Exeltis USA, Inc. et al v. Lupin Ltd. et al, No. 1:2022cv00434 - Document 298 (D. Del. 2024)
Court Description: MEMORANDUM OPINION: Providing claim construction for multiple terms in U.S. Patent Nos. 11,123,299, 11,291,632, 11,351,122, 11,478,487, 11,413,249, and 10,179,140 (see Memorandum Opinion for further details). Signed by Judge Richard G. Andrews on 2/20/2024. (nms)
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Exeltis USA, Inc. et al v. Lupin Ltd. et al Doc. 298 IN THE UNITED STATES DIS CT COURT FOR THE DISTRICT OF D LAWARE EXELTIS USA, INC., LABORATORIOS LEON FARMA, S.A., CHEMO IBERICA, S.A., and CHEMO RESEARCH, S.L., Plaintiffs, Civi Action No. 22-434-RGA V. LUPIN LTD. and LUPIN PHARMACEUTICALS, INC., Defendants. MEMORANDUM OPINION Martina Tyreus Hufnal, Douglas E. McCann, Gregory R. Boofer, FISH & RICHARDSON P.C., Wilmington, DE; Philip K. Chen, FISH & RICHARDSON P.C., Boston, MA; Brian Coggio, Excylyn Hardin-Smith, FISH & RICHARDSON P.C., New Ybrk, NY; Megan A. Chacon, Madelyn McCormick, Bernard Cryan, FISH & RICHARDSOr P.C., San Diego, CA, Attorneys for Plaintiffs. I John C. Phillips, Jr. , David A. Bilson, PHILLIPS MCLAUGHLIN & HALL, P.A. , Wilmington, I DE; Michael Nutter, MCGUIREWOODS LLP, Chicago, IL; <torinne S. Hockman, MCGUIREWOODS LLP, Raleigh, NC; Daniel Withers, MCGUIREWOODS LLP, Dallas, TX; Merritt Westcott, MCGUIREWOODS LLP, Houston, TX; Derrus D. Gregory, MCGUIREWOODS LLP, Austin, TX, Attorneys for Defendants. February '/..0 , 2024 1 Dockets.Justia.com Before me is the issue of claim construction of multi pl terms in U.S. Patent Nos. 11 ,123,299 ("the '299 patent"), 11,291,632 ("the '632 patent", 11,351,122 ("the '122 patent"), 11,478,487 ("the '487 patent"), 11,413,249 ("the ' 249 patent", and 10,179,140 ("the '140 patent"). I have considered the parties' letters. (D.I. 286, 287 295, 296). I. BACKGROUND Plaintiffs filed U.S. Patent Application No. 13/171,41 ! ("the '410 application") in 2011. The '410 application issued as U.S. Patent No. 10,849,857 an is not asserted in this case. (See D.I. 82 at 26). The '140 patent is a continuation-in-part of the '410 application. (Id. at 28 n.4). The other asserted patents are continuations of the '410 applic tion. (D.I. 109 at 14:21-25). In March 2023, I construed various terms in the asserted patents. (See D.I. 107, 111). The trial is scheduled to begin on February 26, 2024. See D.I. 282). On January 26, 2024, the parties filed a joint letter raising claim construction disputes. (D.I. 272). I ordered the parties to submit proposed constructions prior to the pretrial c Inference. (D.I. 278). After reviewing the proposed constructions (D.I. 279, 280), I asked he parties to brief the disputed terms (D.I. 285 at 13:21- 23). II. LEGAL STAND ARD "It is a bedrock principle of patent law that the claims fa 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) (en bane) (cleaned up). "' [T]here is no magi, formula or catechism for conducting claim construction.' Instead, the court is free to a1 ach the appropriate weight to appropriate sources ' in light of the statutes and policies that inform patent law. " ' Soft View LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013 ) (alteration in original) (quoting 2 Phillips, 415 F.3d at 1324). When construing patent claims, a court considers the literal language of the claim, the patent specification, and the prosec tion history. Markman v. Westview Instruments, Inc. , 52 F. 3d 967, 977- 80 (Fed. Cir. 19r 5) (en bane), aff'd, 51 7 U.S. 370 (1996). Of these sources, "the specification is always highly T levant to the clai~ construction analysis. Usually, it is dispositive; it is the single best guide ti the meaning of a disputed term." Phillips, 415 F.3d at 1315 (cleaned up). "While claim terms are understood in light of the specification, a claim construction must not import limitations from the specification into the claims." Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 135 (Fed. Cir. 2012) (citing Phillips, 415 F.3d at 1323). "[T]he words of a claim 'are generally given their ordi ary and customary meaning.' ... [It is] the meaning that the term would have to a person of ord nary skill in the art in question at the time of the invention, i.e., as of the effective filing date of he patent application." Phillips, 415 F.3d at 1312-13 (citations omitted). "[T]he 'ordinary me ing' of a claim term is its meaning to [an] ordinary artisan after reading the entire patent" Id. at 1321. "In some cases, the ordinary meaning of claim language as understood by a perso of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the wide! y accepted meaning of common!y undt rstood words." Id at 1314. When a court relies solely on the intrinsic evidence-the patent claims, the specification, and the prosecution history- the court's construction is a detJ ination of law. See Teva Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S . 318,331 (2015). The court may also make factual the patent and prosecution history, including expert and inven or testimony, dictionaries, and learned treatises." Phillips, 415 F.3d at 1317- 19 (quoting Markman, 52 F.3d at 980). Extrinsic 3 evidence may assist the court in understanding the underlying echnology, the meaning of terms I to one skilled in the art, and how the invention works. Id. Exrnsic evidence, however, is less reliable and less useful in claim construction than the patent a1d its prosecution history. Id. III. CONSTRUCTION OF DISPUTED TERMS I set forth claims 1 and 14 of the '299 patent and clai s 1 and 33 of the '140 patent to illustrate the disputed terms. These claims state: 1. A pharmaceutical composition comprising: 6P, 7P:15P, 16P-Dimethylene-3-oxo-17a-pregn-4-ene 21, 17-carbolactone in the form of particles that have: (i) a median par "cle size ranging from 10 micrometers (µm) to 30 µm; (ii) a d90 particle siie of less than 100 µm; and (iii) a dlO particle size of more than 3 µm , wherein the 6P, 7P:15P, 16PDimethylene-3-oxo-17a-pregn-4-ene-21, 17-carb ,lactone is present in an amount ranging from 3 milligrams (mg) to 4.5 mg; and one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition does not com rise estrogen; and wherein the pharmaceutical composition is formulated uch that no more than 50% of the 6P, 7P:15P, 16P-Dimethylene-3-oxo-17a-pregn-4-ene-21 , 171 carbolactone initially present in the pharmaceutictl composition is dissolved within 30 minutes if subjected to an in vitro disso ution test according to the USP XXIII Paddle Method. ('299 patent at 61:38-56 (disputed terms balded and italicized,). 14. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is formulated as a tablet or a capsule. ('299 patent at 62:40-42 (disputed terms balded and italicized). 1. A method of providing contraception in a patient hrving a BMI of 25 kg/m 2 or more and bleeding events, the method comprising: administering a pharmaceutical composition compris ng 2.5 mg to 5.5 mg of crystalline drospirenone and one or more harmaceutically-acceptable excipients to a patient having a BMI of 25 kg/m 2 or ore for an initial treatment cycle and for subsequent consecutive treatment cycles, the pharmaceutical composition being administered daily for at leas portions of the initial and subsequent consecutive treatment cycles; wherein the administering results in a limited numbe of days of bleeding events per treatment cycle in at least one of the subseq tent consecutive treatment cycles and wherein the pharmaceutical composition does not ontain an estrogen. 4 ('140 patent at 64:14- 29 (disputed terms bolded and italicized). 33. The method of claim 1, wherein the crystalline dr spirenone is present in an amount of 4 mg. (' 140 patent at 66: 17- 18 (disputed terms bolded and italicized ). 1. "an in vitro dissolution test according to the USP II Paddle Method" ('299 patent, claim 14; '632 patent, claims 12 and 21; '12 patent, claim 29; '487 patent, claim 19; '249 patent, claim 7) a. Plaintiffs' proposed construction : plain and or inary meaning as understood by a POSA reading the intrinsic record: in vitro dissblution test performed in 900 mL of water at 37° C (±0.5 ° C) using apparatus 2 a a stirring rate of 50 rpm / not indefinite b. Defendants ' proposed construction : an in vitro dissolution test using the Paddle (Apparatus 2) Method described in USP XXIII (D.I. 286 at 1) c. Court 's construction: an in vitro dissolution test using the USP XXIII Paddle Method Plaintiffs contend the patents disclose "specific test cor itions" for