UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`No. 15—cv-3654 (KM)(MAH)
`
`OPINION
`(Markman)
`
`FRESENIUS KABI USA, LLC,
`
`Plaintiff,
`
`FERA PHARMACEUTICALS, LLC, et al.,
`
`Defendants.
`
`FRESENIUS KABI USA, LLC,
`
`Plaintiff,
`
`V.
`
`INNOPHARMA LICENSING, LLC, et al.,
`
`Defendants.
`
`KEVIN MCNULTY, U.S.D.J.:
`This Opinion contains the Court’s construction of key patent terms
`following a Markman hearing. This patent infringement case is brought by the
`plaintiff, Fresenius Kabi USA, LLC, against the defendants, Fera
`Pharmaceuticals, LLC and Oakwood Laboratories, LLC (collectively, “Fera”) and
`InnoPharma, Inc. and InnoPharma Licensing, LLC (collectively, “InnoPharma”).’
`The patents-in-suit are Patent Nos. 9,006,289 (“the ‘289 patent”), 9,168,238
`
`1 The suit against InnoPharma was originally filed under the docket number
`15—3655, but the cases were consolidated for pretrial purposes upon request of the
`parties. (See ECF No. 79) A third suit, docket number 15—3853, was originally
`consolidated with these two, but those defendants settled with Fresenius after the
`opening briefs were filed. (See ECF No. 120)
`
`1
`
`Mylan Ex 1012, Page 1
`
`

`
`(“the ‘238 patent”), and 9,168,239 (“the ‘239 patent”). All three patents describe
`formulations of levothyroxine, a hormone produced by the thyroid. These
`patents claim a form of lyophilized (i.e. freeze-dried) levothyroxine that can be
`reconstituted and injected into patients who lack a properly functioning
`thyroid. (P1. Opening 1)2
`The Food and Drug Administration approved Fresenius’s New Drug
`Application (“NDA”) on June 24, 2011. (3AC Fera ¶ 15) The ‘289 patent was
`issued on April 14, 2015, and is due to expire on October 3, 2032. (3AC Fera
`¶J 10, 16) The ‘238 and ‘239 patents were issued on October 27, 2015, and are
`due to expire on August 29, 2032. (3AC Fera ¶J 11-12, 16) Fera and
`InnoPharma filed Abbreviated New Drug Applications (“ANDA”) that sought
`
`2 Citations to the record will be abbreviated as follows:
`“3AC Fera” — Third Amended Complaint of Fresenius against Fera (ECF
`No. 83).
`“Fera Answer” — Fera’s Answer to 3AC Fera (ECF No. 84).
`“InnoPharma Answer” — InnoPharma’s Answer to the Second Amended
`Complaint of Fresenius against InnoPharma (ECF No. 85).
`“Joint Br.” — Parties’ Joint Claim Construction and Prehearing Statement (ECF
`No. 92).
`“P1. Opening” — Plaintiff’s Opening Markman Brief (ECF No. 101).
`“P1. Ex.” — Plaintiff’s Exhibits (ECF Nos. 10 1—2 to 10 1—5), attached to the
`Declaration of Justin T. Quinn (ECF No. 10 1-1).
`“P1. Response” — Plaintiff’s Responsive Markman Brief (ECF No. 171).
`“Def. Opening” — Defendants’ Amended Opening Markman Brief (ECF No. 157).
`“Def. Ex.”— Defendants’ Exhibits (ECF Nos. 102—2 to 102—19), attached to the
`Certification of Christina L. Saveriano (ECF No 102—1).
`“Def. Response” — Defendants’ Responsive Markman Brief (ECF No. 170).
`“289 Patent” — United States Patent No. 9,006,289, P1. Ex. 1 (ECF No. 10 1—2).
`“238 Patent” — United States Patent No. 9,168,238, P1. Ex. 2 (ECF No. 10 1—3).
`“‘239 Patent” — United States Patent No. 9,168,239, P1. Ex. 3 (ECF No. 10 1—4).
`“Remington” — Remington: The Science and Practice of Pharmacy, (Alfonso R.
`Gennaro et al. eds. 20th ed. 2000), DefEx. G (ECF No. 102—8).
`
`2
`
`Mylan Ex 1012, Page 2
`
`

