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Public Patent Foundation, Inc v. Glaxosmithkline Healthcare

August 10, 2011

PUBLIC PATENT FOUNDATION, INC., PLAINTIFF,
v.
GLAXOSMITHKLINE HEALTHCARE, L.P., DEFENDANT.



I. Background

FINDINGS OF FACT AND CONSUMER CONCLUSIONS OF LAW

On June 26, 2009, Public Patent Foundation, Inc., a not-for-profit corporation affiliated with Benjamin N. Cardozo School of Law ("Plaintiff"), filed a qui tam complaint against GlaxoSmithKline Consumer Healthcare, L.P. ("Defendant" or "GSK"), alleging that Defendant had violated the False Marking Statute, 35 U.S.C. § 292, since January 2005 "by marking certain [of its] products with [the] patent numbers of expired patents." (Compl., dated June 26, 2009, ¶ 2; Am. Compl., dated Oct. 15, 2010 ("Amended Complaint"), ¶ 2.) Specifically, Plaintiff claims that Defendant improperly labeled two Citrucel brand fiber therapy products with patent numbers 4,626,287 ("287 Patent") and 4,671,823 ("823 Patent," and collectively, "Patents") after the Patents had expired on January 29, 2005, "for the purpose of deceiving the public into believing that [the Citrucel products were still] covered by . . . the . . . [P]atents." (Am. Compl. ¶¶ 2, 13--18, 37--38; see, e.g., Pls. Exs. 71, 77.)*fn1

"In the fall of 2009, after receiving notice of [this] lawsuit, GSK removed the 287 and 823 [P]atent markings from its Citrucel consumer products." (Jt. Pre-Trial Order, dated May 6, 2011 ("JPTO"), § VI.E ("Stipulated Facts").) Since the filing of this lawsuit, GSK has also "implemented a procedure to identify expired patents and remove them from GSK products after expiration." (Aff. of Theodore Furman, dated May 20, 2011 ("Furman Aff."), ¶ 12.)*fn2

On April 5, 2011, Defendant answered the Amended Complaint. Defendant acknowledges that, "for a period of time" after the Patents' expiration on January 29, 2005, Citrucel products "included labeling . . . listing [the Patents]." (Answer, dated Apr. 5, 2011 ("Answer"), ¶¶ 14--17.) Defendant denies that GSK marked the labels with expired Patents either with knowledge that the Patents had expired or for the purpose of deceiving the public in violation of § 292. (Answer at 17 ("Neither GSK nor any agent or employee of GSK possessed the requisite knowledge or intent required to have marked any products, product packaging, or product literature with the [P]atents . . . so as to violate 35 U.S.C. § 292.").)

In preparation for a bench trial (which was held on June 6, 2011), the parties submitted to the Court a joint pre-trial order, trial exhibits, motions in limine, and accompanying memoranda of law. (See JPTO; Pl. Exs. 1--101; Def. Exs. 1--56; Def. Mots. in Limine, dated May 6, 2011; Def. Mem. of Law and Summ. J. Issues, dated May 6, 2011 ("Def. Mem."); Pl. Mem. of Law in Opp'n to Def. Mots., dated May 20, 2011 ("Pl. Mem.")).*fn3 On May 23, 2011, Plaintiff submitted deposition designations in lieu of any direct testimony of four witnesses: Theodore Furman ("Furman"), the head of consumer products patent attorneys at GSK; Dara Dinner ("Dinner"), also a patent attorney at GSK who was supervised by Furman; Andrea Burke ("Burke"), also a patent attorney at GSK; and Michael McCormick ("McCormick"), the director of marketing for GSK's "Advantage Brands," a product line which includes Citrucel. Plaintiff also submitted an affidavit, dated May 20, 2011, in lieu of direct testimony of Plaintiff's proposed expert witness, David Garrod, Ph.D. ("Garrod"), who has also served as one of Plaintiff's own trial attorneys since this case was filed. According to Plaintiff, "[t]he central thrust of Dr. Garrod's testimony goes right" to the "key issue in this case," i.e., "whether GSK knew that its falsely marked [P]atents were expired." (Pl. Mem. of Law in Opp'n to Def. Mot. to Exclude Garrod, dated May 20, 2011, at 2, 4.)