using the USP =m Paddle Method. (D.I. 287 at 1; see also D.I. 295 at 1). Based on the specification, Plaintiffs argue that a POSA would understand the claim term to mean, 'in vitro dissolution test performed in 900 mL of water at 37° C (±0.5° C) using apparatus 2 at as irring rate of 50 rpm." (D.I. 287 at 1 (citing '249 patent at 19:61- 65)). Plaintiffs contend that r e examples in the specification are consistent with this view (see id. (citing ' 249 patent at 38 :26- 31 , fig.2 , 44:65-66, 48:65- 67)), and that the specification does not disclose any other conditioJs for performing the method (id. ). Plaintiffs further rely on the file history, as Dr. Blatnik perfo I ed testing under these conditions. (Id.). Defendants contend that neither the claims nor the U.S Pharmacopoeia require any particular media, media volume, or stirring rate for the Paddle Method. (D.I. 286 at 1). Defendants contend that Plaintiffs have not presented lexicogrr phy or disclaimer arguments and are attempting to read limitations from the specification into t e claims. (Id. at 2). Although the 5 specification describes parameters that may be used with the , addle Method, Defendants argue that the specification does not state that these are the only pej issible parameters. (Id.; see also D.I. 296 at 2). Defendants also contend that Plaintiffs' proposed construction is inconsistent with Plaintiffs' infringement contentions. (D.I. 286 at 2). 1 Dj fendants further note that prior art patents reciting use of the Paddle Method claim testing param ters, unlike the claims at issue. (Id.).2 I am unpersuaded by Plaintiffs' argument that the clai s require specific test conditions. The plain language of the claims does not indicate that the Pa dle Method must be performed under any particular conditions. (See '299 patent at 61 :54- 56f (reciting "an in vitro dissolution test according to the USP XXIII Paddle Method")). Claim te s are "generally given their ordinary and customary meaning as understood by a person o~ ordinary skill in the art when read in the context of the specification and prosecution history." Thorner v. Sony Comput. Ent. Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (citing Phillips, 415 F.3d at 1313). Two exceptions apply: (1) when patentees act as their own lexicographers by l tting out definitions, and (2) when patentees disavow a claim term ' s full scope during prosecutiol or in the specification. Id. (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1580 (Fe<i:l. Cir. 1996)). A patentee acts as its own lexicographer only if it "clearly set forth a definition or the disputed claim term" in the specification. Id. (quoting CCS Fitness, Inc. v. Brunswick Coy-, 288 F.3d 1359, 1366 (Fed. Cir. 2002)). Disavowal, meanwhile, requires the specification to be "both so clear as to show 1 Plaintiffs dispute this and contend that Defendants "had nod ssolution testing in water in [their] ANDA." (D.I. 295 at 2). 2 Plaintiffs argue that Defendants' citations to prior art patents actually support Plaintiffs' position. (D.I. 295 at 2). 6 reasonable clarity and deliberateness, and so unmistakable as o be unambiguous evidence of disclaimer." Dealertrack, Inc. v. Hub er, 674 F.3d 1315, 1322 (Fed. Cir. 2012) (citation omitted). I do not think Plaintiffs have established lexicography I r disavowal for the "Paddle I Method" term. Any lexicography arguments fail because the atents do not include a definition for "Paddle Method." At best, Plaintiffs' argument may be frred as a disavowal of conditions other than 900 mL of water at 37° C (±0.5 ° C) at a stirring rate of 50 rpm. Neither the specification nor the file history, however, constitutes "unmistL able" evidence of disclaimer. In Example 2 of the specification, the dissolution rate "was dete Method using a USP Dissolution Test Apparatus 2 including ined by the USP XXIII Paddle covered glass vessels and 6 paddles." ('299 patent at 38 :27-29). The specification then states, "Tablets were placed in 900 ml water at a temperature of37° C.