Case 2:15-cv-01202-WCB Document 359 Filed 05/18/17 Page 1 of 19 PageID #: 23240
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`Case No. 2:15-CV-1202-WCB
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`§§§§§§§§§§
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`ERFINDERGEMEINSCHAFT UROPEP
`GbR,
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`Plaintiff,
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`v.
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`ELI LILLY AND COMPANY,
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`Defendant.
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`MEMORANDUM OPINION
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`This case was tried to a jury during the week of April 17, 2017. The jury returned a
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`verdict finding that defendant Eli Lilly & Co. (“Lilly”) had infringed U.S. Patent No. 8,791,124
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`(“the ’124 patent”), which is owned by the plaintiff, Erfindergemeinschaft UroPep GbR
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`(“UroPep”). The jury also found that the ’124 patent was not invalid under any of the four
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`theories of invalidity advanced by Lilly—anticipation, obviousness, and failure to satisfy the
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`enablement and written description requirements of 35 U.S.C. § 112, ¶ 1. The jury awarded
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`UroPep $20 million in damages.
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`In the course of the trial, several legal issues arose on which the Court ruled but did not
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`have an opportunity to provide a comprehensive explanation for its rulings. This opinion
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`addresses several of those issues and provides a more detailed rationale for the Court’s rulings
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`than was possible during the trial. In addition, this opinion addresses the issue of prejudgment
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`interest, on which the Court directed the parties to file briefs prior to the Court’s entry of final
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`judgment in this matter.
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`I. Judgment as a Matter of Law on Willfulness
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`At the close of the evidence, the Court granted Lilly’s Rule 50(a) motion for judgment as
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`a matter of law on the issue of willful infringement under 35 U.S.C. § 284. The Court concluded
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`that UroPep had not introduced enough evidence of willfulness to justify submitting that issue to
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`the jury. Dkt. No. 346, at 5-6 (Trial Tr. 1390-91). In addition, the Court stated on the record that
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`even if the jury returned a verdict of willful infringement, the Court would not have enhanced the
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`damages award, based on the evidence presented at trial. Id. at 115 (Trial Tr. 1500).
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`The Supreme Court has made clear that an award of enhanced damages under section 284
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`is reserved for “egregious cases.” Halo Elecs., Inc. v. Pulse Elecs., Inc., 136 S. Ct. 1923, 1932,
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`1934 (2016). As the Supreme Court explained in the Halo case, awards of enhanced damages
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`“are not to be meted out in a typical infringement case, but are instead designed as a ‘punitive’ or
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`‘vindictive’ sanction for egregious behavior. The sort of conduct warranting enhanced damages
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`has been variously described in our cases as willful, wanton, malicious, bad-faith, deliberate,
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`consciously wrongful, flagrant, or—indeed—characteristic of a pirate.” Id. at 1932. Moreover,
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`the party seeking enhanced damages under section 284 has the burden of showing its entitlement
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`to an enhanced award by a preponderance of the evidence. Halo, 136 S. Ct. at 1934; WBIP, LLC
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`v. Kohler Co., 829 F.3d 1317, 1339-40 (Fed. Cir. 2016).1
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`1 Section 284 refers to “increased damages” and does not use the term “willfulness.”
`Perhaps for that reason, the Supreme Court in Halo discussed the section 284 issue by reference
`to the showing necessary to warrant enhanced damages rather than by focusing solely on the
`issue of willfulness. Historically, courts have treated willfulness as a component of the enhanced
`damages analysis that is for the finder of fact, with the ultimate decision on enhancement
`reserved for the court. See In re Seagate Tech., LLC, 497 F.3d 1360, 1368 (Fed. Cir. 2007) (en
`banc), overruled on other grounds, Halo Elecs., Inc. v. Pulse Elecs., Inc., 136 S. Ct. 1923 (2016);
`Beatrice Foods Co. v. New England Printing & Lithographing Co., 923 F.2d 1576, 1578-80
`(Fed. Cir. 1991). The Federal Circuit in Seagate held that the willfulness inquiry had both an
`objective component and a subjective component. See Powell v. Home Depot U.S.A., Inc., 663
`F.3d 1221, 1236-37 (Fed. Cir. 2011). The Supreme Court in Halo rejected Seagate’s two-part
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`In this case, the evidence was not sufficient to support a finding that UroPep had met its
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`burden of showing that Lilly’s conduct was “egregious” or “malicious” behavior that is
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`“characteristic of a pirate.” The evidence on which UroPep relied at trial to support its claim of
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`willfulness was Lilly’s failure to respond to UroPep’s single, one-page letter of October 9, 2014,
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`notifying Lilly about the ’124 patent and stating that the sale of Cialis for BPH “appears to
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`require a license of the ’124 patent.” In addition, UroPep argued that the infringement case
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`against Lilly was strong, given the simplicity and breadth of the ’124 patent. See Dkt. No. 342,
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`at 210, 212-13 (Trial Tr. 469, 471-72); Dkt. No. 344, at 369, 373 (Trial Tr. 1377, 1381).