On May 20, 2011, Defendant submitted affidavits in lieu of direct testimony of four witnesses: Furman, Dinner, McCormick, and Linda Schneider ("Schneider"), an attorney at GSK who does not do patent work. On May 31, 2011, Defendant submitted counter-designated deposition testimony of Burke. Defendant also submitted memoranda, dated May 6, 2011 and May 31, 2011, respectively, opposing Garrod's proposed expert testimony on the grounds that, among other reasons, "a lawyer should not testify as an expert witness about the very matters he helped develop as a lawyer-advocate." (Def. Reply Mem. of Law in Supp. of Mot. to Exclude Garrod's Testimony, dated May 31, 2011, at 6--7 ("[Garrod] has co-authored the [c]omplaint[s], actively taken discovery, participated in designating direct deposition testimony, authored his own testimony, and prepared pre-trial and trial argument.").) Defendant also argued that Plaintiff "ha[d] failed to provide . . . Dr. Garrod's qualifications," and that Garrod's "proposed testimony . . . merely recite[d] factual and legal conclusions," consisted of "speculation," and was not drawn from "reliable expert methodology." (Def. Mem. of Law in Supp. of Mot. to Exclude Garrod's Testimony, dated May 6, 2011, at 3, 4, 6.)

At the trial, the Court had an excellent opportunity to observe witness demeanor and assess witness credibility during the cross examination and re-direct examination of Furman, Dinner, McCormick, and Schneider (all of whom the Court found to be credible).

Garrod's Proposed Expert Testimony

Before the trial began on June 6, 2011, the Court excluded Garrod's affidavit in lieu of direct testimony for several reasons: First, Garrod's testimony could "hardly be considered independent of his client's due to his role as attorney of record in [this] action" which included taking the depositions of at least two of Plaintiff's four witnesses. (Tr. of Pre-trial Conf., dated May 31, 2011, at 4:15-17); see Ziggity Sys., Inc. v. Val Watering Sys., 769 F. Supp. 752, 807 (E.D. Pa. 1990) ("[An attorney with] a direct interest in the . . . case . . . lacks credibility from that deficiency only."); Lippe v. Bairnco Corp., 288 B.R. 678, 688 (S.D.N.Y. 2003). Second, in his proposed testimony, Garrod "improperly . . . assume[d] the role of advocate[] for . . . [P]laintiff's case by arguing as to the intent or motives underlying the conduct of . . . Defendant." (Trial Tr., dated June 6, 2011 ("Tr."), at 3:24--4:1; see, e.g., Garrod's Decl., dated May 20, 2011 ("Garrod Decl."), ¶ 22 (where Garrod concludes that "the evidence clearly demonstrates GSK's awareness of its obligation to cease using the numbers of expired patents.")); Highland Capital Mgmt., L.P. v. Schneider, 379 F. Supp. 2d 461, 469--70 (S.D.N.Y. 2005). Garrod's affidavit was also "largely speculative or conjectural." (Tr. at 5:1-2; see, e.g., Garrod Decl. ¶ 30 ("GSK had plenty of in-house patent talent that knew, or should have known, better.")); Taylor v. Evans, No. 94 Civ. 8425, 1997 WL 154010, at *2 (S.D.N.Y. Apr. 1, 1997) ("[M]usings as to Defendant's motivations . . . would not be admissible if given by any witness-lay or expert."). And, it included "impermissible legal conclusions." (Tr. at 5:23-24; see, e.g., Garrod Decl. ¶ 23 ("An[] objective indication of GSK's deceitful intent is its extensive use of the false labeling 'Citrucel is different: Citrucel is protected by patents.'")); In re IPO Sec. Litig., 174 F. Supp. 2d 61, 64 (S.D.N.Y. 2001) ("[W]hile an expert may provide an opinion to help a jury or a judge understand a particular fact, he may not give testimony stating ultimate legal conclusions based on those facts."); (see also Tr. at 2--7 for a complete record of the Court's reasons for excluding Garrod's testimony.)

