Citations
- 276 F. Supp. 3d 629
Full opinion text
MEMORANDUM OPINION AND ORDER
WILLIAM C. BRYSON, UNITED STATES CIRCUIT JUDGE
In this patent infringement case, the plaintiff Erfindergemeinschaft UroPep GbR (“UroPep”), a German association of urology researchers and physicians, sued the defendant Eli Lilly and Company (“Lilly”) for infringement of U.S. Patent No. 8,791,124 (“the ’124 patent”). Claim 1 of the 124 patent is to a method of administering an effective amount of a compound known as an inhibitor of the enzyme phos-phodiesterase (“PDE”) V, in order to treat the condition of benign prostatic hyperpla-sia (“BPH”). UroPep alleged that Lilly induced infringement of claim 1 by marketing and selling the drug Cialis for the treatment of BPH. Lilly denied infringement and asserted various invalidity defenses. After a trial, a jury found the 124 patent infringed and not invalid. The jury awarded damages in the amount of $20 million.
Pursuant to Rules 60(b) and 59, Fed. R. Civ. P., Lilly now moves for judgment as a matter of law or, in the alternative, a new trial. Dkt. No. 375. The'motion is denied.
BACKGROUND
I. The Invention of 124 Patent
UroPep owns the 124 patent, entitled “Use of Phosphordiesterase [sic] Inhibitors in the Treatment of Prostatic Diseases.” The disclosure was originally filed as part of a PCT application on July 9, 1997—the undisputed priority date of the 124 patent. The application under 35 U.S.C. § 371 (“the 371 application”) was filed in April 2000 and later abandoned. The 371 application, in turn, gave rise to a continuation application that issued as U.S. Patent No. 8,106,061 (“-the ’061 patent”) in January 2012. The 124 patent is a continuation of the patent application that matured into the ’061 patent. 124 patent, col. 1, 11. 5-8.
The original specification filed in July 1997 begins by describing BPH, a condition in which the benign growth of the prostate gland in older males causes constriction of the neighboring urethra and results in lower urinary tract symptoms, including difficulties in urinating. See id., col. 1, 11. 9-24. One prior art treatment method for BPH was surgery to reduce the size of the prostate. Id, col. 1, 11. 14-15. Another prior art method was the administration of drugs, such as alpha-receptor blockers or drugs that interfere with hormonal regulation of the prostate, to induce relaxation of human prostatic muscle. Id., col. 1,11. 20-28. Those drugs, however, were not particularly effective and had significant side effects. Id., col. 1, 11. 24-81; id., col. 1, line 67 through col. 2, line 2.
The inventors of the T24 patent identified a new drug target: phosphodiesterase (“PDE”) enzymes. ’124 patent, col. 1, 11. 32-36. At that time, it was known that smooth muscle cells contain molecules called cyclic adenosine monophosphate (“cAMP”) and cyclic guanosine mono-phosphate (“cGMP”), which promote the relaxation of smooth muscle. Id., col. 1, 11. 39-42. It was also known that PDE enzymes break down cAMP and -cGMP. Id., col. 1,11. 43-44. Finally, it was known that inhibitors of PDEs prevent the breakdown of cAMP and cGMP, which promotes smooth muscle relaxation. Id, col. 1,11. 44-52.
Those skilled in the art had studied PDEs and knew that PDEs-come in different types (subesterases), including PDE1 through PDE5. ’124 patent, col. 1, 11. 58-60. Publications reported that those PDE types are distributed differently throughout the body’s organs and organ systems, and that the activity of those PDE types varies depending on where they are located. Id., col. 1,11. 60-65; see also, e.g., Dkt. No. 342, Trial Tr. at 307-08 (a particular PDE type may not be present in a particular tissue; or, even if the PDE type is present in that tissue, the PDE type may not be functionally relevant in that tissue because other conditions in the tissue render the activity of the PDE meaningless).
The prior art also identified compounds that selectively inhibit specific PDE types, i.e., compounds that suppress the activity of a specific PDE type. 124 patent, col. 1, 11. 44-52; see also id., col. 1, 11. 66-67; id., col. Y,=11. 35-40, 43-45. In particular, hundreds of selective inhibitors of PDE5 were known at that time, including the selective PDE5 inhibitor tadalafil, which is the active ingredient in Lilly’s product Cialis. Dkt. No. 344, Trial Tr. at 1254 (UroPep’s expert describes the advanced state of the art regarding selective PDE5 inhibitors); Dkt. No. 343, Trial Tr. at 791-93 (Lilly’s expert acknowledges that tadalafil, as well as 118 other compounds disclosed in a document published in 1995, were known PDE5 inhibitors before the priority date of the ’124 patent).