`
`approval to commercially market generic versions of Fresenius’s patented
`levothyroxine injections. (InnoPharma Answer ¶ 1; Fera Answer ¶ 17) This
`lawsuit followed.
`
`I.
`
`CLAIM CONSTRUCTION
`
`A. Standard
`
`“The purpose of claim construction is to ‘determin[el the meaning and
`scope of the patent claims asserted to be infringed.”’ 02 Micro Int’l Ltd. v.
`Beyond Innovation Tech. Co., 521 F.3d 1351, 1360 (Fed. Cir. 2008) (quoting
`Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en
`banc), aff’d, 517 U.S. 370, 116 S. Ct. 1384 (1996)). “[T]he words of a claim are
`generally given their ordinary and customary meaning.” Phillips v. AWH Corp.,
`415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal quotation marks and
`citations omitted). Courts interpret claim terms according to an objective
`standard: “[TJhe ordinary and customary meaning of a claim term 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.” Id. at 1313. To make this determination,
`courts may consider evidence intrinsic to the patent, i.e., “the words of the
`claims themselves, the remainder of the specification, [and] the prosecution
`history,” as well as “extrinsic evidence, which consists of all evidence external
`to the patent and prosecution history, including expert and inventor testimony,
`dictionaries, and learned treatises.” Id. at 1314, 1317 (internal quotation
`marks and citations omitted).
`In Phillips, the United States Court of Appeals for the Federal Circuit,
`sitting en banc, explained that its prior case law had “attempted to explain
`why, in general, certain types of evidence are more valuable than others.” Id. at
`1324 (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582
`(Fed.Cir. 1996)). Phillips assigned significant value to intrinsic evidence and less
`weight to extrinsic evidence, holding extrinsic evidence useful only to the extent
`
`3
`
`Mylan Ex 1012, Page 3
`
`

`
`that “those sources are not used to contradict claim meaning that is
`unambiguous in light of the intrinsic evidence.” Id.
`Thus, a court “first look[s] to the actual words of the claims and then
`reads] them in view of the specification.” Profectus Tech. LLC v. Huawei Techs.
`Co., 823 F.3d 1375, 1380 (Fed. Cir. 2016). “[C]laims must be read in view of
`the specification, of which they are a part” because the specification “is the
`single best guide to the meaning of a disputed term.” Phillips, 415 F.3c1 at
`1315. “[IJf the specification reveals a special definition given to a claim term by
`the inventor, then the inventor’s lexicography governs, even if it differs from the
`term’s ordinary meaning.” David Netzer Consulting Eng’r LLC v. Shell Oil Co.,
`824 F.3d 989, 994 (Fed. Cir. 2016) (citing Phillzs, 415 F.3d at 1316). The court
`may also consider, where relevant, the patent’s prosecution history, “which
`consists of the complete record of the proceedings before the PTO and [J the
`prior art cited during the examination of the patent.” Phillips, 415 F.3d at
`1317. Extrinsic evidence, considered in the context of the intrinsic evidence,
`may “help educate the court regarding the field of the invention and [] help the
`court determine what a person of ordinary skill in the art would understand
`claim terms to mean.” Phillips, 415 F.3d at 1319.
`
`B. Levothyroxine
`
`The specification section of the patents3 provides some background
`information on levothyroxine:
`A healthy thyroid produces hormones that regulate multiple
`metabolic processes and that play important roles in growth and
`development, in maturation of the central nervous system and
`bone including augmentation of cellular respiration and
`thermogenesis, and in metabolism of proteins, carbohydrates and
`lipids. The thyroid accomplishes its regulation functions by
`producing the hormones L-triiodothyronine (liothyronine; T3) and
`L-thyroxine (levothyroxine; T4).
`
`The three patents all contain the same specification, so a citation to the
`specification of the ‘289 Patent applies equally to all. (See P1. Opening 7 n.4)
`
`4
`
`Mylan Ex 1012, Page 4
`
`

