VIA FEDERAL EXPRESS
`TO: Joseph C. Papa
`Chairman & CEO
`Bausch & Lomb Inc.
`Bausch Health Companies, Inc.
`400 Somerset Corporate Blvd.
`Bridgewater. NJ 08807
`
`President
`Bausch & Lomb. Inc,
`1400 North Goodman Street
`Rochester, NY 14609
`
`Wood, Phillips, Katz, Clark & Mortimer
`Attn: Mark V. Polyakov
`500 W. Madison Street
`Suite 1130
`Chfcago, IL 60661-2562
`
`Robert D. Rowlett
`Founder & Chief Executive
`Eye Theraples. LLC
`26933 Camino De Estrella. 2nd FL
`Dana Point, CA 92624
`
`FROM:
`
`Slayback Pharma LLC
`
`DATED:
`
`August 13, 2021
`
`NOTICE OF PARAGRAPH IV CERTIFICATION RE: SLAYBACK
`PHARMA LLC'S BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION,
`0.025%; U.S. PATENT NOS. 8,293,742 and 9,259,425
`
`RE:
`
`Dear Sirs:
`
`Pursuant to § 505Q)(2)(B)(ii) and § 505U)(2)(B)(iv) of the Federal Food, Drug and
`Cosmetic Act ("the Act") and § 314.95 of Title 21 of the Code of Federal Regulations
`("C.F.R."), please be advised that Slayback Pharma LLC ("Slayback") has filed a patent
`certification pursuant to § 5050)(2)(A)(vii)(IV) of the Act and § 314.94(a)(12)(i)(A)(4) of
`Title 21 of the C.F.R in support of its Abbreviated New Drug Application ("ANDA") No.
`216361 with respect to Slayback's proposed Brimonidine Tartrate Ophthalmic Solution,
`0.025% ("Slayback's proposed product"). Slayback seeks to obtain approval to engage
`in the commercial manufacture, use, or sale of Slayback's proposed product before the
`expiration of U.S. Patent Nos. 8,293,742 ("the '742 patent") and 9,259,425 ("the '425
`patent"). We understand that the holder of the application under§ 505(b) of the Act ("New
`Drug Application" or "NDA") No. N208144 in connection with brimonidine tartrate
`ophthalmic solution/drops, 0.025%, (reference listed drug: LUMIFY®) is Bausch and Lomb
`Inc. ("Bausch and Lomb"). We further understand based on information available 1n the
`United States Patent and Trademark Office ("USPTO'') patent assignments database that
`Eye Therapies. LLC ("Eye Therapies") 1s the assignee of the '742 and '425 patents and
`we understand from the USPTO Public Pair database that Wood, Phillips, Katz, Clark &
`Mortimer are the attorney correspondents.
`
`Slayback Pharma LLC, 301 Carnegie Center, Suite 303, Princeton, NJ 08540, USA Ph: + 1 609-945 -3443
`www.slayback pharina.corn
`
`

`

`Pursuant to § 505U)(2)(B)(iv) of the Act and 21 C.F.R. § 314.95(c), Slayback
`provides the following information:
`
`(1)
`
`(2)
`
`(3)
`
`(4)
`
`(5)
`
`(6)
`
`(7)
`
`The U.S. Food and Drug Administration CFDA") has received an ANDA
`required bioavailability or
`submitted by Slayback containing any
`bioequ1valence data or information with respect to brimonidine tartrate
`ophthalmic solution, 0.025%:
`
`The ANDA number is 216361 ;
`
`Slayback has received the Paragraph-IV acknowledgment letter for its
`ANDA No. 216361 from the FDA;
`
`The established name of the proposed drug product, as defined in
`§ 502(e)(3) of the Act, is ~brimonidine tartrate ophthalmic solution. 0.025%";
`
`The active ingredient of Slayback's proposed product is 5-bromo-N-(4,5-
`dihydro-lH-imidazol-2-yl)-6-quinoxalinamine L-tartrate, commonly known as
`brimonidine tartrate: the dosage strength is 0. 025%: and the dosage form
`,s an ophthalmic solution;
`
`The U.S. patent numbers and expiration dates of the patents listed in the
`electronic version of the FDA publication Approved Drug Products with
`Therapeutic Equivalence Evaluations ("Orange Book") for LUMIFY®, as
`known to Slayback, alleged to be invalid, unenforceable, or not infringed
`are:
`
`Patent No.
`
`Expiration Date
`
`8,293,742
`9,259,425
`
`July 14, 2030
`July 14, 2030
`
`Slayback certified with the FDA pursuant to§ 505U)(2)(A)(vii)(IV) of the Act
`and 21 C.F.R. § 314.94(a)(12)(i)(A)(4) ("Paragraph IV Certification") that the
`'7 42 and '425 patents are invalid, unenforceable, or will not be infringed by
`the manufacture, use, or sale of Slayback's proposed product for which
`Slayback has submitted its ANDA Therefore, pursuant to 21 U.S.C §
`355U)(2)(B)(iv)(ll) and 21 C.F.R. § 314.95(c)(7), a detailed statement of the
`legal and factual basis for the Paragraph IV Certification is enclosed
`herewith and is made a part hereof. The information detailed in this letter
`and the attached memorandum is supplied for the sole purpose of
`complying with the above-referenced statutes and regulations, and neither
`Slayback nor its attorneys waive any attorney-client privilege or attorney
`work product
`immunity concerning
`the subject matter of
`this
`communication; and
`
`Slayback Pharma LLC, 301 Carnegie Center, Suite 303, Princeton, NJ 08540, USA Ph + 1 609-945 -3443
`www.slaybacl<-pharma.com
`
`

