NOVEN PHARMACEUTICALS v. WATSON LABORATORIES, INC. et al, No. 2:2011cv05997 - Document 155 (D.N.J. 2013)

Court Description: OPINION. Signed by Judge Dennis M. Cavanaugh on 11/26/2013. (nr, )

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NOT FOR PUBLICATION UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY NOVEN PHARMACEUTICALS. INC.. Hon. Dennis M. Cavanaugh Plaintiff, OPINION v. WA I SON LABORM ORIES INC and WATSON PHARMACEUTICALS. INC.. Civil Action No. 1 i-cv-5997 (DMC)(JBC) DeF.ndants. DENNIS M. CAVANAUGH, U.S.D.J,: This matter comes before the Court upon the following Motions: i) the Motion of DeIndants Watson Laboratories. Inc. and Actavis, Inc. (collectively Delndants ) for Summar Judgment of Invalidity of Asserted Claims of US Patent No 6,210,705: ii) Defendants Motion Ihr Partial Summary Judgment of Non-Infrmgement of US Patent No 6,348.211; iii) the Cross Motion of Plaintiff Noven Pharmaceuticals. Inc. ( Plaintiff) for Leave to File Amended Infringement Contentions and For Additional Claim Constructiom and iv) Plaintiffs CrossMotion for Summary Judgment of No Invalidity of the Asserted Claims of U.S. Patent No. 6.210,705. Pursuant to FED. R. Civ. P 78, no oral argument was heard. Based on the following and for the reasons expressed herein, Defendants Motion for Summary Judgment of Invalidity of Asserted Claims of US Patent No 6,210,705 is granted, Defendants Motion for Partial Summary Judgment of Non-Infringement of US Patent No 6,348211 is granted, Plaintiffs Effective January 24, 2013, the entity name of Watson Pharmaceuticals. Inc. was changed to Actavis. Inc. Cross-Motion for Leave to File Amended Infringement Contentions and For Additional Claim Construction is denied, and Plaintiiis Cross Motion for Summary Judgm ent of No Invalidity ol the Asserted Claims of U.S. Patent No. 6.210.705 is denied. I. 2 HACKGROUNI) A. The Patents-in-Suit The instant Motions stem from the following two patents that are lawfully owned by Plaintiff: i) United States Patent No, 6,210,705, entitled Compositions and Methods bor Treatment of Attention Deficit Disorder and Attention DefIcit/Hyperactivity Disord er With Methvlphenidate (the 705 Patent ). and ii) United States Patent No. 6.348. 211. also entitled Compositions and Methods For Treatment of Attention i)eficit [)isorder and Attent ion Deficit/Hyperactivity Disorder With Methylphenidate (the 211 Patent ). Both patents claim. in/er a/ia. compositions and methods for treatment of attention deficit disorder and attention deficit/hyperactivity disorder (collectively ADHD ) with transdermal methyipheni dale delivery systems. 1) The 705 Patent The 705 Patent was duly issued by the United States Patent and Trademark Of/ice ( USPTO ) on April 3, 2001. Claims 1. 16, 18. and 25 of the 705 Patent include a limitat ion that requires that the composition compromise of no more than about 5 vt % of acid functio nal monomers. The claims are as follows: 1. A composition for topical application of methvlphenidate compr ising methylphenidate in a flexible, finite system, wherein the methyiphenidate is presen t in a therapeutically effective amount sufficient to achieve substantially zero order kinetics lbr delivery to the skin or mucosa of a patient in need thereof over a period of Itime] at least 10 hours, and i herein the colnposition COfllJ)1iSCS nO iflOiC thou ((bout .3 wt % of acid functional monomers. The facts from this section are taken from the parties pleadings. 2 16. A method of treating attention deficit disorder and attention deficit/hyperactivit y disorder comprising topically administering methyiphenidate in a flexible, finite system, wherein the methylphenidate is present in a therapeutically effective amount sufficient to achieve substantially zero order kinetics for delivery to the skin or mucosa of a patient in need thereof over a period of time at least 10 hours, and wherein acidfunctional monomers are present in an amount ofno more than aboui Swt%. 18. A composition for topical application of methylphenidate comprising methylphenidate in a flexible, finite system, wherein the methylphenidate is present in an amount sufficient to permit a therapeutically effective dose in a patient over a total duration of 24 hours, wherein the total delivered amount of methylphenidate is from about 0.5 mg to about 100 mg, and wherein acidfunctional monomers are present in an amount ofno more than about 5 wi %. 