`
`A patient who has had their thyroid gland removed, or whose
`thyroid gland functions at an undesirably low level
`(hypothyroidism), may be treated by administration of a daily
`maintenance dose of 50-100 micrograms (pg) of levothyroxine
`sodium. A patient in need of additional intervention may be treated
`by administration of an initial dose of 200-500 pg or 300-500 pg of
`levothyroxine sodium and/or with a 2nd day dose of 100-300 pg of
`levothyroxine sodium.
`(‘289 Patent 1:13—47) The drug at issue in this suit is a lyophilized, or freeze-
`dried, formulation of levothyroxine that is later reconstituted and injected into
`patients. (P1. Opening 1)
`Levothyroxine injections have been available in the United States since
`1969. (Def. Opening 3) Fresenius’s newly patented formulations contain
`levothyroxine, a buffer, and a specific amount of a bulking agent called
`mannitol. The mannitol provides bulk to the “cake” that remains after the
`formulation is freeze dried. Fresenius’s patents are based on the discovery that,
`contrary to expectation, a reduction in the proportion of mannitol improved the
`stability of the freeze dried cake. (P1. Opening 1—2)
`
`C. Disputed Claims
`
`The parties presented charts that jointly summarize their positions as to
`the eleven disputed claims. I will present the charts in groups of related terms
`as I consider the claim construction arguments.
`
`1.
`
`“Buffer” and “Phosphate Buffer”
`While Fresenius “does not believe that the construction of any disputed
`term will be most significant to the resolution of the case” (Joint Br. 5), both
`Fera and InnoPharma consider construction of the term “buffer” to be
`potentially case dispositive. (Id. at 5—6) As to the “buffer” term, the parties
`summarize their positions as follows:
`
`5
`
`Mylan Ex 1012, Page 5
`
`

`
`Term
`
`Fresenius
`
`InnoPharma
`
`Fera
`
`“buffer”
`(‘289 Patent: 1, 4
`9, 14, 16; ‘238
`Patent: 1, 10, 11,
`20, 21, 30; ‘239
`Patent: 1, 7, 8)
`
`“phosphate
`buffer”
`(‘289 Patent: 1, 4,
`9, 14, 16; ‘238
`Patent: 10, 20,
`30; ‘239 Patent:
`7, 8)
`
`Plain and
`“A compound
`ordinary meaning that resists
`changes in pH
`“A system that
`resists changes in when an acid or
`base is added,
`pH when acid or
`and is present in
`base is added.”
`an amount not
`exceeding 800 pg
`total mass.”
`
`“A buffer is a
`solution of a
`weak acid and its
`conjugate base,
`the base being
`provided by one
`of its soluble
`salts.”
`
`Plain and
`“A buffer (as
`This term does
`ordinary meaning otherwise
`not require a
`construed)
`separate
`“A buffer
`comprising one or construction from
`comprising a
`more phosphate
`“buffer”; its
`phosphate.”
`groups.”
`meaning should
`be consistent
`with the Court’s
`construction of
`“buffer.”
`
`(P1. Opening 6-7; Def. Opening 7)
`Claim 1 of each of the three patents describes the “buffer” as part of the
`“lyophilized solid composition” and does not state an amount or mass of the
`buffer.4 (See, e.g., ‘289 Patent Claim 1; ‘238 Patent Claim 1; ‘239 Patent Claim
`1) Other dependent claims in the ‘289 and ‘239 Patents designate the “buffer”
`as “dibasic sodium phosphate,” and give a fixed measurement for it of between
`400 and 600 pg. (‘289 Patent Claims 4, 9, 16; ‘239 Patent Claim 8) Dependent
`claims of the ‘238 Patent simply refer to the “phosphate buffer” without stating
`any particular amount. (‘238 Patent Claims 10, 20, 30
`The specifications of all three patents contain the following language
`discussing “buffers”:
`
`The ‘289 Patent specifies a “phosphate buffer.” (‘289 Patent Claim 1)
`
`6
`
`Mylan Ex 1012, Page 6
`
`