Immediately after the Court's ruling excluding Garrod's testimony, Defendant stated its intention to "make a motion for judgment as a matter of law" pursuant to Federal Rule of Civil Procedure 52(c).*fn4 (Tr. at 8:20--9:1 (DEF. COUNSEL: "[W]e feel that at an appropriate time we should make a motion for judgment as a matter of law, but . . . with the Court's permission we'll make that motion at the conclusion of all evidence." COURT: "All right.").)

On June 13, 2011, Plaintiff submitted post-trial proposed findings of fact and conclusions of law without expressly addressing Defendant's proposed Rule 52(c) motion. (See Pl. Proposed Findings of Fact and Conclusions of Law, dated June 13, 2011 ("Pl. Findings").) On June 20, 2011, Defendant submitted post-trial proposed findings of fact and conclusions of law, along with a memorandum supporting its motion for judgment as a matter of law. (See Def. Proposed Findings of Fact and Conclusions of Law, dated June 20, 2011 ("Def. Findings"); Def. Mem. of Law in Supp. of Proposed Findings, dated June 20, 2011 ("Def. Mem. II").)

In support of its Rule 52(c) motion, Defendant argues that Plaintiff has failed to meet its burden of establishing false marking under § 292. While acknowledging that Citrucel labels were marked with expired Patents, GSK contends (persuasively) that Plaintiff "did not adduce evidence that any GSK employee had actual knowledge that Citrucel products were marked with expired Patents." (Def. Mem. II at 13, 17.); see S.F. Tech., Inc. v. Hi-Tech Pharmacal Co., 10 Civ. 3630, 2011 WL 477729, at *3 (E.D.N.Y. Feb. 4, 2011) ("[A §] 292 plaintiff [is required] to establish that there was misrepresentation, and to prove that the defendant knew that the marking was false." (citing Clontech Labs., Inc. v. Invitrogen Corp., 406 F.3d 1347 (Fed. Cir. 2005))); Solo Cup, 608 F.3d at 1362. "Neither Mr. Furman, Ms. Dinner, nor Ms. Burke recall knowing the expiration date of the 287 and 823 [P]atents at any point in time." (Def. Mem. at 11--12.) "Mr. McCormick did not know that the [P]atents included on the Citrucel [labels] were expired." (Def. Mem. at 14.) In sum, Plaintiff lacks any evidence that any GSK employee knew that the markings at issue were false. (See Def. Mem. at 1.) Accordingly, Plaintiff "lacks any evidence that any GSK employee possessed an affirmative intent to deceive the public." (Def. Mem. at 1.)

Plaintiff counters that "[t]here is substantial evidence in this case that shows Defendant either had knowledge of the falsity of its marks or, at minimum, did not have a reasonable belief that its Citrucel articles were properly marked." (Pl. Findings ¶ 54.)

For the reasons set forth below, Defendant's motion for judgment as a matter of law is granted. And, assuming arguendo that Plaintiff had established Defendant's "knowledge of falsity," Clontech, 406 F.3d at 1352, the evidence adduced at trial showed that GSK did not mark Citrucel labels with expired Patents "for the purpose of deceiving the public," 35 U.S.C. § 292(a).

II. Legal Standard

"Rule 52(c) provides in pertinent part that '[i]f during a trial without a jury a party has been fully heard on an issue and the court finds against the party on that issue, the court may enter judgment as a matter of law against that party with respect to a claim . . . that cannot under the controlling law be maintained . . . without a favorable finding on that issue . . . ." MacDraw, Inc. v. CIT Grp. Equip. Fin., Inc., 157 F.3d 956, 959 n.2 (2d Cir. 1998) (quoting Fed. R. Civ. P. 52(c)); see Conopco, Inc. v. Campbell Soup Co., 95 F.3d 187, 194 (2d Cir. 1996). Rule 52(c) "authorize[s] a dismissal at the close of the plaintiff's case if the plaintiff ha[s] failed to carry an essential burden of proof." LaMarca v. United States, 31 F. Supp. 2d 110, 123 (E.D.N.Y. 1998); see Wechsler v. Hunt Health Sys. Ltd., 330 F. Supp. 2d 383, 433 (S.D.N.Y. 2004).

