Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 1 of 28 PageID #: 1751
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`CMP DEVELOPMENT, LLC,
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`AMNEAL PHARMACEUTICALS LLC,
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`v.
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`Plaintiff,
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 21-549 (MN)
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`Defendant.
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`MEMORANDUM OPINION
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`
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`Kelly E. Farnan, Tyler E. Cragg, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE;
`Christopher J. Sorenson, Paige Stradley, MERCHANT & GOULD PC, Minneapolis, MN; Andrew
`O. Larson, MERCHANT & GOULD PC, New York, NY; Hayley M. Ostrin, MERCHANT & GOULD
`PC, Alexandria, VA – Attorneys for Plaintiff
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`Anne Shea Gaza, Samantha G. Wilson, YOUNG CONAWAY STARGATT & TAYLOR, LLP,
`Wilmington, DE; Steven A. Maddox, Jeremy J. Edwards, PROCOPIO, CORY, HARGREAVES &
`SAVITCH LLP, Washington, DC, Victor Sai, Dave Deonarine, Lianlian Wu, PROCOPIO, CORY,
`HARGREAVES & SAVITCH LLP, San Diego, CA – Attorneys for Defendant
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`September 29, 2023
`Wilmington, Delaware
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`

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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 2 of 28 PageID #: 1752
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`NOREIKA, U.S. DISTRICT JUDGE:
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`Plaintiff CMP Development, LLC (“Plaintiff” or “CMP”) brought this Hatch-Waxman
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`action against Defendant Amneal Pharmaceuticals LLC (“Defendant” or “Amneal”). Amneal
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`filed Abbreviated New Drug Application No. 215572 (“Amneal’s ANDA”) with the U.S. Food
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`and Drug Administration (“FDA”) seeking approval to market a generic version (“ANDA
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`product”) of CMP’s CaroSpir® product before the expiration of United States Patent Nos.
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`10,624,906 (“the ’906 patent”), 10,660,907 (“the ’907 patent”) and 10,888,570 (“the ’570
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`patent”) (collectively, “the Asserted Patents”). Plaintiff alleges that Amneal will infringe
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`claims 1 and 8 of the ’906 patent, claims 1 and 10 of the ’907 patent and claims 1 and 7-10 of the
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`’570 patent. Validity of the claims of the Asserted Patents is not contested. (D.I. 99 ¶ 7).
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`The Court conducted a two-day bench trial on January 13, 2023 and January 18, 2023.
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`(See D.I. 110-111 (“Tr.”)). The parties completed post-trial briefing on March 13, 2023.
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`(D.I. 112, 114, 117). With their briefing, the parties submitted proposed findings of fact.
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`(D.I. 113, 115).
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`After considering the entire record and the applicable law, the Court concludes that
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`Plaintiff has failed to show that Defendant’s ANDA product will infringe claims 1 and 8 of the
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`’906 patent, claims 1 and 10 of the ’907 patent and claims 1 and 7-10 of the ’570 patent.
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`Because the Court finds that Plaintiff has not met its burden on infringement, the Court declines
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`to reach Defendant’s legal defenses as to infringement.1 This opinion constitutes the Court’s
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`findings of fact and conclusions of law pursuant to Rule 52(a) of the Federal Rules of Civil
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`Procedure.
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`1
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`In its post-trial brief, Defendant argues that CMP is barred from asserting the doctrine of
`equivalents by prosecution history estoppel, inherently narrow claiming and ensnarement.
`(D.I. 114 at 17-25). At trial, Defendant also argued that CMP was barred from asserting
`the doctrine of equivalents by specification disclaimer but appears to have dropped this
`argument in its post-trial briefing. (See, e.g., Tr. at 46:18-47:2; see also D.I. 114).
`
`1
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`

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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 3 of 28 PageID #: 1753
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`I.
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`FINDINGS OF FACT (“FF”)
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`A.
`
`1.
`
`Introduction
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`CMP is a limited liability company organized and existing under the laws of the
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`State of Delaware, with a principal place of business at 8026 U.S. 264A, Farmville, North
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`Carolina 27828. (D.I. 99, Ex. 1 ¶ 2).
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`2.
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`Amneal is a limited liability company organized and existing under the laws of
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`the State of Delaware, having a principal place of business at 400 Crossing Boulevard, Third
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`Floor, Bridgewater, New Jersey 08807. (Id. ¶ 3).