The inventors of the ’124 patent performed several experiments. See Dkt. No. 342, Trial Tr. at 316-17 (referencing experiments described in patent disclosure). The first set of experiments revealed that PDE1, PDE4, and PDE5 were present and had significant activity in human pros-tatic tissue. ’124 patent, col. 2,11. 6-11. The second set of experiments showed that compounds that selectively inhibit PDE1, PDE4, and PDE5 caused the relaxation of strips of human prostatic tissue. Id., col. 7, 11.11-34. Based on those results, the inventors determined that compounds that selectively inhibit those three PDEs would treat BPH. See ¾ col. 7,11. 35-37; id., col. 8,11. 5-16’ The disclosure identifies a number of “preférred selective' inhibitors of PDE I, IV, and V,” including 10 discrete chemical compounds and two classes of chemical compounds. Id., col. 2, line 28 through col. 4, line 46. For convenience, those “preferred selective inhibitors of PDE I, IV, and V” will be referred to as “the identified preferred selective inhibitors.” Tadalafil is not among those identified preferred selective inhibitors.
The disclosure also 'describes and incor-: porates “known methods” to • determine whether any particular compound is, a “selective inhibitor” .of a specific PDE type. 124.patent, col. 7, line 35 through col 8, line 16. If a compound is a selective inhibitor of one of the identified PDE types (PDE1, PDE4, or PDE5), then that compound is “suitable for the purpose according to the invention,” id., col. 7,11. 35-37— namely, for the prophylaxis and treatment of BPH and other prostatic diseases, id., col. 2,11.17-27.
In the original Patent Cooperation Treaty (“PCT”) application, the patentees claimed the “[u]se of [any of the identified preferred selective inhibitors] in the prophylaxis and- treatment of prostatic diseases, in particular benign prostatic hyper-plasia” and others. PCT Application, at 4 (claim 1); see also id. at 5 (claim 2 covers “medicaments for” the prophylaxis and treatment of BPH and other prostatic diseases using any of the identified preferred selective inhibitors); id. at 6 (claim 3 covers the use of the identified preferred, selective inhibitors “in the preparation of medicaments for- the prophylaxis and treatment of’ BPH and other prostatic diseases). The ’061 patent, filed in May 2003, claims “[a] method of treating” BPH or prostatism by “administering a selective inhibitor of [PDE] IV and/or [PDE] V,” selected from a group of six of the identified preferred selective inhibitors. ’061 patent, col. 8, 11. 4-26 (independent claim 1); see also id., col, 8, 11. 29-53 (independent claim 3 is to a method of “relaxing prostatic muscles” by adhiinistering, to someone with BPH or prostatism, a selective inhibitor of PDE4 and/or PDE5 selected from a group of nine of the identified preferred selective inhibitors).
In the 1980s and 1990s, some drug .companies were investigating PDE5 inhibitors for the treatment of other conditions, such as erectile dysfunction. See, e.g., Dkt. No. 342, Trial Tr. at 314-16 (Pfizer was investigating the PDE5 inhibitor sildenafil (Viagra) in the 1980s and 1990s). Lilly was one of them: Lilly developed Cialis (with tada-lafil as the active ingredient) ás a drug for erectile dysfunction, and Lilly sought approval of Cialis in the United States and Europe for that indication in mid-2001. See Dkt. No. 343, Trial Tr. at 955. Then, in December 2001, Lilly began discussing other possible indications for Cialis, including whether to develop Cialis as a treatment for BPH. See id., Trial Tr. at 958, 996. Lilly decided to engage in that development and obtained FDA approval for the BPH indication in 2011. Id., Trial Tr. at 1003. Lilly then began marketing and selling Cialis for the treatment of BPH.
The ’061 patent was " in effect at that time. The claims of the ’061 patent, however, do not cover Cialis, because tadalafil is not one of the identified preferred selective inhibitors required by the claims of the ’061 patent.
In December 2011, the patentees filed a continuation application that later issued as the ’124 patent. During prosecution, the examiner rejected the claims on the basis of nonstatutory double-patenting over the ’061 patent. See Dkt. No. 106-8, at 63-64. The patentees then amended claim 1 to exclude many of the identified preferred compounds required in the claims of the ’061 patent. See Dkt. No. 106-8, at 115. Claim 1 of the issued ’124 patent recites:
A method for prophylaxis or treatment of benign prostatic hyperplasia comprising administering to a person in need thereof an effective amount of an inhibitor of phosphodiesterase (PDE) V excluding a compound selected from the group consisting of
dipyridamole,
2-(N-(4-carboxypiperidine)-6-chloro-4(3,4-(methylendioxy)benzyl)ami-no)quinazoline,
2,3-dihydro-8-hydroxy-7-nitro-l,4-benzodioxine-2-methanol, alpha-nitrate.
4((3,4-(methylendioxy)benzyl)amino)-6,7,8-trimethoxy-quinazoline, 1-methyl-3-propyl-6-(5-(N-(4-me-thylmorpholino)sulfonyl)-2-ethoxy-phenyl)pyrazole[4,5]pyrimidin-4(5H)one,
2-n-butyl-5-chloro-l-(2-chloroben-zyl)-4-methylacetate-imidazole, l-cyclopentyl-3-methyl-6-(4-pyridi-nyl)pyrazolo(3,4-d)pyrimidin-4(5H)-one,
7-(3-(4-acetyl-3-hydroxy-2-propyl-' phenoxy)-2-hydroxy-propoxy)-2-car-boxy-2,3-didehydro-chronan-4-óne, and pharmacologically compatible salts thereof.