To meet its burden under § 292, a plaintiff must show "the fact of misrepresentation coupled with proof that the party making it had knowledge of its falsity." Clontech, 406 F.3d at 1352; see Presidio Components, Inc. v. Am. Technical Ceramics Corp., 723 F. Supp. 2d 1284, 1332 (S.D. Cal. 2010). Accordingly, "[w]ithout evidence that [the defendant] knowingly marked its [products] with expired patents," a plaintiff's claim for false marking under § 292 must fail. Timex, 2011 WL 1399806, at *10.

III. Analysis

(1) Defendant's Rule 52(c) Motion

Plaintiff's evidence -- consisting principally of the deposition testimony of Furman, Dinner, Burke, and McCormick, and Citrucel product label exhibits (see Ex. A) -- does not establish false marking under § 292. See, e.g., Timex, 2011 WL 1399806, at *10. While it is undisputed, under Solo Cup, 608 F.3d at 1362, that Plaintiff has shown "false marking" because the Patents appeared on Citrucel labels after their expiration in January 2005 (see Answer ¶¶ 14--17), Plaintiff has failed to show "knowledge" by Defendant that the Patents appearing on its labels had, in fact, expired, Solo Cup, 608 F.3d at 1362; see Timex, 2011 WL 1399806, at *10; In re BP Lubricants USA Inc., 637 F.3d 1307, 1312 (Fed. Cir. 2011).

First, Plaintiff's (own) evidence demonstrates that GSK's attorneys did not review Citrucel product labels and were not aware that such labels were marked with expired patents between 2005 and 2009. (See Dep. Tr. of Dinner, dated Feb. 18, 2011 ("Dinner Dep."), at 76:1-4 (DINNER: "I did not . . . have anything to do with the [Citrucel label] review process."), 114:7-25 (PL. COUNSEL: "So it's fair to say . . . that you had nothing to do with the continued marketing of Citrucel products with the 823 and 287 patent numbers after the expiration of the products?" DINNER: "I did not review the labels."); Dep. Tr. of Furman, dated Feb. 3, 2011 ("Furman Dep."), at 16:13--20:20 (FURMAN: "I didn't have any direct responsibility for Citrucel." . . . PL. COUNSEL: "[T]o your knowledge Ms. Dinner was never asked to review a single Citrucel label from 2002 until the filing of this lawsuit?" FURMAN: "Not that I'm aware of."), 75:9-15 (PL. COUNSEL: "So you're not aware of any efforts, if any, by GSK to promote bulk Citrucel products as patented?" FURMAN: "That's correct." PL. COUNSEL: "Or any effort to describe bulk Citrucel products as protected by patents?" FURMAN: "I'm not aware of that."); Dep. Tr. of Burke, dated Mar. 21, 2011 ("Burke Dep."), at 140:3-8 (BURKE: "I don't really remember the particulars of [any Citrucel labeling issues].").) Indeed, Plaintiff concedes that "every label" created between 2005 to 2009 was "created without consult[ing] a competent patent attorney." (Pl. Mem. at 5); see Timex, 2011 WL 1399806, at *10 (where plaintiff offered no evidence that defendant's attorneys were aware that defendant's promotional materials featured expired patent numbers); Heathcote, 2011 WL 874148, at *2.

Plaintiff's only other witness, McCormick, also demonstrated a lack of knowledge of the patent contents of the Citrucel labels, testifying at trial that "I don't believe we ever touted our products as patented." (Tr. at 117:17.) He also said credibly that "I wasn't one of the parties" that placed patent-related messaging on Citrucel labels. (Tr. at 117:18--118:9 (PL. COUNSEL: "Why did [GSK] use the phrase 'Citrucel is different. Citrucel is protected by patents'?" COURT: "If you know." McCORMICK: "I do not know." PL. COUNSEL: "That's all I have, your Honor.").) And, there is no evidence that McCormick, a marketing director at GSK, had any training in patent law or ever sought counsel's advice about what GSK could or could not include on Citrucel packaging. (See Dep. Tr. of McCormick, dated Mar. 9, 2011 ("McCormick Dep."), at 51:3-17 (PL. COUNSEL: "Do you know who sits on the [product packaging] copy review committee?" McCORMICK: "I do not." . . . PL. COUNSEL: "What awareness do you have of the process [used to authorize marketing content]?" MCCORMICK: "None."), 65:3-5 (McCormick was not responsible for "legal compliance of the selling points [on Citrucel labels]."); Timex, 2011 WL 1399806, at *8.*fn5