`
`A solid composition that includes levothyroxine sodium and
`mannitol may include one or more other substances. Non-limiting
`examples of other substances include bulking agents, carriers,
`diluents, fillers, salts, buffers, stabilizers, solubilizers,
`preservatives, antioxidants, and tonicity contributors. Substances
`that may be useful in formulating pharmaceutically acceptable
`compositions, and methods of forming such compositions, are
`described for example in Remington: The Science and Practice of
`Pharmacy, 20th Ed., ed. A. Gennaro, Lippincott Williams &
`Wilkins, 2000, and in Kibbe, “Handbook of Pharmaceutical
`Excipients,” 3rd Edition, 2000.
`A solid composition that includes levothyroxine sodium and
`mannitol may be prepared by forming a liquid mixture containing a
`solvent, levothyroxine sodium and mannitol, and lyophilizing the
`liquid mixture. Forming a liquid mixture for use in preparing the
`solid composition may include combining ingredients including the
`solvent, levothyroxine sodium and mannitol. The ingredients used
`to form the liquid mixture may include a phosphate buffer;
`however the ingredients preferably do not include tribasic sodium
`phosphate. In one example, the ingredients used to form the liquid
`mixture include a phosphate buffer other than tribasic sodium
`phosphate, such as dibasic sodium phosphate (Na2HPO4) or
`monobasic sodium phosphate (NaH2PO4). The amount of
`phosphate buffer in the ingredients may be an amount sufficient
`to provide a beneficial pH buffering effect in the liquid mixture.
`Preferably the ingredients used to form the liquid mixture include
`from 100 to 800 pg, from 200 to 700 pg, from 300 to 700 pg, or
`from 400 to 600 ig dibasic sodium phosphate. Dibasic sodium
`phosphate may be added as a hydrate, such as dibasic sodium
`phosphate heptahydrate.
`(‘289 Patent 4:24—55 (emphasis of each occurrence of the word “buffer” added))
`To support their construction of “buffer,” Fresenius and Fera both quote
`the Remington textbook. (Def. Opening 11; P1. Response 5—6) Remington is
`cited in the specification itself, albeit rather generally as a reference for
`“[sjubstances that may be useful” and “methods” of formulation. (See first
`paragraph of passage quoted immediately above.)
`Fresenius derives its functional construction of the term “buffer” from
`page 240 of Remington, which is the opening sentence of that textbook’s
`discussion of buffers: “The terms buffer, buffer solution, and buffered solution,
`when used with reference to hydrogen-ion concentration or pH, refer to the
`
`7
`
`Mylan Ex 1012, Page 7
`
`

`
`ability of a system, particularly an aqueous solution, to resist a change of pH
`on adding acid or alkali, or on dilution with a solvent.” (Remington 240)5 Fera
`quotes a brief reference from page 380 of Remington. The entire quotation at
`page 380 states: “Buffers are used to maintain the pH of a medicinal at an
`optimal value. A buffer is a solution of a weak acid and its conjugate base, the
`base being provided by one of its soluble salts. Refer to Chapterl7 for an
`extensive discussion of pH and buffers.” (Remington 380)
`Fera’s proposed construction, whether plausible or not, contradicts the
`language of the claims and specification. In addition, it is based on a textbook
`definition that declares itself to be incomplete and cross-references a more
`complete discussion elsewhere in the Remington treatise.
`The claims and specification repeatedly discuss the buffer as a
`component of a solid composition. (See, e.g., ‘289 Patent Claim 1, 2:53—58,
`4:36—55; ‘238 Patent Claim 1; ‘239 Patent Claim 1) The specification explains:
`A solid composition ... is formed by a method that includes
`combining ingredients to form a liquid mixture, and lyophilizing
`the liquid mixture.... The term “lyophilizing” means removing from
`a solution or an emulsion one or more substances having the
`lowest boiling points by freezing the solution or emulsion and
`applying a vacuum to the frozen mixture.
`(E.g., ‘289 Patent 2:53—3:2) The patents do not limit the definition of a buffer to
`a liquid solution; rather, they explicitly use the term “buffer” to delineate the
`component in the lyophilized solid composition that performed and would
`perform the buffering action when the composition is in a liquid state.6
`The specification’s general citation to the Remington textbook as a whole
`is not a license to extract passages from that work in derogation of the clear
`
`InnoPharma appears to agree with Fresenius that the definition should be
`derived from this part of Remington.
`6 In this plain-language way, it is like referring to a substance as a “sweetener,”
`although it has that effect only when it chemically stimulates the taste receptors. E.g.,
`Purves D, Augustine GJ, Fitzpatrick D, et al., eds., Neuroscience (2d ed., Sunderland
`(MA): Sinauer Associates, 2001), excerpted at ww.ncbi.nlm.nih.gov/books/NBK1 1148.
`
`8
`
`Mylan Ex 1012, Page 8
`
`

