Abbott Laboratories v. Lupin Ltd. (753 F. Supp. 2d 382, 2010)

United States District Court for the District of Delaware 2010-07-30

Citations

Full opinion text

ORDER

JOSEPH J. FAENAN, JR., District Judge.

WHEREAS, Magistrate Judge Stark issued a Report and Recommendation (D.I. 95) dated June 18, 2010, concerning Claim Construction;

WHEREAS, the Report and Recommendation provided construction for the terms disputed by the parties;

WHEREAS, Defendants filed Objections to Judge Stark’s Report and Recommendation (D.I. 97);

WHEREAS, the Court concludes that Judge Stark’s Report and Recommendation should be adopted for the reasons stated by Judge Stark in his Report and Recommendation;

WHEREAS, Plaintiffs filed an unopposed Motion For Clarification And Correction Of the Report And Recommendation Regarding Claim Construction (D.I. 98);

WHEREAS, Defendants filed an unopposed Motion For Clarification/ Correction Of the Report And Recommendation Regarding Claim Construction (D.I. 104);

NOW THEREFORE, IT IS HEREBY ORDERED that:

1. The Motions For Clarification (D.I. 98; D.I. 104) are GRANTED;

2. Defendants’ Objections (D.I. 97)are OVERRULED;

3. The Report and Recommendation (D.I. 95) is ADOPTED.

REPORT AND RECOMMENDATION REGARDING CLAIM CONSTRUCTION

LEONARD P. STARK, United States Magistrate Judge.

Plaintiffs Abbott Laboratories and Abbott Respiratory LLC (collectively, “Abbott”) filed this patent infringement action against Defendants Lupin Limited and Lu-pin Pharmaceuticals, Inc. (collectively, “Lupin”) on March 6, 2009. (D.I. 1) Abbott alleges that Lupin infringes seven of its patents relating to Abbott’s drug Niaspan®: U.S. Patent No. 6,080,428 (the “'428 patent”), U.S. Patent No. 6,129,930 (the “'930 patent”), U.S. Patent No. 7,011,848 (the “'848 patent”), U.S. Patent No. 6,406,715 (the “'715 patent”), U.S. Patent No. 6,818,229 (the “'229 patent”), U.S. Patent No. 6,676,967 (the “'967 patent”), and U.S. Patent No. 6,746,691 (the “'691 patent”) (collectively, the “Abbott patents”). The patents-in-suit are all part of the same family and all relate to compositions for and methods of treating hyperlipidemia. (D.I. 54 at 1; D.I. 55 at 3) Each of the Abbott patents refers to initial application 08/124,392, filed in 1993. (D.I. 54 at 2) That application was abandoned, but the continuation-in-part application 08/368,378, filed in 1995, issued in June 2000 as the '428 patent. (Id.) The '930 patent is a continuation-in-part from the '428 patent. (Id.) The '229, '691, '715, and '967 patents are all continuations-in-part from the '930 patent, and the '848 patent is a continuation from the '930 patent. (Id.) In this Report & Recommendation, I provide my recommendations as to the proper construction of the disputed claim terms in each of the Abbott patents.

BACKGROUND

A. Procedural Background

Claim construction issues in this case were referred to the undersigned magistrate judge per the Court’s order of February 4, 2010. (D.I. 51) Briefing was completed in March 2010 (D.I. 54; D.I. 55; D.I. 58; D.I. 60) and a Markman hearing was held on May 21, 2010. See Transcript of May 21, 2010 hearing (D.I. 94) (hereinafter “Tr.”).

B. Hyperlipidemia

Hyperlipidemia “is characterized by the presence of excess fats such as cholesterol and triglycerides in the blood stream,” and is associated with abnormally high levels of “bad cholesterol,” which includes high levels of low density lipoproteins (“LDL”), triglycerides, and apolipoprotein(a) (“Lp(a)”). (D.I. 55 at 3) Abnormally low levels of “good cholesterol,” also known as high density lipoproteins (“HDL”), are also associated with hyperlipidemia. (Id.) Hyperlipidemia can lead to an increased risk of atherosclerosis, which is a hardening of the arteries due to an accumulation of cholesterol plaque in the arterial walls. (Id. at 3-4) Atherosclerosis may cause a number of significant health problems, such as coronary heart disease (that often leads to heart attacks), peripheral arterial disease, and strokes. (Id. at 4)

C.Prior Art Treatments for Hyperlipidemia

Niacin, or “nicotinic acid,” has long been used to reduce total cholesterol, LDLs, triglycerides, and LP(a), while increasing HDLs. (Id.) Niacin administered to treat these conditions, however, is accompanied by uncomfortable and dangerous side effects. (Id.) The type of niacin treatment determines its effects and side effects; generally, niacin is given to patients in either immediate release or sustained release dosage forms. (D.I. 54 at 2-3)

“Immediate release” (“IR”) niacin treatments are typically administered three or four times per day, and release nearly all of their niacin in the bloodstream very quickly (e.g., within 30 to 60 minutes of ingestion). (D.I. 55 at 4) While IR niacin treatments were generally known to reduce unfavorable cholesterol and increase desirable cholesterol, they were also commonly associated with “flushing,” a side effect that causes a patient to develop a visibly red, uncomfortable, tingly and/or hot feeling for about one hour after each niacin dose. (Id.; D.I. 54 at 3) For some, these effects are severe enough to stop taking the drug. (D.I. 55 at 4) “As a result, physicians have been reluctant to recommend IR niacin (and patients have been reluctant to take it), despite its beneficial lipid-altering effects.” (Id.)

“Sustained release” (“SR”) niacin was developed to avoid the flushing side effect that accompanies IR niacin. (Id. at 5) Although normally dosed between two and four times per day, SR niacin is designed to release niacin slowly into the bloodstream over a prolonged period of time— “usually 12 to 24 hours.” (Id.) By lowering the peak concentration of niacin in the patient’s blood at any one time, this dosage formulation reduces or eliminates the flushing effect. (Id.; D.I. 54 at 3) However, SR niacin has been shown to be less effective than IR niacin, yielding a significantly lower reduction in “bad” cholesterol and a much smaller increase in “good” cholesterol. (D.I. 55 at 5) Additionally, prior-art SR niacin therapies produced liver damage and harmful increases in uric acid or blood glucose levels. (Id.) Prior to Niaspan®, the FDA had not approved SR niacin for the treatment of hyperlipidemia. (Id. at 4)

The safety and usefulness of these various niacin treatments depend on the treatment’s effects on a patient’s liver. The Abbott patents discuss, among other things, three aspects of a patient’s health that are tested to detect liver or other damage. (D.I. 54 at 3-4) Specifically, physicians monitor the risk of gout, diabetes, and liver damage in patients on drug therapies like niacin. (Id. at 4) The presence of high levels of uric acid in a patient’s bloodstream is often correlated with gout (inflammation of the joints). (Id.) Excessive levels of glucose in the bloodstream can indicate diabetes. (Id.) When liver damage has occurred in a patient, three enzymes are released into the bloodstream: alanine transaminase (ALT), aspartate aminotransferase (AST), and alkaline phosphates (ALK). (Id.)