`

`(8)
`
`Slayback reserves its right to supplement this letter and the attached
`memorandum detailing the factual and legal basis for Slayback's assertion
`of invalidity, unenforceability, or non-infringement of the above listed
`patents should subsequent investigations reveal additional grounds for
`asserting invalidity, unenforceability, or non-infri ngement.
`
`Offer of Confidential Access:
`In addition to and not in lieu of the limitations
`contained in 21 U.S.C. § 3550)(5)(C)(i)(III) (as amended December 8, 2003) and pursuant
`to 21 C.F.R. § 314.95(c)(8), Slayback hereby offers confidential access to only those
`portions of Slayback's ANDA that, in Slayback's judgment, are needed by Bausch and
`Lomb and/or Eye Therapies to determine whether an action under Section 355 should be
`filed within the statutory 45 days of the receipt of this letter. Access to the information is
`and shall be limited to only those attorneys acting as outside counsel for Bausch and
`Lomb and/or Eye Therapies that are needed to evaluate the information, and such
`persons who are to have access shall be identified to Slay back's outside counsel, Andrew
`J. Miller, Esq. at Windels Marx Lane & Mittendorf, LLP, One Giralda Farms, Madison, NJ
`07940 (e-mail: amiller@windelsmarx.com) before access is granted. Such persons so
`identified shall agree in writing that the information can and only will be used to determine
`whether an action under Section 355 should be filed within the statutory 45 days of the
`receipt of this letter. Those persons receiving access to Slayback's ANDA materials shall
`not engage, formally or informally, directly or indirectty ,n. any work (prosecution or post4
`issuance) before any patent office, including the USPTO, relating to brimonidine or its
`salts; or in any counseling, litigation or other work before or involving a regulatory agency,
`including the United States FDA. relating to brimonidine or its salts. Slayback's ANDA
`materials and any tangible form of information derived from a review of the ANDA
`materials shall be destroyed, with notlce to Slayback's outside counsel, within the
`statutory 45 days of receipt of this letter or upon the filing of an action against Slayback,
`whichever is earlier. Pursuant to 21 C.F.R. § 314.95(c)(8), by providing this Offer of
`Confidential Access, Slayback maintains the right and ability to bring and maintain a
`Declaratory Judgment action under 28 U.S.C. §§ 2201 et seq., pursuant to 21 U.S.C §
`3550)(5)(C).
`
`Slayback Pharma LLC, 301 Carnegie Center, Suite 303, Princeton, NJ 08540, USA Ph: + 1 609·945· 3443
`www.slaybac< pharmr1.crnn
`
`

`

`Attached hereto is a memorandum setting forth Slayback's detailed statement of
`the factual and legal basis supporting its Paragraph IV Certification.
`
`n ·n
`L
`By: ( \ \q...,t. ·~~~
`Ajay K. Singh
`Chief Executive Officer
`Slayback Pharma LLC
`301 Carnegie Center, #303
`Princeton, NJ 08540
`
`Slayback Pharma LLC. 301 Carnegie Center, Suite 303, Princeton, NJ 08540, USA Ph: + 1 609-945-3443
`www.slayback · RDM..!llil.J:Rm
`
`