± (0.5° C.) and stirred at 51 rpm." (Id at 38:30-31). This language does not suggest that no other test conditions could r tisfy the broad claim language of performing a dissolution test "according to the USP XXIII Pa dle Method." (Id. at 61 :54- 56). Other references to the Paddle Method in the specification an file history are similarly insufficient to limit the claim scope to only one set of conditior s. (See, e.g., id. at 19:58-63). I thus find that Plaintiffs' proposed construction would import limitations into the claims. Such a construction would contradict the claims' plain langua! e. See Renishaw PLC v. Marposs Societa'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998) ("T [e construction that stays true to be, in the end, the correct construction."). I thus reject Plainti fs' proposed construction. 2. "particle size" I "dlO particle size" I "d90 particle s+ze" / "median particle size" ('299 patent, claim 14; '632 patent, claims 12 and 21) a. Plaintiffs ' proposed construction: the diameter of an equivalent sphere expressed as a volume based distribution/ not indefinite 7 b. Defendants' proposed construction: plain and 9rdinary meaning as previously decided by the Court. That meaning includes: farticle size as determined by any means, and "d 10 particle size," "d50 particle sif e," "d90 particle size" as determined by any means, including by volum9, number or weight c. Court 's construction: plain and ordinary meani g: particle size as determined by any means Plaintiffs contend that the term "particle size" refers to a volume-based distribution only. (D.I. 287 at 2- 3; see also D.I. 295 at 2). Plaintiffs rely on thei expert, Dr. Bugay, to contend this is a customary use of "particle size" in the field of pharma:ceutical products. (D.I. 287 at 3). Plaintiffs argue that the specification is consistent with this cJ tomary use, as the disclosed examples "uniformly" recite using laser diffraction to determi~e particle size distribution. (Id. (citing '632 patent at 37:45-48)). Laser diffraction, Plaintiffs bontend, is a volume-based technique. (Id.) . Plaintiffs argue that Defendants are merely' attempting to create a[n] indefiniteness problem where none exists." (Id. at 4). Defendants argue that I previously rejected Plaintiffs' urrent position. (D.I. 286 at 4; see also D.I. 296 at 3). Defendants contend that Plaintiffs are atter pting to import limitations into the claims, as "no explicit statement in the specification mandates a volume method." (D.I. 286 at 4-5). Defendants note that the specification states, "particl, size distribution, in particular d90, dl0 and d50 values, may be determined by well-known methods of the prior art such as sieve analysis, laser diffraction methods, photoanalysis or optl al counting methods." (Id. at 4 (citing '299 patent at 22:46- 50); see also D.I . 296 at 3 ("At let.st 'optical counting' produces a number-based distribution .... ")).3 Defendants further argue r •t Plaintiffs are advancing mutually exclusive positions: (1) that individual particle size •easurements should not be limited 3 Plaintiffs respond, "Lupin does not explain why that one, ge eral sentence would suggest to a skilled artisan that the claimed particle size distribution can bd number- or volume-based .... " (D.I. 295 at 2-3). 8 to a particular method, and (2) that particle size distribution sl ould be limited to volumetric measurement. (D.I. 296 at 3-4). I did not decide this issue at the Markman stage. Plaintiffs originally argued that this term has its plain and ordinary meaning, while Defendants argj_ed the term is indefinite. (See D.I. 82 at 41 - 53). Defendants argued the patent does not teach "the manner in which the particles should be measured to determine their size, diameter,1or surface area (collectively 'particle size'), nor does the intrinsic evidence specify how th . distributions of such particles be presented." (Id. at 43-44). The briefing obscurely raised the olume issue, but I did not resolve 1 it. I proposed a tentative construction of plain and ordinary mi aning because I did not think that Defendants had shown indefiniteness in the briefing. (D.I. 100 at 1). After meeting and conferring, the parties rested on their papers for the claim te, (see D.i. 104 at 1), so I issued an order construing the term to have its plain and ordinary meaning (see D.I. 111 at 2-3). I did not distribution. Plaintiffs' focus on laser diffraction is unpersuasive. J lthough Plaintiffs are correct