25. A method oftreating attention deficit disorder and attention deficit/hyperactivity disorder comprising topically administering methylphenidate in a flexible, finite system, wherein the methylphenidate is present in an amount sufficient to permit a therapeutically effective dose in a patient over a total duration of 24 hours, wherein the total delivered amount of methylphenidate is from about 0.5 mg to about 100 mg, and wherein acidfunctional monomers are present in an amount qf no more than about 5 WI %. Additionally, claims 15, 17,24, and 26 include limitations of I wt % of acid functional monomers. The claims containing the 5 wt % limitations and the claims containing the I wt % limitations will be referred to collectively as the 705 Claims. During claim construction proceedings, Plaintiff argued that the wt % limitations compare the weight of acid functional monomers to the total monomer content. After a Markman hearing held on December 6, 2012, this Court adopted Plaintiff s construction for the wt % limitations as follows: Wherein, for the monomers in the flexible, finite system. no more than about 5 wt % are acid functional. Wherein, for the monomers in the flexible, finite system, no more than about 1 wt % are acid functional. (ECF No. 91, Jan. 4, 2013). 3 2) The 211 Patent The 211 Patent was duly issued by the USPTO on iebruarv 19. 2002. Claims 1-2. 0-7. 11 -14, 16-21. and 28 of the 21 1 Patent (the 211 Claims ) recite or incorporate the flllo wing limitation: wherein the proportion of methvlphenidate:silicone adhesive:acrylic adhesive (wt (4) dry) is about 5-30:0-70:0-70, respectively (hereinafter the proportion limitation ). During claim construction proceedings, Plaintiff argued that the term about allows for ranges of 080% or 0-90% acrylic adhesive. However, this Court agreed with Defendants construction and held that the term about onlY allows for the additional margin appropriate for rounding decimals to whole numbers. B. The Watson ANI)A Product The accused product is Abbreviated New Drug Application No. 200147 (the \\atson ANDA Product ), submitted by Defendants on August 3 1. 2009. The Watson ANDA Product is a methylphenidate transdermal system that is indicated for the treatment of A1)l-li). Plaintiff believes that the Watson ANDA Product infringes various claims of the 705 and 211 Patents. C, The Motions On July 8, 2013, Defendants filed a Motion for Summary .ludgment of Invalidity of Asserted Claims of US Patent No 6,210,705 ( Def. s 705 Mot., ECF No. 120) and a Motion for Partial Summary Judgment of Non-Infringement of US Patent No 6,348,211 (ECF No. 121). On August 9, 2013, Plaintiff filed an Opposition to Defendants Motion for Partial Summary Judgment of Non Infringement of US Patent No 6,348,211 and a Cross Motion for I eave to File Amended Infringement Contentions and 1 or Additional Claim Construction (1ECF No. I 2 On August 1 0. 201 3. Plaintiff liled a Cross-Motion for Summary .Tuclginent of \o Inval iditv a! the Asserted Claims of U.S. Patent No. 6,210,705 ( Pl. s 705 Mot.. ECF No. I 34). On August 4 30, 2013. Defendants filed a Combined Reply Brief in Support of their Motion for Partial Summary Judgment of Non-Infringement of US Patent No 6.3482l 1 and Opposition to PlaintifPs Cross Motion br Leave to File Amended Infringement Conten tions and for Additional Claim Construction (ECF No, 139) and a Combined Reply in Support of their Motion h)r Summary Judgment of Invalidity of Asserted Claims of US Patent No 6,2 1 0705 and Opposition to Defendants Cross-Motion for Summary Judgment of No Invalid ity ( Def s 705 Reply. ECF No. 140). [1. STANDARD OF REVIEW Pursuant to Fed. R. Civ. P. 56(c). summary judgment must be granted if the pleadin gs. depositions. answers to interrogatories, and admissions on file, together with the affidav its, if any. show that is no genuine issue as to any material fact and that the moving party is entitle d to a judgment as a matter of law. The moving party hears the initial responsibility of inform ing the district court of the basis for its motion, and identifying those portions of the [the record which it 1 believes demonstrate the absence of a genuine issue of material fact. ç otexCor.vCatr ett, 477 U.S. 317, 323 (1986). A genuine issue of material fact exists only if sufficient eviden ce is presented favoring the nonmoving party for a jury to return a verdict for that party. Anders on v.Liherty Lobby, Inc., 477 U.S. 242, 248 (1986). Thus, to withstand a properly supported motion for summary judgment, the nonmoving party must identify specific facts and affirma tive evidence that contradict those offered by the moving party. Red Roof Franchisinc. LLC v. AA Hospitality Northshore, LLC, 877 F. Supp. 2d 140. 147 (D.N.J. 2012) (citing Anderson. 