`

`Bausch & Lomb lnc.
`Eye Therapies, LLC'
`Wood, Phillips, Katz, Clark & Mortimer
`August 13, 2021
`Page 5 of 43
`
`DETAILED STATEMENT OF FACTUAL AND LEGAL BASIS FOR SLA \'BACK'S
`ASSERTION OF INVALIDITY, UNENFORCEAHILITV OR NON-INFRINGEMENT
`OF U.S. PATENT NOS. 8,293,742 and 9,259,425
`
`I.
`
`INTRODUCTION
`
`Pursuant to § 505(i)(2)(B)(iv)(II) of the Federal Food, Drug, and Cosmetic Act ("the
`
`Act") (codified at 21 U.S.C § 355(i)(2)(B)(iv)(ll)) and 21 C'.F.R. § 314.95(c)(7), given below 1s
`
`the detailed factual and legal basis for Slayback's Paragraph IV Certification alleging that U.S.
`
`Patent Nos. 8,293,742 ("the '742 patent") and 9,259,425 (''the · 425 patent") are invalid,
`
`unenforceable, or will not be mfrmged by the manufacture, use or sale of Slayback's proposed
`
`product described m its ANDA No, 216361.
`
`The defenses herein are stated in the alternative Nothing herem 1s or should be
`
`construed to be an admission with respect to the claim construction of any claim of the '742 or
`
`'425 patents, that any claim of the '742 or '425 patents is valid or infringed, or that any claim of
`
`the '742 or '425 patents is enabled by, or has written description in, the respective application
`
`from which those patents issued or any application in their respective chain of claimed priority.
`
`II.
`
`LEGAL PRINCIPLES
`
`A.
`
`Law of Infringement
`
`The test for infringement ofa patt.!nt 1s set forth in .1 5 U SC.* 27l(a).
`
`(a) [w]hoever \Vlthout authority makes, uses, offers to sell or sells any
`patented invention, within the United States or imports into the United
`States any patented invention dunng the term of the patent therefor,
`infringes the patent.
`
`(K02.7ll5:l-1'21
`
`

`

`Bausch & Lomb lnc.
`Eye Therapies, LLC
`Wood, Phillips, Katz. Clark & Mortimer
`August 13, 2021
`Page 6 of 43
`
`I. Claim Construction
`
`The first step in an mfrmgement analysis 1s to ascertain the meaning and scope of the
`
`claims. SeC', e.g., Process Control Co17,. ,, Hydrec:laim Cow , 190 F.3d 1350 (Fed. Cir.
`
`1999). The "ultimate interpretation" of a patent claim "is a legal conclusion." Tem Pharms.
`
`USA, Inc.:. ,,
`
`,\'a,uloz. Inc., 135 S. Ct. 831 , 841 (2015); !l·ce also Markman ,, Wes11·ic11·
`
`lnstn1111e111s, 52 F.3d 967, 976 (Fed. Cir. 1995) (en hanc), qff"d, 517 U.S. 370 (1996).
`
`Construction of a claim term involves evaluating ''the term's plain and ordinary meaning as
`
`understood by a person of ordinal)' skill in the art." Allergan, Inc. v. Apu1ex. Inc., 754 F.3d 952,
`
`957 {Fed. Cir 2014). , ·11111g, Pl111/1p.\ 1· AWJ-1 <"017, .. ~II S F .hi 1303, 1.313 (Fed Cir. 2005) (L'II
`
`ham:). The ordinal)' and customaty meaning of a claim term 1s the meaning that a person of
`
`ordinary skill in the art in question, at the time of invention, would have understood the drum to
`
`mean. Phillips, 415 F.3d at 1313. The sources available to understand disputed claim language
`
`include the words of the claims themselves, the remainder of the specification, the prosecution
`
`histol)', and extrinsic evidence, including relevant scientific principles, the meaning of technical
`
`terms, and the state of the art. hi. at 13 14
`
`"[C)la1m construction involves consideration of primarily the intrinsic evidence, l'iz., the
`
`claim language, the speciticat1on, and th~ prosccuuon lw;tory '"
`
`//1m1.~ ln.H1w11e111s. Inc 1·
`
`Na111il11s. Inc., 783 F 3d 1374, 1378 (Fed. Cir. 2015) (c1tauon omitted). lndeed, "the best source
`
`for understanding a technical term is the specification from which it arose, informed, as needed,
`
`by the prosecution histoty." Philftps, 4 I 5 F.3d at 1315, quoting Multi Form Desiccants, Inc. 1·
`
`Medzam. Ltd., 133 F 3d 1473, 1478 (Fed. Cir 1998) Along with the specification and the
`
`tM0270514 .:?I
`
`