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`3.
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`CMP owns the Asserted Patents, which are listed in the FDA publication,
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`“Approved Drug Products with Therapeutic Equivalence Evaluations” (“the Orange Book”), as
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`covering CMP’s CaroSpir® product. (D.I. 99 ¶ 5; D.I. 1 ¶ 30).
`
`4.
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`By letters dated March 4, 2021 and March 25, 2021, Amneal advised CMP that it
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`had submitted its ANDA 215572 to the FDA under 21 U.S.C. § 355(j) seeking FDA approval to
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`engage in the commercial manufacture, use or sale of a generic version of CaroSpir® before the
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`expiration of the Asserted Patents. (D.I. 99, Ex. 1 ¶ 34). Defendant’s ANDA No. 215572
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`contains certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) for each of the Asserted
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`Patents. (Id. ¶ 35).
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`5.
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`This action was commenced before the expiration of forty-five days from receipt
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`of Defendant’s notice letters, and the thirty-month stay of final FDA approval of Defendant’s
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`pending ANDA application expired on September 5, 2023.2 (Id. ¶ 36).
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`2
`
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`By letter dated August 21, 2023, the parties agree that Amneal will not launch its product
`until the Court enters final judgment on the case up until September 29, 2023. (D.I. 120).
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`2
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`

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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 4 of 28 PageID #: 1754
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`B.
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`The Witnesses
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`1.
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`Fact Witnesses
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`6.
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`Anthony Pipho testified live at trial. Mr. Pipho is the Vice President of
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`Operations at CMP and oversees product development, regulatory, logistics and manufacturing.
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`(Tr. at 50:5-17). Mr. Pipho has worked at CMP for more than eight years. (Id.). He was hired
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`by CMP to develop a spironolactone suspension, was responsible for developing CaroSpir® and
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`participated in CMP’s efforts to have CaroSpir® approved by the FDA. (Tr. at 50:2-73:9).
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`Mr. Pipho is a named inventor on the Asserted Patents. (D.I. 99, Ex. 1 ¶¶ 6, 14, 21; JTX-001 at
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`2; JTX-002 at 2; JTX-003 at 2).
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`7.
`
`Hardik Patel testified live at trial. Mr. Patel has worked at Amneal for more than
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`fifteen years and is currently the Senior Director of Research and Development. (Tr. at 194:19-
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`24). Mr. Patel was primarily responsible for Amneal’s research and development of the ANDA
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`product. (Tr. at 198:3-16).
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`2.
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`Plaintiff’s Expert Witness
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`8.
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`Dr. Sriramakamal Jonnalagadda testified live at trial. Dr. Jonnalagadda has been
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`a professor at the Philadelphia College of Pharmacy, St. Joseph’s University for twenty years.
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`(Tr. at 110:1-4; JTX-035). He received a Ph.D. from the University of Nebraska Medical Center,
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`focusing on the examination of polymers, polymer characteristics, and the use of polymers to
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`design drugs. (Tr. at 110:4-12). Dr. Jonnalagadda’s research focuses on the development of
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`solid and liquid forms, including liquid forms that rely on polymeric materials. (Tr. at 110:13-
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`111:1). The Court recognized Dr. Jonnalagadda as an expert in the field of rheological
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`properties of polymers used in liquid dispersion systems and pharmaceutical dosage forms.
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`(Tr. at 114:9-15).
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`3
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 5 of 28 PageID #: 1755
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`3.
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`Defendant’s Expert Witness
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`9.
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`Dr. Richard Christian Moreton testified live at trial. Dr. Moreton has a Ph.D.
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`from the University of Wales in Cardiff in the field of pharmaceuticals. (Tr. at 242:21-243:7;
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`DTX-144). Dr. Moreton’s work focuses on the performance and function of excipients in
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`pharmaceutical formulations, including suspensions. (Tr. at 242:7-252:6). The Court recognized
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`Dr. Moreton as an expert in the field of pharmaceutical science including pharmaceutical
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`formulation and excipient technology. (Tr. at 252:7-13). The Court found Dr. Moreton to be
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`particularly credible.
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`C.
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`The Asserted Patents
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`1.
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`The ’906 Patent
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`10.