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`On the other hand, UroPep’s letter was a barebones assertion of infringement. Nothing in
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`the notification letter set out the strength of UroPep’s infringement case or addressed the issue of
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`validity. Nor was there evidence of any follow-up communications from UroPep after the
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`October 9, 2014, letter. Meanwhile, during the pretrial proceedings and at trial Lilly raised
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`substantial arguments as to the validity of the ’124 patent, from which it could be inferred that
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`Lilly reasonably concluded that even if the patent covered the use of tadalafil to treat BPH,
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`Lilly’s continued marketing of Cialis did not infringe a valid patent.
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`Perhaps the strongest point in UroPep’s favor on the willfulness issue is that Lilly did not
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`offer any explanation for its failure to respond to UroPep’s October 9, 2014, notification letter.
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`Rather than offering an explanation for its silence in response to the letter, such as whether its
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`silence was the product of oversight or a considered decision based on analysis of the patent,
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`Lilly chose to rest mainly on the fact that UroPep bore the burden of proof on willfulness and the
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`test, holding that the objective component is not part of the section 284 inquiry, and that the
`“subjective willfulness of a patent infringer, intentional or knowing, may warrant enhanced
`damages, without regard to whether his infringement was objectively reckless.” Halo, 136 S. Ct.
`at 1932-33. The Court reiterated, however, that the ultimate decision whether to award enhanced
`damages is for the court. Id. at 1933-34.
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`argument that UroPep failed to satisfy that burden. See Dkt. No. 344, at 370, 373 (Trial Tr.
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`1378, 1381). Lilly did not, for example, offer an advice of counsel defense. On the other hand,
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`the Patent Act expressly provides that the “failure of an infringer to obtain the advice of counsel
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`with respect to any allegedly infringed patent, or the failure of the infringer to present such
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`advice to the court or jury, may not be used to prove that the accused infringer willfully infringed
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`the patent . . . .” 35 U.S.C. § 297. Therefore, the Court may not take into account Lilly’s failure
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`to offer evidence that it consulted counsel regarding the ’124 patent after receiving notification
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`of the patent in October 2014.
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`In addition, Lilly pointed out that the single communication sent by UroPep prior to the
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`filing of the complaint was sent after Lilly had already been marketing Cialis for the treatment of
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`BPH for almost three years, so it was not surprising that Lilly would not have lightly concluded
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`that its entire “Cialis for BPH” marketing program was at risk because of the ’124 patent. See
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`Dkt. No. 344, at 370-71 (Trial Tr. 1378-79). This is not a case in which the defendant copied
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`patented technology; Lilly clearly developed the use of Cialis for BPH without consulting the
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`’124 patent, which is a factor that cuts against a finding of willfulness and an award of enhanced
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`damages.
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`After weighing the evidence at trial, the Court concluded that there was no direct
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`evidence of willfulness (or lack of willfulness). All that the parties on either side could point to
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`was circumstantial evidence. In the end, the Court concluded that the circumstantial evidence
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`relied on by UroPep was not strong enough to justify submitting the issue of willfulness to the
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`jury, particularly in light of the fact that UroPep bore the burden of proof on the issue of
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`willfulness and was required to show that Lilly’s conduct was sufficiently extreme to qualify as
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`“egregious” under the Supreme Court’s articulation.