`

`Bausch & Lomb Inc.
`Eye Therapies, LLC
`Wood, Phillips, Katz, Clark & Mortimer
`August 13, 2021
`Page 7 of 43
`
`prosecution history, 111 some cases. a court will be required "to consult extrinsic evidence in
`
`order to understand, for example, the background science or the meaning of a term in the
`
`relevant art during the relevant time period" Tem, 135 S. Ct. at 841 . "Though the ultimate
`
`construction of a claim term is a legal question reviewed de novo, underlying factual
`
`determinations made by the district court based on extrinsic evidence are reviewed (by the
`
`appellate court] for clear error.'' Biosig, 783 F.3d at 1378, citing Teva, 135 S. Ct. at 842
`
`2. Liternl Infringement
`
`Literal infringement 1s found where an accused product or process falls within the scope
`
`of the asserted claims as properly interpreted. So11J/111all Techs .. Inc. v. Cardinal !G Co., 54 F.3d
`
`1570, 1575 (Fed Cir. 1995). The application of a patent claim to an accused product or process
`
`1s a question of fact. J'ri/ogy Commc '11s. Inc. 1• Times Fiber Co111111c 'm·. Inc., I 09 F.3d 739, 741
`
`(Fed. Cir. 1997). For literal infringement, each limitation m an asserted claim must be found
`
`present in the accused product or process. General Mills. Inc. v. H11111-Wesso11. Inc., I 03 F.Jd
`
`978, 981 (Fed. Cir. 1997); 1i·ansocean Ojf.~Jwre Deep1ra1er Drilling. Inc. 1•. Maersk Dnllmg
`
`Uni1ed Slates, Inc., 699 F.3d 1340, 1356 (Fed. Cir. 2012), citing Su111hwa/l, 54 F.3d at 1575 ('To
`
`establish literal mfnngement, every l1m1tation set forth in a claim must be found m an accused
`
`product, exactly.").
`
`3. Infringement Undel' the Doctrine of Equivalents
`
`Infringement may also be found under the Judicially created doctrine of equivalents. The
`
`doctrine of equivalents requires asking if an accused product contains element(s) equivalent to
`
`each claimed element of the patented invention. Warner-Jenkinson Co. v. Hi/1<m /)m•is ('hem.
`
`1)!027115-',1·21
`
`

`

`Bausch & Lomb Inc.
`Eye Therapies, LL('
`Wood, Phillips, Katz, Clark & Mortimer
`August 13, 2021
`Page 8 of 43
`
`Co., 520 U.S. 17, 29, 40 ( 1997). One test for whether an element is equivalent is whether the
`
`substitute element performs substantially the same function; way and result of the claimed
`
`element, or whether the substitute element plays a role substantially different from the claimed
`
`element Id : ( in11·cr Tank & A-Jf.v,. ( ·o ,. /,1,uf,., Au- !'nu/.\ ( ·o . 339 US. 605, 608 ( I 950).
`
`There are several limits on the use of doctrine of equivalents For example, the range of
`
`equivalents may not be expanded to cover the prior art. W,lson Sporting Goods \'. Da11id
`
`Geq{frey & As.we., 904 F.2d 677, 684-85 (Fed. Cir. 1990) (the doctrine of equivalents cannot be
`
`extended to ensnare what is in the prior art). In addition, claims may not be expanded by the
`
`doctrine of equivalents to capture unclaimed, but disclosed, subject matter. "[A] patentee cannot
`
`narrowly claim an invention to avoid prosecution scrutiny by the PTO, and then, after patent
`
`issuance, use the doctrine of equivalents to establish mfrmgement because the specification
`
`d1sclo'ies eqwvalents.'' Jol,11.wn ,\.'· .lohm-1011 A .1wc1 1·. U.H. Sen•. Co. 285 F.Jd 1046, 1054
`
`(Fed. Ctr. 2002) (en heme.:).
`
`Prosecution history estoppel also limits the expansion of claim scope under the doctrine
`
`of equivalents. Phanuacia & Upjohn Co. 1•. Mylan !'harms., Inc., 170 F.3d 1373, I 376-77 (Fed.
`
`Cir. 1999). Prosecution history estoppel comes rnto play after no literal infringement has been
`
`found, and limits the expansion of claim scope under the doctrine of equivalents
`
`Id.
`
`"Prosecution history estoppel precludes a patentee from obtaining under the doctrine of
`
`equivalents coverage of subJect matter that has been relinquished during the prosecution of us
`
`patent application"
`
`Id at I J7b. The rcle\'ant prosecution l11s tory includes the parent or
`
`grandparent apphcauons, as well as related applications Mark I. Markermg ( 'm71. ,·. RR.
`
`