Some prior-art SR niacin products caused toxicity in the liver where the nicotinic acid (niacin) is broken down into its metabolites, an excess of which can cause liver damage. (D.I. 54 at 3) By contrast, IR niacin products cause less of a toxic effect because the liver generally breaks down heavy doses of niacin quickly, shielding the liver from dangerous metabolites, but the quicker release rate delivers less of the drug. (Id.)

D. The Patents-in-Suit

Given the harmful side effects of both IR and SR niacin, the Abbott patents claim a treatment regimen for niacin of one dose of an “effective antihyperlipidemic amount of a sustained release niacin composition, delivered once per day in the evening or at night.” (D.I. 55 at 5-6 (citing '428 patent, col. 1 lines 12-21)) Dosing patients in the evening allowed the drug to act “when the rate of cholesterol synthesis was believed to be at its highest.” (D.I. 55 at 6 (citing '715 patent, col. 4 line 54 to col. 5 line 55)) Further, dosing patients only once per day “helped prevent liver damage (hepatotoxicity) and increases in glucose and uric acid by avoiding constantly exposing the liver to nicotinic acid, as typically occurred when prior art [SR] products were administered several times per day.” (D.I. 55 at 5 (citing '715 patent, col. 5 lines 17-26)) This basic dosing regimen was used to develop additional inventions “focused on the biopharmaceutical properties—such as the urinary metabolite profile, the plasma concentration profile, and the dissolution profile—necessary to effectively and safely treat hyperlipidemia.” (D.I. 55 at 6)

1. The '428 Patent

The '428 patent was filed on January 14, 1995 and issued on June 27, 2000, naming David Bova as the inventor. The disputed terms to be construed in the '428 patent appear in independent claim 1 and dependent claim 3 and are highlighted below:

1. A method of treating hyperlipidemia in a hyperlipidemic comprising dosing the hyperlipidemic with an effective antihyperlipidemic amount of nicotinic acid once per day in the evening or at night, wherein said nicotinic acid is combined with at least one pharmaceutically acceptable carrier to form an oral solid dosage form.

3. A method as set forth in claim 1 which causes little or no serious liver damage.

('428 patent, col. 12 lines 17-22, 26-27)

2. The '930 Patent

The '930 patent was filed on March 6, 1997 and issued on October 10, 2000 as a continuation-in-part of the '428 patent, naming David Bova as the inventor. The disputed terms to be construed in the '930 patent appear in independent claims 18, 51, 115, and 133. Claims 18, 51, and 115 are shown below as examples, with the disputed language emphasized:

18. A sustained release composition of nicotinic acid for oral administration to a patient once per day during the evening or night for providing an effective antihyperlipidemic amount of nicotinic acid to the patient to induce at least some lowering of total cholesterol, LDL cholesterol, triglycerides and Lp(a) and at least some increase in HDL cholesterol in the patient’s blood stream, without causing abnormalities in uric acid levels or glucose levels or both to an extent which would require the use of said release composition by the patient to be discontinued, said sustained release composition comprising (a) an effective antihyperlipidemic amount of nicotinic acid, and (b) an excipient to provide sustained release of the nicotinic acid.

51. A daily method of treating hyperlipidemia in a patient without inducing treatment-limiting abnormalities in uric acid levels or glucose levels or both in the patient, said daily method comprising orally dosing the patient with an effective antihyperlipidemic amount of nicotinic acid once per day during the evening or at night as a single dose for providing an effective antihyperlipidemic amount of nicotinic acid to the patient to induce at least some decrease in levels of total cholesterol, LDL cholesterol, triglycerides and Lp(a) in the patient to induce at least some increase in levels of HDL cholesterol in the patient, without causing abnormalities in either uric acid or glucose levels or both to an extent which would require said daily treatment to be discontinued by the patient, wherein the nicotinic acid is combined with at least one pharmaceutically acceptable component to form an oral sustained release solid dosage form.

115. A method of treating hyperlipidemia in a patient without inducing treatment-limiting (i) hepatotoxicity and (ii) abnormalities in uric acid levels or glucose levels or both, said method comprising orally dosing the patient with an effective antihyperlipidemic amount of nicotinic acid once per day during the evening or at night as a single dose, wherein the nicotinic acid is combined with at least one pharmaceutically acceptable component to form an oral sustained release solid dosage form, wherein the oral sustained release solid dosage form is effective in reducing a serum lipid without causing treatment-limiting (i) hepatotoxicity and (ii) elevations in uric acid levels or glucose levels or both in the patient to a level which would require said treatment to be discontinued by the patient when it is ingested by the patient once per day during the evening or at night as the single dose in accordance with said single dose treatment.

('930 patent, col. 16 lines 23-35, col. 18 lines 47-63, col. 24 lines 5-20)

3. The '229 Patent '691 Patent, '715 Patent, and '967 Patent

The '229, '691, '715, and '967 patents (collectively, the “OP patents”) are continuation-in-part patents to the '930 patent. Many of the same disputed terms appear several times throughout these patents, and representative examples are shown below:

17. An intermediate release nicotinic acid formulation suitable for oral administration once-a-day for treating hyperlipidemia without causing drug-induced hepatotoxicity to a level which would require use of said intermediate release nicotinic acid formulation to be discontinued, said intermediate release nicotinic acid formulation con-taming at least about 750 mg of nicotinic acid and having:

a nicotinuric acid Cmax in the range from between about 3 ug/ml and 3.2 ug/ml;

a nicotinuric acid Tmax in the range of between about 5.6 hours and about 6 hours; and

an AUC for nicotinuric acid in the range of from between about 11 ughr/ml and about 13 ughr/ml.