to the extent that examples in the specification mention laser di, action (see, e.g. , '299 patent at 37:46-48), the specification does not indicate that the claims j nly cover volume-based techniques like laser diffraction. The specification instead star s, "The active drug (such as drospirenone) particle size distribution, in particular d90, dl0 nd d50 values, may be determined by well-known methods of the prior art such as sieve analysis, laser diffraction methods, photoanalysis or optical counting methods." (Id. at 22:46- 50) Defendants contend that these methods are not all volume-based (see D.I. 286 at 4-5), and P aintiffs do not argue otherwise. 9 Plaintiffs' reliance on their expert, Dr. Bugay, is also T persuasive. Although Dr. Bugay opines that "particle size is customarily presented as the diameter of an equivalent sphere expressed as a volume-based distribution" (D.l. 287 at 3 (citin~ D.J. 287-6116, 8)), the specification states that well-known methods other than vohnr -based techniques may be used to determine particle size. Dr. Bugay's opinion is unhelpful to tT extent that it is inconsistent with the claim language and specification. See Vitronics, 90 F.3d at 1584 ("[E]xtrinsic evidence in general, and expert testimony in particular, may be used only lo help the court come to the proper understanding of the claims; it may not be used to vary or contradict the claim language."); Phillips, 415 F.3d at 1318 ("[A] court should dis ount any expert testimony 'that is clearly at odds with the claim construction mandated by the claims themselves, the written I description, and the prosecution history, in other words, with T e written record of the patent. " ' (citation omitted)). I therefore reject Plaintiffs' proposed construction. 3. " [drospiren one] in the form of particles" / "particle~ comp rising [d rospirenone]" ('299 patent, claim 14; '632 patent, claims 12 and 2r '487 patent, claim 19) a. Plaintiffs ' proposed construction : [drospirenonf.] in the form of discrete units of material ('299 patent, claim 14; '632 patent, clt"ms 12 and 21) / discrete units of material which include drospirenone (' 487 pate t, claim 19) b. Def endants ' proposed construction: a discrete I nit of material, where discrete has its usual meaning of individually separate and distinct, . . . which consist essentially of molecules of drospirenone ('299 t atent, claim 14; ' 632 patent, claims 12 and 21) / ... which include molecules of drospirenone ('487 patent, claim 19) c. Court's construction: [drospirenone] in the for of discrete units of material ('299 patent, claim 14; '632 patent, claims 12mfid 21) / discrete units of material which include drospirenone (' 487 patent, clai] 19) I Plaintiffs dispute that drospirenone particles must be" ndividually separate and distinct." (D.I. 287 at 4). Plaintiffs argue Defendants' proposed construr ion "is untethered to any intrinsic or extrinsic evidence and contrary to the plain wording of the laim." (Id. at 4- 5). Defendants, meanwhile, contend that Plaintiffs "refuse ' to explain what they mean by "discrete." (D.I. 286 at 4). Defendants argue that "particles," an ordinary word, "implies discrete units of material that are individually separable and distinct from one another and from other units of material." (Id. at 3; see also D.I. 296 at 3). I am unpersuaded by Defendants' argument. Althoug I agree with Defendants that "particle" is an ordinary English word, "particle" is generally efined as "a relatively small or the smallest discrete portion or amount of something." 4 Plaintiffs proposed construction reflects that meaning, and I think it is sufficient. I therefore adopt Pla"ntiffs' proposed construction. 