`

`Bausch & Lomb Inc.
`Eye Therapies, LLC
`Wood, Phillips, Katz, Clark & Mortimer
`August 13, 2021
`Page 9 of 43
`
`/Jmmelly & Som Co, 66 F,3d 285, 291 (Fed. Cir. 1995); .fons.wn v. Stanley Works, 903 F.2d
`
`812, 818 (Fed. Cir. 1990). l11e Supreme Court explained the purpose of prosecution history
`
`estoppel as follows:
`
`Prosecution history estoppel ensures that the doctrine of equivalents
`remains tied to its underlying purpose Where the original application
`once embraced the purported equi valent but the patentee narrowed his
`claims to obtain the patent or to protect 11s validity, the patentee cannot
`assert that he lacked the words to describe the subject matter in question.
`The doctrine of equivalents 1s premised on language's inability to capture
`the essence of innovation, but a prior application describing the precise
`element at issue undercuts that premise. In that instance the prosecution
`history has established that the inventor turned his attention to the subject
`matter in question. knew the words for both the broader and narrower
`claim, and aftirmauvely chose the latter.
`
`Festo Corp. 11• Shoketsu Kinzoku Kogyo Kahushiki Co., 535 U.S. 722, 734-35 (2002).
`
`Finally, if an independent claim is not infringed, then the narrower claims that depend
`
`from 11 cannot be infringed. An independent claim stands alone, while a dependent claim
`
`111corporates the l1m1tation~ of the clatm(s) from which it depends
`
`··A claim in dependent form
`
`shall contain a reference to a claim prev10usly set forth and then specify a further limitation of
`
`the subject matter claimed. A claim in dependent form shall be construed to incorporate by
`
`reference all of the limitations of the claim to winch 1t refers." 35 U.S.C. § 112. " It is axiomatic
`
`that dependent claims cannot be found infrmged unless the claims from which they depend have
`
`been found to have been infringed." Wahpe!On Canvas Co .. ,. Frontier. Inc., 870 F.2d 1546,
`
`I 553 (Fed. Cir. 1989).
`
`

`

`Bausch & Lomb Inc.
`Eye Therapies, LLC
`Wood, Phillips, Katz, Clark & Mortimer
`August 13, 2021
`Page 10of43
`
`4. Induced Infringement
`
`35 U.S.C. § 271(b) provides that ''whoever actively induces infnngement of a patent shall
`
`be liable as an infringer." According to the United States Supreme Court, "induced infringement
`
`under § 27l(b) requires knowledge that the induced acts constitute patent infringement."
`
`Global-Tech Appliances. inc. v. SEB S.A ., 563 U.S. 754, 766 (2011 ). Liability for inducement of
`
`111rnngement •'may anse '11'. but only 11: (there 1s]
`
`direct 1nfnngemen1 .. /,1111l'ligh1 Nclll'orh.
`
`Inc. 1·. Akamai Techs .. Inc., 572 U.S. 915,921 (2014) (citation omitted; alteration in the original).
`
`''Inducement requires a showing that the alleged inducer knew of the patent, knowingly
`
`induced the mfrmgmg acts, and possessed a specific intent to encourage another's mfnngement
`
`of the patent " V11a-M1.,· Co17, v. Basic Holdmg. Inc.:., 581 FJd 1317, 1328 (Fed. Cir. 2009),
`
`citing DSU Med. Coq,. 11 • • IMS Co., 471 F.3d 1293, 1306 (Fed. Cir. 2006) (en bane in pertinent
`
`part). "The mducement rule
`
`.. premises liability on purposeful, culpable expression and
`
`conduct. ... " Metro-Goldll'yn-MayerStudios Inc. , .. Grokster, Ltd, 545 U.S. 913,937 (2005).
`
`The Supreme Court "has clarified that the mtent rl.!quirement for inducement requires
`
`more than Just intent to cause the acts that produce direct infringement. Beyond that threshold
`
`knowledge, the inducer must have an affirmative intent to cause direct infringement." DSU, 471
`
`F.3d at 1306, cit in~ Grohrcr. "The 'mere knowledge of possible infringement by others does
`
`not amount to inducement; specific intent and action to induce mfringement must be proven ....
`
`Id at 1305, quoting Warner-Lambert Co. v. Apotex Corp., 316 FJd 1348, 1364 (Fed. Cir. 2003 );
`
`see also Grokster, 545 U.S. at 93 7 ("mere knowledge of infringing potential or of actual
`
`1nfnngmg uses would not be enough here to subJect a d1stnbutor to hab1l1ty"). Moreover,
`
`

