Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`Ordered accordingly.
`
`Procedural Posture(s): Judgment.
`
`West Headnotes (56)
`
`KeyCite Blue Flag – Appeal Notification
` Appeal Filed by EXELA PHARMA SCIENCES, LLC v. DR. REDDY'S
`LABORATORIES S.A., Fed.Cir., October 12, 2022
`
`
`
`620 F.Supp.3d 108
`United States District Court, D. Delaware.
`
`EXELA PHARMA SCIENCES, LLC, Plaintiff,
`v.
`ETON PHARMACEUTICALS, INC., Defendant.
`
`C.A. No. 20-365 (MN)
`|
`Signed August 8, 2022
`
`Synopsis
`Background: Patentee brought action against competitor
`pursuant to Hatch-Waxman Act, alleging infringement of
`three patents covering an injectable L-cysteine composition
`containing low aluminum levels and methods of using such
`composition.
`
`[1]
`
`[2]
`
`Patents
`Questions of law or fact
`The ultimate question of the proper construction
`of a patent is a question of law, although
`subsidiary fact-finding is sometimes necessary.
`
`Patents
`Plain, ordinary, or customary
`meaning in general
`Patents
`State of the art
`The words of a patent claim are generally given
`their ordinary and customary meaning, which is
`the meaning that the term would have to a person
`of ordinary skill in the art in question at the time
`of the invention, i.e., as of the effective filing date
`of the patent application.
`
`Patents
`Context
`Although the patent claims themselves provide
`substantial guidance as to the meaning of
`particular claim terms, the context of the
`surrounding words of the claim also must be
`considered.
`
`Patents
`Plain, ordinary, or customary
`meaning in general
`Patents
`State of the art
`The ordinary meaning of a patent claim term is
`its meaning to the ordinary artisan after reading
`the entire patent.
`
`Holdings: The District Court, Maryellen Noreika, J., held
`that:
`
`[3]
`
`[1] competitor directly infringed patent claim covering a
`method of treating a patient with an adverse health condition
`responsive to L-cysteine administration;
`
`[2] prior art product did not anticipate claim;
`
`[3] foreign manufacturer's certificate of analysis for single lot
`of prior art product was insufficient to prove anticipation;
`
`[4]
`
`[4] competitor failed to establish by clear and convincing
`evidence that it was obvious to use prior art product with
`particular vials;
`
`[5] patentee's product filled long-felt need for low-aluminum
`cysteine composition; and
`
`[6] competitor failed to meet its burden of proving patent
`claims were obvious with respect to specific aluminum-over-
`time and cystine-over-time claim limitations of each asserted
`claim.
`
`[5]
`
`Patents
`Specifications and Drawings;
` Written Description
`is always highly
`The patent specification
`relevant to the claim construction analysis, as it is
`the single best guide to the meaning of a disputed
`term.
`
` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
`
`1
`
`Nexus Ex. 1007
`Page 1 of 34
`
`

`

`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`[6]
`
`[7]
`
`[8]
`
`[9]
`
`Patents
`Contemporaneous construction
`It is possible that the patent specification may
`reveal a special definition given to a claim term
`by the patentee that differs from the meaning
`it would otherwise possess; in such cases, the
`inventor's lexicography governs.
`
`Patents
`Preferred embodiment
`Even when the patent specification describes
`only a single embodiment, the claims of the
`patent will not be read restrictively unless the
`patentee has demonstrated a clear intention to
`limit the claim scope using words or expressions
`of manifest exclusion or restriction.
`
`Patents
`Rejection and Amendment of
`Claims;  Prosecution History
`In addition to the patent specification, a court
`construing the claims of a patent should also
`consider the patent's prosecution history, if it is
`in evidence.
`
`Patents
`Rejection and Amendment of
`Claims;  Prosecution History
`A patent's “prosecution history,” which is
`intrinsic evidence, consists of the complete
`record of proceedings before the Patent and
`Trademark Office (PTO) and includes the prior
`art cited during the examination of the patent.
`
`[10]
`
`Patents
`Rejection and Amendment of
`Claims;  Prosecution History
`A patent's prosecution history can often
`inform the meaning of the claim language by
`demonstrating how the inventor understood the
`invention and whether the inventor limited the
`invention in the course of prosecution, making
`the claim scope narrower than it would otherwise
`be.