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`Contrary to the thrust of UroPep’s argument at trial, a finding of willfulness is not
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`required simply because the infringer knew about the patent at issue. As Justice Breyer noted in
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`his concurring opinion in Halo, 136 S. Ct. at 1936 (Breyer, J., concurring), “a court is not
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`required to award enhanced damages “simply because the evidence shows that the infringer
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`knew about the patent and nothing more. . . . It is ‘circumstanc[e]’ that transforms simple
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`knowledge into such egregious behavior, and that makes all the difference.” In this case, there
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`was no evidence in addition to the evidence of Lilly’s pre-suit knowledge of the patent that
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`showed that Lilly’s infringement was “egregious,” “deliberate,” “wanton,” or otherwise
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`characteristic of the type of infringement that warrants the “punitive” sanction of enhanced
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`damages. See Continental Circuits LLC v. Intel Corp., No. CV 16-2026, 2017 WL 679116, at
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`*11 (D. Ariz. Feb. 21, 2017) (after Halo, “awareness of the patent and continued use of the
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`infringing product despite ‘an objectively high likelihood’ of infringement or ‘reckless disregard’
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`of that risk no longer compel a finding of willfulness”); Vehicle IP, LLC v. AT&T Mobility
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`LLC, C.A. No. 09-1007, 2016 WL 7647522, at * 8 (D. Del. Dec. 30, 2016) (“[A] party’s pre-suit
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`knowledge of a patent is not sufficient, by itself, to find ‘willful misconduct’ of the type that may
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`warrant an award of enhanced damages.”); Greatbatch Ltd. v. AVX Corp., C.A. No. 13-723,
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`2016 WL 7217625, at *3 (D. Del. Dec. 13, 2016) (“The key inquiry in this case is whether there
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`is evidence in addition to AVX’s pre-suit knowledge of the patents that could show that AVX’s
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`infringement was ‘egregious,’ ‘deliberate,’ ‘wanton,’ or otherwise characteristic of the type of
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`infringement that warrants the Court in exercising its discretion to impose the ‘punitive’ sanction
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`of enhanced damages.”); CG Tech. Dev., LLC v. Big Fish Games, Inc., 2:16-cv-587, 2016 WL
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`4521682, at I14 (D. Nev. Aug. 29, 2016) (plaintiff failed to state a claim for willful infringement
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`under Halo because the complaint “fail[ed] to allege any facts suggesting that Defendant’s
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`conduct is ‘egregious . . . beyond typical infringement.”) (quoting Halo, 136 S. Ct. at 1935);
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`Dorman Prods., Inc. v. Paccar, Inc., 201 F. Supp. 3d 663, 681 (E.D. Pa. 2016) (“Halo requires
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`more than simple awareness of the patent and awareness of infringement.”).
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`Finally, the Court notes that the question whether the issue of willfulness should have
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`been submitted to the jury is rendered largely moot by the fact that the decision whether to
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`enhance damages on a finding of willfulness is for the Court. Halo, 136 S. Ct. at 1934. And as
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`the Supreme Court explained in Halo, there is no requirement that enhanced damages must be
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`awarded, even following a finding of egregious misconduct. Id. at 1933.
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`The Court in this case explained at trial that it would not have enhanced damages even if
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`the jury had found Lilly’s infringement to be willful. See Read Corp. v. Portec, Inc., 970 F.3d
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`816, 826 (Fed. Cir. 1992) (a finding of willful infringement “does not mandate that damages be
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`enhanced”; identifying a number of factors that bear on the district court’s enhancement
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`decision); Brigham & Women’s Hospital, Inc. v. Perrigo Co., Civil Action No. 13-11640, 2017
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`WL 1496916, at *5 (D. Mass. Apr. 24, 2017).