`

`Bausch & Lomb Inc.
`Eye Therapies, LLC
`Wood, Phillips, Katz, Clark & Mortimer
`August 13, 2021
`Page 11 of 43
`
`·'[s]uch intent cannot be inferred merely based upon selling a product where that product has
`
`substantial non-infringing uses." Acorda 17,erapemics Inc. v. Apotex Inc., No. 07-4937, 2011
`
`WL 4074116, at * 14 (D.N.J. Sept. 6, 201 I) (citations omitted). ajf'd witho111 opinum, 476 F.
`
`App'x 746 (Fed. Cir. 2012).
`
`The Federal Circuit has reiterated that the "sale of a lawful product by lawful means, with
`
`the knowledge that an unaffiliated, third party may infringe, cannot, in and of itself, constitute
`
`mducement of mfrmgement." Takeda />harms. ll.S.A. /11e,•. v. West-Ward Phann. Corp., 785
`
`F Jd 025, 6.W (Fed Cir 2015 ), c11101111g 1Jy11awrc /-loldm,rJ,., ( '0111 1·
`
`l I S JJ/11/tps ( ·0171, 363
`
`F 3d 1263, 1276 n.6 (Fed. Cir. 2004).
`
`The Supreme Court has recognized that providing instructions for using a product could
`
`constitute "active steps" that would support a finding of intent to induce mfringement. Grokstcr,
`
`545 U.S at 936 The issue 1s whether the "instructions teach an infringing use of the device such
`
`that we are willing to infer from those instructions an affirmative intent to infringe the patent."
`
`Vita-Mix, 581 F.Jd at 1329 n.2.
`
`In V11a-Mix, the Federal Circuit recognized that product
`
`instructions (there, directions for operating a blender) did not evidence a specific intent to
`
`encourage infnngement because they taught a stirring action that the defendant "could have
`
`reasonably believed was non-infnngmg " Id at 1329. After being apprised of the patentee' s
`
`infringement contentions (before suit was filed), the accused mfnnger amended its mstructions to
`
`''teach an und1sputedly non-infringing use,'' which the court said "evidenc[ ed] an mtent to
`
`discourage infringement.'' Id (emphasis added)~ see a{!;o h:,·crgcn C.:017,. 1·. Wal-Mart Store.\,
`
`Inc., 575 F.3d 1312, 1322 (Fed. Cir. 2009) (reversing jury verdict of inducement where "any
`
`

