WILLIAM C. BRYSON, Circuit Judge.
This case was tried to a jury during the week of April 17, 2017. The jury returned a verdict finding that defendant Eli Lilly & Co. ("Lilly") had infringed U.S. Patent No. 8,791,124 ("the '124 patent"), which is owned by the plaintiff, Erfindergemeinschaft UroPep GbR ("UroPep"). The jury also found that the '124 patent was not invalid under any of the four theories of invalidity advanced by Lilly—anticipation, obviousness, and failure to satisfy the enablement and written description requirements of 35 U.S.C. § 112, ¶ 1. The jury awarded UroPep $20 million in damages.
In the course of the trial, several legal issues arose on which the Court ruled but did not have an opportunity to provide a comprehensive explanation for its rulings. This opinion addresses several of those issues and provides a more detailed rationale for the Court's rulings than was possible during the trial. In addition, this opinion addresses the issue of prejudgment interest, on which the Court directed the parties to file briefs prior to the Court's entry of final judgment in this matter.
At the close of the evidence, the Court granted Lilly's Rule 50(a) motion for judgment as a matter of law on the issue of willful infringement under 35 U.S.C. § 284. The Court concluded that UroPep had not introduced enough evidence of willfulness to justify submitting that issue to the jury. Dkt. No. 346, at 5-6 (Trial Tr. 1390-91). In addition, the Court stated on the record that even if the jury returned a verdict of willful infringement, the Court would not have enhanced the damages award, based on the evidence presented at trial.
The Supreme Court has made clear that an award of enhanced damages under section 284 is reserved for "egregious cases."
In this case, the evidence was not sufficient to support a finding that UroPep had met its burden of showing that Lilly's conduct was "egregious" or "malicious" behavior that is "characteristic of a pirate." The evidence on which UroPep relied at trial to support its claim of willfulness was Lilly's failure to respond to UroPep's single, one-page letter of October 9, 2014, notifying Lilly about the '124 patent and stating that the sale of Cialis for BPH "appears to require a license of the '124 patent." In addition, UroPep argued that the infringement case against Lilly was strong, given the simplicity and breadth of the '124 patent.
On the other hand, UroPep's letter was a barebones assertion of infringement. Nothing in the notification letter set out the strength of UroPep's infringement case or addressed the issue of validity. Nor was there evidence of any follow-up communications from UroPep after the October 9, 2014, letter. Meanwhile, during the pretrial proceedings and at trial Lilly raised substantial arguments as to the validity of the '124 patent, from which it could be inferred that Lilly reasonably concluded that even if the patent covered the use of tadalafil to treat BPH, Lilly's continued marketing of Cialis did not infringe a valid patent.
Perhaps the strongest point in UroPep's favor on the willfulness issue is that Lilly did not offer any explanation for its failure to respond to UroPep's October 9, 2014, notification letter. Rather than offering an explanation for its silence in response to the letter, such as whether its silence was the product of oversight or a considered decision based on analysis of the patent, Lilly chose to rest mainly on the fact that UroPep bore the burden of proof on willfulness and the argument that UroPep failed to satisfy that burden.
In addition, Lilly pointed out that the single communication sent by UroPep prior to the filing of the complaint was sent after Lilly had already been marketing Cialis for the treatment of BPH for almost three years, so it was not surprising that Lilly would not have lightly concluded that its entire "Cialis for BPH" marketing program was at risk because of the '124 patent.
After weighing the evidence at trial, the Court concluded that there was no direct evidence of willfulness (or lack of willfulness). All that the parties on either side could point to was circumstantial evidence. In the end, the Court concluded that the circumstantial evidence relied on by UroPep was not strong enough to justify submitting the issue of willfulness to the jury, particularly in light of the fact that UroPep bore the burden of proof on the issue of willfulness and was required to show that Lilly's conduct was sufficiently extreme to qualify as "egregious" under the Supreme Court's articulation.
Contrary to the thrust of UroPep's argument at trial, a finding of willfulness is not required simply because the infringer knew about the patent at issue. As Justice Breyer noted in his concurring opinion in
Finally, the Court notes that the question whether the issue of willfulness should have been submitted to the jury is rendered largely moot by the fact that the decision whether to enhance damages on a finding of willfulness is for the Court.
The Court in this case explained at trial that it would not have enhanced damages even if the jury had found Lilly's infringement to be willful.
In the
Claim 1 of the '124 patent recites in part "A method for prophylaxis or treatment of benign prostatic hyperplasia. . . ." '124 patent, col. 8, ll. 18-19. Lilly requested an instruction that UroPep was required to enable both prophylaxis and treatment, and that it would not be sufficient to enable treatment alone.
Lilly is correct that in the case of a claim that recites a method for performing two objectives stated in the alternative, the enablement requirement in of 35 U.S.C. § 112, ¶ 1 requires that the specification enable the performance of each of the alternative objectives.