`
`language in the specification and claims. See SkinMedica, Inc. v. Histoqen Inc.,
`727 F.3d 1187, 1207 (Fed. Cir. 2013) (“We see no reason for such a non
`specific reference to trump the clear disclaimer in the specification....”); cf
`Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir.
`2000) (“To incorporate material by reference, the host document must identify
`with detailed particularity what specific material it incorporates and clearly
`indicate where that material is found in the various documents.”).
`At any rate, the cited page 380 of Remington directs the reader to
`chapter 17, where on pages 240—42 there is a detailed discussion of buffers.
`That discussion includes Fresenius’s proposed definition, as well as a section
`that discusses the “buffer action” of certain “strong acids and bases.”
`(Remington 242) Thus a buffer, even taking Fera’s approach, would not
`necessarily be a liquid containing acids or bases that are weak. Fera’s proffered
`definition of buffer, which limits the term to such a solution, is neither
`consistent with the meaning given in the patent by the inventor nor with the
`ordinary meaning. See Reckitt Benckiser Pharm. Inc. v. Watson Labs., Inc., Civ.
`No. 13—1674, 2015 WL 3978883, at *3 (D. Del. June 26, 2015) (“Even though
`the definitions strongly suggest that a buffer often—or in its ‘commonest
`example’—contains both a weak acid and a conjugate base, that does not
`appear to always be the case. Instead, the fundamental characteristic of a
`buffer is that it buffers, or resists changes to, pH.”).
`InnoPharma does not go along with Fera’s position as to the term
`“buffer”; it generally agrees with Fresenius’s definition. InnoPharma, however,
`would insert a mass limitation: “an amount not exceeding 800 pg total mass.”
`(Def. Opening 7) There is no language in the patent to support this limitation.
`Dependent claims in two of the patents do assign the buffer component a fixed
`mass between 400 and 600 pg. (‘289 Patent Claims 4, 9, 16; ‘239 Patent Claim
`8) Further, the specification gives exemplars of mass ranges for one buffer,
`dibasic sodium phosphate: “Preferably the ingredients used to form the liquid
`mixture include from 100 to 800 pg, from 200 to 700 pg, from 300 to 700 pg,
`or from 400 to 600 pg dibasic sodium phosphate.” (‘289 Patent 4:51—54) But as
`
`9
`
`Mylan Ex 1012, Page 9
`
`

`
`a preface to those examples, the specification states: “The amount of phosphate
`buffer in the ingredients may be an amount sufficient to provide a beneficial pH
`buffering effect in the liquid mixture.” (‘289 Patent 4:48—5 1)
`These patent claims do not impose a clear mass limitation on the term
`“buffer”. A specification may shed light on the meaning of a claim, but a court
`must be cautious in extrapolating a claim limitation from particular examples
`or preferred amounts in a specification: “When consulting the specification to
`clarify the meaning of claim terms, courts must take care not to import
`limitations into the claims from the specification.” Abbott Labs. u. Sandoz, Inc.,
`566 F.3d 1282, 1288 (Fed. Cir. 2009). The claim itself is paramount.7
`A mass limit is not a standard feature of, or a concept inherent in, the
`ordinary meaning of the word buffer, and the patent never defines buffer in this
`way. The examples in the specification are prefaced with the term “[p)referably”
`and they address one specific type of buffer, dibasic sodium phosphate. (‘289
`Patent 4:51—54) Even if that were not the case, specifying an amount of an
`ingredient would not ordinarily limit the definition of the ingredient. If an
`inventor did want to limit a component’s definition it would have to do so
`clearly and specifically. “To act as its own lexicographer, a patentee must
`clearly set forth a definition of the disputed claim term other than its plain and
`ordinary meaning.” Thomer v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362,
`1365 (Fed. Cir. 2012) (internal quotations marks and citation omitted)
`Ascribing an arbitrary mass limit to “buffer” plucked from examples in the
`specifications neither accords with the plain and ordinary meaning or the term
`nor identifies an idiosyncratic definition within this patent.
`
`Adding an upper mass limit to the defmition of this term is also arbitrary. Why
`only an upper limit? Why only this component? InnoPharma proffers no sufficient
`answer. Because InnoPharma is not really reasoning forward from the claims of the
`patent, I might infer that it is reasoning backward from its desire to market a
`compound containing over 800ig. Such an inference is not, however, central to my
`reasoning here.
`
`10
`
`Mylan Ex 1012, Page 10
`
`