4. "wherein the crystalline drospirenone is present in n amount of 4 mg" ('140 patent, claim 33) a. Plaintiffs ' proposed construction: wherein the ospirenone, some of which is in crystalline form, no particular percentage requi ed, is present in an amount of 4 mg b. Defendants' proposed construction: crystalline drospirenone that is present in the pharmaceutical composition in an amount of 4 g c. Court 's construction: wherein the composition contains 4 mg of crystalline drospirenone Plaintiffs contend Defendants are asking for reconside ation of an issue I already decided. (D.I. 287 at 5-6 (citing D.I. 107 at 7-8); see also D.I. 295 at 31" Plaintiffs argue that "4 mg" in claim 33 refers to drospirenone in general, not to crystalline drospirenone. (D.I. 287 at 5). Plaintiffs thus contend that only some of the 4 mg must be in Jlrystalline form. (Id.; see also D.I. 295 at 3 (arguing "the claims ... broadly encompass any amo nt of crystallinity")). A contrary construction, Plaintiffs argue, would "improperly read out" an embodiment from the 4 See particle, Merriam-Webster Dictionary, https://www.me 1amwebster.com/dictionary/particle. 11 specification; that embodiment describes drospirenone with" crystalline form . (D.I. 287 at 5 (citing ' 140 patent at 38:2- 5)) least over about 50%" in 5 Defendants argue that this issue has not already been litigated. (D.I. 286 at 6). They contend that all four milligrams of drospirenone must be crystl lline. (Id.). Defendants argue I that "4 mg" modifies "crystalline" in the claim, and "crystall1 e" modifies "drospirenone." (Id.). Defendants contend that Plaintiffs' proposed construction "wl uld effectively vitiate the 'crystalline' limitation, allowing 99.99% of the drospirenone ! be amorphous." (Id.). I agree with Defendants that I have not construed this erm before; I ruled on a different issue for a similar term. (See D.I. 107 at 6- 8 (deciding whethL the term "crystalline drospirenone" "specifies a threshold for the percentage of the t rospirenone by weight that must be in crystalline form")) . I did not discuss the constructions i the context of specific weight requirements. I also agree with Defendants that the claim requires 4 g of crystalline drospirenone. As Defendants argue, "4 mg" modifies the word "crystalline," an "crystalline" modifies "drospirenone." I think this interpretation is the only sensible reading of the claim language. Otherwise, if the composition does not include 4 mg of crystalline drospirenone, what does "4 mg" refer to? Plaintiffs would like it to refer to "drospirenon+ which could then include some crystalline drospirenone and some amorphous drospirenone. (Claims 1 and 33 twice use the phrase "crystalline drospirenone." The claims do not otherwi e recite "drospirenone." "Drospirenone" only appears twice; it is always modified by " rystalline." Plaintiffs are thus 5 Defendants dispute this. They contend, "As ' comprising' cl ims, the pharmaceutical composition may include additional drospirenone that is not ~ crystalline form, so long as it includes at least 4 mg of drospirenone in crystalline form. " ( .I. 296 at 5). 12 seeking a major rewrite of the claims so that "4 mg" limits at rm that does not appear in the claims. Defendants' proposed construction, on the other hand reflects the term's plain and ordinary meaning. Under Defendants' proposed construction, the preferr! embodiment (see '140 patent at 38:2-4) would be within the scope of the claim. See Vitronic 90 F.3d at 1583 (A claim construction that excludes the preferred embodiment "is rare!{ if ever, correct and would require highly persuasive evidentiary support."). I also note that the embodiment containing "at least l with the claim language. The over about 50%" of crystalline drospirenone is not inconsistel claim requires 4 mg of crystalline drospirenone, even if amorp ous drospirenone is also present. I reject Plaintiffs' proposed construction. 5. "administering a pharmaceutical composition ... t a patient" ('140 patent, claim 33) a. Plaintiffs' proposed construction: delivering drospirenone to the bloodstream of a patient b. Defendants' proposed construction: the act of i troducing a pharmaceutical composition to the body of a patient c. Court's construction: administering a pharmaceutical composition to a patient is the patient taking the pharmaceutical compositjon, however delivered Plaintiffs contend that the term "administering" has di ferent meanings "depend[ing] on what the inventors were seeking to achieve with the invention" (D.I. 287 at 6). Plaintiffs contend that the '140 patent does not limit "administering" to he moment a patient swallows a pill. (Id.; see also D.I. 295 at 3). Instead, Plaintiffs argue that the patent uses "administering" to describe particular results- 11 a good bleeding profile" and "co traceptive efficacy." (D.I. 287 at 6 (citing '140 patent at 3:20- 23, 4:21-28); see also D.I. 295 a~ 4). Plaintiffs thus contend that "administering" refers to "the first time the patient has enoug Idrug levels in the body to achieve contraceptive efficacy." (D.I. 287 at 6). 