FRESENIUS KABI USA, LLC v. FERA PHARMACEUTICALS, LLC

Filing 327

OPINION (Markman). Signed by Judge Kevin McNulty on 9/20/16. (DD, )

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY FRESENIUS KABI USA, LLC, No. 15—cv-3654 (KM)(MAH) Plaintiff, OPINION (Markman) 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 brough t 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, “InnoP harma”).’ The patents-in-suit are Patent Nos. 9,006,289 (“the ‘289 patent” ), 9,168,238 The suit against InnoPharma was originally filed under the docket number 15—3655, but the cases were consolidated for pretrial purposes upon reques t of the parties. (See ECF No. 79) A third suit, docket number 15—3853, was origina lly consolidated with these two, but those defendants settled with Fresenius after the opening briefs were filed. (See ECF No. 120) 1 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) levo thyroxine that can be reconstituted and injected into patients who lack a prop erly functioning thyroid. (P1. Opening 1)2 The Food and Drug Administration approved Freseniu s’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 Octo ber 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 Citations to the record will be abbreviated as follows: “3AC Fera” Third Amended Complaint of Fresenius against Fera (ECF No. 83). 2 — “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 Statemen t (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), attac hed 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—1 9), 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, (Alfon so R. Gennaro et al. eds. 20th ed. 2000), DefEx. G (ECF No. 102—8). — — — — — — — — — 2 approval to commercially market generic versions of Fresenius’s patente d 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) (quotin g 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 objecti ve 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 determ ination, courts may consider evidence intrinsic to the patent, i.e., “the words of the claims themselves, the remainder of the specification, [and] the prosec ution history,” as well as “extrinsic evidence, which consists of all evidence externa l to the patent and prosecution history, including expert and inventor testimo ny, 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 eviden ce and less weight to extrinsic evidence, holding extrinsic evidence useful only to the extent 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 the [J prior art cited during the examination of the patent.” Phillips, 415 F.3d at 1317. Extrinsic evidence, considered in the context of the intrinsic eviden ce, 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 unders tand claim terms to mean.” Phillips, 415 F.3d at 1319. B. Levothyroxine The specification section of the patents provides some background 3 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 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 lyophi lized, or freezedried, formulation of levothyroxine that is later reconstituted and injected into patients. (P1. Opening 1) Levothyroxine injections have been available in the United State s since 1969. (Def. Opening 3) Fresenius’s newly patented formulati ons contain levothyroxine, a buffer, and a specific amount of a bulking agent called mannitol. The mannitol provides bulk to the “cake” that rema ins after the formulation is freeze dried. Fresenius’s patents are based on the discovery that, contrary to expectation, a reduction in the proportion of man nitol improved the stability of the freeze dried cake. (P1. Opening 1—2) C. Disputed Claims The parties presented charts that jointly summarize their posi tions as to the eleven disputed claims. I will present the charts in grou ps 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 “buffe r” to be potentially case dispositive. (Id. at 5—6) As to the “buffe r” term, the parties summarize their positions as follows: 5 Term “buffer” Fresenius InnoPharma Fera Plain and ordinary meaning “A buffer is a solution of a weak acid and its conjugate base, the base being provided by one of its soluble salts.” “phosphate buffer” Plain and ordinary meaning (‘289 Patent: 1, 4, 9, 14, 16; ‘238 Patent: 10, 20, 30; ‘239 Patent: 7, 8) “A buffer comprising a phosphate.” “A buffer (as This term does otherwise not require a construed) separate comprising one or construction from more phosphate “buffer”; its groups.” meaning should be consistent with the Court’s construction of “buffer.” (‘289 Patent: 1, 4 9, 14, 16; ‘238 Patent: 1, 10, 11, 20, 21, 30; ‘239 Patent: 1, 7, 8) “A compound 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.” (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 4 buffer. (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) Depen dent claims of the ‘238 Patent simply refer to the “phosphate buffer” withou t 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 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 solutio n, when used with reference to hydrogen-ion concentration or pH, refer to the 7 ability of a system, particularly an aqueous solution, to resis t a change of pH on adding acid or alkali, or on dilution with a solvent.” (Remi ngton 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 med icinal at an optimal value. A buffer is a solution of a weak acid and its conj ugate base, the base being provided by one of its soluble salts. Refer to Chap terl7 for an extensive discussion of pH and buffers.” (Remington 380) Fera’s proposed construction, whether plausible or not, cont radicts 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 Pate Claim nt 1, 2:53—58, 4:36—55; ‘238 Patent Claim 1; ‘239 Patent Claim 1) The specifi cation explains: A solid composition is formed by a method that includes combining ingredients to form a liquid mixture, and lyophi lizing the liquid mixture.... The term “lyophilizing” means remov ing 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 “buffe r” to delineate the component in the lyophilized solid composition that perfo rmed and would perform the buffering action when the composition is in a liquid state. 