`
`[11]
`
`[12]
`
`[13]
`
`[14]
`
`[15]
`
`Patents
`Extrinsic Evidence
`“Extrinsic evidence,” for purposes of construing
`the claims of a patent, consists of all
`evidence external to the patent and prosecution
`history, including expert and inventor testimony,
`dictionaries, and learned treatises.
`
`Patents
`Expert and inventor testimony
`Expert testimony can be useful, for purposes
`of construing the claims of a patent, to ensure
`that the court's understanding of the technical
`aspects of the patent is consistent with that of
`a person of skill in the art, or to establish that
`a particular term in the patent or the prior art
`has a particular meaning in the pertinent field;
`nonetheless, courts must not lose sight of the fact
`that expert reports and testimony are generated at
`the time of and for the purpose of litigation and
`thus can suffer from bias that is not present in
`intrinsic evidence.
`
`Patents
`Extrinsic Evidence
`Although extrinsic evidence may be useful to
`a court construing the claims of a patent, it
`is less reliable than intrinsic evidence, and
`its consideration is unlikely to result in a
`reliable interpretation of patent claim scope
`unless considered in the context of the intrinsic
`evidence.
`
`Patents
`Extrinsic Evidence
`intrinsic record unambiguously
`the
`Where
`describes the scope of a patented invention,
`reliance on any extrinsic evidence, for purposes
`of claim construction, is improper.
`
`Patents
`In general;  comparison with
`patent claims
`Courts employ a two-step analysis in making a
`patent infringement determination: first, a court
`must construe the asserted claims; next, the trier
`of fact must compare the properly-construed
`
` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
`
`2
`
`Nexus Ex. 1007
`Page 2 of 34
`
`

`

`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`claims to the accused infringing product.
`U.S.C.A. § 271(a).
`
`35
`
`[22]
`
`[16]
`
`[17]
`
`[18]
`
`[19]
`
`[20]
`
`Patents
`In general;  comparison with
`patent claims
`Literal patent infringement occurs where every
`limitation in a patent claim is found in an accused
`product, exactly.
`35 U.S.C.A. § 271(a).
`
`Filing of applications for drug
`
`Patents
`approval
`In a patent infringement action brought pursuant
`to the Hatch-Waxman Act, the infringement
`inquiry is whether, if a particular drug were put
`on the market, it would infringe the relevant
`patent.
`35 U.S.C.A. § 271(e)(2)(A).
`
`Patents
`As to Patentability and Validity
`An issued patent is presumed to be valid. 35
`U.S.C.A. § 282.
`
`Patents
`Degree of proof
`To
`invalidate a patent,
`the party seeking
`invalidation must carry its burden of proof by
`clear and convincing evidence. 35 U.S.C.A. §
`282.
`
`Patents
`Degree of proof
`“Clear and convincing evidence,” for purposes
`of the burden of proof of the party seeking to
`invalidate a patent, is evidence that proves in the
`mind of the trier of fact an abiding conviction
`that the truth of the factual contentions is highly
`probable. 35 U.S.C.A. § 282.
`
`[21]
`
`Patents
`Questions of law or fact
`Patent anticipation is a question of fact. 35
`U.S.C.A. § 102(a).
`
`[23]
`
`[24]
`
`[25]
`
`[26]
`
`[27]
`
`Patents
`Single reference disclosing every
`element or limitation of claim
`Patents
`Inherent anticipation
`A patent claim is anticipated if each and every
`limitation is found, either expressly or inherently,
`in a single prior art reference. 35 U.S.C.A. §
`102(a).
`
`Patents
`Prior Art and Relation of Claimed
`Invention Thereto
`The test for patent anticipation mirrors, to
`some extent, the test for infringement, and it is
`axiomatic that which would literally infringe, if
`later, anticipates, if earlier. 35 U.S.C.A. § 102(a).
`
`Patents
`Single reference disclosing every
`element or limitation of claim
`In order to anticipate a patent, a reference must
`show all of the limitations of the claims arranged
`or combined in the same way as recited in the
`claims. 35 U.S.C.A. § 102(a).