First, as the Court noted following the charge conference, there was very little discussion at trial of the issue of prophylaxis; the focus of the evidence at trial, including the evidence supporting Lilly's invalidity defense, was on treatment. To the extent that prophylaxis was discussed at all, it was discussed in the context of treatment.
In support of its proposed instruction, Lilly pointed out that one of Lilly's expert witnesses, Dr. Claus Roehrborn, testified that a person of ordinary skill in the art would not be able to determine the amount of a PDE5 inhibitor that would be required for the effective treatment of BPH. He was then asked, "Did the ['124] patent provide any information that you can determine or a person of ordinary skill in the art can regarding the effective amount that would be given to have prophylaxis of BPH?" He responded, "No it does not." Dkt. No. 342, at 286 (Trial Tr. 545). There is very little other evidence regarding the enablement or written description issues as they pertain to prophylaxis. Instead, throughout the trial, and in other portions of Dr. Roehrborn's testimony, prophylaxis and treatment were treated together as a single process.
Second, and relatedly, the terms "treatment" and "prophylaxis," as used in the '124 patent, do not describe distinct processes. In its initial claim construction order in this case, the Court acknowledged that, as UroPep's expert explained, there was "no clear distinction [drawn] between prophylaxis and treatment for BPH." Dkt. No. 131, at 9. The Court stated that "a course of medication designed to deal with the condition could be regarded as either prophylaxis or treatment, depending on the physician's judgment as to whether the patient has BPH or merely has risk factors for BPH or has at least one of the symptoms of BPH."
Third, the instruction that Lilly sought was directed to the principle that section 112, paragraph 6, requires that the specification enable the full scope of the claim, not just a single embodiment or group of embodiments.
As part of the Court's instructions on the written description requirement, Lilly urged the Court to include an instruction regarding the "negative limitation" in claim 1 of the '124 patent—specifically, the limitation in the claim that excludes seven identified compounds from the class of PDE5 inhibitors covered by the claim. Lilly proposed an instruction that negative claim limitations "are adequately supported when the specification describes a reason to exclude the matter. The reason can be shown, for example, by properly describing alternative features of the patented invention." Dkt. No. 317-1, at 25. Based on the decisions in
In the
558 F.2d at 1019.
The same principle applies here. The list of compounds that are excluded from claim 1 of the '124 patent derived from a parent patent, U.S. Patent No. 8,106,061 ("the '061 patent"). The specification explains that the '124 patent is a continuation of the '061 patent, and the '061 patent claims each of the compounds that were excluded from the '124 patent, except for sildenafil. The '061 patent and the '124 patent are clearly complementary patents. They share the same title, the same abstract, and the same common specification. It is clear that the '124 patent claims the genus of PDE5 inhibitors, while excluding from the claim the species previously patented in the '061 patent, plus sildenafil, which was also previously patented. The reason for the negative limitation is clear on the face of the two patents—the drafters of the '124 patent sought to claim the genus of PDE5 inhibitors, while excluding the particular compounds that had previously been patented. That approach is consistent with the approach taken, and approved, in the
The rationale of
The court in
That analysis applies directly here. The '124 patent, viewed in light of the cited '061 patent, makes clear that the inventors "decide[d] what bounds of protection" they would seek.
In light of these principles, Lilly's proposed instruction, which required that the specification "disclose[] a reason to exclude" the subject matter of the negative claim limitation, would have been misleading to the jury. The specification of the '124 patent, read in light of the '061 patent, provided an adequate description of the negative claim limitation; no further "reason to exclude" was required, and an instruction requiring the jury to find such an explanation in the specification would have been erroneous.
During the charge conference, Lilly requested that the Court instruct the jury that "the discovery of a phenomenon of nature cannot be the basis for patent protection." Dkt. No. 325, at 4.
For the Court to in effect insert a section 101 defense into the case at the instruction stage would be unwarranted. Lilly did not plead section 101 as a defense in its answer, and nothing in the pretrial proceedings or the presentation of the case to the jury laid the basis for a section 101 defense. An instruction essentially directed to such a defense would have been confusing to the jury and unfairly prejudicial to UroPep.
Moreover, the instruction requested by Lilly would have been misleading. While it is true that a patent cannot be obtained on a natural law or phenomenon, it would be incorrect to instruct the jury that "the discovery of a phenomenon of nature cannot be the basis for patent protection." The discovery of a natural law or a phenomenon of nature can indeed serve as the "basis" for patent protection, as long as the phenomenon of nature is applied to achieve a useful result. As the Supreme Court has explained, "a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm. It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection."
At the charge conference, Lilly proposed an instruction that "the simple discovery that PDE5 is in the prostate or that PDE5 plays a functional role in the prostate is not part of the analysis for this claim." Dkt. No. 344, at 353 (Trial Tr. 1361). That instruction, if given, would have been erroneous, as it is perfectly legitimate for the discovery of the functional role of PDE5 to be "part of the analysis" of patentability, particularly when that discovery is applied to the administration of a PDE5 inhibitor in an effective amount to treat BPH—a prostatic disease.