13 Defendants contend that "administering" refers to "the act of introducing the pharmaceutical to the body of a patient." (D.I. 286 at 5). The argue that the specification and even Plaintiffs' own expert testimony are consistent with this view. (Id.). Defendants contend that Dr. Shoupe, Plaintiffs' expert, "was unable to identify an1 portion of the patent specification supporting the position that ' administration' includes changes Ito a tablet after it is swallowed." (ld.) .6 I agree with Defendants that "administering" refers to • patient taking the drospirenone composition, not to the moment drospirenone achieves the desired effects in a patient' s body. Plaintiffs' argument about the differences between administral on and ingestion is unpersuasive I to the extent that the relevant patent claims do not use words lr e "take," "intake," or "ingest." (See '140 patent at 64: 14-29, 66: 17- 18). Although Plaintiffs r e correct that the '140 patent' s I specification describes effects such as contraceptive efficacy, do not think Plaintiffs' citations to the specification establish that "administering" continues for a prolonged period after a patient takes drospirenone. The specification suggests that the benefi1s of drospirenone occur after administration, not that administration itself involves these ef~cts. For instance, the specification states : In one embodiment, the pharmaceutical composition ay comprise an active contraceptive drug, wherein the pharmaceutical comp9sition allows for a 28 day daily dosing regimen, and wherein after initial administration of the active contraceptive drug has established its contraceptive ef~ect in a patient, the patient may skip up to 4 doses ... within any 28 day daily dosing regimen period. 6 Plaintiffs respond that Defendants distort Dr. Shoupe' s testimony. Plaintiffs contend Dr. Shoupe testified that "administering" refers to delivery of the ~rug to the bloodstream. (D.I. 295 at 4). Defendants, meanwhile, argue that "[n]o crystalline dro pirenone exists in solution or in the blood." (D.I. 296 at 4). 14 ('140 patent at 3:32- 39). The evidence is thus insufficient to onstrue "administering" as anything more than a patient taking a drug. I reject Plaintiffs' proposed construction. 6. "a limited number of days of bleeding events per tr atment cycle in at least one of the subsequent consecutive treatm ent cycles" ('140 batent, claim 33) a. Plaintiffs ' proposed construction: plain and or~inary meaning: wherein the administration results in a limited [small/low] ~umber of bleeding events per treatment cycle in at least one of the subsequent consecutive treatment cycles b. Def endants' proposed construction: fewer day of bleeding events in at least one of the subsequent consecutive treatment cycles as compared to the initial treatment cycle c. Court 's construction: plain and ordinary meani g: wherein the administration results in a limited [small/low] number of blee ing events per treatment cycle in at least one of the subsequent consecutive treatr ent cycles The parties dispute the meaning of "limited" in claim 3 of the '140 patent. 7 Plaintiffs contend that the claim does not require a co parison of one cycle to another. (D.I. 287 at 7). Alternatively, if the claim does require a com arison, Plaintiffs argue the claim contemplates a comparison to any preceding cycle, not to the • itial cycle only. (Id. at 7- 8). Plaintiffs contend, "what is ' limited' is the number of days of r.leeding, as a percentage of 28 days of treatment." (Id. at 8). In the context of the claims, Plaintiffs thus argue that "limited" "simply means small." (Id.). They contend that clinical trial L sults described in the specification show that subsequent cycles are not compared to the initial cycle (see id. (citing '140 patent at 55 :50- 55, 56:52- 63, tbls.9- 10)), because "the rst cycle naturally has irregular bleeding as the patient's body adjusts to the hormone therapy' (id.) . Plaintiffs further argue that 7 I note that Plaintiffs' proposed construction is for a slightly ifferent term, as Defendants do not start with "wherein." 