’124 patent, col. 8,11.18-41 (duplicate compound removed). Those eight compounds excluded from claim 1 are all among the identified preferred selective inhibitors. Thus, claim 1 of the ’124 patent on its, face includes selective PDE5 inhibitors such as tadalafil, which is not among the identified preferred selective inhibitors.
The 124 patent issued in July 2014. In October 2014, UroPep notified Lilly by letter of potential infringement of the 124 patent. Lilly received the letter but did not fespond. In July 2015, UroPep filed this action for infringement..
II. The Trial
At trial, the partiés introduced evidénee from several sets of competing experts, including physicians skilled in urology, medicinal chemists skilled in drug development, and economists. In addition, UroPep called one of the named inventors of the 124 patent, Dr. Stefan Uckert, to testify about the invention. Lilly called employees Dr. Lars Viktrup and Janelle Sabo to speak about Lilly’s development of Cialis for the BPH indication.
In its Rule 50 and Rule 59 motions, Lilly has not challenged the sufficiency of the evidence of infringement. UroPep introduced ample, .evidence that the administration of Cialis for BPH infringed claim 1 of the 124 patent. The Court construed claim 1 of the 124 patent to require that an effective amount of a “selective PDE5 inhibitor”—i.e., a compound that is at least 20 times more selective for PDE5 than for PDE1 through PDE4—be administered, to treat an individual suffering from BPH. See Dkt. No. 149, at 27; Dkt. No. 234, at 16. At trial, UroPep introduced the Cialis drug label approved by the U.S. Food & Drug Administration (“FDA”). That, drug label expressly identifies tadalafil, the active ingredient in Cialis, .as an inhibitor more than 20 times more selective for PDE5 than for PDE1, PDE2, PDE3, and PDE4. The label also states that five milligrams of Cialis is an effective amount to treat BPH, and the label directs physicians to prescribe Cialis as a treatment for individuals suffering from BPH. Dkt. No. 341, Trial Tr. at 216, 218. UroPep’s expert urologist, Dr. Anthony Sliwinski, went through the Cialis label and explained how it met each of the limitations of claim 1. Id., Trial Tr. at 222-23; see also Dkt. No. 342, Trial Tr. at 323-24, 327 (UroPep’s expert medicinal chemist, Dr. Andrew Bell, did the same). Dr. Sliwinski also testified about his medical practice, in which he diagnoses patients with BPH and prescribes Cialis for the treatment of that condition. Dkt. No. 341, Trial Tr. at 216-18.
Second, UroPep provided evidence that Lilly had induced infringement by marketing Cialis for the treatment of BPH. For example, the Cialis label, which is addressed to physicians and patients, counsels the administration of Cialis for the treatment of BPH.- See Dkt. No. 341, Trial Tr. at 216-19. UroPep also introduced numerous advertisements, brochures, coupons, and other marketing materials that Lilly has distributed to physicians and consumers regarding the use of Cialis as a treatment for BPH. See Dkt. No. 341, Trial Tr. at 223-27; see also Dkt. No. 342, Trial Tr. at 394-95 (evidence that Lilly spent over $100 million to run one television advertisement regarding the use of Cialis for BPH and erectile dysfunction); ich, Trial Tr. at 396-97 (same message regarding the administration of Cialis for BPH and erectile' dysfunction on Lilly’s websites). In addition, Dr. Sliwinski testified about his receipt of such materials, Cialis drug samples, and visits from Lilly pharmaceutical representatives, all of which caused him and the partners in his practice to prescribe Cialis for BPH. See Dkt. No. 341, Trial Tr. at 206-07, 220, 223-27.
Lilly presented four primary invalidity defenses: lack of written description under 35 U.S.C. § 112, ¶ 1; lack of enablement under that same provision; anticipation under 35 U.S.C. § 102; and obviousness under 35 U.S.C. § 103. Although the jury rejected each defense, Lilly argues that each is a ground for judgment as a matter of law or, in the alternative, a new trial. Lilly also contends that the Court improperly rejected Lilly’s argument that claim 1 of the T24 patent is indefinite and that the Court’s claim constructions are erroneous, requiring judgment as a matter of law or a new trial. Finally, according to Lilly, the Court gave several erroneous jury instructions and made several erroneous eviden-tiary rulings, each of which requires a new trial.
DISCUSSION
Lilly asserts that the Court should enter judgment in Lilly’s favor pursuant to Rule 50(b) based on (1) any one of Lilly’s invalidity defenses asserted at trial, (2) indefiniteness of the claim term “inhibitor of phosphodiesterase (PDE) V,” and (3) any of the rejected claim constructions. Lilly also argues that it is entitled to a new trial pursuant to Rule 59 on any of those grounds, or based on (4) the Court’s jury instruction on enablement, (5) the Court’s failure to give an instruction based on 35 U.S.C. § 101, (6) the exclusion of certain evidence based on untimely disclosures, or (7) the assertedly improper impeachment of one of Lilly’s experts.