('229 patent, col. 30 lines 5-17)

1. An intermediate release nicotinic acid formulation suitable for oral administration once-a-day as a single dose for treating hyperlipidemia without causing drug-induced hepatotoxicity and (ii) elevations in uric acid or glucose or both, to levels which would require use of said intermediate release nicotinic acid formulation to be discontinued, said intermediate release nicotinic acid formulation comprising nicotinic acid and a swelling agent, said intermediate release nicotinic acid formulation having an in vitro urinary metabolic profile resulting from the absorption of the nicotinic acid released from the intermediate release formulation following the oral administration of the nicotinic acid formulation to an individual when the nicotinic acid formulation is dosed at about 1000 mg (a) nicotinic acid and nicotinic acid present in the urine in an amount of from about 4.0% to about 26%, and (b) Pathway 2 metabolites present in the urine in an amount of from about 74% to about 95%.

('715 patent, col. 28 line 54 to col. 29 line 4) 16. A method of reducing flushing in an individual being treated for a lipidemic disorder with an intermediate release nicotinic acid formulation suitable for oral administration once-a-day as a single dose without causing treatment-limiting hepatotoxicity and treatment-limiting elevations in uric acid or glucose levels or both in the individual to a level which would require use of the nicotinic acid formulation to be discontinued by the individual, comprising ....

a dissolution curve similarity fit factor F2 of at least about 44, and

an in vitro dissolution profile, when measured in a type I dissolution apparatus (basket) according to U.S. Pharmacopeia XXII, at about 37°C. in deionized water at about 100 rpm, as follows

(a) less than about 15% of the nicotinic acid is released after about 1 hour in the apparatus,

(b) between about 15% and about 30% of the nicotinic acid is released after about 3 hours in the apparatus,

(c) between about 30% and about 45% of the nicotinic acid is released after about 6 hours in the apparatus,

(d) between about 40% and about 60% of the nicotinic acid is released after about 9 hours in the apparatus,

(e) between about 50% and about 75% of the nicotinic acid is released after about 12 hours in the apparatus, and

(f) at least about 75% of the nicotinic acid is released after about 20 hours in the apparatus.

('967 patent, col. 30 lines 22-62)

4. The '848 Patent

The '848 patent was filed on December 22, 1999 and issued on March 14, 2006, with David Bova as the named inventor. The disputed terms in the '848 patent appear in claims 1 and 3 as follows:

1. A method of treating hyperlipidemia in a hyperlipidemic comprising dosing the hyperlipidemic with an effective antihyperlipidemie amount of nicotinic acid or compound metabolized to nicotinic acid by the body, once per day in the evening or at night combined with pharmaceutically acceptable carriers, to produce a reduction in total and LDL cholesterol, triglycerides and Lp(a), with a significant increase in HDL cholesterol.

3. A method of claim 1, which causes minimum liver damage, uric acid increases or elevations in fasting glucose levels.

('848 patent, col. 15 line 66 to col. 16 lines 32-37, col. 16 lines 41-43)

LEGAL STANDARDS

“It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir. 2005) (internal quotation marks omitted). Construing the claims of a patent presents a question of law. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-78 (Fed.Cir.1995), aff’d, 517 U.S. 370, 388-90, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). “[T]here is no magic formula or catechism for conducting claim construction.” Phillips, 415 F.3d at 1324. Instead, the court is free to attach the .appropriate weight to appropriate sources “in light of the statutes and policies that inform patent law.” Id.

“[T]he words of a 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.” Id. at 1312-13 (internal citations and quotation marks omitted). “[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent.” Id. at 1321 (internal quotation marks omitted). The patent specification “is always highly relevant to the claim construction analysis. Usually, it is dis-positive; it is the single best guide to the meaning of a disputed term.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996).

While “the 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. Phillips, 415 F.3d at 1314. Furthermore, “[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment ... [b]ecause claim terms are normally used consistently throughout the patent ....” Id. (internal citation omitted).

It is likewise true that “[deferences among claims can also be a useful guide .... For example, the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim.” Id. at 1314-15 (internal citation omitted). This “presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim should be read into the independent claim.” Sun-Race Roots Enter. Co. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed.Cir.2003).

It is also possible that “the 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.” Phillips, 415 F.3d at 1316. It bears emphasis that “[e]ven when the 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,” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed.Cir.2004) (internal quotation marks omitted), aff’d, 481 F.3d 1371 (Fed.Cir.2007).

In addition to the specification, a court “should also consider the patent’s prosecution history, if it is in evidence.” Markman, 52 F.3d at 980. The prosecution history, which is “intrinsic evidence,” “consists of the complete record of the proceedings before the PTO [Patent and Trademark Office] and includes the prior art cited during the examination of the patent.” Phillips, 415 F.3d at 1317. “[T]he 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.” Id.

A court also may rely on “extrinsic evidence,” which “consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.” Markman, 52 F.3d at 980. For instance, technical dictionaries can assist the court in determining the meaning of a term to those of skill in the relevant art because such dictionaries “endeavor to collect the accepted meanings of terms used in various fields of science and technology.” Phillips, 415 F.3d at 1318. In addition, expert testimony can be useful “to ensure that the court’s understanding of the technical aspects of the patent is consistent with that of a person of ordinary 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.” Id. 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.” Id. Overall, while extrinsic evidence “may be useful” to the court, 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.” Id. at 1318-19.

Finally, “[t]he construction that stays true to the claim language and most naturally aligns with the patent’s description of the invention will be, in the end, the correct construction.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed.Cir.1998). It follows that “ ‘a claim interpretation that would exclude the inventor’s device is rarely the correct interpretation.’ ” Osram GmbH v. Int’l Trade Comm’n, 505 F.3d 1351, 1358 (Fed. Cir.2007). Thus, if possible, claims should be construed to uphold validity. See In re Yamamoto, 740 F.2d 1569, 1571 (Fed.Cir. 1984).

CONSTRUCTION OF THE DISPUTED TERMS

The parties present over 50 disputed claim terms across the Abbott patents. Fortunately, however, the number of issues that must be resolved is far fewer. As is set out in detail below, the proper construction of the disputed terms follows from the answers to the following six questions: (A) do the Abbott patents exclude an “internal hydrophobic component”; (B) whether the “treatment-limiting” terms should be numerically defined; (C) whether “sustained release” can be defined in relation to “immediate release”; (D) whether “significant increase” should be numerically defined; (E) whether “intermediate release” can be defined in relation to both “sustained release” and “intermediate release”; and (F) whether “about” should be numerically defined.