`

`Bausch & Lomb Inc.
`Eye Therapies, LLC
`Wood, Phillips, Katz, Clark & Mortimer
`August 13, 2021
`Page 12 of 43
`
`customer who actually followed [the accused 111frmger'sj 111struct1ons would not have performed
`
`the steps recited in the asserted claims .. ).
`
`In the Hatch-Waxman context, "the question of induced infringement turns on whether
`
`[the alleged infringers] have the specific intent, based on the contents of their proposed labels, to
`
`encourage physicians to use their proposed ANDA products to [practice the claimed method of
`
`treatment."]. Grunemhal GmbH v Alkem Lahoralorics I.Id., 919 F.3d 1333, 1339 (Fed. Cir.
`
`2019) (citing Takeda, 785 F.3d at 631. To induce infringement "[t]he [ANDA product] label
`
`must encourage, recommend, or promote infringement." Takeda, 785 F.3d 625 at 631 . In
`
`detenrnrnng induced mf'nngement. tht! federal C1 rcu11's ··111qu1ry focuses on whether the
`
`instructions reflect an •affirmative' or 'specific intent to encourage infringement."' HZNP
`
`t,.,fcdidnes v. Aclavis Lah 's u·,: Inc:., 940 F.3d 680, 702 (Fed. Cir. 20 I 9), quoting Vila-Mix, 58 I
`
`F.3d at 1329 n.2.
`
`'/'aA-eda, 785 F.3d at 631. "[V]ague label language cannot be combined with speculation
`
`about how physicians may act to find inducement" because this "would seem to too easily
`
`transform that which we have held is 'legally irrelevant.' [in] Wamer-Lambcn, 316 F.Jd at
`
`1364--mere knowledge of infringing use--into induced infringement." Takeda, 785 F.3d at 632.
`
`Indeed, as the Federal Circuit recogrn zed 111 1akeda .
`
`This requirement of inducing acts is particularly important
`in the Hatch-Waxman Act context because the statute was
`designed to enable the sale of drugs for non-patented uses even
`though this would result in some off-label infringing uses See
`Camc:o [JJ/1am1. Labs, Lid r. Nm·o NordH·k AS, 566 U.S. 399,
`4 I 4-4 J 5 (2012)) ("Congress understood [that] a smgle drug may
`have muluple methods of use, only one or some of which a patent
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`I H02705~4'2 l
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`covers" and that the statute "contemplates that one patented use
`will not foreclose marketing a generic drug for other unpatented
`ones."); Warner-Lamber/, 316 F.3d at 1359 ("the Hatch-Waxman
`Act was not mlended "as a sword against any competitor's A DA
`seeking approval to market an off-patent drug for an approved use
`not covered by the patent.").
`
`Id at 631-32. In the Hatch Waxman context. non-indicated results in patients treated for an
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`indicated use are not the basis of induced infringement. Bayer Sc/wring Phan11a AG v. Lupin
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`l.td , 676 F.3d 131 6, 1321-22 (Fed. Cir. 20 12) (no induced infringement based on non-FDA
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`approved results).
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`5, Contributory Infringement
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`Contributory infringement liability arises under 35 U S.C. ~ 27l(c), which reads as follows:
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`Whoever offers to sell or sells within the United States or
`imports into th e United States a component of a patented maclune,
`manufacture. comb1nat1on or composit1011, or a material or
`apparatus for use m pract1cmg 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 commodtly of commerce suitable
`for substantial noninfringing use, shall be liable as a contributory
`infringer.
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`The existence of a substantial non-infringing use defeats a claim for contributory
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`infringement as a matter of law. Vita-Mix, 581 F.3d at 1328; see also Toshiba Co,p. v. Imation
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`Co17J., 68 I F.3d 1358, 1362 (Fed. Cir. 201 2). "[N]on-mfnnging uses are substantial when they
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`are not unusual, far-fetched, illusory, impractical. occasional, aberrant. or experimental." Vita(cid:173)
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`Ah r, 581 F.3d at 1327 Thus, "a sale of an article which though adapted to an infnngmg use 1s
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`also adapted to other and lawful uses, is not enough to make the seller a contributory infringer."
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`Sony Corp. v. Universal City Studios. Inc., 464 U.S. 417, 441 ( 1984 ), quoting Hcn,y v. A.B. Dick
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`Co., 224 U.S. I, 48 ( 1912). The burden of showing "no substantial non-infringing uses" is on
`the patentee nsu, 471 F.3d at 1303.
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`B.
`
`Law of Invalidity
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`I.
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`Presumption of Validity
`
`Under 35 U.S.C. § 282, a U.S. patent 1s presumed valid, and overcoming that
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`presumption requires clear and convincing evidence. Microsqfi Corp. 11 i./i Ltd P '.\'hip, 564
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`U.S. 91, 95 (20 I I). However, "there is no heightened or added burden" when invalidity defenses
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`"are based upon references that were before the Patent Office. The burden is always the same,
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`clear and convincing evidence." Sc:ie/e J>han11., Inc.:. 1· l.upin LrJ., 684 F.3d 1253, 1260 (Fed.
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`Cir. 2012) ("The burden does not suddenly change to something higher • extremely clear and
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`convincing evidence· or · c1ystal clear and conv111cmg 1.'\ 1dence · - sunply becau'ie the pnor art
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`references were considered by the PTO." ).
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`2.
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`Claim Construction
`
`The first step in an invalidity analysis 1s to ascertain the meanmg and scope of the
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`claims. See, e.g., Merck & C'o. ,,. 'l'em />harms. ll.\:4. Inc., 395 F.Jd 1364, 1369-72 (Fed Cir.
`
`2005). This analysis, called claim construction, is an issue of law. See supra Section VI.A. I. for
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`the law of claim construction.
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`3.
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`The Law of Obviousness•
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`A claim may be found invalid for obviousness under pre-AJA 3 5 U.S.C. § I 03(a), which