`
`Fresenius’s proposed functional definition of a buffer as “[a] system that
`resists changes in pH when acid or base is added” is consistent with both the
`language of the patent and the plain and ordinary meaning of the term. In
`addition, I accept that as a construction of the term “buffer” because, from the
`context, I judge that the patent clearly uses that term in a functional sense.
`The parties do not present additional argument about the meaning of
`“phosphate buffer.” They do not dispute the meaning of “phosphate,” so the
`only issue that divides them is the construction of “buffer,” already discussed
`above. (See, e.g., Def. Response 6 n.4.) Further construction of “phosphate
`buffer” is therefore unnecessary.
`
`2.
`
`“Dibasic Sodium Phosphate”
`
`Term
`
`Fresenius
`
`InnoPharma
`
`Fera
`
`“dibasic sodium
`Plain and
`“A member of the No proposed
`phosphate”
`ordinary meaning family of sodium construction
`phosphates
`(‘289 Patent: 4, 5,
`“A compound
`having two
`9, 10, 16, 17;
`which includes
`hydrogens that
`‘239 Patent: 8) Na2HPO4
`may be replaced
`by a monovalent
`metal or radical,
`i.e., ‘Na2HPO4.”
`
`,,
`
`(P1. Opening 9; Def. Opening 6)
`This dispute between Fresenius and InnoPharma is over whether “dibasic
`sodium phosphate” refers only to the anhydrous form or includes the hydrate
`forms as well. (E.g., Def. Opening 6; P1. Response 7) The claims use the term
`“dibasic sodium phosphate” without further defining it. The specification
`provides:
`In one example, the ingredients used to form the liquid mixture
`include a phosphate buffer other than tribasic sodium phosphate,
`such as dibasic sodium phosphate (Na2HPO4) or monobasic
`sodium phosphate (NaH2PO4). The amount of phosphate buffer in
`the ingredients may be an amount sufficient to provide a beneficial
`
`11
`
`Mylan Ex 1012, Page 11
`
`

`
`pH buffering effect in the liquid mixture. Preferably the ingredients
`used to form the liquid mixture include from 100 to 800 pg, from
`200 to 700 pg, from 300 to 700 pg, or from 400 to 600 pg dibasic
`sodium phosphate. Dibasic sodium phosphate may be added as a
`hydrate, such as dibasic sodium phosphate heptahydrate.
`(‘289 Patent 4:44—55)
`InnoPharma argues that the specification defines dibasic sodium
`phosphate as anhydrous because, immediately following the chemical name, it
`places the anhydrous chemical formulation in parentheses, thus: “dibasic
`sodium phosphate (Na2HPO4).” (P1. Opening 7) But this proposed construction
`ignores the language three sentences later in the specification, which states
`that “Edjibasic sodium phosphate may be added as a hydrate, such as dibasic
`sodium phosphate heptahydrate.” (‘289 Patent 4:54-55) InnoPharma argues
`that this separate mention of the hydrate form carries the negative implication
`that “dibasic sodium phosphate,” as used earlier, referred only to the
`anhydrous form. That is not a natural reading of the language, which does not
`suggest a contrast. The first reference contains no language that tends to
`exclude hydrate forms. The second reference does not say that the hydrate
`form may be used in addition to, or as an alternative to, dibasic sodium
`phosphate; it says that dibasic sodium phosphate may be added “as a
`hydrate,” implying that the hydrate form is encompassed by the definition of
`dibasic sodium phosphate. If, as InnoPharma urges, the term “dibasic sodium
`phosphate” excluded hydrate forms, then it would make little sense to
`immediately give a hydrate form as a specific example of it.8
`
`Defendants also cite to a scientific and technical dictionary. (Def. Opening 6)
`The dictionary, however, does not specifically define “dibasic sodium phosphate.” (See
`Def. Ex. F. (ECF No. 102—7)) Instead, defendants piece their definition together from
`“dibasic” and “sodium phosphate.” But sodium phosphate is defined generally, and
`the dictionary definition does not specify whether both anhydrous and hydrate forms
`would be included in sodium phosphate compounds. (See Def. Ex. F. 1373) This
`extrinsic evidence does not undermine the strong intrinsic evidence,
`
`12
`
`Mylan Ex 1012, Page 12
`
`