A. Do the Abbott Patents Exclude an “Internal Hydrophobic Component”?

The critical dispute between the parties over the construction of several claims of the Abbott patents is whether they should be construed to exclude “an internal hydrophobic component.” (D.I. 55 at 2; D.I. 54 at 5-6) The parties agree that the resolution of this issue should apply to all the claims for which Lupin proposes this exclusionary language. (Tr. at 89-90) The disputed claims and the parties’ proposed constructions for them are as follows:

i. Abbott’s Position

Abbott argues that Lupin’s proposed constructions excluding an “internal hydrophobic component” are facially incorrect. (D.I. 55 at 12) For instance, several of the '428 patent’s dependent claims “expressly provide for tablets comprising a lubricating agent, such as stearic acid or magnesium stearate, which are hydrophobic components.” (Id. (citing '428 patent, claims 8, 9)) Additionally, the '428 patent’s specification describes the use of swelling agents, which “ ‘include, but are not limited to, polymers such as ... ethylcellulose and waxes ....’” (Id. at 13-14 (quoting '428 patent, col. 4 lines 14-18)) The specification also states that “[processing aids, such as lubricants, including stearic acid,” may be used. ('428 patent, col. 4 lines 44-45) Ethylcellulose, waxes, and stearic acid are all hydrophobic components. (D.I. 55 at 14) Further, the specification provides that the swelling agent may be “‘compounded with the nicotinic acid,’ making it an ‘internal’ component of the tablet.” (Id. (quoting '428 patent, col. 4 lines 5-12, col. 5 lines 12-13)) Abbott also notes that the '428 patent’s specification does not exclude any particular component (hydrophobic or otherwise) from the invention; the only reference to a “hydrophobic component” in the patent is in the “Background of the Invention” section describing the prior art. (D.I. 55 at 13 & n. 2 (citing '428 patent, col. 1 lines 62-65)) Therefore, Abbott concludes, the '428 patent explicitly encompasses an oral solid dosage form that contains an “internal hydrophobic component,” so to construe claim 1 to exclude such a component would exclude one of the patent’s preferred embodiments. {Id. at 13-14)

Regarding Lupin’s argument that the '930 patent’s specification excludes hydrophobic components by utilizing a “hydrophilic matrix controlled drug delivery system,” Abbott responds that this description in the specification is merely “the best mode” for producing Niaspan®, which is only one embodiment of the '930 invention, and that nothing in the asserted claims requires use of a hydrophilic matrix delivery system. (D.I. 58 at 14) Moreover, Abbott contends that use of a hydrophilic matrix controlled delivery system does not preclude using hydrophobic components. {Id.) According to Abbott and its expert, Dr. McGinity, a person of ordinary skill in the art would understand that “hydrophobic components (e.g., ethylcellulose or waxes) may be combined with the hydrophilic swelling agent to achieve the desired release of the active ingredient.” {Id. (citing Supp. McGinity Deck ¶ 18))

Abbott also argues that the prosecution history of the '428 patent’s claim 1 undermines Lupin’s proposed construction of “oral solid dosage form.” According to Abbott, during “much” of the '428 patent’s prosecution, the PTO Examiner took the position that the pending application and another patent, U.S. Patent No. 5,268,181 (the “O’Neill patent”), claimed the same invention, thereby requiring an interference to determine which inventor had priority of invention. (D.I. 55 at 15 (citing JA000270, '428 File History, June 10, 1996 Office Action and JA000292, '428 File History, Nov. 22, 1996 Office Communication)) The PTO applies a two-way test in order to decide whether the same invention is claimed by two patents: the claims of the application being examined “must anticipate or render obvious” the claims of the other patent and vice versa. Eli Lilly & Co. v. Bd. of Regents of the Univ. of Wash., 334 F.3d 1264, 1268-69 (Fed.Cir.2003).

The '428 patent inventor argued that no interference should be declared for two reasons: (1) the O’Neill patent was not anticipated by nor obvious in light of the '428 application because the O’Neill patent’s claimed method “required a specific composition (that included an internal hydrophobic component), while the '428 application did not require such a specific composition;” and (2) the '428 application’s claimed method centered around the dosing and time of administration, neither of which were anticipated by nor obvious in light of the O’Neill patent. (D.I. 55 at 16 (citing JA000277-78, '428 File History, Aug. 5, 1996 Amendment and Response at 3^1)) In concluding that an interference was not necessary, the Examiner appeared to accept the inventor’s distinctions, stating that:

[I]t is apparent that the composition employed in the methods of the ['428] applications are materially different than [the O’Neill patent], specifically there is no requirement of added hydrophobic component to be mixed with Niacin prior to tablet formulation.

{Id. at 16-17 (quoting JA000473, '428 File History, June 30, 1999 Notice of Allowability at 2)) In response, the '428 patent inventor confirmed that “ ‘[u]nlike the [O’Neill patent], such unique methods, as claimed in claims 1-9 and 15-18 [of the '428 application], are accomplished ... irrespective of whether a hydrophobic component is mixed with the nicotinic acid prior to tablet or other product formulation.’” (Id. at 17 (quoting JA000484-85, '428 File History, Oct. 15, 1999 Comments on Statement for Reasons for Allowance at 1-2))

With respect to the term “dosing” in claim 1 of the '848 patent, Abbott argues that its construction is confirmed by the term’s plain language and the '848 patent’s specification. (D.I. 55 at 36-37 (citing '848 patent, col. 3 lines 32-36, col. 9 lines 58-60)) Abbott also argues that the prosecution history confirms its construction. Original claim 1 of the '848 patent contained the term “dosing” and issued without amendment or argument between the Examiner and the applicant about the meaning of the term. (Id. at 37)

ii. Lupin’s Position

Lupin asserts that both the specification and prosecution history of the '428 patent demonstrate that the disputed claims should be construed to include the negative limitation “not containing an internal hydrophobic component.” (D.I. 54 at 6-7) Lupin maintains that the specification “identifies hydroxypropyl methylcellulose (a well-known hydrophilic material) as the preferred swelling agent” and discloses “no mechanism other than the use of a swelling agent to obtain a sustained release.” (Id. at 7) Lupin further states that the Summary of the Invention portion of the '428 patent “no doubt identifies the formulation’s essential components, i.e., nicotinic acid and a hydrophilic material.” (Id.)