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`The ’906 patent is titled, “Spironolactone Aqueous Compositions” and issued on
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`April 21, 2020, from U.S. Application No. 16/682,477 filed on November 13, 2019. (JTX-001 at
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`2). The named inventors of the ’906 patent are Anthony Pipho and Michael Paul DeHart. (Id.).
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`The ’906 patent expires on October 28, 2036. (D.I. 99, Ex. 1 ¶ 12).
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`11.
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`CMP asserts that the ANDA Product will infringe claims 1 and 8 of the ’906
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`patent. Claims 1 and 8 claim:
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`1. A ready-to-use liquid formulation, comprising:
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`(a) about 0.20% w/v to about 1.0% w/v of spironolactone;
`(b) from about 0.18% w/v to about 0.36% w/v of a xanthan gum;
`(c) a pharmaceutically acceptable excipient; and
`(d) a sufficient amount of a water vehicle;
`wherein the formulation has a spironolactone content of 100±10%
`labeled content when stored for about 24-months at 25±2ºC. and
`40±5% relative humidity.
`
`8. The ready-to-use liquid formulation of claim 1, which comprises
`about 0.5% w/v of spironolactone.
`
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`(JTX-001).
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`4
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 6 of 28 PageID #: 1756
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`2.
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`The ’907 Patent
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`12.
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`The ’907 patent is titled, “Spironolactone Aqueous Compositions” and issued on
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`May 26, 2020, from U.S. Application No. 16/823,604 filed on March 19, 2020. (JTX-002 at 2).
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`The named inventors of the ’907 patent are also Anthony Pipho and Michael Paul DeHart. (Id.).
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`The ’907 patent expires on October 28, 2036. (D.I. 99, Ex. 1 ¶ 19).
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`13.
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`CMP asserts that the ANDA Product will infringe claims 1 and 10 of the ’907
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`patent. Claims 1 and 10 claim:
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`1. A ready-to-use liquid formulation, comprising:
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`(a) about 0.20% w/v to about 1.0% w/v of spironolactone;
`(b) from about 0.18% w/v to about 0.36% w/v of a xanthan gum;
`(c) a pharmaceutically acceptable excipient; and
`(d) a sufficient amount of a water vehicle;
`wherein the formulation has a spironolactone content of 100±10%
`labeled content when stored for about 12-months at 25±2ºC. and
`40±5% relative humidity.
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`10. The ready-to-use liquid formulation of claim 1, which
`comprises about 0.5% w/v of spironolactone.
`
`
`(JTX-002).
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`3.
`
`The ’570 Patent
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`14.
`
`The ’570 patent is titled, “Spironolactone Aqueous Compositions” and issued on
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`January 12, 2021, from U.S. Application No. 16/878,092 filed on May 19, 2020. (JTX-003 at 2).
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`The named inventors of the ’570 patent are Anthony Pipho and Michael Paul DeHart. (Id.). The
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`’570 patent expires on October 28, 2036. (D.I. 99, Ex. 1 ¶ 27).
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`15.
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`CMP asserts that the ANDA Product will infringe claims 1 and 7-10 of the ’570
`
`patent. Claims 1 and 7-10 claim:
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`1. A ready-to-use liquid formulation, comprising:
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`(a) about 0.20% w/v to about 1.0% w/v of spironolactone;
`(b) from about 0.18% w/v to about 0.36% w/v of a xanthan gum;
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`5
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`

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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 7 of 28 PageID #: 1757
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`the ready-to-use
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`(c) a pharmaceutically acceptable excipient; and
`(d) a sufficient amount of a water vehicle;
`wherein the formulation exhibits a content uniformity of about
`100% labeled content after shaking the formulation for about 10
`seconds.
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`7. A dosage container comprising
`formulation of claim 1.
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`8. The container of claim 7 comprised of an enclosed bottle,
`wherein the bottle comprises a polyethylene terephthalate and an
`amber colorant.
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`9. The bottle of claim 8 having a volume of said bottle of 4 oz. or
`16 oz.
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`10. The ready-to-use liquid formulation of claim 1, which
`comprises about 0.5% w/v of spironolactone.
`
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`liquid
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`The Products at Issue: CaroSpir® and the ANDA Product
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`CMP holds approved New Drug Application (“NDA”) No. 209478,3 filed on
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`(JTX-003).