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`In the Read case, the Federal Circuit set out a number of factors that are pertinent to the
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`decision whether to award enhanced damages under section 284. The Court reviewed those
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`factors and concluded that several of the most important of them cut against an enhanced
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`damages award in this case. In particular, the Court concluded that there was no evidence of
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`deliberate copying; there was no improper behavior by the infringer in its capacity as a party to
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`the litigation; Lilly made reasonable arguments with respect to certain of the issues of invalidity;
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`there was no showing that Lilly had a motivation (or sought) to harm UroPep; and there was no
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`evidence that Lilly attempted to conceal any misconduct. Read, 970 F.2d at 827-28. The Court
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`therefore would have exercised its discretion to deny an award of enhanced damages even if the
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`jury had returned a verdict finding that Lilly’s infringement was willful.
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`II. Enablement of Both Prophylaxis and Treatment
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`Claim 1 of the ’124 patent recites in part “A method for prophylaxis or treatment of
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`benign prostatic hyperplasia . . . .” ’124 patent, col. 8, ll. 18-19. Lilly requested an instruction
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`that UroPep was required to enable both prophylaxis and treatment, and that it would not be
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`sufficient to enable treatment alone.2
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`Lilly is correct that in the case of a claim that recites a method for performing two
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`objectives stated in the alternative, the enablement requirement in of 35 U.S.C. § 112, ¶ 1
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`requires that the specification enable the performance of each of the alternative objectives. See
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`Sitrick v. Dreamworks, LLC, 516 F.3d 993, 995 (Fed. Cir. 2008); Automotive Techs. Int’l, Inc.
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`v. BMW of N. Am, Inc., 507 F.3d 1274, 1277 (Fed. Cir. 2007); Liebel-Flarsheim Co. v. Medrad,
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`Inc., 481 F.3d 1371, 1378-79 (Fed. Cir. 2007). In this case, however, Lilly’s request for an
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`instruction to that effect was properly denied, for two reasons.
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`First, as the Court noted following the charge conference, there was very little discussion
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`at trial of the issue of prophylaxis; the focus of the evidence at trial, including the evidence
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`2 There was some confusion at trial about whether Lilly’s objection on this ground was
`directed to the Court’s instruction on written description or to the Court’s instruction on
`enablement. At the charge conference, Lilly objected to the language in the Court’s instruction
`on written description. Dkt. No. 344, at 363-64 (Trial Tr. 1371-72). For that reason, the Court at
`that time understood Lilly to be making a written description argument, Dkt. No. 344, at 363
`(Trial Tr. 1371); Dkt. No. 346, at 129 (Trial Tr. 1396). In its brief subsequently submitted in
`support of its argument on that point, however, Lilly presented its argument as an enablement
`argument. Dkt. No. 325, at 5-6. In light of the position formally taken by Lilly in its brief, the
`Court will treat Lilly’s objection as directed to the Court’s instruction on enablement. But in any
`event, the reasons for rejecting Lilly’s requested instruction as to enablement are also applicable
`to Lilly’s written description defense.
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`supporting Lilly’s invalidity defense, was on treatment. To the extent that prophylaxis was
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`discussed at all, it was discussed in the context of treatment.
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`In support of its proposed instruction, Lilly pointed out that one of Lilly’s expert
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`witnesses, Dr. Claus Roehrborn, testified that a person of ordinary skill in the art would not be
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`able to determine the amount of a PDE5 inhibitor that would be required for the effective
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`treatment of BPH. He was then asked, “Did the [’124] patent provide any information that you
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`can determine or a person of ordinary skill in the art can regarding the effective amount that
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`would be given to have prophylaxis of BPH?” He responded, “No it does not.” Dkt. No. 342, at
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`286 (Trial Tr. 545). There is very little other evidence regarding the enablement or written
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`description issues as they pertain to prophylaxis. Instead, throughout the trial, and in other
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`portions of Dr. Roehrborn’s testimony, prophylaxis and treatment were treated together as a
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`single process. See id. at 287-88 (Trial Tr. 546-47) (“And when it comes to looking at the issue
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`of prevention or progression, it is even more complicated because it is highly unpredictable of a
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`thousand men, how many of them will progress and how many will the symptoms get worse. . . .
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`So if you want to show an effect on preventing or progression, it would take a long, long time.”);
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`id. at 288 (Trial Tr. 547) (“it is very difficult to define an effective amount given that the claim
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`involves prevention, prophylaxis, and treatment”).
