalent of a recited claim limitation is missing in the accused device. Corning Glass
`Works, 868 F.2d at 1259. Thus, the question of insubstantiality of the differences is inapplicable
`if a claim limitation is totally missing from the accused device. Warner-Jenkinson, 520 U.S. at
`· 33-34; Pennwalt, 833 F .2d at 934-35. Moreover, "the concept of equivalcncy cannot embrace a
`structure that is specifically excluded from the scope of the claims." Dolly, Inc. v. Spalding &
`Evenjlo Cos., 16 F.3d 394, 400 (Fed. Cir. 1994).
`
`Prior Art Limitations on the Doctrine of Equivalents
`iii.
`The prior art may act as a limitation on the application of the doctrine of equivalents
`where a hypothetical claim including the asserted equivalent would have been anticipated or
`obvious over the prior art. Marquip, Inc. v. Fosher Am., Inc., 198 F.3d 1363, 1367 (Fed. Cir.
`1999); Wilson Sporting Goods v. David Geoffrey & Assoc., 904 F.2d 677, 683 (Fed. Cir. 1990).
`
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`Prosecution Histoo' Estoimel
`iv.
`The doctrine of prosecution history estoppel limits the degree to which the patentee may
`rely on the doctrine of equivalents. "Prosecution history estoppel requires that the claims of a
`patent be interpreted in light of the proceedings in the PTO during the application process."
`Festo VIII, 535 U.S. at 733, on remand lo, FestoX 344 F.3d 1 359, 1366 (Fed. Cir. 2003)
`(reinstating previous holding that "a narrowing amendment made to comply with any provision
`of the Patent Act, including § 112, may invoke an estoppel."). The patentee cannot contradict or
`ignore arguments made before lhe PTO during the prosecution of the patent application. An
`amendment narrowing the patent claim in order to receive PTO approval may give rise to an
`estoppel. Festo Vll/, 535 U.S. at 733. "The doctrine of equivalents is premised on language's
`inability to capture the essence of innovation, but a prior application describing the precise
`element at issue undercuts that premise." Jd. at 734. The patentee cannot recapture through
`equivalents certain coverage given up during prosecution. See, e.g., Wang Lab. v. Mitsubishi
`Elecs. Am., 103 F.3d 1571, 1577 (Fed. Cir. 1997). Thus, for a full appreciation of the scope of
`any claim, reference should be made to the written record of the administrative procedures
`conducted in the PTO when the patent was granted. Id.
`Prosecution history estoppel may arise as a result of amendments that narrow the scope of
`a claim. Festo VIII, 535 U.S. at 734. A narrowing amendment by a patentee occurs either when
`"a preexisting claim limitation is narrowed by amendment'• or when "a new claim limitation is
`added by amendment." Honeywell Int '/ Inc. v. Hamilton Sundstrand Corp., 370 F.3d l 131, 1 140
`(Fed. Cir. 2004). There is no distinction between the two and each creates a presumptive
`estoppel if made for a purpose related to patentabj)jty. Id.
`A presumption of surrender also applies where a patentee rewrites a dependent claim into
`independent fonn, cancels the original independent claims and the amendment constitutes a
`narrowing amendment. Id at 1 141. The fact that the scope of the new rewritten independent
`claim is unchanged does not "preclude the application of prosecution history estoppel if . . . the
`scope of subject matter claimed in the [ original] independent claim has been narrowed to secure
`the patent." Id. at J 142. Narrowing amendments create a rebuttable presumption of estoppel.
`Festo VIII, 535 U.S. at 738-40. The patentee bears the burden of overcoming this presumption
`by "showing that the amendment does not surrender the particular equivalent in question." Id.
`The presumption can be overcome if 1he patentee demonstrates that the equivalent was
`unforeseeable at the lime of the amendment, the rationale underlying the amendment bears no
`more than a tangential relation to the equivalent in question, or there is some other reason
`suggesting that the insubstantial substitute in question could not reasonably have been expected
`to be described by the patentee. Id. at 738-40. "[R]ebuttal of the presumption of surrender is a
`question of law to be detennined by the court, not a jury." Festo X 344 F.3d at 1367.
`
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`v. Festo Exception: Foreseeable Equivalents
`
`Whether an equivalent is foreseeable requires inquiry into the relevant prior art known to
`one of ordinary skill in the art at the time the amendment was made. Festa Corp. v. Shoketsu
`Kinzoku Kogyo Kabushiki Co., Ltd., 493 F.3d 1368, 1378 (Fed. Cir. 2007) ("Festo XI'').
`Foreseeability, thus, is tied to "whether the applicant would have been expected to know of, and
`thus properly claim, the proposed equivalent at the time of the amendment." Smith/dine
`Beecham Corp. v. Excel Pharms., Inc., 356 F.3d 1357, 1 364 (Fed. Cir. 2004) (citing Festo VIII.
`53S U:S. at 740). Accordingly, the Federal Circuit has stated that "an alternative is foreseeable if
`it is known in the field of the invention as reflected in the claim scope before amendment " and
`that it would be inappropriate to apply an insubstantial differences test in order to detennine
`foreseeability. Feslo XI, 493 F.3d. at 1379 (emphasis added) . Furthermore, in demonstrating
`unforseeability at the time of the amendment, a patentee must show that the alleged equivalent
`would have been unforeseeable to a person of ordinary skill in the art - an objective inquiry.
`Festo X, 344 F.3d. at 1369.
`
`vi. Festa Excention: Tangential Relationship
`
`Determination of a "tangential relationship" in the context of prosecution history estoppel
`requires that "a patentee demonstrate that 'the rationale underlying the