Plainly, none of Plaintiff's witnesses focused on the substance of the Citrucel products' patent markings. See Heathcote, 2011 WL 874148, at *2 ("[Where a] defendant's attorneys were involved in the [initial] assignment of . . . intellectual property [to the defendant's products but] . . . did not review . . . [the products' subsequent] packaging," and where the employees who did review product packaging did not "seek counsel's advice on what [they] could or could not include on such packaging," it cannot be said that anyone employed by defendant was aware that defendant's packaging was marked with expired or inapplicable patents.).

Second, even if Plaintiff's witnesses had known between 2005 and 2009 that the Patents appeared on Citrucel labels -- which Plaintiff has not established -- Plaintiff still fails to meet its burden under § 292 because Plaintiff's case is devoid of evidence that any GSK employee was aware that the Patents had expired on January 29, 2005. In 2000 (five years before the Patents expired), Dinner determined that Citrucel was covered by the 287 and 823 Patents and that, at that time, it was appropriate to mark Citrucel products with the Patents. (See Dinner Dep. at 70:19-23, 75:5--76:15.) But, Plaintiff adduced no evidence that Dinner determined the Patents' eventual expiration date during her 2000 review or that, assuming she did have such knowledge in 2000, "years later at the actual time of expiration, [Dinner] retained the specific knowledge of those [Patents'] expiration dates." (Def. Mem. at 1; see Tr. at 113:5-6 (DINNER: "[In 2000, w]e were [only] looking into whether or not [the] [P]atents would in fact cover [Citrucel] products.").) Dinner was never asked to review, nor did she review, the Patents' placement on Citrucel labels at any time after 2000. (See Def. Mem. at 1; Dinner Dep. at 70:6--71:19.)

Likewise, Plaintiff presents no evidence that Furman (who began working at GSK in 2002), or Burke (a patent attorney who does not regularly handle issues related to Citrucel), or McCormick (a marketing director) had any knowledge whatsoever of the Patents' expiration date(s). (See Furman Dep. at 16:13-21 (FURMAN: "[Citrucel] was handled by . . . Dinner." PL. COUNSEL: "Okay. And so to the extent you dealt with Citrucel, it would have been through reports coming up from Ms. Dinner?" FURMAN: "Correct."), 67:2--68:25 (PL. COUNSEL: "So you're not aware of any instance when [general in-house attorneys] would have asked [whether] it [was] still appropriate to [have] these [P]atent numbers on [the Citrucel products]?" FURMAN: "No."); Burke Dep. at 152:7 (BURKE: "I have no idea [why language may have been changed on Citrucel labels in 2005 and 2006]."); McCormick Dep. at 51:13-14 (McCORMICK: "[I am n]ot specifically aware of what the . . . [patent review] process is.")); see Timex, 2011 WL 1399806, at *10.

In sum, Plaintiff's evidence does not show that a single person in Defendant's employ knew that Citrucel products contained false (i.e., expired patent) markings between 2005 and 2009. (See Pl. Exs. 57, 58, 59, 62, 70, 71, 73, 75, 76); Heathcote, 2011 WL 874148, at *4.