`
`Patents
`Prior knowledge or use in general
`If an invention was known to or used by others in
`the United States before the date of the patentee's
`invention, the later inventor has not contributed
`to the store of knowledge, and has no entitlement
`to a patent. 35 U.S.C.A. § 102(a).
`
`Patents
`Accessibility to public of prior art;
` concealed inventions
`For prior art to anticipate a patent claim because
`it has been “used,” the use must be accessible to
`the public. 35 U.S.C.A. § 102(a).
`
`Patents
`Prior knowledge or use in general
`The prior knowledge and use of prior art by a
`single person is sufficient to anticipate a patent
`claim. 35 U.S.C.A. § 102(a).
`
` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
`
`3
`
`Nexus Ex. 1007
`Page 3 of 34
`
`

`

`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`[28]
`
`[29]
`
`[30]
`
`[31]
`
`Patents
`Incorporation by reference
`Material not explicitly contained in a single
`prior art document may still be considered,
`in determining whether a patent claim is
`anticipated, if that material is incorporated by
`reference into the document. 35 U.S.C.A. §
`102(a).
`
`Patents
`Incorporation by reference
`“Incorporation by reference,” for purposes
`of determining whether a patent claim is
`anticipated, provides a method for integrating
`material from various documents into a host
`document by citing such material in a manner
`making clear that the material is effectively part
`of the host document as if it were explicitly
`contained therein. 35 U.S.C.A. § 102(a).
`
`Patents
`In general;  multiple factors
`Patents
`Questions of law or fact
`Patent obviousness is a question of law based
`on underlying factual findings concerning: (1)
`the scope and content of the prior art; (2) the
`differences between the claims and the prior art;
`(3) the level of ordinary skill in the art; and (4)
`objective considerations of nonobviousness. 35
`U.S.C.A. § 103(a).
`
`Patents
`Combination of prior art
`references;  "teaching, suggestion, or
`motivation" test
`Patents
`Expectation or probability of
`success;  predictability
`Patents
`Level of Ordinary Skill in the Art
`To prove that a patent is obvious, a party must
`demonstrate that a skilled artisan would have
`had reason to combine the teaching of the prior
`art references to achieve the claimed invention,
`and that the skilled artisan would have had a
`reasonable expectation of success from doing so.
`35 U.S.C.A. § 103(a).
`
`[32]
`
`[33]
`
`[34]
`
`[35]
`
`[36]
`
`Patents
`Combination of prior art
`references;  "teaching, suggestion, or
`motivation" test
`teaching,
`Although an analysis of any
`suggestion, or motivation to combine known
`elements is useful to a patent obviousness
`analysis, the overall obviousness inquiry must be
`expansive and flexible. 35 U.S.C.A. § 103(a).
`
`Patents
`Level of Ordinary Skill in the Art
`Patents
`Time of evaluation;  hindsight
`The use of hindsight is not permitted when
`determining whether a patent claim would have
`been obvious to one of ordinary skill in the art.
`35 U.S.C.A. § 103(a).
`
`Patents
`In general;  multiple factors
`To protect against the improper use of hindsight
`when assessing patent obviousness, the court
`is required to consider objective or secondary
`considerations, or indicia, of non-obviousness,
`such as commercial success, failure of others,
`unexpected results, and long-felt but unmet need.
`35 U.S.C.A. § 103(a).
`
`Patents
`Particular products or processes
`Patents
`Drugs and medicines
`Term “about,” as used in patent claim covering
`a method of treating a subject having an adverse
`health condition that is responsive to L-cysteine
`administration, meant approximately, and was
`not indefinite.
`
`Patents
`Particular products or processes
`Patents
`Drugs and medicines
`Term “pharmaceutically acceptable amount of
`cystine,” as used in patent for stable and highly
`pure L-cysteine compositions for
`injection
`and methods of use, meant an amount of
`cystine that was compatible chemically and/or
`toxicology with the other ingredients comprising
`
` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
`
`4
`
`Nexus Ex. 1007
`Page 4 of 34
`
`

`

`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`a formulation and/or the mammal being treated
`therewith, and was not indefinite.