I. Legal Standard
Fifth Circuit law determines what legal standards apply to a mdtion for judgment as a matter of law under Rule 50(b) and a motion for a new trial under Rule 59. Wi-Lan, Inc. v. Apple, Inc., 811 F.3d 455, 461 (Fed. Cir. 2016). A motion for judgment as a matter of law “is a challenge to the legal sufficiency of the evidence supporting the jury’s-. verdict.” Dresser-Rand Co. v. Virtual Automation Inc., 361 F.3d 831, 838 (5th Cir. 2004); see also Vadie v. Miss. State Univ., 218 F.3d 365, 372 (5th Cir. 2000) (“A jury verdict must be upheld unless ‘there is no legally sufficient evidentiary basis for a reasonable jury to find’ as it did.”) (quoting Fed. R. Civ. P. 50). The court must “draw[ ] all reasonable inferences and resolv[e] all credibility determinations in the light most favorable to the non-moving party.” Dresser-Rand, 361 F.3d at 838. The court “grants great deference to a jury’s verdict and will reverse only if, when viewing the evidence in the light most favorable to the verdict, the evidence points so strongly and overwhelmingly in favor of one party that the court believes that reasonable jurors could not arrive at any contrary conclusion.” Id.; accord Wi-Lan, 811 F.3d at 461 (applying Fifth Circuit law).
As for the alternative motion for a new trial, Lilly must show that “it is reasonably clear that prejudicial érror has crept into the record or that substantial justice has not been done.” Laxton v. Gap Inc., 333 F.3d 572, 586 (5th Cir. 2003) (internal quotation marks omitted). In making that determination, the “court weighs all of the evidence,” but the court “need not view [the evidence] in the light most favorable to the nonmoving party.” Id. The court, however, may not grant a new trial “unless the verdict is against the great weight of the evidence.” Dresser-Rand, 361 F.3d at 838; accord Wi-Lan, 811 F.3d at 461 (applying Fifth Circuit law); see also Laxton, 333 F.3d at 586 (“A new trial is warranted if the evidence is against the great, and not merely the greater, weight of the evidence.”).
II. Written Description
The written description requirement of 35 U.S.C. § 112, ¶ 1 provides, in pertinent part:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in‘such full, clear, concise, and exact terms as to enable any person skilled in the art 'to which it pertains, or with which it is most nearly connected, to make and use the same....
35 U.S.C. § 112 ¶ 1 (2006). For purposes of written description, that clause has been interpreted to require that the specification “describe the invention, sufficiently to convey to a person of skill in the art that the patentee had possession of the claimed invention at the time of the application, i.e., that the” patentee invented what is claimed.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 (Fed. Cir. 2010) (enbanc).
Both parties offered expert testimony and numerous exhibits addressed to the written description issue. The primary point of contention was whether the disclosure supports the claim term “an inhibitor of phosphodiesterase (PDE) V,” construed as “a selective inhibitor of PDE5, which is at least 20 times more effective in inhibiting PDE5 as compared to PDE1 through PDE4.” See Dkt. No. 346, Trial Tr. at 1412-13. Lilly’s theory at trial was that the disclosure is inadequate to describe the genus encompassed by that claim term' as construed. In response, UroPep presented evidence that the disclosure described both a sufficient number of representative species within the scope of that genus and structural features common to the members of the genus. See Ariad, 598 F.3d at 1351.
Over ÚroPep’s objection, the Court adopted Lilly’s proposed instruction • regarding the written description requirement. Compare Dkt. No. 344, Trial Tr. at 1357 (Lilly “suggests] ‘a sufficient number of representative compounds’ ”) with Dkt. No, 346, Trial Tr. at 1427 (Court instructs jury that written description must include “a sufficient .number of representative compounds or a common structural feature so that a person of ordinary skill in the art would understand, from reading the patent, that the inventor invented the full scope of the claimed method.”); see also Dkt. No. 346, Trial Tr. at 1897-98 (Court rejects UroPep’s proposed reference to “one or more representative compounds”). Under Lilly’s proposed instruction, the jury found that Lilly had failed to prove invalidity by clear and convincing evidence.
A. Written Description Support for the Claim Limitation of a Selective Inhibitor of PDÉ5
In its post-trial motion, Lilly argues that the evidence introduced at trial shows that Lilly is entitled to a judgment of invalidity for lack of an adequate written description of a selective inhibitor of PDE5, or a new trial. The Court disagrees.
According to Lilly, the claim term describes a genus using functional language—that is, “a selective inhibitor of PDE5” is defined by its function 'as a compound that selectively inhibits PDE5. Lilly contends that no reasonable jury could find that the disclosures contained within the “four corners” of the specification describe a sufficient number of representative species within the scope of the genus, or structural features common- to the members of the genus. See Dkt. No. 375, at 15 (quoting Ariad, 598 F.3d at 1351); see also Dkt. No. 393, at 6-7 (Lilly argues that UroPep is restricted to the “four corners” of the patent and cannot rely upon “that which is undescribed but allegedly obvious from the art.”). ,
Lilly proceeds from the wrong premise. As the Federal Circuit explained in Ariad, the possession inquiry is not limited to what is expressly described within the “four corners” of the specification. Instead, the possession inquiry is an objective one that is viewed from the perspective of a persón of ordinary skill in the art:
The term “possession” ... has never been very enlightening. It implies that as long as one can produce records documenting a written description of a claimed invention, one can show possession. But the hallmark of written description is disclosure. Thus, “possession as shown in the disclosure” is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.