6 ... The specification’s general citation to the Remington textb ook as a whole is not a license to extract passages from that work in dero gation of the clear InnoPharma appears to agree with Fresenius that the definition should be derived from this part of Remington. 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., Neuros cience (2d ed., Sunderland (MA): Sinauer Associates, 2001), excerpted at ww.ncbi.nlm.nih.go v/books/NBK1 1148. 6 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 specifi cation....”); cf Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000) (“To incorporate material by reference, the host docu ment must identify with detailed particularity what specific material it incorpora tes and clearly indicate where that material is found in the various docu ments.”). At any rate, the cited page 380 of Remington directs the read er to chapter 17, where on pages 240—42 there is a detailed discu ssion 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 inve ntor nor with the ordinary meaning. See Reckitt Benckiser Pharm. Inc. v. Watso n 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 char acteristic 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. Inno Pharma, 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 supp ort 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 Pate nt 4:51—54) But as 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 consultin g 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 7 paramount. A mass limit is not a standard feature of, or a concept inhe rent in, the ordinary meaning of the word buffer, and the patent neve r 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 sodi um 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 citat ion omitted) Ascribing an arbitrary mass limit to “buffer” plucked from examples in the specifications neither accords with the plain and ordin ary meaning or the term nor identifies an idiosyncratic definition within this paten t. 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 patent, I might infer that it is reasoning backward from its desire the claims of the to market a compound containing over 800ig. Such an inference is not, however, central to my reasoning here. 10 Fresenius’s proposed functional definition of a buffer as “[a] system that resists changes in pH when acid or base is added” is consisten t 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 “buffe r” 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 mean ing of “phosphate buffer.” They do not dispute the meaning of “pho sphate,” 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 “dibasic sodium phosphate” Plain and ordinary meaning (‘289 Patent: 4, 5, 9, 10, 16, 17; ‘239 Patent: 8) “A compound which includes HPO4 2 Na ,, “A member of the family of sodium phosphates having two hydrogens that may be replaced by a monovalent metal or radical, i.e., ‘Na .PO 4 H” 2 Fera No proposed construction (P1. Opening 9; Def. Opening 6) This dispute between Fresenius and InnoPharma is over whet her “dibasic sodium phosphate” refers only to the anhydrous form or inclu des the hydrate forms as well. (E.g., Def. Opening 6; P1. Response 7) The claim s use the term “dibasic sodium phosphate” without further defining it. The specification provides: In one example, the ingredients used to form the liquid mixt ure include a phosphate buffer other than tribasic sodium phos phate, such as dibasic sodium phosphate (Na2HPO or monobasic ) 4 sodium phosphate (NO The amount of phosphate buffer ). 4 P aH 2 in the ingredients may be an amount sufficient to provide benefic a ial 11 pH buffering effect in the liquid mixture. Preferably the ingre dients 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 adde d 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 parenthe ses, thus: “dibasic sodium phosphate (Na (P1. Opening 7) But this prop HPO4).” 2 osed construction ignores the language three sentences later in the specification, which states that “Edjibasic sodium phosphate may be added as a hydr ate, such as dibasic sodium phosphate heptahydrate.” (‘289 Patent 4:54-55) Inno Pharma argues that this separate mention of the hydrate form carries the negativ e implication that “dibasic sodium phosphate,” as used earlier, referred only to the anhydrous form. That is not a natural reading of the lang uage, 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, diba sic 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 mak little e 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 definit ion 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 eviden ce, 12 I conclude that when the claims use the term dibasic sodium phosph ate, they intend it as a general designation encompassing both the anhydr ous and hydrate forms. On the other hand, however, Fresenius’s proposed construction— “A compound which includes Na2HPO4”— too broad and is openended. For the reasons expressed above, in the context of the patent language, I find that “dibasic sodium phosphate” means anhydrou s Na2HPO4 and the hydrate forms of Na HPO4. 