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`D.
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`16.
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`January 11, 2016, which sought approval to sell CaroSpir®. (D.I. 99, Ex. 1 ¶ 32).
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`17.
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`18.
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`FDA approved NDA No. 209478 for CaroSpir® on August 4, 2017. (Id. ¶ 33).
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`CaroSpir® is a ready-to-use liquid oral suspension with spironolactone as the
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`active pharmaceutical ingredient. (Tr. at 67:7-16; PTX-020 at 1).
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`19.
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`CaroSpir® is indicated for the treatment of heart failure, hypertension and edema
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`caused by cirrhosis. (PTX-020 at 1; Tr. at 54:5-9).
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`20.
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`CaroSpir® is commercially available in 118 mL or 473 mL amber polyethylene
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`terephthalate bottles. (PTX-020). CaroSpir® is approved with a dosage strength of 25 mg/5ml of
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`the suspension. (Id.)
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`3
`
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`There is a typo in the Pretrial Order (D.I. 99, Ex. 1 ¶ 32) with respect to the NDA
`number. (See Tr. at 376:15-18). The parties corrected the typo at trial. (Tr. at 378:11-
`14, 407:11-12). The correction is reflected above.
`
`6
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`

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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 8 of 28 PageID #: 1758
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`21.
`
`All Asserted Patents are listed in the Orange Book as covering CaroSpir®.
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`(D.I. 99 ¶ 5).
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`22.
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`Amneal’s ANDA seeks approval to market its ANDA product, a generic version
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`of CaroSpir®, prior to the expiration of the patents listed in the Orange Book. (Id. ¶ 2-3).
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`23.
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`The ANDA product has been established as bioequivalent to CaroSpir®. (Tr. at
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`200:3-203:9, 215:8-17; JTX-048).
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`24.
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`CaroSpir® and the ANDA Product are both pharmaceutical suspensions. A
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`pharmaceutical suspension is a liquid oral dosage form in which the active ingredient is often
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`undissolved. (Tr. at 51:23-52:2).
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`25.
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`Suspensions provide an option for patients who have difficulty swallowing
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`tablets, such as pediatric and geriatric patients, and thus need a liquid form of the active
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`ingredient (here, spironolactone). (Tr. at 51:7-18, 67:17-20).
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`26.
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`Suspensions are inherently unstable, both chemically and physically. (Tr. at
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`124:15-125:2). A suspending agent works to help maintain the uniformity of the particles in a
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`suspension (i.e., the active ingredient) by increasing the viscosity of a suspension to slow the rate
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`of sedimentation. (Tr. at 52:11-53:16, 255:16-256:14). Particles in a suspension will eventually
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`settle at the bottom of a bottle over time even if a suspending agent is used in a suspension.
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`(Tr. at 53:14-18, 255:13-256:14).
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`27.
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`A viable ready-to-use suspension allows sedimented particles to be resuspended
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`easily but is (at the same time) not so thick that it becomes difficult to resuspend settled particles
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`or dispense the dose. (Tr. at 62:19-22, 312:13-25).
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`28.
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`CaroSpir® uses xanthan gum as a suspending agent. (Tr. at 217:22-218:5).
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`7
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 9 of 28 PageID #: 1759
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`29.
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`Defendant’s ANDA product does not use xanthan gum as a suspending agent.
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`(D.I. 99, Ex. 1 ¶ 37). Defendant’s ANDA product uses tragacanth powder as a suspending agent.
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`(Id. ¶ 38).
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`30.
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`Defendant engaged in independent experimentation to select tragacanth powder as
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`its suspending agent and to optimize the amount of tragacanth powder in its ANDA product.
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`(Tr. at 199:18-202:15, 310:8-22). The experimentation lasted at least six months, involved
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`multiple working groups within Amneal, required making and testing about 150 formulations,
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`and involved testing more than a dozen different potential suspending agents or combinations of
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`suspending agents. (Tr. at 199:18-200:20, 201:11-202:15, 203:10-206:17, 206:24-208:8, 210:8-
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`16).
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`E.
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`Claim Construction
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`By letter dated January 25, 2022, the parties agreed that no terms in the Asserted Patents
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`needed construction (D.I. 32) and, as a result, “the plain and ordinary meaning of each term in
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`the claims of the Asserted Patents as understood by a [person of ordinary skill in the art] should
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`apply.” (D.I. 99, Ex. 1 ¶ 28).