477 U.S. at 256-57). To do so. [aj party opposing summary judgment must do more than just rest upon mere allegations, general denials, or vague statements. j. (citing anav.1ai1Corp., 260 F.3d 228, 232 (3d Cir. 2001 )). Accordingly, [w]here the record taken as a whole could not lead a rational trier of fact to find for the non moving party, there is no genuine issue thr trial Matsushita Flee, Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). ilL DISCUSSION A. The 705 Patent 1)efendants move for Summary Judgment of invalidity of the 705 Claims. arguing thai. the claims are invalid for lack of adequate written description. Plaintiff opposes Defendani.s Motion and simultaneously moves fbr Summary Judgment of no invalid ity. A claim is invalid if it lacks written description support in the specilication as required by 35 U.S.C. § 112. To comply with this requirement, the specification must describe an invent ion understandable to [the] skilled artisan and show that the inventor actually invent ed the invention claimed. Ariad Pharm.. Inc. v. Eli Lilly & Co.. 598 F,3d 1336, 1351 (Fed. Cir. 2010): see also Carnegie Mellon Univ. v. Hoffmann La Roche Inc., 541 F.3d 1115. 1122 (Fed. Cir. 2008) ( To satisfy the written description requirement, the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claime d. (internal quotations and citation omitted)). Although compliance with this requirement is a question of fact, it is amenable to summary judgment in cases where no reasonable fact tinder could return a verdict for the non-moving party. Boston Scientific Corp. yJoJi oi Johnson, 647 F.3 d 1353. 1361 (Fed. Cir. 2011) (citation omitted). 1) The 5 wt % Limitations Defendants assert that the 705 Claims containing the 5 wt % limitation are invalid . arguing that these claims lack written description support because this Court construed the 5 ut % limitations as referring to the amount of acid functional monomers by the weight oft/ic 6 monomer content, but the 705 Patent specification refers to the amount of acid functional monomers hi wekht 0/ acri lie monomer (Def s 705 Mot. at I ). Thus. Defendants claim that the specification does not convey to a person of ordinary skill in the art that the acrylic adhesive may contain an excess of about 5 wt% acid functional monomers provided that the acid functional monomers [do] not exceed about 5 wt% of the total monomer content of the composition (Id. at 8). Essentially. Defendants argue that the invention claimed is broader than the invention described in the specification. In response, Plaintiff first argues that this Court should rule against Defendants because it already rejected Defendants written description arguments when it adopted Plaintiffs construction of the wt % limitations after the Markman hearing. However, Plaintiff is mistaken in believing that the 705 Claims are necessarily valid simply because this Court adopted Plaintiff s broad interpretation of the vi % limitations during claim construction proceedings. In Liehel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1383 (Fed. Cir, 2007), one of the terms at issue was physical indicia. In claim construction proceedings, the district court agreed with the plaintiff s broad interpretation of the term. Id. at 1376. However, the district court subsequently found that the plaintiffs patent claims were invalid because the limited written description did not sufficiently convey the breadth of the patent. Id. The Federal Circuit affirmed and noted that the plaintiff argued for a broad meaning, and succeeded, but suffers a Pyrrhic victory. at 1383. Thus, this Court will not deny Defendants Motion and grant Plaintiff s solely because it ruled for Plaintiff during claim construction proceedings. Second, Plaintiff points to portions of the 705 Patent specification and argues that they show that the degradation of methyiphenidate is reduced by minimizing acid functional groups, regardless of the source. For example, the specification states that methylphenidate, in 7 particular the base form, can be unstable and undergoes degradation in the presence of acid functional groups which are contained in adhesives. . . and other components of the topical composition and discloses that the degradation of methylphenidate increases with each 1% increase of acid functional component. However, Defendants persuasively argue that although this language describes the effect of reducing acid functional groups in general, it provides no blaze marks that would lead a person of ordinary skill to compositions having no more than 5 wt % acid functional monomers by weight of the total monomer content (Def. s 705 Reply at 9). Third, Plaintiff contends that the 705 Patent specification includes the original claims filed, and that a number of these claims demonstrate ample written description beyond the specific preferred 5 wt % acrylic embodiment (Pl. s 705 Mot. at 9). However, during the prosecution of the 705 Patent, the Examiner rejected these claims as not reasonably provid[ing] enablement for a composition wherein the amounts and proportions are not claimed, leaving a person of ordinary skill unable to obtain the desired flux rate for the desired period of time based on the patent s teachings. Plaintiff acquiesced in the rejection and amended the original claims to include the 5 wt % limitations. Thus, Plaintiff cannot argue that the original