`
`I conclude that when the claims use the term dibasic sodium phosphate,
`they intend it as a general designation encompassing both the anhydrous and
`hydrate forms. On the other hand, however, Fresenius’s proposed
`construction— “A compound which includes Na2HPO4”—is too broad and
`openended. For the reasons expressed above, in the context of the patent
`language, I find that “dibasic sodium phosphate” means anhydrous Na2HPO4
`and the hydrate forms ofNa2HPO4.
`
`3. Numerical Terms
`
`Term
`
`Fresenlus
`
`“At most 0.20%”
`Plain and ordinary
`(‘289 Patent: 6, 7 meaning
`8, 11, 12, 13)
`“0.20% or less
`
`“At most 0.15%”
`Plain and ordinary
`(‘289 Patent: 18, meaning
`19, 20, 21)
`“0.15% or less.”
`
`InnoPharma & Fera
`
`“not more than 0.20% (no
`nonzero number after the 2)”
`
`“not more than 0.150% (no
`nonzero number after the 5)”
`
`“Less than
`0.20%”
`(‘238 Patent: 2,
`12, 22; ‘239
`Patent: 2, 4)
`
`Plain and ordinary
`meaning
`“Below 0.20%.”
`
`“less than or equal to
`0.19999999%”
`
`(P1. Opening 11; Def. Opening 21)
`Fresenius maintains that no construction of these terms is necessary.
`(P1. Opening 12) 1 agree. “Less than” is a logical operator, encompassing all
`values below the stated value, but not the stated value itself. It has a fixed
`meaning in common parlance, as well as in mathematics, where it is
`represented symbolically as <. “At most”, too, is a common, unambiguous
`phrase, encompassing all values below the stated value as well as the stated
`value itself. It means “less than or equal to”, and is represented symbolically as
`
`13
`
`Mylan Ex 1012, Page 13
`
`

`
`or <.
`“Less than .20%”, “at most 0.15%”, and “at most 0.20%” are not
`terms that require further construction.
`The defendants’ alteration of the plain meaning, in which they substitute
`their own numbers for those in the patent, is inappropriate. Anyone might
`challenge a patent, I suppose, by suggesting that every number in it should be
`carried to additional decimal places. Before accepting this as a Markman issue
`requiring my intervention, I would have to be persuaded that the issue has
`some practical or chemical consequence. No such argument is made here. The
`repeating decimals here, moreover, seem to ignore obvious practical limits and
`inject a level of faux precision that can only create mischief. At oral argument,
`the parties acknowledged that this dispute was not substantial. I will construe
`these terms as-is.
`
`9 Wolfram Lang. & Sys. Documentation Center, Relational and Logical Operators,
`https:// reference. wolfram. com/ language! tutorial/ RelationalAndLogicalOperators.html
`
`14
`
`Mylan Ex 1012, Page 14
`
`

`
`4.
`
`“Converted to liothyronine”
`
`Fresenius
`
`Plain and
`ordinary
`meaning
`“Turned into
`liothyronine”
`
`Plain and
`ordinary
`meaning
`
`Plain and
`ordinary
`meaning
`
`Plain and
`ordinary
`meaning
`
`Term
`
`“Converted to liothyronine”
`(‘289 Patent: 6, 7, 8, 11, 12,
`13, 18, 19, 20, 21; ‘238
`Patent: 2, 12, 22; ‘239
`Patent: 2, 4)
`
`“The composition of claim
`[X], where when the
`composition is stored at
`[X]°C., at most [Xj% of the
`levothyroxine sodium is
`converted to liothyronine
`over a period of [X] months.”
`(‘289 Patent: 6, 7, 8, 11, 12,
`13, 18, 19, 20, 21)
`
`“The lyophilized solid
`composition of claim [X],
`wherein when the
`lyophilized solid composition
`is stored at 25°C. for a
`predetermined time period,
`less than 0.20% of the salt
`of levothyroxine is converted
`to liothyronine.”
`(‘238 Patent 2 12 22)
`
`‘
`
`‘
`
`“The lyophilized solid
`composition of claim [X],
`wherein when the
`lyophilized solid composition
`is stored at IXI°C. for a
`predetermined time period,
`less than 0.20% of the salt
`of levothyroxine is converted
`to liothyronine.”
`(‘239 Patent 2 4)
`
`‘
`
`(P1. Opening 12—15; Def. Opening 13—14)
`
`15
`
`InnoPharma & Fera
`
`“Turned into liothyronine via a
`chemical reaction, cumulatively
`over a period of time
`
`“The composition of claim [X],
`where when the composition is
`stored at [XJ DC, not more than
`[X]% of the total levothyroxine
`sodium is turned into
`liothyronine via a chemical
`reaction, cumulatively over any
`[X] month period of storage.”
`
`“The lyophilized solid
`composition of claim LX],
`wherein when the lyophilized
`solid composition is stored at
`25°C, less than or equal to
`0.19999999% of the total
`levothyroxine sodium is turned
`into liothyronine via a chemical
`reaction, cumulatively over any
`time period of storage equal to
`the predetermined time period.”
`
`“The lyophilized solid
`composition of claim [X],
`wherein when the lyophilized
`solid composition is stored at
`[X] °C, less than or equal to
`0.19999999% of the total salt
`of levothyroxine is turned into
`liothyronine via a chemical
`reaction, cumulatively over any
`time period of storage equal to
`the predetermined time period.”
`
`Mylan Ex 1012, Page 15
`
`