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`provides. in part:
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`A patent may not be obtained though the invention is not
`identically disclosed or described as set forth in section I 02 of this
`title, if the difforence-, between the subjet.:t matter sought to be
`patented and the prior art are such that the subJect matter as a
`whole would have been obvious at the tune the invention was
`made to a person having ordinary skill in the art to which said
`subject matter pertains.
`
`Obviousness 1s a conclusion of law based on a number of underlying factual inquiries.
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`<iraham 1• John Uecre Co., 383 U.S. I, 17 (1966); Comta111 , .. Admnced Mic:ro•Oc,•ice.,. Im:,
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`848 F.2d 1560, 1572 (Fed. Cir. 1988). The Supreme Court has stated that three factual
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`determinations are required in an analysis under § I 03 · (I) the scope and content of the prior art;
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`( 2) the differences between the prior art and the claims at issue; and ( 3) the level of ordinary ski II
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`111 the art <lraha111, 383 U.S. at 17, sc'<.? also KSN i,11cma11011a/ ( ·o. 1·. 'frll'/le.r Im.·. 5 )0 lJ S. 398,
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`406 (2007). Secondary considerations bearing on obviousness, also known as objective indicia
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`of non-obviousness, must also be considered. Id.; Graham, 383 U.S. at 17-18.
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`In KSR, the Supreme Court rejected rigid and mandatory formulaic approaches to the
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`obviousness inquiry, and cautioned that·
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`1 Pursuant to § 3(n)( I) of the America Lnvents Act (''AIA"), Pub. L. No. 112-29, amended § 102
`and § I 03 apply to patent applications with claims having an effective filing date on or after
`March 16, 2013. At least because the application from which the '742 patent issued was filed
`before this date and because the application from which the '425 patent issued was filed as a
`continuation of an application that issued before this date, it is assumed herein that the pre-AlA
`versions of 35 U.S.C'. § 102 imd § 103 appl} At.:cordingly, all references herein to § 102 and
`§ 103 should he understood to mean the pre-A IA \ ersionc, of'§ 102 m1d § 103.
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`[t]he obviousness analysis cannot be confined by a formalistic
`conception of the words, teaching, suggestion, and motivation, or
`by overemphasis on the importance of published articles and the
`explicit content of the issued patents In many fields it may be that
`there is little discussion of obvious techniques or combinations,
`and it often may be the case that market demand, rather than
`sc1ent1fic literature will drive design trends
`
`KSR, 550 U.S. at 419.
`
`The Supreme Court reiterated that "the [(iraham] factors continue to define the inquiry"
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`that controls the determination of obviousness. Id at 406. Although "rejections on obviousness
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`grounds cannot be sustained by mere conclusory statements," the obviousness "analysis need not
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`seek out precise teachings directed to the specific subject matter of the challenged claim, for a
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`court can take account of the inferences and creative steps that a person of ordinary skill m the
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`art would employ." Id at 418. A broad survey of the prior art 1s warranted m an obviousness
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`determination. Sec id. ("Often it will be necessary for a court to look to interrelated teachings of
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`multiple patents . .. and the background knowledge possessed by a person having ordinary skill
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`m the art . . .. ").
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`The Supreme Court pointed out that a "person of ordinary skill [in the art) is also a
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`person of ordinary creauv,ty, not an automaton:·
`
`Id at 421 . The results ol' "ordinary
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`mnovation'' are not patentable. Id at 427. For example:
`
`lf a person of ordinary skill can implement a predictable variation,
`§ 103 likely bars its patentability. For the same reason, if a
`technique has been used to improve one device, and a person of
`ordinary skill in the art would recognize that It would improve
`similar devices in the same way, usmg the technique is obvious
`unless its actual application is beyond his or her skill.
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`Id at 417.
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`Moreover, contrary to the Federal Circutt's pnor interpretation of the law of obviousness,
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`something shown to be ''obvious to try" might indeed be "obvious" under § 103:
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`When there is a design need or market pressure to solve a problem
`and there are a finite number of identified, predictable solutions, a
`person of ordinary skill has good reason to pursue the known
`options within his or her technical grasp.
`If this leads to the
`anticipated success, it is likely the product not of innovation but of
`ordinary skill and common sense. In that instance the fact that a
`combination was obvious to try might show that it was obvious
`under§ I 03 .
`
`Id at 421.
`
`Further, although hindsight bias is impermissible, the Supreme Court in KSR rejected
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`"rigid. preventative rules that deny factfinders recourse to common sense .... "
`
`Id. at 421.
`
`"Indeed, the common sense of those skilled in the art demonstrates why some combinations
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`would have been obvious where others would not " J,eapfrog hi11c17wi.\CS, Im:. 1•. Ftshcr-l'nce.
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`!11c .• 485 F.3d 1157, 1161 (Fed. Cir. 2007)
`
`Finally, objective indicia of non-obviousness, also known as secondary considerations, if
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`present, must be considered. Secondary considerations include, imr:r alw, unexpected results,
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`commercial success, copying, long felt but unrc .. olved need, failure