Jack B. Blumenfeld, Jeremy A. Tigan, Julia Heaney, Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE, Attorneys for Plaintiff.
Jeffrey I.D. Lewis, Richard Maidman, Sean Marshall, Edward R. Tempesta, Patterson Belknap Webb & Tyler LLP, New York, NY, Of Counsel for Plaintiff.
Richard L. Horwitz, Bindu Ann George Palapura, David Ellis Moore, Potter Anderson & Corroon, LLP, Wilmington, DE, Attorneys for Defendants.
Douglas Carsten, Katherine Van Gunst, Elham F. Steiner, Matthew J. Bresnahan, Wilson Sonsini Goodrich & Rosati PC, San Diego, CA,
T.O. Kong, Wilson Sonsini Goodrich & Rosati PC, San Francisco, CA, Of Counsel for Defendants.
RENÉE MARIE BUMB, District Judge.
This is an action for patent infringement brought by Plaintiff Endo Pharmaceuticals Inc. ("Endo" or "Plaintiff") against Defendants Mylan Pharmaceuticals Inc. and Mylan, Inc. (collectively, "Mylan" or "Defendants") pursuant to 35 U.S.C. § 271(e)(2)(A), and §§ 271(a), (b), and (c). Specifically, Endo alleges that Mylan has infringed and/or will infringe U.S. Patent Nos. 5, 464, 864 (filed Nov. 7, 1995) (the "864 Patent"), 5, 637, 611 (filed June 10, 1997) (the "611 Patent"), and 5, 827, 871 (filed Oct. 27, 1998) (the "871 Patent") (collectively, the "King Patents") in connection with Mylan's submission of Abbreviated New Drug Application ("ANDA") number 202931 seeking the approval of the U.S. Food & Drug Administration ("FDA") to market its generic ANDA Product prior to the expiration of the King Patents.
On July 18, 2013, the Honorable Joseph E. Irenas held a hearing pursuant to Markman v. Westview Instruments, Inc. , 517 U.S. 370 (1996), and subsequently issued a claim construction opinion addressing three disputed claim terms of the King Patents (the "Claim Construction Opinion"). (Dkt. Ent. 167.) Although Mylan disputes the claim construction adopted by the Court, it conceded prior to trial that, under the Court's claim construction, Mylan infringes or will infringe the asserted claims of the King Patents. (Notice of Concession of Infringement, Dkt. Ent. 182.) However, Mylan maintained that the King Patents are invalid under the doctrines of anticipation, obviousness, written description, and enablement. The Court held a bench trial from November 12 through November 21, 2013, after which it permitted the parties to submit proposed findings of fact and conclusions of law.
After consideration of the evidence and the parties' post-trial submissions, and for the reasons set forth below, the Court finds that (1) Endo has waived and is now judicially estopped here from pursuing claims against Mylan related to the 871 and 611 Patents in this litigation, and (2) the asserted claims of the 864 Patent are valid. Accordingly, the Court enters judgment against Mylan and in favor of Endo. This Opinion constitutes the Court's findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a).
A. The Drug Approval Process
Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., the FDA must approve all new drugs before they may be distributed in interstate commerce. 21 U.S.C. § 355(a). To secure approval for a new drug, an applicant may file a New Drug Application ("NDA") that includes, inter alia, the number and expiration date of any patents which claim the drug or a method of using the drug if a claim of patent infringement could reasonably be asserted. Id . § 355(b)(2). "The FDA publishes the names of approved drugs and their associated patent information in the Approved Drug Products with Therapeutic Equivalence Evaluations list, commonly referred to as the Orange Book.'" AstraZeneca LP v. Apotex, Inc. , 633 F.3d 1042, 1045 (Fed. Cir. 2010). An applicant seeking approval to market a generic version of a drug that has already been approved may file an ANDA, which "allows an applicant to rely on the safety and efficacy information for the listed drug if the applicant can show that the generic drug is bioequivalent' to the listed drug." Id . (citing 21 U.S.C. § 355(b)(2), (j)).