In Lupin’s view, the word “internal” means a “a hydrophobic component intimately mixed with niacin in the dosage form, e.g., intimately mixed with niacin in granules later compressed into tablets.” (D.I. 60 at 2) The hydrophobic lubricating agents listed in the '428 patent are not “internal” to the niacin mixture, however. (Id. at 2) Rather, they are “external” components, “blended” with a granulated material (composed of niacin, the swelling agent Methocel, and the granulating/binding agent povidone) and then “pressed into tablets.” (Id. at 2 (citing '930 patent, col. 7 lines 20-65 to col. 8 lines 25-32)) “The Methocel mixed with niacin to form the granules is called ‘intragranular,’ whereas the Methocel used with the lubricating agent is called ‘extragranular.’ ” (Id. (citing '930 patent, col. 6 lines 1-18 (table IB), col. 6 lines 34-65)) Also, the lubricating agent is described as “external.” (Id. (citing '930 patent, col. 5 lines 56-58); see also JA001118, '930 File History, Mar. 15, 1999 Office Action at 2)

Additionally, Lupin argues that the portion of the '930 specification describing the “‘hydrophilic matrix controlled delivery system’ ” used to manufacture the preferred embodiment demonstrates that the patent excludes use of an internal hydrophobic component. (D.I. 54 at 8 (quoting '930 patent, col. 5 lines 20-36)) According to Lupin, to achieve the desired controlled-release delivery system as described in the '930 patent, the Abbott inventors used “polymer wetting, a phenomenon occurring with hydrophilic materials, not hydrophobic materials.” (Id. at 8) Lupin insists that because “hydrophobic materials have little or no affinity for water, the desired ‘wetting’ and expansion in vivo would not occur with hydrophobic materials.” (Id.) Thus, the '930 patent’s repeated references to the word “hydrophilic” when discussing “the present invention” demonstrate that the claimed invention “concern[s] the use of hydrophilic materials together with nicotinic acid.” (Id.)

With respect to the '428 patent’s prosecution history, Lupin contends that because the Abbott patents constitute a family of patents stemming from a common patent application and containing common disclosures, “the claims must be interpreted consistently across all asserted patents.” (Id. at 10) Further, “the prosecution histories of all the relatives in the family are relevant to the claim-construction analysis for a shared term or phrase, including the prosecution histories of later issued patents in the family.” (Id. at 10-11 (citing Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1306-07 (Fed.Cir.2007); MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1327 (Fed.Cir.2007))) Lupin acknowledges that the wording differs in the limitations among the various Abbott patents, but insists that “they all concern the same concept, namely, an object containing nicotinic acid as an active ingredient intended for use by individuals having hyperlipidemia. Consequently, the prosecution disclaimer attaching to any of these limitations should attach to all.” (D.I. 54 at 14)

Specifically, in June 1995, the PTO Examiner rejected claims in the '428 patent application as “clearly anticipated” by the O’Neill patent. (Id. at 11 (citing JA000191, '428 File History, June 30, 1995 Office Action at 3)) The patentee responded that “the O’Neill patent claims are distinct at least because the O’Neill formulation requires a ‘hydrophobic component’ ” and is based on prior art that “teach[es] that the hydrophobic component is an ‘essential component of the invention,’ ” whereas the '428 patent inventor “did not find that ‘a hydrophobic component’ was essential for the efficacy of his nicotinic acid composition.” (Id. at 11-12 (quoting JA000280-81, '428 File History, Aug. 5, 1996 Amendment and Response at 6-7)) Similarly, the '428 patentee explained during an October 1997 interview that the “ ‘O’Neill patent requires ‘hydrophobic component’ where as in the instant claimed application there is no ‘hydrophobic component.’ ” (Id. at 12 (quoting JA000351, '428 File History, Oct. 8, 1997 Interview Summary))

Thereafter, the patentee responded to the Examiner’s final rejection by arguing that “ ‘the specification of the ... ['428 patent does not] teach or suggest the ‘hydrophobic component’ as claimed in independent claim 1 of the O’Neill patent.’ ” (Id. (quoting JA000397, '428 File History, Feb. 26, 1999 Response After Final at 9)) The Examiner was “apparently persuaded,” and allowed the patent, stating that “the composition employed in the methods of the instant application are materially different than [the O’Neill patent], specifically there is no requirement of added hydrophobic component to be mixed with Niacin prior to tablet formulation.” (Id. (quoting JA000473, '428 File History, June 30, 1999 Notice of Allowability at 2)) Thus, according to Lupin, “during the '428 patent’s prosecution, the patentee clearly and unequivocally disclaimed compositions or dosage forms that contain an internal hydrophobic component.” (Id.)

Further, Lupin asserts that the '428 patentee repeated this “disclaimer” during prosecution of the continuation-in-part application that issued as the '930 patent. (Id. at 12-13) During an October 1998 interview with the Examiner, the Abbott patent inventor sought to overcome the PTO’s rejection (based on the O’Neill patent) of some of the '930 patent’s claims by agreeing to include the limitation that “ ‘wherein said ... [dosage form or tablet or preparation or composition] does not contain an internal hydrophobic component.’” (Id. at 13 (quoting JA00000957, '930 Patent File History, Oct. 28, 1998 Interview Summary)) The Examiner also noted that the prior art patents “have an internal hydrophobic component which is essential whereas in the instant ['930 patent] application there is no internal hydrophobic component .... ” (Id. at 13 (quoting JA00000957, '930 Patent File History, Oct. 28, 1998 Interview Summary)) Additionally, Lupin argues that in a November 1998 amendment, the '930 patentee divided the pending claims into four groups and assigned the limitation “ ‘wherein said ... [dosage form or tablet or preparation or composition] does not contain an internal hydrophobic component’ ” to group I. (Id. (quoting JA00001009, '930 File History, Nov. 20, 1998 Amendment at 38)) While acknowledging that the '930 patentee chose to proceed with different claims, Lu-pin still contends that the proposed negative limitation “clearly disavowed nicotinicacid compositions containing an internal hydrophobic component.” (Id.)