2 3. Numerical Terms Term “At most 0.20%” (‘289 Patent: 6, 7 8, 11, 12, 13) “At most 0.15%” Fresenlus InnoPharma & Fera Plain and ordinary meaning “not more than 0.20% (no nonzero number after the 2)” “0.20% or less Plain and ordinary meaning (‘289 Patent: 18, 19, 20, 21) “0.15% or less.” “Less than 0.20%” Plain and ordinary meaning (‘238 Patent: 2, 12, 22; ‘239 Patent: 2, 4) “not more than 0.150% (no nonzero number after the 5)” “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 necess ary. (P1. Opening 12) 1 agree. “Less than” is a logical operator, encom passing 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, unamb iguous 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 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 4. “Converted to liothyronine” Term Fresenius “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.” Plain and ordinary meaning InnoPharma & Fera “Turned into liothyronine via a chemical reaction, cumulatively over a period of time “Turned into liothyronine” Plain and ordinary meaning “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 Plain and composition of claim [X], ordinary wherein when the meaning 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.” “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.” (‘289 Patent: 6, 7, 8, 11, 12, 13, 18, 19, 20, 21) (‘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.” Plain and ordinary meaning “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 (‘239 Patent 2 4) the predetermined time period.” ‘ (P1. Opening 12—15; Def. Opening 13—14) 15 Only the term “[c]onverted to liothyronine” is truly at issue here. The other three disputed terms just insert defendants’ proposed constru ctions (most of which I have already rejected) into the existing paten t 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 provid e solid compositions, which were then stored in amber tinted vials at temperatures of 400 C. or 55° C. The stability of the levothyroxin e in the solid compositions at different temperatures was determ ined 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)/0.30 In contras t, 1. the amount of T3 in the compositions containing from 2 mg to 4 mg mannitol remained relatively stable under the same condit ions, 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 stabilit y, Fresenius should have isolated the rate at which levothyroxine is conver ted 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 degrad es 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 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 his invention,” Intervet Am., Inc. v. Kee-Vet Labs., Inc., 887 F.2d 1050, 1053 (Fed. Cir. 1989), and I will not do so here. The meaning of “converted” in the patent is plainly and unambiguously “turned into.” (Indeed, “turned into” does not really add any clarity to “converted,” the meaning of which is already apparent.) There is nothing in the record before me that would support an alternative definition. Consider a claim for “an automobile that travels at 800 mph.” In a Markman hearing, a challenger might urge that the radar gun must have been improperly calibrated, a contention which, if correct, would suggest that this is not really a miracle car. That contention, however, would seem to present a patentability issue, rather than a claim construction issue. There is no definitional dispute as to what “800 mph” means. 10 17 5. “Predetermined time period” Term Fresenius InnoPharma & Fera “Predetermined time period” Plain and ordinary meaning (‘238 Patent: 2, 3, 12, 13, 22, 23; ‘239 Patent: 2, 3, 4) “A set period of time for storing.” Indefinite under 35 U.S.C. § 112. (P1. Opening 16; Def. Opening 22) courts in this Circuit routinely decline to address indefiniteness arguments in claim construction because they are potentially dispositive, require a high burden of proof, and may more profitably be considered in connection with patent validity. See Waddington N. Am,, Inc. u. Sabert Corp., Civ No. 09—4883, 2010 WL 4363137, at *2 (D.N.J. Oct. 27, 2010); see also, e.g., Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC, Civ No. 12—5311, 2014 WL 2624787, at *6 (D.N.J. June 11, 2014), aff’d, 627 F. App’x 931 (Fed. Cir. 2016); Alcon Research, Ltd. v. Barr Labs. Inc., Civ No. 09—03 18, 2011 WL 3901878, at *16 (D. Del. Sept. 6,2011); CSB-Sys. Int’l Inc. v. SAP Am., Inc., Civ No. 10—2156, 2011 WL3240838, at *18 (E.D. Pa. July 28, 2011). 1, too, find it prudent to defer this indefiniteness argument. II. CONCLUSION I construct the disputed terms as follows: 1. “Buffer” means a system that resists changes in pH when acid or base is added. 2. “Phosphate buffer” requires no further construction in light of #1. 3. “Dibasic sodium phosphate” refers to anhydrous Na2HPO4 and the hydrate forms associated with Na2HPO4. 4. The numerical terms “at most 0.15%”, “at most 0.20%”, and “less than .20%” do not require further construction. 18 5. “Converted to liothyronine” means turned into liothyronine, and the rest of the disputed conversion terms require no further construction in light of ## 1-4, above. 6. I decline to address indefiniteness arguments during claim construction; they may be raised at a later stage. An appropriate order accompanies this Opinion. Dated: September 20, 2016 Hon. Kevin McNulty United States District Jud 19

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