"[F]or each patent listed in the Orange Book that claims either the listed drug or a use of the listed drug for which the applicant is requesting approval, an ANDA must include either one of four certifications or a section viii statement.'" AstraZeneca LP , 633 F.3d at 1046. If an applicant submits a certification, the applicant must certify "(I) that... patent information has not been filed, (II) that such patent has expired, (III)... the date on which such patent will expire, or (IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug." 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV). The last of these is known as a "paragraph IV certification". If an ANDA applicant submits a paragraph IV certification and a patent infringement suit is commenced within 45 days, then the FDA may not approve the ANDA application until expiration of a 30-month statutory period. Id . § 355(c)(3)(C).
On November 8, 2001, the FDA approved NDA No. 21-006 for Frova (frovatriptan succinate) oral tablets. (Stipulated Facts ("SF"), Dkt. Ent. 172 ¶ 8.) Frova is indicated for the acute treatment of migraine attacks with or without aura in adults. (Id. ¶ 10; see also John Campbell ("Campbell") Tr. 29:8-20, 29:25-30:10.) Physicians also prescribe Frova "off-label" for the treatment of menstrual migraine. (Dr. Brian Grosberg ("Grosberg") Tr. 1374:12-1376:2; see also Campbell Tr. 46:22-47:6.) The Orange Book associates the King Patents with frovatriptan succinate. (Answer, Dkt. Ent. 9 ¶ 36.)
Endo commercially markets Frova, which contains a compound chemically designated as (R)-()-3-methylamino-6-carboxamido-1, 2, 3, 4-tetrahydrocarbazole monosuccinate monohydrate, known as frovatriptan monosuccinate monohydrate, as the active pharmaceutical ingredient ("API"). (SF ¶ 5; Dr. Vincent Rocco ("Rocco") Tr. 126:8-10; see also Dr. Graham Johnson ("Johnson") Tr. 1024:4-6.) The label for Frova refers to the API as frovatriptan succinate. (Rocco Tr. 125:8-10; Campbell Tr. 28:10-12; PX-0008; PX-0009; PX-0059.)
The empirical formula for frovatriptan monosuccinate monohydrate is C14H17N3O·C4H6O4·H2O, and it has a molecular weight of 379.4. (SF ¶ 6; PX-0008; PX-0059.) Frova tablets contain 3.91 mg frovatriptan monosuccinate monohydrate, equivalent to 2.5 mg of frovatriptan free base. (SF ¶ 9; PX-0008; PX-0009.) This difference in weight is accounted for by the weight of the succinate and water molecules added to the free base. (Rocco Tr. 128:3-15.)
Chemical compounds may exist in a variety of forms, including free base forms, salts, solvates, hydrates, salt-hydrates, and salt-solvates. Frovatriptan monosuccinate monohydrate is a hydrated salt form of frovatriptan. (Rocco Tr. 99:15-101:22.) A salt is formed through a reaction between an acid and a free base (Rocco Tr. 99:15-17; Dr. Albert Lee ("Lee") Tr. 389:4-23); here, succinic acid reacts with the frovatriptan free base to form the salt (Rocco Tr. 99:18-100:8). A salt may be hydrous or anhydrous, depending on whether the molecule has water associated with it. (Rocco Tr. 101:3-12.) Frovatriptan monosuccinate monohydrate is a hydrate, which means that it is a crystalline form of a compound in which water is part of the crystal lattice. (Lee Tr. 390:4-6; Rocco Tr. 100:24-101:6.) Like a hydrate, a solvate is a crystalline form of a compound with solvent molecules that form part of the crystal lattice. (Lee Tr. 390:12-13; see also Rocco Tr. 102:13-15.) As such, a hydrate can be considered a solvate in which water is the specific solvent. (Lee Tr. 390:13-15; see also Rocco 102:18-20.)
Certain molecules may exist in different orientations in three-dimensional space. (SF ¶ 30.) A molecule's three-dimensional configuration is referred to as its stereochemistry. (See Rocco Tr. 94:14-23.) Compounds may have the same molecular formula but different three-dimensional configurations, or stereoisomers. (See Rocco Tr. 94:19-23.) Where the stereoisomers are related to each other, and form non-superimposable mirror images of one another, they are known as enantiomers. (Rocco Tr. 94:24-95:25.)
A molecule's stereochemistry is indicated by certain naming conventions, such as inclusion of an (R) or (S) before the molecular formula, and may also be reflected in a diagram of the chemical structure. (SF ¶¶ 32-33; see also Rocco Tr. 96:4-97:9.) In a diagram, a line connecting two atoms represents a chemical bond located on the plane of the paper. A solid triangle represents a bond extending out in front of the paper (i.e., towards the reader), and a hatched triangle represents a bond extending behind the paper (i.e., away from the reader). (SF ¶ 33; Rocco Tr. 96:4-97:9.)