Additionally, Lupin argues that the Abbott patent inventor’s alleged disclaimer of formulations and dosage forms having an internal hydrophobic component in the patents issued after the '428 patent should be imputed to all the Abbott patents by virtue of their familial relationship. (Id. at 14) Lupin’s argument regarding the term “dosing” in claim 1 of the '848 patent, however, is unique to that term. Lupin asserts that although the '848 patent does not contain an express formulation or dosage-form limitation, it includes an implied limitation on the dosage form—ie., “dosing” in a dosage form containing an active ingredient (“nicotinic acid”) and inactive ingredients (“pharmaceutically acceptable carriers”), but not containing an “internal hydrophobic component.” (Id. at 14-15) Lupin also repeats its argument that the Abbott patents’ prosecution histories support its proposed limitation of “no internal hydrophobic component.” (Id.) In particular, Lupin contends that the fact that the '848 inventor changed the application’s title from “Nicotinic Acid Compositions ...” to “Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions ...” as part of a preliminary amendment shows that the patentee intended to limit the '848 patent dosage forms to those not containing an internal hydrophobic component. (D.I. 60 at 19-20) Although the patentee later changed the title back to its original form after the application was accepted, Lupin argues that its stated reason for doing so—-that “[n]either the specification nor the claims contain the term ‘hydrophobic’ ”—is merit less, because the specification recites “hydrophobic” when discussing the O’Neill patent’s parent patent and contains the antonym “hydrophilic” to describe NiaspanO’s controlled-delivery system. {Id. at 20 (citing '848 patent, col. 2 lines 1-4, col. 5 lines 32-48))

iii. Recommended Construction

After reviewing the claims, specifications, and prosecution histories of the Abbott patents, as well as the extrinsic evidence of record, I am not persuaded that the disputed claim terms should include Lupin’s proposed negative limitation “not containing an internal hydrophobic component.” I recommend that the Court adopt Abbott’s proposed constructions.

Among Lupin’s strongest evidence for its proposed exclusion is the statement in the specification of the '428 patent—the “grandparent” patent—disclosing a hydrophilic substance as the preferred type of swelling agent. Specifically, as Lupin emphasizes, the '428 patent’s specification states: “[a]n exemplary and preferred swelling agent is hydroxypropyl methylcellulose .... ” ('428 patent, col. 4 lines 23-26) The force of this statement, however, is undermined by the following statement, which appears in the same portion of the '428 patent’s specification:

Such swelling agents include, but are not limited to, polymers such as sodium carboxymethylcellulose and ethylcellulose and waxes such as bees wax and natural materials such as gums and gelatins or mixtures of any of the above.

('428 patent, col. 4 lines 14-18) Ethylcellulose and waxes are hydrophobic components. (D.I. 56 AA Ex. B, McGinity Declaration (“McGinity Decl.”) ¶ 44) Thus, the specification expressly contemplates use of hydrophobic components as swelling agents.

Lupin’s proposal would inappropriately limit the '428 patent’s invention to its preferred embodiment {i.e., one containing hydrophilic, but not hydrophobic, components). The '428 patent’s preferred embodiment is Niaspan®, which does not contain a hydrophobic material as a swelling agent. “Even when the 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.” Liebel-Flarsheim, 358 F.3d at 906. Lupin has not pointed to words or expression of manifest exclusion or restriction in the '428 patent’s specification that would justify reading the specification so restrictively.

Lupin’s assertion that the Summary of the Invention discloses a formulation “containing only nicotinic acid and the hydrophilic swelling agent hydroxypropyl methylcellulose” (D.I. 54 at 7 (emphasis added)) is also incorrect. That passage states that the '428 invention “comprises” nicotinic acid and hydroxypropyl methyl-cellulose. ('428 patent, col. 3 lines 8-12) “Comprising is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed.Cir.1997); see also Mars, Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1375-76 (Fed.Cir.2004) (same); Dow Chem. Co. v. NOVA Chems. Corp. (Canada), 629 F.Supp.2d 397, 407-08 (D.Del.2009) (same). Another problem with Lupin’s argument is that the Summary of the Invention is disclosing a preferred embodiment, but (as discussed above) there is no basis in the '428 patent to limit the scope of the claims to just this preferred embodiment.

For the reasons just explained in connection with the '428 patent, the '930 patent’s specification also does not support including Lupin’s proposed limitation of “no internal hydrophobic component.” This conclusion is not altered by the '930 specification’s description of a “hydrophilic matrix controlled delivery system.” Such a delivery system is an exemplary mode of manufacturing the preferred embodiment, but is itself only one way of practicing the '930 patent. ('930 patent, col. 4 line 65 to col. 5 line 37) Given that Lupin fails to direct the Court to support for Lupin’s assertion that hydrophobic components could not be used in conjunction with a “hydrophilic matrix controlled delivery system,” and that this kind of delivery system is not required by any of the asserted claims, I am not persuaded that the '930 patent should be construed to exclude hydrophobic components.

I turn now from the specifications to the prosecution histories. When the prosecution history of the '428 patent is considered as a whole, as it must be, see Elbex Video, Ltd. v. Sensormatic Elecs. Corp., 508 F.3d 1366, 1372 (Fed.Cir.2007), Lupin’s contention that it contains a disclaimer (warranting inclusion of Lupin’s proposed negative limitation) is revealed to be unpersuasive. A party seeking to show a prosecution disclaimer must demonstrate an “unambiguous” disclaimer, based on “clear and unmistakable evidence” that some of the scope that would otherwise be captured by the claim was relinquished during prosecution. See Voda v. Cordis Corp., 536 F.3d 1311, 1321 (Fed. Cir.2008). The same is true of disclaimers made during the prosecution history of a patent in the same family as the patent-in-suit. See Verizon Servs. Corp., 503 F.3d at 1306-07.

Even when considering the prosecution histories of all of the Abbott patents, I find no “unambiguous,” “clear and unmistakable” disavowal of claim scope. A careful review of the file histories shows that the patentee consistently told the PTO only that his invention did not require a hydrophobic component; the patentee never stated that a hydrophobic component was excluded, from the scope of the claims. Moreover, the patentee distinguished his invention from O’Neill by emphasizing that O’Neill required a specific composition, while the patents-in-suit do not, and further emphasizing that the patents-in-suit disclose a specific dosing size and timing, while the O’Neill patent does not None of this constitutes the disavowal Lupin requires to prevail on its proposal to read the “internal hydrophobic” exclusion into the claims.

The analysis begins with the '428 patent. At first the Examiner rejected the '428 patent’s claims as anticipated by the O’Neill patent. (D.I. 62, JA000270, '428 File History, June 10, 1996 Office Action) Then, however, the Examiner withdrew that rejection and indicated that an interference proceeding was necessary. (Id.) In response, the '428 inventor amended his claims and distinguished the O’Neill patent based on (1) the O’Neill patent’s requirement of using a particular composition, whereas the '428 invention did not require a particular composition, and (2) the O’Neill patent’s disclosure of administering the invention once per day, whereas the '428 patent requires its invention to be administered once daily at a specific time of day. (D.I. 62 JA000280, '428 File History, Aug. 5, 1996 Amendment and Response (hereinafter “August 1996 Amendments”) at 3-8) Thus, the '428 inventor stated:

The compositions described in new claim 15 [issued claim 10] and in the O’Neill patent claims are distinct at least because the O’Neill formulation requires a “hydrophobic component.” ... Significantly, [O’Neill’s parent application] teach[es] that the hydrophobic component is an “essential component of the invention.” ... In contrast to [O’Neill’s parent application], the ['428] inventor did not find that a “hydrophobic component” was essential for the efficacy of his nicotinic acid composition. Furthermore, the hydrophobic component is not included in the nicotinic acid composition of the ['428 invention], as defined by claim 15.