claims render the specification sufficient. Fourth, Plaintiff points to the following language in the 705 Patent specification and argues that it shows that aS wt % functional acrylic polymer is only a prqferred embodiment: In view of the foregoing, acrylic polymers that are non-functional, hydroxyl functional, or minimally acidfunctional are preferred. A preferred embodiment for attaining at least 10 hours of substantially zero-order delivery is to include in the composition the polymers described above, such as the acrylics having no or minimalfunctional groups. Plaintiff contends that it is improper to consider only the preferred embodiments in assessing the scope of a patent s written description. This Court finds that nothing in the above quoted 8 language relates to a person of ordinary skill that Plaintiff Possessed other embodiments having an acrylic adhesive with more than 5 wt % acid functional monom ers. Thus, contrary to Plaintiffs assertion, the scope of the 705 Claims cannot be derive d from the teachings of the spec itcation (Id. at 1 3). Fifth, Plaintiff claims that Defendants overbreadth argument defies logic and common sense because nothing in the 705 Patent supports the contention that the degradation of methyiphenidate changes substantially if the same overall level of acid functional monomers came from just one acrylic, instead of comin g from two different acrylics (Id. at 14). Plaintiff argues that Defendants expert, Dr. Walter s. testified that he did not know i fit would make a difference if the overall acid functional monomer level was the preferred 5 wt % or less, hut one of more of the acrylic components was above the 5 wt % criterion. However, at issue is what Plaintiffs specification disclos ed, and Dr. Walters concluded that a person of ordinary skill would not understand that the inventors possessed the full breadth of the invention covered by the 5 wt % limitation. ge 1CLJ Med., iicx.J Mc4Sy1Lnc, 558 F.3d 1368, 1377-78 (Fed. Cir. 2009) (affirming a finding of invalidity when the patent specification only included valves with spikes but the claims covered valves both with and without spikes). This Court finds that this conclu sion is sound for the reasons discussed above. Further, this Court agrees that the testimony ol Dr. Enseore. Plaintifrs expert, is suspect, as Dr. Enscore admitted at his deposition that his opinions were based on inserting the word acrylic into the Court s claim construction a word that is completely absent from the construction that the court upheld after the Markman hearing. Finally, this Court finds that it is telling that not a single one of the twenty nine examples 9 in the 705 Patent specification include an acrylic adhesive having more than 5 wt % acid functional monomers by weight of the acrylic polymer. Although Plaintilf correctly asserts that it is not required that the patent specification disclose every example that falls within the claims. the lack of any example including an acrylic adhesive having more than 5 wt % acid functional monomers by weight of the acrylic polymer weighs against Plaintiffs constant argument that 705 Patents general teachings show that such a composition is included. Thus. this Court finds that Defendants have adequately shown that the 705 Claims are broader than the disclosure in the specification Accordingly, Defendants Motion for Summary Judgment is granted and Plaintiff s Cross-Motion for Summary Judgment is denied. 2) The 1 wt % Limitations In its Motion for Summary Judgment. Defendants assert that [cllaims 1 5. 1 7. 24 and 20 of the 705 patent, which contain the 1 wt % limitations, fail to satisfy the written description requirement for the same reasons as the claims containing the 5 wt % limitations (I)ef. s 705 Mot. at 1 9). Defendants do not elaborate on this argument because Drs. \Valters and Enscore are in agreement that the analysis for the 5 wt % limitations applies equally to the I wt % limitations (Id.). In its Cross-Motion and Opposition, Plaintiff claims that Defendants Motion should be denied because it did not address the 1 wt % limitations and states that [Defendants overbreadth concerns do not apply to the I wt % limitations (Pl, s 705 Mot. at 22-23). Plaintiff cannot argue that a different analysis applies to the I vt % limitations alter consistentk agreeing that the analysis for the I wt % limitations the 5 wt % limitations. (See Lydisgen Dec., Ex. 7 ¶ is the same as the analysis for 135 ( The same analysis applies to Dr. Walters assertions concerning the 1 wt % limitation. ); 2nd Lydisgen Dec., Ex 18 at 153 ( The 10 claims containing the 1 wt % acid functional monomer limitations have adequate support for the same reasons as discussed, supra. for the 5 wt % acid functional monomer limitations. )), Accordingly. this Court rules in favor of Defendants with respect to the claims containing the 1 wt % limitations for the same reasons as discussed for the claims containing the 5 wt limitations. B. The 211 Patent Defendants seek partial Summary Judgment of non-infringement of the 2l I Claims, arguing that the Watson ANDA Product does not literally infringe these claims. Plainti I ! Cross- Moves for leave to file amended infringement contentions and for additional claim construction. 