There are two enantiomers for frovatriptan, based upon whether the "NHCH3" component at the 3-position is extending towards or away from the reader. (Rocco Tr. 96:4-97:9.) The specific frovatriptan enantiomer used as the API in Frova is the (R)-() enantiomer, which has the following chemical structure:
(PX-0008 at 1 (Frova product label); see also SF ¶¶ 5, 20.)
C. Migraine and Migraine Treatment
Frova is indicated for the acute treatment of migraine. Migraines are a neurologic (i.e., central nervous system) syndrome characterized by episodes of severe cephalic (head) pain, which may be associated with neurological, autonomic, and/or gastrointestinal symptoms and which are frequently accompanied by nausea, vomiting, and/or sensitivity to light or sound. (SF ¶¶ 15-16; see also Dr. Stephen Peroutka ("Peroutka") Tr. 534:9-536:1; Grosberg Tr. 1336: 14-22; Johnson Tr. 659:7-661:21.) The art had a similar understanding as of the priority date. If untreated or unsuccessfully treated, a migraine attack typically lasts from 4 to 72 hours, with a median duration of 24 hours. (Grosberg Tr. 1336:15-22.) The causes of migraine are unknown. (Grosberg Tr. 1338:9-10.)
Medication used to treat acute migraine attacks include both specific and nonspecific treatments. A nonspecific treatment for migraine is a treatment that addresses the symptoms of migraine, and includes acetaminophen or Tylenol, aspirin, non-steroidal anti-inflammatory drugs like ibuprofen, and combination analgesics. (Grosberg Tr. 1339:15-19.) Nonspecific treatments are sometimes available without prescription and may be effective in less severe attacks, but they are susceptible to overuse and have potential side effects. (Grosberg Tr. 1339:25-1340:5.) A specific treatment for migraine refers to a treatment that addresses the mechanism of migraine, and includes ergotamines and triptans. (Grosberg Tr. 1339:19-1340:14.) Specific treatments are generally prescription medications that are more efficacious but have lower recurrence and potential for overuse. (Id.)
Ergotamines, or ergots, were an early form of specific treatment for migraine that became available in the 1920s. (SF ¶ 18; Peroutka Tr. 537:5-9.) Ergots were non-selective,  and had low tolerability and notable side effects, such as the contraction of blood vessels in the leg leading in some cases to gangrene. (Peroutka Tr. 553:21-554:12; Johnson Tr. 662:5-663:13; Grosberg Tr. 1340:14-17.) Compounds in the ergot family include dihydroergotamine ("DHE"), ergotamine, and methysergide. (Rocco Tr. 1687:24-1688:20 (referring to Slide 3).)
The "triptan" family of compounds, a class of tryptamine derivative compounds used to treat migraine, were an improvement over ergotamines. (SF ¶¶ 19-20; PX-0219 at 83.) Frovatriptan is a member of the triptan family, and is one of seven triptans currently on the market. (SF ¶ 20; Campbell Tr. 29:15-24.) Sumatriptan was a prior art triptan. (SF ¶ 22.) The others are listed below with the chemical structure, year of FDA approval, marketing company, and trade name.
(SF ¶¶ 22, 25-29; Campbell Tr. 25:21-22; PX-0121 at 62.) Frovatriptan is the only FDA-approved triptan with a fused three-ring or tricyclic core structure, known as a 1, 2, 3, 4-tetrahydrocarbazole. (Rocco Tr. 123:15-17, 1696:3-11.) The other triptans have only a 2-ring core structure. (Id.) In addition, frovatriptan is the only FDA-approved triptan with an unsubstituted carboxamido substituent at its 6-position and a methylamino in its 3-position. (See Rocco Tr. 1697:8-1699:17.)