(D.I. 62, JA000280-281, August 1996 Amendments at 6-7) (emphasis added) While Lupin emphasizes the final sentence of this passage, the entirety of the passage demonstrates only that the hydrophobic component “required” by O’Neill and its parent application is not required by the '428 patent’s then-pending claim 15. See Elbex Video, 508 F.3d at 1372 (finding no prosecution disclaimer, even though certain prosecution statements “could be argued to be a disclaimer,” because, “[w]hen the prosecution history as a whole is considered, the inventor’s response to the PTO is not as clear”).

The same conclusion arises from review of the Examiner’s October 7, 1997 Interview Summary. There, the Examiner stated that counsel for the '428 patent’s applicant:

explained that the O’Neill patent requires “hydrophobic component” where as in the ['428] application there is no “hydrophobic component.” The examiner informed the counsel that claim 1 has the open-ended expression “comprising” and it is inclusive of all the unrecited ingredients. The counsel informed the examiner that claim 15 is different than claim 1 of the O’Neill patent as the claim 15 requires administering the niacin at night or evening which is not claimed by claim 1 of the O’Neill patent.

(D.I. 62, JA000351, '428 File History, Oct. 7, 1997 Interview Summary) This is not a clear disavowal of “hydrophobic components,” internal or otherwise. The phrase “where as in the ['428] application there is no ‘hydrophobic component’ ” refers to the “hydrophobic component” required by O’Neill. It is as natural to infer that counsel meant that the '428 application has no required “hydrophobic component” as it is to assume that counsel intended to disavow hydrophobic components completely. Thus, it is improper to conclude that the '428 patent’s applicant intended to disavow an internal hydrophobic component. See W.E. Hall Co. v. Atlanta Corrugating, LLC, 370 F.3d 1343, 1351-53 (Fed.Cir. 2004) (giving disputed terms their plain and ordinary meaning where Examiner’s interview summary was susceptible to both limited reading and full ordinary meaning); see also generally Univ. of Pittsburgh v. Hedrick, 573 F.3d 1290, 1296-97 (Fed.Cir. 2009) (Examiner’s interview summary too terse to inform definition of claim terms).

Lupin points to the '428 inventor’s response to the Examiner’s final rejection, in a section the inventor entitled “The Specification of the ['428 Application] Does Not Have Support for All Limitations Found in Independent Claim 1 in the O’Neill Patent,” There the inventor stated:

By way of example, the specification of the ['428 application] does not teach or suggest the particular hydroxypropyl methylcellulose claimed by independent claim 1 of the O’Neill Patent. Nor does the specification of the ['428 application] teach or suggest the “hydrophobic component” as claimed in independent claim 1 of the O’Neill Patent.

(D.I. 62, JA000397, '428 File History, Feb. 26, 1999 Response After Final at 9) When viewing this February 26, 1999 Response as a whole, the '428 inventor repeatedly asserted that the key distinctions from the O’Neill patent are, inter alia, the '428 patent’s lack of a specific nicotinic acid composition and the '428 patent’s requirement of a particular time of day for dosing. (D.I. 62, JA000394-95, '428 File History, Feb. 26, 1999 Response After Final at 6-7) The excerpt relied on by Lupin, then, most reasonably shows that the '428 inventor was arguing that the O’Neill patent’s claim 1 “required both a particular hydroxypropyl methylcellulose (i.e., '5-30% high viscosity hydroxypropyl methylcellulose having a nominal viscosity’) and a particular quantity of hydrophobic component (i.e., '2-20% of a hydrophobic component’).” (August 1996 Amendments at 4 (quoting LA000962, O’Neill patent, col. 10 lines 24-25, 29-30)) (emphasis in original) By contrast, the '428 specification does not disclose a required, particular form of hydroxypropyl methylcellulose. Nor does it disclose the “‘hydrophobic component’ as claimed in independent claim 1 of the O’Neill Patent,” because the hydrophobic component disclosed in O’Neill’s claim 1 is an express limitation—and is thus “required”—as part of a particular formulation.

This conclusion is further supported by the Examiner’s eventual decision to allow the '428 patent application over the potential interference by O’Neill. The Examiner’s statement of reasons for allowance provides that;

Upon reconsideration, reading the claims in light of the ['428 patent’s] specification, it is apparent that the composition employed in the methods of instant application are materially different than [the O’Neill patent], specifically there is no requirement of added hydrophobic component to be mixed with Niacin prior to tablet formulation.

(D.I. 62, JA000473, '428 File History, June 30, 1999 Notice of Allowability at 2) (emphasis added) Thus, the Notice of Allowability shows that the Examiner agreed with the inventor’s argument that while the O’Neill patent “requires” an “added hydrophobic component to be mixed with Niacin prior to tablet formulation,” the '428 patent does not. The inventor confirmed this distinction in his Comments on Reasons for Allowance, stating:

Unlike [O’Neill], such unique methods, as claimed in claims 1-9 and 15-18, are accomplished ... irrespective of whether a hydrophobic component is mixed with the nicotinic acid prior to tablet formulation. Thus, claims 1-9 and 15-18 are not limited to the requirement of adding a hydrophobic component for mixing with the nicotinic acid prior to tablet formulation, as suggested by the Examiner in paragraph 1 of the Notice of Allowance.

(D.I. 62, JA000484-485, '428 File History, Oct. 15, 1999 Comments on Reasons for Allowance at 1-2) (emphasis added) In sum, the prosecution history of the '428 patent contains no unambiguous, clear, and unmistakable disavowal of “internal hydrophobic components.”

Lupin’s argument that a “repeated disclaimer” of “compositions or dosage forms that contain an internal hydrophobic component” is found in the prosecution history of the '930 patent is similarly unavailing. The inventor’s March 3, 1998 amendments in response to the Examiner’s rejection primarily address the inventor’s attempt to distinguish the O’Neill patent on the grounds that the '930 patent accomplished its goals “without inducing hepatotoxicity” and without being limited to a particular nicotinic acid composition. (D.I. 62, JA000633, '930 File History, Mar. 3, 1998 Amendment at 27, 33-34) According to the Examiner’s interview summary of October 1998, the Examiner and the applicants agreed that:

[Applicants will amend all the independent claims and add claims from the parent case to include the limitation “wherein said (dosage form or tablet or preparation form) does not contain an internal hydrophobic component.” The [O’Neill patent and its parent patent] have an internal hydrophobic component which is essential whereas in the instant application there is no internal hydrophobic component and external stearic acid is used only as lubricant.