`
`[40]
`
`[41]
`
`[42]
`
`Filing of applications for drug
`
`Patents
`approval
`What an Abbreviated New Drug Application
`(ANDA) applicant asks for and receives
`approval to market, if within the scope of a valid
`claim, is a patent infringement.
`35 U.S.C.A.
`§ 271(e)(2).
`
`Patents
`Scope of inquiry and power of
`court in general
`Competitor, whose abbreviated new drug
`application (ANDA) product met all limitations
`of patentee's patent claim covering a method
`of
`treating a patient with an adverse
`health condition
`responsive
`to L-cysteine
`administration, waived its argument in parties'
`infringement dispute that if claim limitation “not
`more than” could mean zero, then patent claim
`was invalid, where competitor raised argument
`for the first time in post-trial brief, and did not
`present argument at trial or in pre-trial order.
`
`Patents
`Drugs and medicines
`Competitor's abbreviated new drug application
`(ANDA) product, which met all limitations of
`patent claim covering a method of treating
`a patient with an adverse health condition
`responsive to L-cysteine administration, was not
`the same as prior art product, and thus prior art
`product did not anticipate claim; ANDA product
`and prior art product differed as to amount of
`aluminum over time, ANDA product required
`additional sterilization step and oxygen controls
`that were material to integrity of product, prior
`art product used different vial which could affect
`how much aluminum leached into product, and
`products were made with cysteine sourced from
`different companies, which sold ingredients with
`different impurity profiles. 35 U.S.C.A. § 102(a).
`
`[37]
`
`[38]
`
`[39]
`
`Patents
`Drugs and medicines
`Term “stable L-cysteine composition,” in patent
`claim for method of treating a subject having
`an adverse health condition that is responsive to
`L-cysteine administration, meant an L-cysteine
`composition that had the component profiles
`described therein, for example, aluminum, L-
`cystine, and pyruvic acid, at the levels described
`and for the amount of time identified; in other
`words, a stable composition that contained the
`specified levels of all components for sufficient
`period of time to enable the composition to
`be commercially manufactured, stored, shipped,
`and administered in a clinical setting.
`
`Patents
`Drugs and medicines
`Term “pyruvic acid relative to L-cysteine not
`more than about 2.0 wt %,” as used in patent
`claim covering a method of treating a subject
`having an adverse health condition that was
`responsive to L-cysteine administration, had its
`plain and ordinary meaning, which set a limit to
`the amount of pyruvic acid when present, but did
`not require the presence of pyruvic acid.
`
`Patents
`Drugs and medicines
`Competitor's abbreviated new drug application
`(ANDA) product met all limitations of patent
`claim covering a method of treating a patient
`with an adverse health condition responsive to
`L-cysteine administration, and thus competitor
`directly infringed claim, even if ANDA product
`did not contain pyruvic acid, where court
`construed asserted claim to require only that the
`amount of pyruvic acid not exceed the maximum
`stated, such that claim did not require any amount
`of pyruvic acid to be present.
`35 U.S.C.A. §
`271(e)(2).
`
`[43]
`
`Patents
`Drugs and medicines
`Foreign manufacturer's certificate of analysis
`for single lot of prior art product, which
`competitor alleged anticipated patent claim
`
` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
`
`5
`
`Nexus Ex. 1007
`Page 5 of 34
`
`

`

`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`[44]
`
`[45]
`
`covering a method of treating a patient with
`an adverse health condition responsive to L-
`cysteine administration, was insufficient to prove
`anticipation, even if manufacturer prepared other
`lots of product for public use or sale in the United
`States; there was no evidence that single lot was
`in public use, on sale, or otherwise available
`to public at time of invention, aluminum levels
`of lots were highly variable, and single lot's
`certificate of analysis was only certificate,
`among many submitted as evidence, that met
`aluminum limit claimed. 35 U.S.C.A. § 102(a).
`
`Patents
`Drugs and medicines
`Competitor, whose abbreviated new drug
`application (ANDA) product infringed three
`patents for an injectable L-cysteine composition
`containing low aluminum levels and methods
`of using such composition, failed to establish
`by clear and convincing evidence
`that
`it
`was obvious to use prior art product with
`particular vials, which allegedly reduced amount
`of aluminum leaching into product; reduction
`of aluminum in a cysteine formulation was
`not wholly independent of all other properties
`and characteristics of formulation, including
`acceptable levels of impurities, and complex
`chemistry of cysteine was not always predictable
`in a practical setting. 35 U.S.C.A. § 103(a).