Serotonin is a member of the tryptamine class of compounds that, as of the priority date, was believed to affect migraine treatment. (SF ¶ 14; Rocco Tr. 110:10-25.) Serotonin is a naturally-occurring molecule that can function as a neurotransmitter; its chemical name is 5-hydroxytryptamine or "5-HT" and it bears the following chemical structure: (Id.; see also SF ¶¶ 11-13; Peroutka Tr. 536:2-14.) By 1991, there was a lot of general interest in serotonin because of its numerous biologic effects and research into serotonin was "extremely active". (DTX-1196 at 1; Peroutka Tr. 517:14-25; see also Johnson Tr. 938:21-939:6 (explaining that Glennon 1987 was a "very significant paper in the field of serotonin research").)
Serotonin interacts with numerous receptors throughout the body, known as 5-HT or serotonin receptors, and causes a physiological response. (See Nelson Tr. 1198:3-7; Rocco Tr. 110:23-111:9.) A chemical compound that binds to a receptor can be referred to as a "ligand." (Peroutka Tr. 614:25-615:2.) If the ligand binds to the receptor and causes a physiological or biological response, then the ligand is called an "agonist." (Rocco Tr. 111:1-9.) If the ligand binds to the receptor but does not cause a physiological or biological response, then it is called an "antagonist." (Rocco Tr. 111:10-22.) Serotonin treats migraine by interacting with certain 5-HT receptors. (Rocco Tr. 110:23-111:9.)
Serotonin receptors are categorized into general families, indicated by subscripts after 5-HT, such as the "5-HT1 family". (Rocco Tr. 112:23-113:4.) Some families are further subdivided as indicated by subscript letters that follow the numerical designation, such as 5-HT-1B and 5-HT-1D. (Rocco Tr. 112:23-113:4.) As of 1991, identification of serotonin receptor subtypes was ongoing and designations changed as research regarding the subtype structure advanced. (See Peroutka Tr. 546:9-547:19, 545:4-546:8.) By the beginning of the 1990s, a person of ordinary skill in the art knew that migraine drugs interacted with the 5-HT1 receptor family. (Peroutka Tr. 546:9-17; Rocco Tr. 112:2-4.)
D. The King Patents
1. '864 Patent
On November 7, 1995, the United States Patent and Trademark Office (the "PTO") issued the 864 Patent, entitled "Use of Tetrahydrocarbazole Derivatives As 5HT1 Receptor Agonists." (PX-0001.) The 864 Patent issued from U.S. Patent Application No. 08/167, 846, filed June 17, 1992, and lists a foreign application priority date of June 26, 1991. (Id.) The named inventors are Francis D. King, Laramie M. Gaster, Alberto J. Kaumann, and Rodney C. Young. The 864 Patent was granted a Patent Term Extension under 35 U.S.C. § 156 on February 10, 2006, which on its face extends the patent term to November 7, 2015. (SF ¶ 39.)
At issue in this case are claims 1, 2, 3, and 6 of the 864 Patent.
2. '611 Patent
On June 10, 1997, the United States Patent and Trademark Office issued the 611 Patent, entitled "Medicaments." (PX-0003.) The 611 Patent issued from U.S. Patent Application No. 08/442, 719, filed May 15, 1995, and is a continuation of the application which led to the 864 Patent. The 611 Patent originally expired on June 10, 2013. (SF ¶ 46.) However, on October 30, 2013, Endo filed a terminal disclaimer with respect to the 611 Patent, which effectively disclaimed that portion of its term that extends beyond the term of the 864 Patent. (See Dkt. Ent. 178.) The PTO accepted the terminal disclaimer on November 27, 2013. (Dkt. Ent. 188.)
The asserted claims are 1, 2, 3, 8, 9, and 10 of the 611 patent.
3. '871 Patent
On October 27, 1998, the United States Patent and Trademark Office issued the 871 Patent, entitled "Medicaments 1, 2, 3, 4, -Tetrahydrocarbazoles and 5-HT1 Agonist Use Thereof." (PX-0002.) The 871 patent issued from U.S. Patent Application No. 08/442, 720, filed May 15, 1995, and is a continuation-in-part of the application leading to the 864 Patent. The 871 Patent originally expired on October 27, 2015. (SF ¶ 53.) However, Endo filed a terminal disclaimer, which disclaims that portion of its term that extends beyond the '611 and '864 Patents. (See Dkt. Ent. 178.) The PTO accepted the terminal disclaimer on November 27, 2013. (Dkt. Ent. 188.)
The asserted claims are 1, 2, 3, 4, 5, 6 and 7 of the 871 patent.