15 certain dependent claims- which do require a comparison bet een the initial cycle and subsequent cycles-support their position.8 (Id.; see also D.I. 295 at 5). 9 Defendants note that the phrase "limited number of da s of bleeding events" only appears in the claims. (D.I. 286 at 7). The specification, though, inclj des the phrase "a number of days of bleeding events." (Id. (citing '140 patent at 32:9- 11)). Bal d on the specification' s use of that phrase, Defendants contend that "limited number of bleed ng days" "must be a term of degree referring to a number of days in a treatment cycle." (Ir . Defendants argue, however, that the specification refers to bleeding days in various ways ithout explaining which of those ways are "limited." 10 (Id.). Defendants contend that the term cannot be definite if it does not provide a standard for measuring whether a particular number of bleeding days is low/small. (Id. at 8). Still, Defendants argue that the claim requires a compar son of bleeding events between the initial treatment cycle and a subsequent cycle. (Id. at 7- 8) I agree with Plaintiffs that claim 33 does not require a omparison of one treatment cycle to another. The clinical trial data disclosed in Tables 9 and 10 of the specification do not support Defendants' argument, as the tables suggest that a comparison to the initial treatment cycle is not required. Claim differentiation principles support Plaintiffs' position as well. Whereas claims 2 8 Claim 33 of the ' 140 patent depends from claim 1. 9 Defendants contend that claim differentiation principles actu lly support their position, as "claims 7-11 specify the amount of reduction (expressed as a ercentage) from the initial cycle to the subsequent cycle." (D.I. 296 at 5). 10 Defendants contend that the specification mentions bleedin days as an overall percentage of the treatment cycle, as a comparison between overweight wo en and those who are not overweight, and as ranges for reduction in certain treatment c~cles. (D.I. 286 at 7 (citing ' 140 patent at 33:49- 60, 34:26- 33, 35:6- 10)). In their answering letter, Plaintiffs argue that the specification and dependent claims show the number of bleedi g days that satisfy the "limited" requirement. (D.I. 295 at 5). 16 through 6 include the phrase "limited number of days of bleedmg events," claims 7 through 11 include the phrase "number of days of limited bleeding events " 11 (See generally ' l 40 patent at 64 :30- 65 :2). Because claim 1 recites "limited number of day of bleeding events," and that is the same language that appears in claims 2 through 6, but not •n claims 7 through 11 , I think claims 2 through 6 are more pertinent in construing claim 1. Claim 2 states: The method of claim 1, wherein the limited number of days of bleeding events in at least one of the subsequent consecutive treatment cycles of administration does not exceed about 13% per treatment cycle. l (Id. at 64:30- 33). The language in claims 3 through 6 only di fers in the percentage recited. (See id. at 64:34-49). These dependent claims, which appear lo track the results reported in Table 9 of the patent, indicate that the "limited" limitation in claim 1 refers to a small or low number of bleeding events within a particular treatment cycle. Dependent claims 7 through 11 , on the other hand, add a new limitation, requiring a comparisol between the initial treatment I cycle and a subsequent cycle. (Se e id. at 64:50- 65:2). Defen1ants have not shown that the comparison limitation in claims 7 through 11 should apply to independent claim 1 (and, by extension, to dependent claim 33). I thus reject Defendants' proposed construction, and I dopt Plaintiffs' proposed construction. I will not allow an indefiniteness challenge to tJ is claim term, as the issue was not I raised at the Markman stage and does not appear to be the subject of any expert report. IV. CONCLUSION For the reasons stated, I adopt the above constructions. 11 I have my doubts that "number of days of limited bleeding events" makes much sense. 17
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