1) Non-Infringement A determination of patent infringement involves two steps. The first step is determining the meaning and scope of the patent claims asserted to be infringed. The second step is comparing the properly construed claims to the device accused of infringing. Markman v. 52 F.3d 967, 976 (Fed. Cir. 1995). A patentee must present proof that the accused product meets each and every claim limitation. Lorest_L..1igbb Labs., 239 F.3d 1305, 13 1 0 (Fed Cir. 2001). If even one limitation is missing in the accused product, there is no literal infringement. See Dolly, Inc. v. Spaulding & E mflo Cos,. 1 6 l.3d 394, 397 (Fed. Cir. 1994); Kraft Foods, Inc. v. Int l Trading Co., 203 F.3d 1362, 1370 (Fed. Cii . 2000). Therefore, the second step may be decided on summary judgment when no reasonable jury could find that every limitation recited in the properly construed claim either is or is not found in the accused device. Bai v. L & L Wings, Inc., 160 F.3d 1350. 1353 (Fed. Cir. 1998). Defendants assert that the Watson ANDA Product does not infringe the 2 ii Claims because all dosage strengths of the Watson ANDA Product include methvlphenidate:silicone 11 adhesive:acrylic adhesive (wt % dry) in the following proportion: 21:0:7 9. Thus, Defendants argue that because this Court found that the term about in the propor tion limitation only allows for the rounding of decimals to whole numbers, the 79% acrylic adhesi ve present in the Watson ANDA product does not literally fall within the 0-70 claimed range for the acrylic adhesive required by the proportion limitation. Plaintiff; however, contends that the temis proportion and ratio refer to the total weight of the composition (which includes compo nents other than methylphenidate, silicone adhesive, and acrylic adhesive). Therefore, accord ing to Plaintiff, because the Watson ANDA Product contains 18.3 % methylphenidate and 68.7 % acrylic adhesive, it literally infringes the 211 Claims. This Court finds no support for the proposition that the terms proportion and ratio refer to the entire composition rather than to the dry weight of the three compo nents. Plaintiffs expert even admitted that Watson s ANDA Products contain a slightly differe nt ratio of methylphenidate:silicone adhesive:acrylic adhesive (wt % dry) [than the propor tion limitation], namely the ratio of 2l%:0%:79%, and went on to assert that the use of 79% acrylic adhesive in the Watson ANDA Product is nonetheless equivalent to the proportion limitat ion under the doctrine of equivalents (Pe Decl., Ex. 10 ¶ 115-117). As discussed below, the doctrine of equivalents arises when a claim element is not literally present in the accuse d product. Further. the language used by Plaintiff throughout this action shows that Plaintiff unders tood that proportion refers to the ratio of the three components based on their combin ed dry weight, not the weight of the entire composition. For example, in its Amended Infringement Contentions. Plaintiff asserts that Watson s ANDA Products contain methylphenidate:sili cone adhesive:acrylic adhesive (wt % dry) in the ratio of 21%:0%:79% (Lydis gen Dec., Ex. 5) (emphasis added). 12 This Court finds no need to conduct additional claim construction regarding the word proportion, Plaintiff was free to raise this issue during claim construction proceedings. it seems that Plaintiff is attempting to find an alternative way to show literal infringement after its interpretation of the word about was denied. Additionally, this Court finds that Plaintiff has not been diligent in seeking to amend its infringement contentions. as it has known of the composition of the Watson ANDA Product since November 4, 2011, the date that Defendant produced its i-\NDA to Plaintiff. Further, allowing Plaintiff to amend its infringement contentions would prejudice Defendants, as T)efendants have already gone through the claim construction process, engaged in expert discovery, and filed a motion for summary judgment in reliance upon the interpretation of the word proportion that has been used by both parties. Accordingly, Plaintifis Cross Motion for Leave to File Amended Infringement Contentions and for Additional Claim Construction is denied. 