E. Ownership of Frova and the King Patents
The King Patents identify SmithKline Beecham P.L.C. ("SKB") as the assignee. (SF ¶ 56.) SKB licensed certain rights to Frova to Vernalis Ltd. (f/k/a Vanguard Medica, and referred to herein as "Vernalis"). (Philip Green ("Green") Tr. 2011:23-2012:4; see also SF ¶ 57.) In 1999, Vernalis submitted to the FDA NDA 21-006 for frovatriptan tablets, which the FDA approved on November 8, 2001. (SF ¶¶ 58, 60.) However, in 1998, while Frova was still in development, Vernalis licensed North American sales and distribution rights to Elan Corporation P.L.C. ("Elan"). (SF ¶ 59.)
In 2000, SKB and Glaxo Wellcome P.L.C. merged. (PX-0378 at 3.) However, because the merged entity would have owned three of the seven triptans, the United States Federal Trade Commission entered into a Consent Agreement with the merging entities pursuant to which SKB agreed to "transfer and surrender, absolutely and in good faith, all Frovatriptan Assets... to Vernalis...." (Id. at 37.) As a result, SKB transferred all of the rights to the Frova product and assigned the King Patents to Vernalis. (Green Tr. 2012:4-12.)
Pursuant to an agreement with Vernalis, and in conjunction with UCB Pharma Inc., Elan launched the Frova product in the United States in 2002. (See Campbell Tr. 30:11-14; Green Tr. 2004:6-15; DTX-1153 at 9.) Two years later, Vernalis reacquired from Elan the commercialization rights for the Frova product in North America. (Green Tr. 2012:13-16.) Vernalis subsequently licensed the U.S. rights to Endo in 2004 (DTX-1003; Green Tr. 2012:17-18) and ultimately assigned the King Patents to Endo in 2011 (SF ¶ 61; DTX-1059).
F. This Court's Claim Construction Opinion
On August 7, 2013, the Honorable Joseph E. Irenas issued a Claim Construction Opinion that addressed three disputed claim terms of the King Patents. First, the Court construed the term "compound of (general) formula (I), " which appears in claim 1 of each of the King Patents. (See Claim Constr. Op. 8-10.) After noting that the parties agreed that the compound includes "all R [enantiomers] and no S to all S and no R, and every ratio in between, " the Court determined that this term refers to "the formula without regard to its stereochemistry." (Id. at 9.)
Second, the Court construed the term "or a salt, solvate or hydrate thereof, " which appears in claim 1 of the 864 Patent, as meaning "or one or more of salt, solvate or hydrate thereof." (Id. at 11-14.) The Court saw "no basis for finding that salt' does not also include a salt that is also a hydrate or also a solvent." (Id. at 12.) The parties agreed that salt should be similarly construed in claim 6, which refers to "a physiologically acceptable salt thereof." (Id. at 11.)
Third, the Court construed the term "treatment of a condition wherein a 5-HT1-like agonist is indicated, " which appears in claim 2 of the 864 Patent,  claim 1 of the 871 Patent, and claim 10 of the 611 Patent, as meaning "treatment without prophylaxis." (Id. at 20.)
A patent and each of its claims are presumed to be valid, even where those claims may be dependent upon other invalid claims in the patent. 35 U.S.C. § 282(a). A party may rebut this presumption of validity with clear and convincing evidence of invalidity. Sciele Pharma Inc. v. Lupin Ltd. , 684 F.3d 1253, 1260 (Fed. Cir. 2012) (citing 35 U.S.C. § 282 and Microsoft Corp. v. i4i Ltd. P'ship, ___ U.S. ___ , 131 S.Ct. 2238, 2245 (2011)). "The clear and convincing' standard of proof of facts is an intermediate standard which lies somewhere between beyond a reasonable doubt' and a preponderance of the evidence'... [and] has been described as evidence which produces in the mind of the trier of fact an abiding conviction that the truth of [the] factual contentions are highly probable.'" Buildex Inc. v. Kason Indus., Inc. , 849 F.2d 1461, 1463 (Fed. Cir. 1988) (citations omitted).