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`F.
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`Facts Related to Infringement
`
`1.
`
`Person of Ordinary Skill in the Art
`
`31.
`
`The definition of a person of ordinary skill in the art applied by CMP’s expert for
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`the purposes of the Asserted Patents is as follows:
`
`A hypothetical person of ordinary skill in the art would have been
`someone with a degree in pharmaceutical chemistry, analytical
`chemistry, or pharmacy (or a similar subject related
`to
`formulations) with 4-6 years of work experience
`in
`the
`development of, or research related to, drug formulations.
`
`(D.I. 99, Ex. 1 ¶ 29).
`
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`8
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 10 of 28 PageID #: 1760
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`32.
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`The definition of a person of ordinary skill in the art applied by Defendant’s
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`expert for the purposes of the Asserted Patents is as follows:
`
`A hypothetical person of ordinary skill in the art would have an
`advanced degree in pharmaceutical science, analytical chemistry,
`or a similar subject related to formulations, and at least 2 years’
`experience in research and/or development relating to drug
`formulations; or a person with a bachelor’s degree
`in
`pharmaceutical science, analytical chemistry, or a similar subject
`related to formulations, and at least 5 years’ experience in research
`and/or development relating to drug formulations.
`
`The opinions offered by each sides’ expert as to the infringement of the Asserted
`
`
`(Id. ¶ 30).
`
`
`33.
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`Patents do not change based on which of the above-stated definitions of person of ordinary skill
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`in the art is applied. (Id. ¶ 31).
`
`34.
`
`At the time of invention, both Dr. Jonnalagadda and Dr. Moreton met the
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`definitions of a person of ordinary skill in the art offered by each side. (See Tr. at 109:18-
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`114:15; JTX-035; Tr. at 242:5-246:7, 255:4-9; DTX-144).
`
`2.
`
`Doctrine of Equivalents
`
`35.
`
`The parties agree that Amneal’s ANDA product will literally infringe all elements
`
`of the asserted independent claims except for one: the presence of “from about 0.18% w/v to
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`about 0.36% w/v of a xanthan gum,” which is a limitation in all asserted claims in this case.
`
`(See D.I. 99, Ex. 1 ¶¶ 10-11, 17-18, 25-26).
`
`36.
`
`Plaintiff argues that this limitation is met under the doctrine of equivalents by the
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`suspending agent in Defendant’s ANDA product – i.e., tragacanth powder. (D.I. 112 at 3).
`
`37.
`
`In their briefs, the parties address whether (a) tragacanth powder is the equivalent
`
`of xanthan gum and (b) the specified amount of tragacanth powder in the ANDA product is the
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`equivalent of the recited amount of xanthan gum in the claims.
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`9
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 11 of 28 PageID #: 1761
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`a.
`
`Equivalence of Xanthan Gum and Tragacanth Powder
`
`38.
`
`Plaintiff argues that tragacanth powder is the equivalent of xanthan gum under
`
`both the function-way-result test and the insubstantial differences test.4 (D.I. 112 at 4).
`
`i.
`
`The Way Xanthan Gum and Tragacanth Powder Increase
`Viscosity
`
`
`39. With respect to the function-way-result test, Defendant does not dispute that
`
`tragacanth powder performs substantially the same function to obtain substantially the same
`
`result as the recited xanthan gum. (See D.I. 112 at 3; Tr. at 20:25-21:6). The function of the
`
`claimed xanthan gum is to act as a suspending agent, and the result achieved is a ready-to-use
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`liquid oral spironolactone suspension that results in 100% ± 10% labeled content after 24 months
`
`or after about 10 seconds of shaking.
`
`40.
`
`The dispute centers on whether tragacanth powder works in substantially the same
`
`way as xanthan gum. That is, whether tragacanth powder and xanthan gum increase viscosity in
`
`their respective suspensions in substantially the same way. (See D.I. 112 at 3; Tr. at 20:25-21:6).
`
`41.
`
`Xanthan gum increases the viscosity of a suspension through the random
`
`entanglement of its polymer chains. (Tr. at 140:18-141:14, 296:8-25, 297:13-24).
`
`42.