Because “the patent specification is written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before ... it is unnecessary to spell out every detail of the invention in the specification; only enough must be included to convince a person of skill in the art that the inventor possessed the invention....” LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005). The level of detail required to satisfy the written description requirement therefore “varies depending on the nature and scope of the.claims and on the complexity and predictability of the relevant technology.” Ariad, 598 F.3d at 1351; see also Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005) (what is required “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence”).
Under the proper legal standard, Lilly cannot establish that it is entitled to the requested relief. As the Federal Circuit has emphasized, in written description cases, “[t]he primary consideration is factual and depends-on the nature of the invention and the amount of knowledge imparted to those skilled in the art by .the disclosure.” Union Oil Co. of Cal. v. Atl. Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000); see also ScriptPro, LLC v. Innovation Assocs., Inc., 762 F.3d 1355, 1359 (Fed. Cir. 2014) (sufficiency of the written description is a question of’fact).'There was sufficient evidence for the jury to find that Lilly did not prove by clear and convincing evidence that the ’124 patent failed to disclose “either a representative number of species falling within the scope of the genus or structural features common to members of the genus so that one of skill in the art [could] ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350.
1. Representative Number of Selective PDE5 Inhibitors
A reasonable jury could have found that Lilly failed to show that the disclosure lacked a sufficient number of representative compounds falling within the scope of the genus of selective PDE5 inhibitors. The specification describes a number of “preferred selective inhibitors of PDE I, IV, and V.” ’124 patent, col. 2, line 28. Those “preferred selective inhibitors” include 10 discrete compounds (a) through (j), and two classes of compounds (k) and Cl). Id., col. 2, line 29 through col. 4,-line 47. The patent identifies those compounds and classes of compounds by chemical name and, in most cases, structural drawings. Id.
The evidence át trial showed that many of the compounds identified in the 124 patent as “preferred selective inhibitors of PDE I, IV, and'V’ were known to be selective PDE5 inhibitors in July 1997. Based on his expert knowlédge and pointing to printed publications, UroPep’s expert Dr. Andrew Bell testified that the compounds identified as (a), (c), (d), and (g) in the 124 patent were publicly known as selective PDE5 inhibitors before July 1997.'See Dkt. No. 342, Trial Tr. at 314-15 (sildenafil, MY5446, and zaprinast—com-pounds (a), (c), and (g) in the specification—were known selective PDE5 inhibitors); Dkt. No. 344, Trial Tr. at 1260-61, 1265-66 (compound E4021—compound (d) in the specification—was a known selective PDE5 inhibitor). Experts called by Lilly also testified as to the known PDE5 activity of those compounds in July 1997. Dr. Nicholas Terrett noted that the scientific literature showed that a number of qiiina-zolirie compounds—within the class of compounds (k) in the specification—were known to inhibit PDE5. Dkt. No. 343, Trial Tr. at 710-11. Lilly’s expert Dr. David Rotella explained that sildenafil (compound (g)) is a pyrazolopyrimidone and within the class of compounds (l) in the specification. Id,, Trial, Tr, at 740; see also id., Trial Tr. at 723 (Dr. Rotella admits sildenafil was a known selective PDE5 inhibitor in July 1997).
- In addition to the compounds expressly disclosed in the ’124 patent, the jury heard undisputed evidence ■ that hundreds of PDE5 inhibitors were known by July 1997. Dr. Bell testified about the advanced state of the art regarding selective PDE5 inhibitors in July 1997: “There were hundreds of known inhibitors, selective inhibitors of PDE5 known at that time. This was a pretty mature area.” Dkt. No. 342, Trial Tr. at 318; see also' Dkt. No. 344, Trial Tr. at 1254 (explaining that hundreds of selective PDE5 inhibitors were known by July 1997); id., Trial Tr. at 1267-68 (explaining that skilled artisans were aware of hundreds of other selective PDE5 inhibitors beyond those expressly named in a 1995 review article). Lilly’s expert Dr. Rotella admitted that tadalafil, as well as 118 other compounds in one sample paper published in 1995, were known PDE5 inhibitors before July 1997. Dkt. No. 343, Trial Tr. at 792-93. There was also evidence that at least two selective PDÉ5 inhibitors—in particular, sildenafil and zaprinast—had been subjected to human clinical testing long before July 1997, albeit for conditions other than BPH. Dkt. No. 344, Trial Tr. at 1293-94; see also Dkt. No. 342, Trial Tr. at 315-18 (Dr. Bell describes Viagra clinical trials in 1980s and 1990s).