Where an invalidity challenge is based upon prior art that was considered by the PTO during the patent prosecution, and where a patent was issued notwithstanding the prior art, "a court owes some deference to the PTO's decision." Minnesota Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc. , 976 F.2d 1559, 1572 (Fed. Cir. 1992) (citations omitted)). Although Defendants' burden does not change, evidence considered by the PTO may not be given the same weight as new evidence. See Sciele Pharma Inc. , 684 F.3d at 1260 ("[N]ew evidence not considered by the PTO may carry more weight... than evidence previously considered by the PTO, ' and may go further toward sustaining the attacker's unchanging burden.'" (citing Microsoft Corp. , 131 S.Ct. at 2251)).
I. Endo Abandoned Its Claims Related to the 871 and 611 Patents
During the trial, Endo abandoned its claims related to the 871 and 611 Patents. As a result, this Court ruled that Endo would be estopped from resurrecting those claims at a later date in this litigation. Endo's abandonment of those claims occurred in the midst of trial after some evidence relating to those patents already had been presented. Endo stated that "with this [terminal] disclaimer everything rises and falls on the 864 patent, we can litigate the 864 patent and that will govern what occurs in the case." (Tr. 268:22-269:19.) Hence, it was the Court's view that any further effort to pursue claims against Mylan related to the 871 and 611 patents, in this litigation, would be judicially estopped. Endo had asserted claims against Mylan relating to the 871 and 611 Patents in the current litigation but midway chose instead to abandon them in favor of the 864 Patent. Permitting Endo to reassert the abandoned claims against Mylan later in this litigation (or even in the future) would be manifestly unjust to Defendants and, therefore, judicial estoppel is an appropriate remedy. Cf. Van Blunk v. McAllister Towing of Phila., Inc., No. 10-00686, 2012 WL 832997, at *5 (D.N.J. Mar. 12, 2012) (judicially estopping plaintiff from presenting inconsistent position in order to "prevent manifest injustice" and prejudice to defendant); Haines & Kibblehouse, Inc. v. Balfour Beatty Constr., Inc. , 789 F.Supp.2d 622, 636 (E.D. Pa. 2011) (same).
Endo now argues that the Court erred because Endo was permitted to file the terminal disclaimer at any point in this litigation and that filing could not be deemed an admission of the merits of the double-patenting allegation. Although Endo is correct as to the legal effect of the terminal disclaimer, its arguments miss the point: the Court based its decision not on the terminal disclaimer, but on the unequivocal statements of counsel signifying Endo's intent to abandon its claims here. See, e.g., Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc. , 592 F.3d 1340, 1347 (Fed. Cir. 2010) (terminal disclaimer may be filed lawfully at any time "after issuance of the challenged patent or during litigation, [or] even after a finding that the challenged patent is invalid for obviousness-type double patenting") (citations omitted); Quad Envtl. Techs. Corp. v. Union Sanitary Dist. , 946 F.2d 870, 874 (Fed. Cir. 1991) ("It is improper to convert this simple expedient of "obviation" [of a rejection of double-patenting] into an admission or acquiescence or estoppel on the merits."); (see also Pl.'s Opening Post-Trial Br. ("Pl.'s Br."), Dkt. Ent. 191, at 36-37). When Endo advised the Court that it had filed a terminal disclaimer with respect to the 871 and 611 Patents, it stated that "[i]n preparing for trial it has become clear that issues concerning Mylan's infringement of the 871 and 611 Patents are consistent with those for infringement of the 864 Patent, " and Endo wished to "simplif[y] the issues for the upcoming trial" by mooting Mylan's double-patenting defense. (Letter, Dkt. Ent. 178 at 2.) The Court understood from this letter, together with the voluntary filing of the terminal disclaimer, that, contrary to the Final Pretrial Order, Endo no longer wished to proceed with its claims against Mylan as to these two patents. Endo treated the terminal disclaimer, in essence, as a withdrawal of Endo's claims. (See, e.g., Tr. 254:24-255:18 ("THE COURT:... either way you look at it Mylan is not threatened by those patents as a result of the filing of the disclaimer... you no longer have any threat of prosecution."); Tr. 268:3-7 ("MS. STAFFORD:... I think Endo is claiming if you allow their terminal claims to moot our defense that their claims for those patents still continue. THE COURT: But not as to Mylan.").)
Endo's counsel then repeatedly confirmed its intention to abandon the claims related to the 871 and 611 Patents as set forth in the Pretrial Order:
THE COURT:... Do I have it all wrong, Mr. Lewis? Maybe I do....
MR. LEWIS: Unfortunately, a lot of it wrong, but not ...