`
`Plaintiff argues that tragacanth powder increases viscosity in substantially the
`
`same way. (D.I. 112 at 3). At trial, Plaintiff attempted to support this assertion primarily
`
`through the testimony of its expert, Dr. Jonnalagadda.
`
`43.
`
`First, Dr. Jonnalagadda testified that he believes tragacanth powder and xanthan
`
`gum work in substantially the same way because, in an experiment conducted by Amneal during
`
`4
`
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`At trial, Plaintiff’s counsel and expert focused on the function-way-result test. In its post-
`trial briefing, Plaintiff argues under both tests but does not distinguish between which
`evidence and arguments it relies on for which test. (See D.I. 112). The Court thus
`addresses the record as a whole in assessing whether Plaintiff has met its burden under
`either test.
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`10
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 12 of 28 PageID #: 1762
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`development of its ANDA product, out of the four suspending agents tested, only tragacanth
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`powder and xanthan gum prevented visually observable sedimentation after seven days. (Tr. at
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`128:3-131:25).
`
`44.
`
`Apart from his say-so and expertise as a polymer scientist, Dr. Jonnalagadda did
`
`not offer any scientific support for the connection he made between the results of this experiment
`
`and his conclusion that the two components work in substantially the same way. (See, e.g., Tr. at
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`140:22-25 (explaining that he “truly believe[s] the mechanism by which they are increasing the
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`viscosity and the formulation on the particles to prevent them from coming together, the
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`mechanism by which that is happening is precisely the same”)).
`
`45.
`
`Dr. Jonnalagadda also opined that Defendant’s ANDA product matches certain
`
`release specifications of CaroSpir® (e.g., visual and physical appearance, viscosity, density, pH,
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`re-suspendability and dissolution) and that these similar physicochemical properties of the
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`finished products indicate that their respective suspending agents both increase viscosity in
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`substantially the same way. (Tr. at 144:9-146:24; JTX-048 at 127-32).
`
`46.
`
`Again, apart
`
`from his say-so and expertise as a polymer scientist,
`
`Dr. Jonnalagadda offered little in the way of scientific support for the connection he made
`
`between the similarity in physicochemical properties of the two finished products and the way in
`
`which their respective suspending agents increase viscosity.
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`47.
`
`In its reply brief, Plaintiff asserts that Dr, Jonnalagadda’s opinion is supported by
`
`reliable experimental data – that is, Amneal’s Product Development Report and the supporting
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`lab notebook. (See D.I. 117 at 1-2). Although these documents may show that the
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`physicochemical properties of both products overall are similar, Dr. Jonnalagadda failed to
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`11
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 13 of 28 PageID #: 1763
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`adequately explain how the documents support his opinion that similarities in the final products
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`evidence the way their respective suspending agents work.
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`48. When asked whether it was possible for Amneal’s product to meet these
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`specifications with a suspending agent that does not work the same as xanthan gum, the
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`explanation Dr. Jonnalagadda gave was the following: “If the mechanism was different, you
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`would not get that match. So the answer I guess would be no.” (Tr. at 146:19-24). In contrast
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`to Dr. Jonnalagadda’s testimony, Dr. Moreton testified that the tests made on the final product
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`“explain nothing about how the viscosity develops or how the individual components work.”
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`(Tr. at 309:18-310:6).
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`49.
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`Dr. Jonnalagadda based his product-to-product comparison and opinion on the
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`premise that the ANDA product and CaroSpir® differ solely with respect to their suspending
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`agents and are otherwise the same. (Tr. at 174:21-25).
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`50.
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`As Dr. Jonnalagadda acknowledged at trial, however, this premise is incorrect
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`because the two formulations also have different buffer systems. (Tr. at 175:20-176:14; see also
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`Tr. at 203:10-204:1). Dr. Jonnalagadda further recognized that having different buffers as well
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`as suspending agents may have required an analysis to determine which of the similar
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`physicochemical properties might ultimately be attributable to the buffer rather than the
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`suspending agent. (Tr. at 175:7-19). Although Dr. Jonnalagadda then purported to have
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`conducted such an analysis, he stated that this was “a while ago,” so his “knowledge of the
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`buffer is not exactly precise.” (Tr. at 176:5-25). Dr. Jonnalagadda did not present or discuss the
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`results of his analysis of the buffers any further.