2) The Doctrine of Equivalents The doctrine of equivalents allows a plaintiff to establish, in certain instances, that a claim element, though not literally present, is nevertheless met by demonstrating that the missing element has been replaced by a structure that performs the same function in the same wa to achieve the same result as the claim element in the patented device. gg Warner Jenkinson Co. v Hilton Dais Chem (.o 520 U S 17 35 (1997) lhc doctnne of equivalents howcver is an equitable tool that is applicable only when the changes rin the accused product] are so insubstantial as to result in a fraud on the patent. Slimfold Ml. Co. v. Kinkead Indus.. Inc.. 932 F.2d 1453, 1457 (Fed. Cir. 1991). The doctrine of equivalents has limitations. When a patentee originally claimed the subject matter alleged to infringe but then narrowed the claim in 13 response to a rejection, he may IlOt argue that the surrendered territory comprised unforeseen subject iattei thai should he deemed equivalent to the literal claims ofthe issued patent. Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 733-34 (2002). A narrow ing amendment that is made to comply with any requirement of the Patent Act can evoke estoppel. at 736. For example. if a § 112 amendment is necessary and narrows the patent s scope even if only for the purpose of - better description estoppel may apply. Id. at 737. However, the Suprem e Court also held that there are three exceptions to this rule: II] The equivalent [was] unforeseeable at the time of the application; [21 the rationale underlying the amendment bear[s] no more than a tangential relation to the equivalent in question; or [3] there [is] some other reason that the patentee could not reasonably be expected to have described the insubstantial substit ute in question. . . . . . . ld at 740-41. Defendants assert that Plaintiff is barred from relying on the doctrine of equiva lents because during the prosecution of the 211 Patent, Plaintiff added the proportion limitation by amendment in order to overcome enablement rejection. Plaintiff however, conten 3 ds that the second Festo exception applies because the Examiner s rejection related to the methylphenidate range, not the acrylic range. and thus the 79 wt % acrylic in the Watson L\NDL\ Product is only tangential to the narrowing amendment. To support this argument. Plaintiff points to the lhct that it argued only as to the proportion of methylphenidate in response to the Examiner s rejection. However, the Examiner s rejection stated that the claims of the 211 Patent were insufficient because, among other things, the claims are silent with regard to the composition of the flexible finite system and [t]he amounts and/or propoi tions and the carrier 4 are both svstem Defendants also claim that Plaintiff is barred from relying on the doctrine of equiva lents based on the disclosure dedication doctrine, Because this court finds that Plaintiff is barred from relying on the doctrine of equivalents due to prosecution history estoppel, it need not address the disclosure dedication doctrine. It is clear from the language of the 211 Patent that an adhesive is a preferred type of carrier (ç Lydisgen Dec., 14 critical to the invention (Lydisgen Dec.. Ex. 7). Further, Defendants correctly argue that the fact that the Examiner s rejection called for the recitation of proportions shows that the rejection pertained not only to methylphenidate hut to other components as well. Finally, Plaintiff s amendment defined not only the amount of methvlphenidate. but the relativ e quantity of silicone and acrylic adhesive. This weighs against Plaintiff s argument that the 79 xvt % acrylic in the Watson ANDA Product is only tangential to the narrowing amendment. See Felix v. Am. Honda Motor Co., Inc., 562 F.3d 1167, 1184 (Fed. Cir, 2009) ( [T]he inquiry into whether a patentee can rebut the Festo presumption under the tangential criterion focuses on the patentees objectively apparent reason for the narrowing amendment[, which must bel discernible from the prosecution history record (citation omitted)). Therefore, this Court finds that Plaintiff is barred from relying on the doctrine of equivalents. Accordingly. Defendants Motion for Summary Judgment of non-infringement of the 2 11 Patent is granted. IV. CONCLUSION For the foregoing reasons Defendants Motion for Summary Judgment of invalid ity of Asserted Claims of US Patent No 6,210,705 is granted, Defendants Motion for Partial Summary Judgment of Non infringement of US Patent No 6.348211 is granted. Plainti ff s Cross Iviotion for Leave to File Amended Infringement Contentions and For Additi onal Claim Construction is denied, and Plaintiffs Cross-Motion for Summary Judgment of No Invalidity of the Claims of U.S. Patent No. 6,210,705 is denied. An appropriate or follows this Opinion. Dennis M. Cavanaugh. U.S.l .1. Date: Original: cc: NovembcrC. 2013 Clerks Office I-Ion. James B. Clark U.S.M.J, All Counsel of Record File Ex. 6) ( in a preferred embodiment, the carrier comprises an adhesive. ). 15

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