`
`Patents
`Drugs and medicines
`Competitor, whose abbreviated new drug
`application (ANDA) product infringed three
`patents for an injectable L-cysteine composition
`containing low aluminum levels and methods of
`using such composition, failed to establish by
`clear and convincing evidence that a person of
`ordinary skill in the art would have chosen to
`use particular vials to reduce aluminum levels
`in cysteine products; problem of aluminum
`leaching remained unresolved for duration of
`period that prior art product was on sale,
`and a person of ordinary skill in the art
`would not have been motivated to try particular
`vials with cysteine formulations by prior art
`patent disclosing use of coated vials to reduce
`
`[46]
`
`[47]
`
`[48]
`
`[49]
`
`aluminum precipitation in lysine formulation. 35
`U.S.C.A. § 103(a).
`
`Patents
`Time of evaluation;  hindsight
`An analysis of patent obviousness requires a
`form of amnesia that “forgets” the invention and
`analyzes the prior art and understanding of the
`problem at the date of invention. 35 U.S.C.A. §
`103(a).
`
`Patents
`Drugs and medicines
`Competitor, whose abbreviated new drug
`application (ANDA) product infringed three
`patents for an injectable L-cysteine composition
`containing low aluminum levels and methods
`of using such composition, failed to establish
`that a person of ordinary skill in the art would
`have had a reasonable expectation of success in
`reducing aluminum in cysteine compositions by
`using particular vial with prior art product, and
`thus, patents were not obvious on such basis;
`no one, including prior art product manufacturer,
`tried using vials despite strong motivation to
`reduce aluminum in cysteine compositions. 35
`U.S.C.A. § 103(a).
`
`Patents
`Time of evaluation;  hindsight
`The use of an inventor's own path itself never
`leads to a conclusion of obviousness; that is
`hindsight. 35 U.S.C.A. § 103(a).
`
`Patents
`Level of Ordinary Skill in the Art
`What matters in determining whether a patent
`claim would have been obvious is the path that
`a person of ordinary skill in the art would have
`followed, as evidenced by the pertinent prior art.
`35 U.S.C.A. § 103(a).
`
`[50]
`
`Patents
`Drugs and medicines
`Patentee's product, which was an embodiment
`of patent claims covering injectable L-cysteine
`composition containing low aluminum levels
`
` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
`
`6
`
`Nexus Ex. 1007
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`

`

`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`[51]
`
`and methods of using such composition,
`filled long-felt need for low-aluminum cysteine
`composition, as would support determination
`that claims were not obvious;
`for over
`two decades before patentee's
`inventions,
`clinical community recognized that aluminum
`contamination of cysteine used
`for
`total
`parenteral nutrition (TPN) was a long-standing
`problem, Food and Drug Administration (FDA)
`implemented regulations requiring labels to
`report maximum content, and product was
`first
`to provide a stable,
`low-aluminum
`cysteine composition that allowed clinicians to
`administer TPN solutions without exceeding
`FDA's recommended daily maximum aluminum
`amount. 35 U.S.C.A. § 103(a).
`
`Patents
`Drugs and medicines
`Competitor, whose abbreviated new drug
`application (ANDA) product infringed three
`patents for an injectable L-cysteine composition
`containing low aluminum levels and methods
`of using such composition, failed to establish
`that prior art product had already filled, at
`time of patentee's inventions, long-felt need for
`low-aluminum cysteine composition, as would
`weigh against determination that patent claims
`were not obvious; clinicians acknowledged and
`called for a solution to the problem of high
`aluminum contamination in cysteine used for
`total parenteral nutrition (TPN) during period in
`which product was sold, product contained more
`than twice the Food and Drug Administration's
`(FDA) recommended daily maximum aluminum
`amount, and aluminum levels in product were
`highly variable. 35 U.S.C.A. § 103(a).