(D.I. 62, JA000957, '930 File History, Oct. 28, 1998, Interview Summary) (emphasis added) Lupin urges that this statement demonstrates the '930 inventors’ disclaimer of internal hydrophobic components. When read in the context of the entire prosecution history of the '930 patent, however, this statement (which is a statement of the Examiner, not the applicants) is not an unambiguous, clear, or unmistakable disclaimer.

After the interview summarized above, the '930 inventors submitted in November 1998 a group of claims (“Group I”) that contained the agreed-upon limitation— “wherein said (dosage form or tablet or preparation form) does not contain an internal hydrophobic component.” (D.I. 62, JA001028, '930 File History, Nov. 20, 1998 Amendment at 38) The inventor’s second supplementary amendment of February 1999 sheds no further light on the Group I amendments. (D.I. 62, JA001104, '930 File History, Feb. 1, 1999 Second Supplemental Amendment at 10-12) After the Group I claims were rejected by the Examiner in March 1999 (D.I. 62, JA001119, '930 File History, Mar. 15, 1999 Office Action at 2), the inventor in December 1999 cancelled them without discussion (D.I. 62, JA001158, '930 File History, Dec. 3,1999 Amendment After Final at 2). The '930 patent’s remaining claims—those not including the limitation “no internal hydrophobic component”—were allowed soon thereafter. (D.I. 62, JA001161, '930 File History, Dec. 17, 1999 Notice of Allowability) The cancelled Group I claims, therefore, never issued.

The key here is that the inventors submitted claims that would have excluded a hydrophobic component, but these claims were rejected. Thus, the claims as issued were not limited to the narrower scope proposed by the inventors. By implication, the claims that did issue—which do not contain the rejected narrowing limitation—are broader, indeed sufficiently broad to allow for the possibility of internal hydrophobic components. See generally Schriber-Schroth Co. v. Cleveland Trust Co., 311 U.S. 211, 220-21, 61 S.Ct. 235, 85 L.Ed. 132 (1940) (“[A] claim in a patent as allowed must be read and interpreted with reference to claims that have been can-celled or rejected, and the claims allowed cannot by construction be read to cover what was thus eliminated from the patent.”). Certainly, this is at least one reasonable interpretation of the prosecution history of the '930 patent. Therefore, again, these portions of the prosecution history do not provide the support Lupin requires to read into the claims the “internal hydrophobic component” exclusion Lu-pin proposes.

In sum, therefore, even when considering the '930 patent’s prosecution history in conjunction with the '428 patent’s history, there is not sufficient evidence to support a finding a prosecution disclaimer of “no internal hydrophobic component.” Thus, again, I recommend that the Court adopt Abbott’s proposed construction of the multiple disputed claim terms in which Lupin would read in a limitation excluding an “internal hydrophobic component.”

B. Treatment-limiting Terms

The “treatment-limiting terms” are a series of claim terms relating to various measures of liver enzymes, uric acid, and blood glucose levels that are referenced in various claims of the Abbott patents. For each of these terms, Abbott proposes to construe the limitation with reference to increases in these measurements that would require treatment with the claimed invention to be discontinued. By contrast, Lupin proposes specific, numerical levels of increases for each of these terms. The specific claim terms, and the parties’ proposed constructions, are given in the table below.

i. Abbott’s Position

Abbott contends its proposed construction of the treatment-limiting terms is supported by the '428 patent’s specification and prosecution history. (D.I. 55 at 18-20, 40-41) The Background section of the patent, describing the invention and the problem it aimed to solve, refers to a study of a prior art SR niacin product given to 23 patients (hereinafter “the McKenney Study”), noting that “18 or 78 percent were forced to withdraw because liver function tests (LFTs) increased indicating potential liver damage.” ('428 patent, col. 2 lines 19-32) Thus, the '428 invention aimed to “provide a method for employing a composition as above, for treating hyperlipidemia which results in little or no liver damage.” (D.I. 55 at 19) The specification continues by adding “a group of 240 patients treated according to the present invention had zero patients drop out, based upon the same criteria for withdrawal” as used in the McKenney Study. ('428 patent, col. 11 lines 44-51) The specification concludes that the '428 invention “caused no elevation in liver function tests (ie., no liver damage).” ('428 patent, col. 11 lines 51-54) In Abbott’s view, the specification thus establishes that “little or no serious liver damage” refers to the absence of “liver damage, that, in the view of the treating clinician, requires the patient to withdraw from treatment (ie., is ‘treatment-limiting’).” (D.I. 55 at 19)

Abbott argues that Lupin’s proposed construction of the '428 patent’s claim term “little or no serious liver damage,” which imposes a cap of 9% on increases of particular liver enzymes, is inappropriate. The 9% figure is derived from Table IV in the specification, “which shows the results of tests for ALT levels in patients treated according to the invention of the '428 patent.” (D.I. 55 at 19) However, while 9% represents the mean change from baseline in patients’ liver enzyme levels after four weeks, some patients who experienced even higher increases in those enzymes during the same time period were not withdrawn from treatment. (Id. (citing '428 patent, col. 11 lines 49-51 (Table IV))) Lupin’s proposed construction would mean that about half of the patients in the study described in the specification suffered “serious liver damage” but continued treatment. (Id.) Thus, Lupin’s construction “cannot be reconciled with the specifications’ teaching that the invention ‘caused no elevation in liver function tests (i.e., no liver damage).”’ (D.I. 58 at 31 (quoting '428 patent, col. 11 lines 51-54)) The same is true for uric acid and glucose levels; approximately half the patients in the clinical trial had increases in uric acid and glucose levels over the “minimum,” yet their treating physicians did not discontinue treatment. (Id.)

Abbott also argues that the '428 prosecution history supports its construction. Claim 3 of the '428 patent was allowed in its amended form, containing the limitation “little or no serious liver damage,” without further amendment or argument during prosecution. Yet, the inventor described the '428 invention as a method of treatment that did not cause “ ‘treatment-limiting side effects,’ ” such as hepatotoxicity. (D.I. 55 at 20 (quoting