`
`Only the term “[c]onverted to liothyronine” is truly at issue here. The
`other three disputed terms just insert defendants’ proposed constructions
`(most of which I have already rejected) into the existing patent language.
`The specification lays out certain test results that allegedly demonstrate
`the increased stability of Fresenius’s levothyroxine formulation with the
`reduced amount of mannitol. For example:
`The stability of levothyroxine was analyzed for solid compositions
`that contained 100 pg levothyroxine sodium and from 2 mg to 10
`mg mannitol.... The liquid mixtures were lyophilized to provide
`solid compositions, which were then stored in amber tinted vials at
`temperatures of 400 C. or 55° C. The stability of the levothyroxine
`in the solid compositions at different temperatures was determined
`by measuring the amount of liothyronine (T3) in each composition
`over time, as T3 is a degradation product of levothyroxine (T4).
`
`As shown in Table 1, during storage at 40° C. the amount of T3 in
`the composition containing 10 mg mannitol varied from 0.30% to
`0.57% over a period of from 1 to 3 months, a range of
`approximately 90% [90.0%= 100%x(0. 57-0.30)/0.301. In contrast,
`the amount of T3 in the compositions containing from 2 mg to 4
`mg mannitol remained relatively stable under the same conditions,
`varying only by approximately 6% [5.6%= 1 00%x(0. 19-0.18)/0.18)].
`In the compositions containing 2 to 4 mg mannitol, at most 0.19%
`of the levothyroxine sodium was converted to liothyronine when
`stored at 40° C. over a period of 3 months.
`(‘289 Patent 5:31—6:17) Table 1 shows snapshots of the level of liothyronine at
`one-month intervals. (‘289 Patent 5:47—63)
`Defendants argue, in essence, that to prove increased stability, Fresenius
`should have isolated the rate at which levothyroxine is converted into
`liothyronine through a “cumulative measure of degradation” and not just
`measured the liothyronine levels at monthly intervals. (Def Opening 14) This
`follows, they say, from the fact that liothyronine also degrades on its own at
`some unspecified rate. (fri. at 15—17) The argument, in one of its permutations,
`seems to be that, while a stable proportion of liothyronine might demonstrate
`stability in the conversion of levothyroxine to liothyronine, it might alternatively
`
`16
`
`Mylan Ex 1012, Page 16
`
`

`
`demonstrate that both levothyroxine and liothyronine are degrading in parallel.
`(Id. at 17—19)
`This appears to be at best an invalidity argument, rather than one
`bearing on claim construction.
`While we have acknowledged the maxim that claims should be
`construed to preserve their validity, we have not applied that
`principle broadly, and we have certainly not endorsed a regime in
`which validity analysis is a regular component of claim
`construction. Instead, we have limited the maxim to cases in which
`the court concludes, after applying all the available tools of claim
`construction, that the claim is still ambiguous.
`Phillzs, 415 F.3d at 1327 (internal quotation marks and citations omitted). It
`may be, as defendants say, that the observed effect is attributable to something
`else. But the claim is clear enough; defendants’ real argument is that the
`patent does not validly claim an invention that functions as advertised.’0
`“lAibsent contravening evidence from the specification or prosecution
`history, plain and unambiguous claim language controls the construction
`analysis.” DSW, Inc. v. Shoe Pavilion, Inc., 537 F.3d 1342, 1347 (Fed. Cir.
`2008). Defendants ask that this Court alter the plain meaning of the patent to
`conform to their theory regarding the proper method of measuring the stability
`of levothyroxine. But “courts cannot alter what the patentee has chosen to
`claim as