Finally, Plaintiff argues that GSK "did not have a reasonable basis to believe [the Citrucel labels] were true, and thus knowledge of falsity . . . is established." (Pl. Mem. at 5 (citing Clontech, 406 F.3d at 1352).) In fact, Defendant's employees did have a reasonable basis to believe its labels were "properly marked (i.e., covered by a patent)," Clontech, 406 F.3d at 1352--53, based upon Dinner's legal determination in 2000 that Citrucel was covered by the 287 and 823 Patents. (See Dinner Dep. at 70:19-23, 75:5--76:15.) It was not until June 10, 2010 that the Federal Circuit first established in Solo Cup that products "marked with expired patent numbers are falsely marked" for purposes of § 292. Solo Cup, 608 F.3d at 1362. As Furman credibly testified at trial, "[i]t was not [o]n [GSK's] radar screen to track patents as far as their expiration because [based on] our reading of [§ 292] at that time we did not see it as an obligation or requirement to remove patents that had been properly affixed in the first place." (Tr. at 14:11-15). Defendant contends that "[i]t strains credulity to argue that [Defendant] could be aware of the 'falsity' of marking with an expired patent when the law had not yet been announced." (Def. Mem. II at 14; see Tr. at 14:9-11 (FURMAN: "Our policy regarding false marking and marking in general was a rigorous adherence to making sure we put the right patent numbers on the right products."); Dinner Dep. at 73:8-19 (DINNER: "I do not believe we had a policy in place for removal of patent numbers from a label upon [a] patent expiring.")); see Clontech, 406 F.3d at 1355 ("[T]he standard is whether . . . [defendant] did not have an honest good faith belief in marking its products.").*fn6

To the extent that Plaintiff attempts to replace Clontech's knowledge standard with a negligence standard, such effort fails. See Mikityanskiy v. Podee, Inc., No. 10 Civ. 6410, 2011 WL 2038773, at *2 (S.D.N.Y. May 24, 2011). Section 292 requires a showing that a defendant "engaged in more than negligent action." Id. (quoting BP Lubricants, 637 F.3d at 1311). Plaintiff failed to present proof that GSK "knowingly" marked Citrucel with the expired Patents. See supra pages 8--11. It would not have been sufficient for Plaintiff to show, assuming arguendo that it had done so, that GSK had "unreasonably" or "negligently" mismarked its labels. Timex, 2011 WL 1399806 at *10; id. at *8 (Section 292 "requires more than carelessness.") (citing Heathcote, 2011 WL 874148 at *4). Plaintiff has also failed to meet its burden of proving that GSK "did not have an honest good faith belief in marking its products."*fn7

Clontech, 406 F.3d at 1355; see Presidio, 723 F. Supp. 2d at 1332 ("Notably, and fatal to [plaintiff's claim], [defendant does] not have to show anything, much less that it did have a 'reasonable belief,' unless [plaintiff] first me[ets] its burden" of "demonstrating 'lack of reasonable belief.'" (emphases in original)).

(2) Evidence Presented at Trial: Post-Trial Findings of Fact & Conclusions of Law Assuming, arguendo, that Plaintiff had established Defendant's knowledge of the falsity of its Citrucel markings (and survived Defendant's Rule 52(c) motion), the Court would conclude by a (clear) preponderance of the evidence that Defendant did not mark Citrucel labels for the "purpose of deceiving the public." 35 U.S.C. § 292; see Solo Cup, 608 F.3d at 1363.*fn8

Findings of Fact

1. Furman, Dinner, Schneider, and McCormick, the four witnesses who testified at the trial on June 6, 2011, each offered credible testimony.

2. GSK does not own the 287 or 823 Patents. (See Aff. of Dinner, dated May 20, 2011 ("Dinner Aff."), ¶ 7; Def. Findings ¶ 7.) GSK holds a license to the Patents, which it received as part of a technology sharing agreement entered into in 1998 with Marion Merrell Dow, now Aventis. (Dinner Aff. ¶¶ 7--8; Def. Findings ¶ 7.)

3. As the licensee of the Patents, GSK was not at any time responsible for "docketing, tracking deadlines, or paying maintenance fees" on the Patents. (Dinner Aff. ¶ 11; Def. Findings ¶ 7.)

4. The 287 and 823 Patents expired on January 29, 2005. (See JPTO § VI.C.)

5. Before GSK placed a patent number on a product label for the first time, GSK's patent attorneys (often in conjunction with outside counsel) conducted "a very careful" review of both the patent and the product. (Tr. at 34:25--35:7.) This process involved an examination of "the formulation of the product" "to ensure that the patent cover[ed] the product," and "an analysis of the product under a literal infringement test, doctrine of equivalent tests, and any other applicable law."*fn9 (Tr. at 34:25--35:1-4; Def. Findings ¶ 15; Tr. at 34:25--35:4.)