Given the evidence of the knowledge of a person of skill in July 1997 regarding PDE5 inhibitors, including tada-lafil, a reasonable jury could have found that the specification disclosed a sufficient number of representative species of selective PDE5 inhibitors. Written description is a question of fact, and “[flor generic claims, [there are] a number of factors for evaluating the adequacy of the disclosure, including ‘the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.’ ” Ariad, 598 F.3d at 1351 (quoting Capon v. Eshhar, 418 F.3d at 1359). UroPep presented evidence as to all of those factors, much of which Lilly failed to rebut. The jury was entitled to credit UroPep’s evidence and find that Lilly failed to meet its burden.
Lilly nevertheless contends that the disclosure of several species of selective PDE5 inhibitors in the ’124 patent is insufficient, because Lilly’s evidence showed that the genus of selective PDE5 inhibitors is large. For example, one witness put on by Lilly testified that the chemical class of quinazolines—identified as preferred in the ’124 patent—contains “billions of compounds.” Dkt. No. 341, Trial Tr. at 182-83. Although far fewer compounds within that class of quinazolines are. selective PDE5 inhibitors such that they would fall within the claimed genus, Dkt. No. 342, Trial Tr. at 342, it was generally undisputed that the claimed genus is nonetheless very large. UroPep’s expert testified that hundreds of PDE5 inhibitors, including tada-lafil, were known in 1997, and that at least tens of thousands have been developed since then! See Dkt. No. 342, at 332, 341-42.
That evidence, however, is not dis-positive. There is no “bright-line rule governing the number of species that must be disclosed to describe a genus claim, as this number necessarily changes with each such.invention, and it changes with progress in a field.” Ariad, 598 F.3d at 1351; see also Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1368 (Fed. Cir. 2006) (“where ... accessible literature sources clearly provided, as of the relevant date, [the species falling within the claimed genus], satisfaction of the written description requirement does not require either the recitation of or incorporation by reference of such [species].”) (parentheticals omitted). The specification of the ’124 patent alone discloses at least four discrete compounds that were known to be selective PDE5 inhibitors, as well as two compound classes .that were known to contain selective PDE5 inhibitors. That express disclosure was in the context of a mature field in which skilled artisans knew what PDE5 inhibitors were and had already discovered hundreds of them. Those representative species would indicate to a skilled artisan at the time of the invention that selective PDE5 inhibitors such as tadalafil, well known in the mature field in 1997, would work in the claimed invention.
The Federal Circuit has rejected a rule that at least one representative compound is always needed to satisfy the written description requirement. See Capon v. Eshhar, 418 F.3d 1349, 1356-1358 (Fed. Cir. 2005) (rejecting the interpretation of “controlling precedent” from the Federal Circuit as “requir[ing] inclusion in the specification of the complete nucleotide sequence of ‘at least one’ chimeric gene”— i.e., one representative species—because the prior art may supply that understanding); cf. Eli Lilly, 119 F.3d at 1569 (“‘Mention of representative compounds encompassed by generic claim language clearly is not required by § 112 or any other provision of the statute. But where no explicit description of a generic invention is to be found in the specification[,] ... mention of representative compounds may provide an implicit description upon which to base generic claim language.’”) (quoting In re Robins, 429 F.2d 452, 456-57 (C.C.P.A. 1970)). The identification of a large number of representative compounds is one way to meet the written description requirement, but not the only way. See, e.g, In re Herschler, 591 F.2d 693, 701 (C.C.P.A. 1979) (specification’s disclosure of a single example species was sufficient because numerous species were known to skilled artisans); In re Fuetterer, 319 F.2d 259, 265 (C.C.P.A. 1963) (Rich, J.) (disclosure of four species was sufficient even for huge genus that was not fully known at the time of the invention); see also In re Angstadt, 537 F.2d 498, 502-03 (C.C.P.A. 1976) (patentees “are not required to disclose every species encompassed by their claims-even in an unpredictable art”) (quoted in Regents of the Univ. of Cal. v. Eli Lilly. & Co., 119 F.3d 1559, 1569 (Fed. Cir. 1997)).
For example, in Capon, the claimed chimeric genes were “prepared from known DNA sequences of known function.” 418 F.3d at 1358. Both parties “explain[ed] that th[e] invention does not concern the discovery of gene function or structure.” Id. Both parties also “explained] that the[ ] invention Is not in discovering-which DNA segments are related to the immune response, for that is in the prior art, but in the novel combination of -the DNA segments to achieve a novel result.” Id. The Federal Circuit ruled that the Board of Patent Appeals and Interferences “erred in -holding that the specifications do not meet the written description requirement because they do not reiterate the structure or formula or chemical name for the nucleotide sequences of the claimed chimeric genes.” Id.; see also Unocal, 208 F.3d at 997 (written description requirement was satisfied because evidence at trial showed that skilled artisans were aware of the properties of raw petroleum sources and knew, upon reading the disclosure, how to vary those sources in combination to achieve a final product with desired characteristics; given the background knowledge of persons of skill in the art, the patentees were not required to “describe the exact chemical component of each combination that falls within the range claims of the” patent).