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`51.
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`In addition, Plaintiff contends that the fact that both suspending agents are natural
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`gums shows that they both work substantially through polymer entanglement. (D.I. 112 at 7).
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`12
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 14 of 28 PageID #: 1764
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`The closest Dr. Jonnalagadda’s testimony comes to supporting this assertion is when, upon being
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`asked why he believed both suspending agents kept sedimentation from occurring in the Amneal
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`experiments, Dr. Jonnalagadda replied, “They’re very similar. They’re both natural gums,” and
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`then proceeded to list other similarities. (Tr. at 131:12-17). This explanation, however, fails to
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`show why both suspending agents being natural gums holds any relevance with respect to the
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`specific way they increase viscosity.
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`52.
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`Dr. Jonnalagadda also testified that xanthan gum and tragacanth powder have
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`similar molecular weights and similar chemical structures (i.e., they are both anionic
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`polysaccharides). (Tr. at 131:10-133:13, 147:2-150:6). Dr. Jonnalagadda opined that these
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`similarities indicate that the two suspending agents increase viscosity in substantially the same
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`way.5 (Id.).
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`53.
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`Apart from his say-so and expertise as a polymer scientist, Dr. Jonnalagadda
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`offered no scientific support for the connection he made between these properties and the way in
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`which the two suspending agents work.
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`54.
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`Plaintiff has failed to establish that the characteristics and qualities that its expert
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`cites (i.e., that both suspending agents prevented visually observable sedimentation, that the
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`finished products exhibit similar characteristics, that both are natural gums, and that they have a
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`similar molecular weight and chemical structure) in fact indicate that xanthan gum and
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`tragacanth powder increase viscosity in substantially the same way.
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`5
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`In its post-trial briefing, Plaintiff also contends that these qualities indicate that both
`suspending agents work through “film formation.” (D.I. 112 at 7). It is unclear what
`Plaintiff is referring to given that, at trial, Dr. Jonnalagadda only briefly noted that he
`would “expect the film formation mechanisms . . . to be the same as well” without
`explaining what film formation is. (Tr. at 141:15-142:14; see also Tr. at 301:10-15).
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`13
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 15 of 28 PageID #: 1765
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`a.
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`Bassorin
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`55.
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`Defendant contends that the two suspending agents do not increase viscosity in
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`substantially the same way due to the presence of bassorin in tragacanth powder. (See D.I. 114
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`at 10-12).
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`56.
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`There is no dispute as to the following facts: (1) xanthan gum is a water-soluble
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`hydrocolloid; (2) tragacanth powder is made up of two components – bassorin and tragacanthin;
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`(3) tragacanthin is water soluble. (Tr. at 118:17-18, 148:18-149:8, 291:5-16; JTX-066 at 1; JTX-
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`070 at 480; see also D.I. 112 at 7-8; D.I. 113 ¶¶ 89-91; D.I. 114 at 4-5).
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`57.
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`Bassorin is the majority component, making up around 60-70% of tragacanth
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`powder. (Tr. at 291:5-16; JTX-066 at 1; JTX-070 at 480). Tragacanthin is the minority
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`component, making up around 30-40% of tragacanth powder. (Tr. at 291:5-16; JTX-066 at 1;
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`JTX-070 at 480; see also D.I. 112 at 7).
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`58.
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`The parties’ experts disagree as to whether the majority component bassorin is,
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`according to Dr. Moreton, “insoluble” in water or, according to Dr. Jonnalagadda, “less soluble”
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`in water.6 (Tr. at 148:18-149:21, 291:5-11, 294:6-296:2).
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`59.
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`Regardless of whether bassorin is categorized as insoluble or less soluble, the
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`parties agree that bassorin – the majority component of tragacanth powder – increases viscosity
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`6
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`through a different mechanism than tragacanthin. That is, in Plaintiff’s words, “tragacanthin (the
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`The Court found Dr. Moreton’s opinion on the solubility of bassorin more credible than
`that of Dr. Jonnalagadda’s given that it was backed by more scientific support and
`explanation. (See Tr. at 291:5-11, 294:6-296:3; JTX-066 at 1; JTX-072 at 2). The Court,
`however, declines to reach the factual issue of whether bassorin is technically “less
`soluble” or “insoluble.” As noted above, regardless of the way bassorin is characterized,
`the parties do not dispute that tragacanth powder is made up of two components rather
`than one and that the way in which bassorin increases viscosity is through swelling in
`water and forming a gel rather than through polymer entanglement. Based on the record
`before the Court, whether bassorin is characterized as either “insoluble” or “less soluble”
`in water compared with tragacanthin would not impact the Court’s determination
`regarding infringement.