6. The Citrucel products were first marked with the Patents in 2000 after Dinner's determination, with the assistance of outside counsel, that the Patents applied to (i.e., covered) the Citrucel products. (See Dinner Aff. ¶¶ 12--14; Def. Findings ¶ 22; Pl. Findings ¶ 5.) GSK followed the careful practice described in ¶ 5 above in connection with its initial marking of the Citrucel products in 2000. (See Dinner Aff. ¶¶ 12--14; Tr. at 89:19--90:4, 101:16-17; Def. Findings ¶ 16.) After making this (patent coverage) determination, Dinner "advised the [Citrucel] brand managers to include the 287 and 823 [P]atents on the Citrucel products." (See Dinner Aff. ¶ 15; Def. Findings ¶ 24; Pl. Findings ¶ 5.)

7. "The decision to mark the Citrucel products was made to preserve GSK's right to pursue past damages against . . . [alleged] infringers" of the 287 and 823 Patents, including Accumed, against whom GSK brought an infringement action in 2000 ("Accumed Action"). (Pl. Findings ¶ 5; Def. Findings ¶ 22; see Tr. at 113:4-14.)

8. Dinner does "not recall calculating the expiration date of [the Patents during her review in 2000] because it was not relevant to whether GSK could bring the suit" against Accumed for infringement of those Patents. (See Dinner Aff. ¶¶ 25--27; Def. Findings ¶¶ 28, 29 ("[A]s long as the [P]atents were in force, the eventual expiration dates were not important to GSK at the time."); Tr. at 99:3-4 (DINNER: "[T]he Accumed [Action] did not require knowing the expiration dates of the [P]atents.").)

9. Dinner did not have "any role in drafting or approving any marketing/advertising language on the [Citrucel] labels." (Dinner Aff. ¶¶ 15, 18--19.) Dinner has "never been responsible for the label review process for any Citrucel product." (Dinner Aff. ¶ 18; see Tr. at 110:1-4 (PL. COUNSEL: "No general lawyer or brand manager ever contacted you regarding Citrucel labels after the original request you made [in 2000] to add the patent numbers?" DINNER: "Not to my knowledge."); Pl. Findings ¶ 40.)

10. GSK's other patent attorneys do not recall reviewing patent markings on Citrucel labels. (Furman Aff. ¶ 16 ("I cannot recall an instance, with respect to any product, where patent attorneys were asked to confirm the appropriateness of patent markings that were already on a product label."); see Burke Dep. at 140:3-8; Tr. at 109:8-10, 113:22-23.)

11. GSK's process after a patent number had been placed on a product label was to have the brand managers in the marketing department, without further involvement from any GSK patent attorney, "decide what claims they wanted to have on the [Citrucel] product label[s]." (Tr. at 65:14-17.) According to Dinner's credible and undisputed testimony, the brand managers responsible for the products . . . work out how they want to put the numbers on the label. It's not something that [the patent attorneys] have anything to do with. So I'm not responsible for the label per se. It's the advice that says please put it on the label. So I haven't seen the labels . . . . I'm not even sure I remember reviewing a label per se at that time [in 2000]. (Tr. at 109:10-20; see Aff.of Michael McCormick, dated May 20, 2011 ("McCormick Aff."),

¶ 14 ("I have never [in 27 years in marketing and sales at GSK] interacted with a patent attorney concerning any patent issue, for any product, including the appropriateness of placing, or retaining, a patent number on a Citrucel product.").)

12. Labels created or updated by the marketing department were reviewed by Schneider "to ensure that [they] . . . complie[d] with GSK's internal standards for that product line" and "with FDA regulations and certain other state requirements." (Schneider Aff. ¶ 9.) But, "GSK did not have a practice of reassessing the appropriateness of the patent markings [when] a label was changed . . . ." (Def. Findings ¶ 17; see Furman Aff. ¶ 16; Schneider Aff. ¶ 18; Tr. at 20:2-20, 49:7-10 (SCHNEIDER: "There's a process that's followed with respect to putting patent numbers on the products. There was no policy prior to the time of this lawsuit that I was aware of with respect to removing patent numbers from the product.").) GSK also had a ...


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