As in Capon, it was undisputed at trial that hundreds of selective PDE5 inhibitors, as well as their function, were known in the art at the time of the invention. See ’124 patent, col. 1,11. 36-65. It was also clear that selective PDE5 inhibitors were not themselves the invention. ’124 patent, col. 2,11.17-20 (describing the invention as the use of selective inhibitors of PDE1, PDE4, and PDE5 in the prophylaxis .and treatment of prostatic diseases, including BPH); see also Dkt. No. 341, Trial Tr. at 174-78 (Lilly’s counsel clarifying that the inventor did not claim the discovery of PDEs, PDE inhibitors, alpha-blockers, or the mechanism of action of cAMP and cGMP in relaxing prostatic muscle); • Dkt. No. 344, Trial Tr. at 1295 (Dr. Bell: a person of skill does not “need to discover' brand-new PDE5 inhibitors to use the ’124 patent invention”); id. at 1283 (Dr. Bell confirming that the UroPep inventors did not “discover PDE5 inhibitors”). The disclosure does not describe the “novel result” of inhibiting.PDE5. Ariad, 598 F.3d at 1349. Such compounds were already well known and the effect of inhibiting PDE5 already achieved; instead, the invention was to use a group of compounds, well known in the art, including tadalafil, in a novel method of treating BPH.
It is often the case that a patent claiming the invention of a new genus, or the use of a new genus, must provide more detail regarding that genus, such as disclosing a number of representative species or a structural feature by which to recognize the new genus. See, e.g., Ariad, 598 F.3d 1336, 1357-58 (claiming methods of using new “molecules potentially capable of reducing NF~kB activity,” where. no such .molecules had been completely synthesized but were merely “prophesized”); Rochester, 358 F.3d 916, 923 (claiming use of new COX-2 inhibitors .that were merely “hypothesized”); Eli Lilly, 119 F.3d 1559, 1567 (claiming cDNA for human insulin that had never been characterized); Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993) (claim to DNA' that was of unknown structure); Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991) (claims directed to unknown gene encoding human erythropoietin, where gene was not adequately characterized); see also Boston Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364-65 (Fed. Cir. 2011) (claiming use of new “macroeyclic lactone analogs of rapamycin” where none were disclosed, only a small number were known in the prior art, very little was known about their function, and no guidance was provided to determine which, if any, would work in the invention). As in Ariad, when one purports to have “invented a genus,” the written description should “disclose a variety of species that accomplish the result,” because “‘[t]he description requirement of the patent statute requires a description of the invention, not an indication of a result that one might achieve if one made the invention.’” 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568). Otherwise, a person of skill in the art would not be aware of -what makes up the new genus, and the claimed invention would not be sufficiently described.
On the other hand, when a genus is well understood in the art and not itself the invention but is instead ⅛ component of the claim, background knowledge may provide the necessary support for the claim. For example, in Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1319 (Fed. Cir. 2003), the invention was the production of recombinant eryth-ropoietin (a hormone). The method claims included the use of vertebrate or mammalian host cells to produce the recombinant erythropoietin. Id. at 1322. In response to a written description challenge based on the generic terms “mammalian cell” and “vertebrate cell,” the Federal Circuit ruled that the disclosure did not need to identify specific representative species or common structural characteristics of the genera of vertebrate and mammalian cells, “because the claim terms at issup here [“vertebrate cells” and “mammalian cells”] are not new or unknown biological materials that ordinarily skilled artisans would easily mis-comprehend.” Id. at 1332 (distinguishing Eli Lilly, 119 F.3d 1559, and Enzo Biochem v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002)).
As another example, the Court of Claims and Patent Appeals determined- that an application disclosing one example of a physiologically active steroidal agent provided sufficient .written description to support claims directed to a novel method of using dimethyl sulfoxide in combination with such steroidal agents for delivery of those agents through topical administration. In re Herschler, 591 F.2d at 701. In that case, numerous steroidal agents were known in the art at the time of the invention. Id. As the court noted, “[w]ere th[e] application drawn to novel ‘steroidal agents,’ a different question would be posed.” Id.; see also Rochester, 358 F.3d at 928 (discussing Herschler).
That principle applies equally to the chemical arts, despite Lilly’s suggestion to the contrary. See Dkt. No. 393, at 9 (Lilly states that “decided cases have long recognized [that the field of pharmaceutical chemistry and drug development] is highly unpredictable.”). Rochester, which Lilly cites in support, in fact states that such distinctions are “irrelevant; the: statute applies to all types of inventions.” 358 F.3d 916, 925; see also Ariad, 598 F.3d at 1352 (noting that the principles underlying the written description requirement “ha[ve] not just been applied to chemical and biological inventions.”) (citing Lizard-Tech, 424 F.3d at 1343-47). Although certain aspects of the chemical arts may be unpredictable, that does not mean that the chemical arts always require the identification of representative species to support a claimed genus, even when there is substantial knowledge in the field regarding the genus.