`
`[52]
`
`Patents
`Drugs and medicines
`Third-party pharmaceutical company's work
`developing
`a
`stable L-cysteine product
`with
`low aluminum at
`the
`same
`time
`patentee was developing invention claimed
`by three patents for an injectable L-cysteine
`composition containing low aluminum levels
`and methods of using such composition did
`not demonstrate
`that patent claims were
`
`[53]
`
`[54]
`
`[55]
`
`obvious, in infringement action brought by
`patentee against competitor, whose abbreviated
`new drug
`application
`(ANDA) product
`infringed patents; simultaneous invention, on
`its own, could not
`support
`finding of
`obviousness, and pharmaceutical company's
`experience developing its product demonstrated
`that claimed invention was unexpected and
`complicated. 35 U.S.C.A. § 103(a).
`
`Patents
`Simultaneous invention
`A single instance of simultaneous invention
`cannot alone support a finding of obviousness.
`35 U.S.C.A. § 103(a).
`
`Patents
`Drugs and medicines
`Competitor, whose abbreviated new drug
`application (ANDA) product infringed three
`patents for an injectable L-cysteine composition
`containing low aluminum levels and methods
`of using such composition, failed to meet its
`burden of proving patent claims were obvious
`with respect to specific aluminum-over-time
`and cystine-over-time claim limitations of each
`asserted claim, which encompassed periods of
`time sufficient for the product to be administered
`in a clinical setting. 35 U.S.C.A. § 103(a).
`
`Patents
`Drugs and medicines
`Competitor, whose abbreviated new drug
`application (ANDA) product infringed patent
`claims covering a cysteine product containing
`specified levels of mercury and/or lead, failed
`to meet its burden of proving patent claims
`were obvious, where competitor's only basis
`for obviousness argument was that a prior art
`product was the same as ANDA product, and
`competitor failed to establish by clear and
`convincing evidence that ANDA product and
`prior art product were the same with respect to
`lead and mercury content. 35 U.S.C.A. § 103(a).
`
`[56]
`
`Patents
`
`In general;  utility
`
` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
`
`7
`
`Nexus Ex. 1007
`Page 7 of 34
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`

`

`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`US Patent 10,583,155, US Patent 10,905,713,
`US Patent 10,912,795. Not Invalid, Infringed.
`
`Go to Markman Construed Terms
`
`Attorneys and Law Firms
`
`*114 Gregory R. Booker, Robert M. Oakes, Douglas E.
`McCann, Fish & Richardson P.C., Wilmington, DE; Corrin N.
`Drakulich, Christina D. Brown-Marshall, Dexter S. Whitley,
`Fish & Richardson, P.C., Atlanta, GA; Karrie Wheatley, Fish
`& Richardson, P.C., Houston, TX; Elizabeth M. Flanagan,
`Deanna Reichel, Fish & Richardson, P.C., Minneapolis, MN;
`Jonathan E. Singer, Fish & Richardson, P.C., San Diego, CA;
`Satish Chintapalli, Chintapalli Law Firm, PLLC, Cary, NC –
`Attorneys for Plaintiff
`
`Timothy Devlin, Peter A. Mazur, Neil A. Benchell, Stephanie
`Berger, Robert Kiddie, Devlin Law Firm LLC, Wilmington,
`DE – Attorneys for Defendant
`
`MEMORANDUM OPINION
`
`NOREIKA, UNITED STATES DISTRICT JUDGE:
`
`Plaintiff Exela Pharma Sciences, LLC (“Exela” or “Plaintiff”)
`brought this Hatch-Waxman action against Defendant Eton
`Pharmaceuticals, Inc. (“Eton” or “Defendant”). Eton has
`filed an Abbreviated New Drug Application (“ANDA”) with
`the U.S. Food and Drug Administration (“FDA”) seeking
`approval to market a generic version (“ANDA product”) of
`Exela's ELCYS ® product before expiration of several patents
`owned by Exela. Plaintiff alleges *115 that Eton's ANDA
`product will infringe claim 27 of the 10,583,155 patent
`(“the ’155 patent”), claims 8, 9, and 10 of the 10,905,713
`patent (“the ’713 patent”) and claims 1, 19, and 27 of the
`10,912,795 patent (“the ’795 patent”). The parties stipulated
`to infringement of all asserted claims of the ’713 and ’795
`patents (D.I. 199), leaving only infringement of claim 27 of
`the ’155 patent disputed. Eton asserts that all asserted claims
`are invalid.