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 16 of 28 PageID #: 1766
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`soluble portion) increases viscosity through random entanglement . . . while bassorin (the less
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`soluble portion), swells and forms a gel.” (D.I. 112 at 8; see also D.I. 114 at 11; Tr. at 297:1-
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`298:6; 319:14-16).
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`60.
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`Thus, as explained by Dr. Moreton at trial, tragacanth powder increases viscosity
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`by a combination of swelling and polymer chain entanglement. (Tr. at 297:1-298:6, 307:9-14).
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`61.
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`In addition, as Dr. Moreton testified, scientific literature reflects that the presence
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`of bassorin interacting with tragacanthin in tragacanth powder has a different effect on viscosity
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`than that of either compound interacting alone with water. (Tr. at 298:7-300:16, 302:9-303:1;
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`JTX-072 at 4-5). Accordingly, as Dr. Moreton explained, tragacanth powder increases viscosity
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`by a combination of three interactions: (1) the majority component of water-insoluble (or less
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`soluble) bassorin swelling with water; (2) the minority component tragacanthin dissolving in
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`water, leading to polymer chain entanglement; and (3) the interaction between bassorin and
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`tragacanthin. (Tr. at 297:1-12, 307:9-14).
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`62.
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`It is undisputed that xanthan gum increases viscosity in a single way – by the
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`entanglement of dissolved polymer chains. (Tr. at 296:8-22, 297:13-24, 140:18-141:14).
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`63.
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`Plaintiff contends, however, that “the presence of bassorin simply does not
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`matter.” (D.I. 112 at 9).
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`64.
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`In support of this argument, Plaintiff first points to Amneal’s experiments that
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`showed tragacanth powder prevented sedimentation. Plaintiff contends that because bassorin
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`takes up to twenty-four hours to fully hydrate without heat and the Amneal scientists did not heat
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`the tragacanth powder batches during their experiments, the experiments show that tragacanthin
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`alone is responsible for the suspension of spironolactone. (D.I. 112 at 10). The testimony that
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`comes closest to supporting this theory is the following from Dr. Jonnalagadda:
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`15
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`Case 1:21-cv-00549-MN Document 123 Filed 09/29/23 Page 17 of 28 PageID #: 1767
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`Q: Assuming [Amneal] heat[ed] the batches, does that change
`your opinion in any way about the manner in which these two
`suspending agents are achieving the increased viscosity of the
`suspension?
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`A: No, the mechanism of action of viscosity increase is the same
`between tragacanth and xanthan.
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`Q: Regardless of whether it’s heated?
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`A: Regardless of whether it’s heated.
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`(Tr. at 143:21-144:3). Dr. Jonnalagadda offered no further explanation as to why heating would
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`not impact the mechanism by which both suspending agents increase viscosity and did not testify
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`that these experiments show that tragacanthin alone is responsible for the suspension of
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`spironolactone. The record is insufficient to support this theory.
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`65.
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`In support of its contention that the presence of bassorin “simply does not matter,”
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`Plaintiff further argues that the asserted claims are all “comprising” claims; that is, they are
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`open-ended and thus the presence of additional material, such as bassorin, does not negate
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`infringement. (D.I. 112 at 9). Plaintiff presented no testimony in support of this argument.
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`66.
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`Furthermore, Plaintiff has waived this argument as it was not properly disclosed
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`in the Pretrial Order. (See D.I. 99).
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`67. When asked whether the difference in solubility between the two portions of
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`tragacanth powder makes a difference as to his opinion that tragacanth powder and xanthan gum
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`increase viscosity in the same way, Dr. Jonnalagadda did not respond with either of Plaintiff’s
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`attorneys’ arguments noted above. Rather, Dr. Jonnalagadda testified that the difference in
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`solubility “does not” make a difference in his opinion because “[t]he less soluble portion is also a
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`[water-soluble] hydrocolloid, that’s what I would call it. Ther