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`Second, and relatedly, the terms “treatment” and “prophylaxis,” as used in the ’124
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`patent, do not describe distinct processes. In its initial claim construction order in this case, the
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`Court acknowledged that, as UroPep’s expert explained, there was “no clear distinction [drawn]
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`between prophylaxis and treatment for BPH.” Dkt. No. 131, at 9. The Court stated that “a
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`course of medication designed to deal with the condition could be regarded as either prophylaxis
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`or treatment, depending on the physician’s judgment as to whether the patient has BPH or merely
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`has risk factors for BPH or has at least one of the symptoms of BPH.” Id. The Court noted that
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`the uncertainty as to whether therapy should be considered treatment or prophylaxis might create
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`a categorical difficulty, but “because the patent claims at issue in this case cover both
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`prophylaxis and treatment, the overlapping nature of the two terms is not problematical.” Id. at
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`9-10. Given that the terms “prophylaxis” and “treatment” are largely overlapping and that Lilly
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`made no effort at trial to suggest that they required significantly different analysis under the
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`written description or enablement requirements, there was no need to instruct the jury that it
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`needed to conduct a separate invalidity analysis for each term. Any such instruction would
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`simply have been confusing to the jury in light of the manner in which the case was tried.
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`Third, the instruction that Lilly sought was directed to the principle that section 112,
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`paragraph 6, requires that the specification enable the full scope of the claim, not just a single
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`embodiment or group of embodiments. See Liebel-Flarsheim, 481 F.3d 1378-79. The Court in
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`fact gave such an instruction, directing the jury that “[t]o be valid, a patent must contain a
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`description of the manner of making and using the invention that would enable a persons of skill
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`in the art to make and use the full scope of the invention without undue experimentation. Lilly
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`contends that claim 1 of the ’124 patent is invalid because the patent does not contain a
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`sufficiently full and clear description of how to make and use the full scope of the invention. In
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`order to invalidate the ’124 patent for lack of enablement, Lilly must prove by clear and
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`convincing evidence that the ’124 patent would not have enabled such a person to make or use
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`the full scope of the invention.” Dkt. No. 346, at 43 (Trial Tr. 1428); see also id. at 44 (Trial Tr.
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`1429).3 The principle to which Lilly’s purported instruction was directed was thus already
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`incorporated in the Court’s charge, although not with the specificity that Lilly requested.4
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`III. Written Description of a Negative Limitation
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`As part of the Court’s instructions on the written description requirement, Lilly urged the
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`Court to include an instruction regarding the “negative limitation” in claim 1 of the ’124
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`patent—specifically, the limitation in the claim that excludes seven identified compounds from
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`the class of PDE5 inhibitors covered by the claim. Lilly proposed an instruction that negative
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`claim limitations “are adequately supported when the specification describes a reason to exclude
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`the matter. The reason can be shown, for example, by properly describing alternative features of
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`the patented invention.” Dkt. No. 317-1, at 25. Based on the decisions in Inphi Corp. v. Netlist,
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`Inc., 805 F.3d 1350 (Fed. Cir. 2015), and In re Johnson, 558 F.2d 1008 (C.C.P.A. 1977), the
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`Court declined Lilly’s request to instruct the jury in that manner.
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`In the Johnson case, the Court of Customs and Patent Appeals dealt with a situation
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`similar to the ’124 patent. The patent in suit in that case excluded two specific compounds from
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`the claimed genus of compounds. The excluded compounds were omitted from the claims in
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`order “to avoid having [the claims] read on a lost interference count.” 558 F.2d at 1019. The
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`court held that omitting the two species compounds from the genus recited in the claims was
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`3 At Lilly’s request, the Court gave a similar instruction with regard to the written
`description requirement: “The written description requirement is satisfied if a person of ordinary
`skill reading the patent would have recognized that it describes the full scope of the invention
`that is claimed in the patent and that the inventor actually possessed the full scope of the
`invention as of the filing date of the patent.” Dkt. No. 346, at 41 (Trial Tr. 1426); see also id. at
`42 (Trial Tr. 1427); Dkt. No. 344, at 357 (Trial Tr. 1365) (Lilly’s counsel argued that, as to
`written description, “whenever we talk about the invention, we need to talk about the full scope
`of the invention.”).