`
`The Court conducted a three-day bench trial from March 14,
`2022 to March 16, 2022. (See D.I. 205-207 (“Tr.”)). The
`parties completed post-trial briefing on April 18, 2022. (D.I.
`209, 212, 220, 222, 228, 229). With their briefing, the parties
`submitted proposed findings of fact. (D.I. 210, 211, 221). 1
`
`Pursuant to Rule 52(a) of the Federal Rules of Civil
`Procedure, and after having considered the entire record and
`the applicable law, the Court concludes that: (1) the ANDA
`product infringes claims 8, 9, and 10 of the ’713 patent and
`claims 1, 19, and 27 of the ’795 patent; (2) Exela has proven
`that Defendant's ANDA product directly and contributorily
`infringes and induces infringement of claim 27 of the ’155
`patent; (3) Eton has failed to prove that claim 27 of the ’155
`patent is invalid as anticipated, and (4) Eton has failed to
`prove that claim 27 of the ’155 patent, claims 8, 9, and 10 of
`the ’713 patent or claims 1, 19, and 27 of the ’795 patent are
`invalid for obviousness. This opinion constitutes the Court's
`findings of fact and conclusions of law.
`
`I. FINDINGS OF FACT
`
`A. Introduction
`1. Exela is a limited liability corporation existing under the
`laws of Delaware, having its principal place of business in
`North Carolina. (D.I. 177, Ex. 1 ¶ 2).
`
`2. Eton is a corporation organized and existing under the laws
`of Delaware, having its principal place of business in Illinois.
`(D.I. 177, Ex. 1 ¶ 4).
`
`3. Exela owns the ’155, ’713, and ’795 patents, which are
`listed in the FDA publication, “Approved Drug Products with
`Therapeutic Equivalence Evaluations” (“the Orange Book”),
`as having at least one claim that covers Exela's ELCYS
`product. (D.I. 177, Ex. 1 ¶ 50).
`
`4. On December 9, 2019, Eton submitted ANDA No. 214082
`to FDA under
`21 U.S.C. § 355(j)(5)(B)(iii) seeking FDA
`approval to engage in the commercial manufacture, use,
`or sale of its ANDA product (i.e., Cysteine Hydrochloride
`Injection, USP, 500 mg/10 mL (50 mg/mL) Single Dose
`Vials). (D.I. 177, Ex. 1 ¶¶ 68, 69). Defendant's ANDA
`contains certifications for each of the patents in this case. (D.I.
`177, Ex. 1 ¶ 71). 2
`
`B. Witnesses
`
` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`1. Fact Witnesses
`
`5. Dr. Phanesh Koneru, a named inventor of the ’155, ’713,
`and ’795 patents and Exela's co-founder and CEO, testified
`live at trial about Exela's development of ELCYS. (Tr. 153:1–
`231:9).
`
`6. Dr. John Hofstetter, a former employee of Allergy
`Laboratories (“Allergy Labs”) and currently the Managing
`Member of Dry Creek Project, LLC, testified live at trial. (Tr.
`285:25–346:4). Dr. Hofstetter *116 testified about Allergy
`Labs work manufacturing an L-cysteine product for Sandoz
`and its later submission of an NDA to market its own L-
`cysteine product. Dr. Hofstetter has a financial interest in
`this case, as his company will receive 12.5% of Eton's profit
`from its proposed ANDA product. (Tr. 337:9–339:4, PTX-33,
`PTX-35).
`
`7. Sean Brynjelsen, Eton's founder and CEO, testified live
`at trial as a fact witness. (Tr. 346:8–374:20). Mr. Brynjelsen
`testified about his work in the pharmaceutical industry,
`including on sterile injectable products and total parenteral
`nutrition (“TPN”) solutions as well as Eton's ANDA product.
`
`8. Warren Johnson, the former owner of Allergy Laboratories,
`Inc. and the Vice President of AL Pharma, Inc., testified by
`deposition. (Tr. 376:8–380:5). Mr. Johnson testified about the
`L-cysteine product Allergy Labs manufactured for Sandoz
`and Allergy Labs's later decision to submit an NDA to market
`its own L-cysteine product
`
`9. Dr. John Maloney, a named inventor of the ’155, ’713, and
`’795 patents and Exela's Head of Research and Development,
`testified by deposition about his work developing ELCYS.