Prior to entering judgment in this case, the Court asked the parties to brief the issues of prejudgment and postjudgment interest. The parties submitted briefs on those issues on May 17, 2017,
Lilly argues that UroPep is not entitled to any prejudgment interest or, in the alternative, that the award of prejudgment interest should be limited to a rate no greater than the prime rate, compounded annually. UroPep argues that prejudgment interest should be calculated at 7 percent, compounded quarterly, on the ground that a small entity such as UroPep would have had to pay that amount as the cost of capital. The effect of the difference in the two rates is significant. Under Lilly's approach, using the prime rate, compounded annually, the total amount of prejudgment interest would be $856,076. Under UroPep's approach, using a 7 percent interest rate, compounded quarterly, the total amount of prejudgment interest up until May 17, 2017, would be $1,843,100.
The Patent Act specifically authorizes the court to award damages to the prevailing claimant, "together with interest and costs as fixed by the court." 35 U.S.C. § 284. While the Supreme Court has construed that language to leave the district court "some discretion in awarding prejudgment interest . . . or perhaps even [to] deny it altogether," the Court has stated that prejudgment interest should be awarded "absent some justification for withholding such an award."
In suggesting that UroPep is not entitled to any award of prejudgment interest, Lilly focuses on UroPep's alleged undue delay in prosecuting this lawsuit. Lilly does not base its argument on the delay of less than a year between the issuance of the patent and the filing of the complaint, which would not be sufficient in any event to justify the denial of prejudgment interest.
The Court rejects Lilly's argument regarding prosecution delay. The delay in prosecution did not prejudice Lilly in any meaningful way. To the contrary, the delay meant that Lilly enjoyed several years of sales of Cialis for the treatment of BPH without being subject to royalties or damages on account of the '124 patent. As for Lilly's claim that it invested substantial sums in marketing and developing Cialis for the treatment of BPH prior to the issuance of the '124 patent, it is implausible to suggest that Lilly would have behaved any differently if the '124 patent had issued earlier, particularly in light of Lilly's decision not to respond to the notification of the '124 patent after the patent issued. Thus, the Court concludes that UroPep is entitled to prejudgment interest. The question is, in what amount.
The rate of prejudgment interest and whether it should be compounded "are matters left largely to the discretion of the district court."
Notwithstanding that authority, UroPep argues that the prime rate should not be used in this case because it is the lowest interest rate at which money can be borrowed commercially, and it is therefore not a rate that would be accessible to a small German partnership such as UroPep. For that reason, UroPep contends that using the prime rate to calculate prejudgment interest would not be sufficient to make UroPep whole.
The problem with UroPep's argument is that it views the loss of the use of the money that is now being awarded as damages as if UroPep had been required to borrow funds during the damages period on the commercial market at a rate of approximately 7 percent. UroPep, however, offers no evidence that it had to borrow funds at all, or indeed had any need or desire to borrow funds, and therefore that the increased amount is necessary to fully compensate UroPep for its loss.
UroPep relies on
The more appropriate way to view the effect of the denial of royalty payments to UroPep during the infringement period is to treat Lilly's nonpayment of royalties during that period as a compulsory loan from UroPep. Had Lilly paid UroPep the $20,000,000 that the jury regarded as the appropriate royalty and UroPep had placed that money in risk-free investments, UroPep would have earned much less than the prime rate on the funds. However, Lilly's infringing conduct deprived UroPep of the choice of how to use that money. Instead, Lilly effectively appropriated the funds for itself and was able to make choices as to how it should be used. Because Lilly effectively compelled UroPep to allow it to keep the money that otherwise would have been used to make royalty payments, it is reasonable to treat that money as a compelled loan from UroPep to Lilly and to value the loan at the rate that Lilly would have been required to pay on the open market for the use of that money.
There is no reason to doubt that if Lilly had sought to borrow funds on the open market, it would have been able to do so at the prime rate. Therefore, a competitive loan from UroPep would have been priced at the prime rate. For that reason, the Court concludes that fair compensation to UroPep for the loss of the use of the funds that Lilly would have paid as a royalty is the prime rate, compounded quarterly, as calculated by UroPep's damages expert Dr. Christopher Vellturo in his declaration attached to UroPep's brief. That amount, up to the May 17, 2017, date that UroPep filed its brief on prejudgment interest is $927,800. The judgment will be filed today, one day later, on May 18, 2017. The Court will therefore add prejudgment interest for that one day. The prejudgment interest for that day will be calculated according to the formula proposed by Dr. Vellturo, and that amount will be added to the $927,800 in interest through May 17, 2017, to calculate the total amount of the prejudgment interest owed by Lilly.
Postjudgment interest is governed by a federal statute, 28 U.S.C. § 1961. The parties agree that postjudgment interest under the statutory formula is "the weekly average 1-year constant maturity Treasury yield . . . for the calendar week preceding the date of the judgment." Interest is calculated from the date of entry of the judgment, is computed daily to the date of payment, and is compounded annually and otherwise follows the requirements of section 1961.