`4 Nothing barred Lilly from making that specific argument to the jury in its closing, but
`Lilly chose not to do so.
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`permissible and did not create a written description problem. In tersely dispatching the written
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`description argument, the court wrote the following:
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`The notion that one who fully discloses, and teaches those skilled in the art how to
`make and use, a genus and numerous species therewithin, has somehow failed to
`disclose, and teach those skilled in the art how to make and use, that genus minus
`two of those species, and has thus failed to satisfy the requirements of § 112, first
`paragraph, appears to result from a hypertechnical application of legalistic prose
`relating to that provision of the statute.
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`558 F.2d at 1019.
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`The same principle applies here. The list of compounds that are excluded from claim 1
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`of the ’124 patent derived from a parent patent, U.S. Patent No. 8,106,061 (“the ’061 patent”).
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`The specification explains that the ’124 patent is a continuation of the ’061 patent, and the ’061
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`patent claims each of the compounds that were excluded from the ’124 patent, except for
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`sildenafil. The ’061 patent and the ’124 patent are clearly complementary patents. They share
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`the same title, the same abstract, and the same common specification. It is clear that the ’124
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`patent claims the genus of PDE5 inhibitors, while excluding from the claim the species
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`previously patented in the ’061 patent, plus sildenafil, which was also previously patented. The
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`reason for the negative limitation is clear on the face of the two patents—the drafters of the ’124
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`patent sought to claim the genus of PDE5 inhibitors, while excluding the particular compounds
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`that had previously been patented. That approach is consistent with the approach taken, and
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`approved, in the Johnson case and does not violate the written description requirement.
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`The rationale of Johnson was reaffirmed by the Federal Circuit recently in Inphi. The
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`Inphi case involved a negative limitation that the appellant argued was not adequately described
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`because the specification did not provide a “reason to exclude” the excluded embodiments. See
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`Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 (Fed. Cir. 2012). The appellant in Inphi
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`initially argued that the specification was required to “identify the comparative advantage of the
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`material remaining after any narrowing amendment,” but then backed away from that argument.
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`805 F.3d at 1355. As the court explained, the remaining question in the case was “whether
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`properly describing alternative features—without articulating advantages or disadvantages of
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`each feature—can constitute a ‘reason to exclude’ under the standard articulated in Santarus.”
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`Id. The court held that it can. Id.
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`The court in Inphi explained that “claims may state the exclusion of alternatives,” and
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`that “if alternative elements are positively recited in the specification, they may be explicitly
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`excluded in the claims.” Id. Quoting the Johnson case, the Inphi court added: “It is for the
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`inventor to decide what bounds of protection he will seek.” Id. It is enough, the court noted, that
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`the specification “properly describ[e] alternative features of the patented invention” to indicate
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`that the patentees “are merely excising the inventions of another, to which they are not entitled.”
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`Id. Because there was substantial evidence that the appellee in Inphi “possessed the negative
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`claim limitation as of the filing date,” the court held that the written description requirement had
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`been satisfied with respect to the negative claim limitation. See Santarus, 694 F.3d at 1351 (The
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`exclusion of sucralfate from the claims “narrowed the claims, as the patentee is entitled to do.
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`The Manual of Patent Examining Procedure explains that claims may state the exclusion of
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`alternatives. See MPEP § 2173.05(i) (‘If alternative elements are positively needed in the
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`specification, they may be explicitly excluded in the claims.’).”).
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`That analysis applies directly here. The ’124 patent, viewed in light of the cited ’061
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`patent, makes clear that the inventors “decide[d] what bounds of protection” they would seek.
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`Inphi, 805 F.3d at 1356. Because six of the excluded compounds had been claimed in the ’061
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`patent and the seventh—sildenafil—was separately patented, it is plain that the ’124 patent
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`inventors were “merely excising the invention of another, to which they are not entitled.” Id.