`(Tr. 380:6–389:16).
`
`10. Dr. Aruna Koganti, a named inventor of the ’155, ’713
`and ’795 patents, testified by deposition. Dr. Koganti was
`not involved with developing the drug product, but was
`responsible for preparing and submitting the New Drug
`Application (“NDA”) for ELCYS and communicating with
`the FDA. (Tr. 389:22–395:25).
`
`11. Dr. Olu Aloba, Vice President of Chemistry,
`Manufacturing, and Controls at Camargo Pharmaceutical
`Services, testified by deposition regarding AL Pharma's
`submission of an NDA for an L-cysteine product and
`about how Camargo made recommendations to improve and
`
`validate AL Pharma's manufacturing process. (Tr. 550:18:–
`556:3).
`
`2. Plaintiffs’ Expert Witnesses
`
`12. Dr. Christian Schoneich is the Chair of the Department of
`Pharmaceutical Chemistry at the University of Kansas. (Tr.
`232:15–21). Dr. Schoneich received a diploma in chemistry
`in 1987 and a Ph.D. from the Technical University in Berlin,
`where he studied the reaction of vials including cysteine,
`including oxidation reactions. (Tr. 232:22–233:10). At the
`University of Kansas, Dr. Schoneich teaches and performs
`research related to amino acid chemistry, including cysteine.
`(Tr. 233:5–234:4, 235:5–11, 236:4–22). Dr. Schoneich has
`authored more than 60 papers related to pharmaceutical
`chemistry, and has more than 30 publications related to
`cysteine chemistry. (Tr. 237:5–14). The Court recognized Dr.
`Schoneich as an expert in pharmaceutical and amino acid
`chemistry, specifically with respect to cysteine chemistry. (Tr.
`239:3–14).
`
`13. Dr. Dennis Jenke is a consultant in the medical and
`pharmaceutical industries who holds a master's degree in
`geochemistry and a Ph.D. in analytical chemistry. (Tr.
`556:24–557:2, 559:17–19). Prior to his consulting career, Dr.
`Jenke spent thirty-four years at Baxter Health Care where he
`worked on at least one hundred aqueous drug formulations
`and developed expertise in extractables and leachables.
`(Tr. 557:3–15, 558:10–23, 559:9–16). The Court recognized
`Dr. Jenke as an expert in aqueous drug formulations and
`packaging. (Tr. 560:4–7).
`
`14. Dr. Robert Kuhn is a pediatric clinical pharmacist at the
`Kentucky Children's Hospital at the University of Kentucky
`and is a professor of pharmacy at the University of Kentucky
`College of Pharmacy. (Tr. 71:25–72:4). Dr. Kuhn received
`his bachelor's degree in pharmacy from *117 Ohio State in
`1980 and a Pharm.D. from the University of Texas in 1984.
`(Tr. 72:14–21). Dr. Kuhn has compounded TPN solutions
`for more than forty years (Tr. 72:22–25, 104:16–25) and has
`published research on aluminum in TPN solutions (PTX-179,
`Tr. 74:17–21). The Court recognized Dr. Kuhn as an expert in
`pharmacy and total parenteral nutrition. (Tr. 75:3–8).
`
`3. Defendant's Expert Witness
`
` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
`
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`Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., 620 F.Supp.3d 108 (2022)
`
`15. Dr. Stephen Baertschi is the President of Baertschi
`Consulting LLC, which provides consulting services to
`pharmaceutical companies pertaining to issues such as
`stability, degradation and impurities. (Tr. 400:13–401:4). Dr.
`Baertschi holds a Ph.D. from Vanderbilt University in organic
`chemistry. (Tr. 401:13–17). Prior to his consulting career, Dr.
`Baertschi worked at Eli Lilly for twenty-five years, where he
`held a variety of technical roles. (Tr. 402:6–18). Dr. Baertschi
`worked with L-cysteine as a graduate student (Tr. 403:10–
`15) and helped organize an extractables and leachables group
`while at Eli Lilly (Tr. 40