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`In light of these principles, Lilly’s proposed instruction, which required that the
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`specification “disclose[] a reason to exclude” the subject matter of the negative claim limitation,
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`would have been misleading to the jury. The specification of the ’124 patent, read in light of the
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`’061 patent, provided an adequate description of the negative claim limitation; no further “reason
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`to exclude” was required, and an instruction requiring the jury to find such an explanation in the
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`specification would have been erroneous.
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`IV. Failure to Instruct on the Discovery of a Phenomenon of Nature
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`During the charge conference, Lilly requested that the Court instruct the jury that “the
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`discovery of a phenomenon of nature cannot be the basis for patent protection.” Dkt. No. 325, at
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`4.5 In support of that request, Lilly cited 35 U.S.C. § 101 and two cases applying section 101,
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`Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), and Mayo
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`Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). The Court
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`declined to give that instruction, noting that Lilly had not raised section 101 as a defense or
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`counterclaim in this case.
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`For the Court to in effect insert a section 101 defense into the case at the instruction stage
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`would be unwarranted. Lilly did not plead section 101 as a defense in its answer, and nothing in
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`the pretrial proceedings or the presentation of the case to the jury laid the basis for a section 101
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`defense. An instruction essentially directed to such a defense would have been confusing to the
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`jury and unfairly prejudicial to UroPep.
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`5 Prior to the charge conference, Lilly submitted some additional proposed instructions,
`including one that explained that a person who discovered that fires require oxygen would not be
`entitled to a patent to the process of making a fire by lighting a flame in the presence of oxygen.
`Dkt. No. 317-1, at 14. That proposed instruction, however, related to the role of inherency in the
`law of anticipation, not to the principle that a natural phenomenon cannot be patented.
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`Moreover, the instruction requested by Lilly would have been misleading. While it is
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`true that a patent cannot be obtained on a natural law or phenomenon, it would be incorrect to
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`instruct the jury that “the discovery of a phenomenon of nature cannot be the basis for patent
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`protection.” The discovery of a natural law or a phenomenon of nature can indeed serve as the
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`“basis” for patent protection, as long as the phenomenon of nature is applied to achieve a useful
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`result. As the Supreme Court has explained, “a process is not unpatentable simply because it
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`contains a law of nature or a mathematical algorithm. It is now commonplace that an application
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`of a law of nature or mathematical formula to a known structure or process may well be
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`deserving of patent protection.” Diamond v. Diehr, 450 U.S. 175, 187 (1981) (quoting Parker v.
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`Flook, 437 U.S. 584, 590 (1978)).
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` At the charge conference, Lilly proposed an instruction that “the simple discovery that
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`PDE5 is in the prostate or that PDE5 plays a functional role in the prostate is not part of the
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`analysis for this claim.” Dkt. No. 344, at 353 (Trial Tr. 1361). That instruction, if given, would
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`have been erroneous, as it is perfectly legitimate for the discovery of the functional role of PDE5
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`to be “part of the analysis” of patentability, particularly when that discovery is applied to the
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`administration of a PDE5 inhibitor in an effective amount to treat BPH—a prostatic disease.
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`Diehr and other section 101 cases stand for the proposition that, in addition to reciting a law of
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`nature, a patent must apply that law of nature to a problem in a way that reflects that the inventor
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`has “invent[ed] or discover[ed]” a “new and useful process.” 35 U.S.C. § 101. Because Lilly
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`did not propose an instruction that would have made clear to the jury the distinction drawn by the
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`Supreme Court in Diamond v. Diehr, it would have been improper for the Court to instruct the
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`jury in the manner Lilly suggested.
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`V. Prejudgment and Postjudgment Interest
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`Prior to entering judgment in this case, the Court asked the parties to brief the issues of
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`prejudgment and postjudgment interest. The parties submitted briefs on those issues on May 17,
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`2017, see Dkt. Nos. 352, 354, and the Court is today separately entering judgment in the case,
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`incorporating its rulings as to prejudgment and postjudgment interest. The reasons for the
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`Court’s rulings on those issues is set out below.
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`Lilly argues that UroPep is not entitled to any prejudgment interest or, in the alternative,
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`that the award of prejudgment interest should be limited to a rate no greater than the prime rate,
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`compounded annually. UroPep argues that prejudgment interest should be calculated at 7
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`percent, compounded q