In a hypothetical case involving ■ the chemical arts, for-example, a claim might be directed to the novel usé óf a particular salt, where-the salt must be dissolved in a “solubilizing agent.” The broad genus of “solubilizing agents” would not require representative species if persons of skill knew of many solvents that could dissolve the salt, and thereby serve as a “solubiliz-ing agent” in that .invention. Patents in the chemical field may often involve claims that include well-understood genera. See, e.g., Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1371-72 (Fed. Cir. 2001) (independent claims to methods for treating patients with taxol-sensitive tumors by administering taxol within a fixed range along “with a medicament that reduces or eliminates hypersensitivity reactions,” and dependent claims specifying that such “medicaments” are chosen from the broad genera of “steroids, antihistamines,' ⅝ receptor antagonists, and combinations thereof.”).
None of the cases cited by Lilly support Lilly’s argument that a disclosure must include some absolute number of species to support any patent claim to a genus. Those cases instead show that patent claims may be invalidated based oh the failure to disclose any, or- more than one, species in a nascent area where knowledge of the art has nothing to add to the disclosure. E.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 918, 923 (Fed. Cir. 2004) (patent clairhs directed to COX-2 inhibitors were invalidated for lack of adequate written description because the existence of such inhibitors was merely “hypothesized”; no such inhibitors were yet known and none were described in the patent); AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300-01 (Fed. Cir. 2014) (affirming verdict of invalidity for lack of written description because the patent disclosed only one very limited subgenus within a diverse claimed genus); Ariad, 598 F.3d 1336, 1355, 1357-58 (holding invalid claims directed ,to “molecules potentially capable of reducing NF-kB activity,” where the disclosure contained “no working or even prophetic examples of methods that reduce NF-kB activity, and no completed synthesis of any of the molecules prophesized to be capable of reducing NF-kB activity,” and where the prior art “was primitive and uncertain” and had not identified even a single example inhibitor), -
Boston Scientific Corp. v. Johnson & Johnson, 647 F.3d 1353 (Fed. Cir. 2011), on which Lilly relies, also does not support Lilly’s position. There, the Federal Circuit affirmed the grant of summary judgment of invalidity “[g]iven the absence of information regarding structural characteristics of [the claimed] macrocylic lactone analogs or examples of macrocylic lactone analogs in the specification, the unpredictability of the art and the nascent state of using drug-eluting stents to inhibit restenosis.” 647 F.3d at 1366-67. Although the paten-tee argued that the mechanism of action was known in the art and supplied the necessary description, the'court noted that the specification expressly “refutes any conclusion that the structural elements of rapamycin and its mechanism of action and biological activity was known.” Id. at 1366. For that reason, although “a patentee may rely on information that is ‘well-known in the art’ for purposes of meeting the written description requirement,” the patentee in Boston Scientific could not rely on such information to overcome the express disclosures of the patent. 647 F.3d at 1366; see also id. (“when the four corners of the specification directly contradict information that the patentee alleges is ‘well-known’ to a person of skill at the effective filing date, no reasonable jury could conclude that the patentee possessed the invention.”).
Where representative compounds are necessary to satisfy the written description requirement, the number of such compounds that must be disclosed depends on the context, including the knowledge already available in the art. Unlike the patent' at issue in Boston Scientific, the ’124 patent expressly provides that the fiéld of PDE5 inhibitors and their mechanism of action was well known before' July 1997. ’124 patent, col. 1,11. 36-65;' see also id., col. 7, 11. 35-45. UroPep also provided substantial extrinsic evidence corroborating that proposition, such as testimony and documents showing that hundreds of selective PDE5 inhibitors, including tadalafil, were known at the time of the invention. The patentees were not required to include those hundreds of compounds in the disclosure, and in fact the law makes it clear that it is preferable that they not do so. See Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1368 (Fed. Cir. 2006) (“As each field evolves, the balance also evolves between what is known and what is added by each inventive contribution. Indeed, the forced recitation. of known sequences in patent disclosures would only add unnecessary bulk to the specification.”). Lilly does not say what nurhber of compounds would be sufficient; even if the Court assumes that Lilly’s position is that the number required must be at least one more than the number of compounds disclosed in the ’124 patent, Lilly has not demonstrated that Lilly is entitled to relief tinder governing law in light of the evidence at trial.
Lilly highlights other evidence, but none of that evidence warrants judgment as a matter of law or a new trial on the written description issue.
1. According to Lilly, it is unclear which of all possible compounds within the genus will selectively inhibit PDE5 and effectively treat BPH. Dkt. No. 375, at 16. Lilly’s .-argument ignores the claim construction and incorrectly assumes that the genus includes all PDE5 inhibitors, whereas the genus in claim 1 includes only selective PDE5 inhibitors. Id. at 17 (citing Dr. Terrett’s testimony that it is “impossible to say” whether all PDE5 inhibitors—as- opposed to all selective PDE5 inhibitors— would treat BPH). Lilly has not pointed to any evidence, much less clear and convincing evidence, that an effective amount of a selective- PDE5 inhibitor would not treat BPH. Compare Dkt. No. 342, Trial Tr. at 338-39 (Dr. Bell testifies that he does not know whether a 10 milligram (relatively small) dose of the selective PDE5 inhibitor zaprinast would effectively treat BPH) with Dkt. No. 375, at 17 (Lilly suggests that Dr. Bell testified that he does not know whether zaprinast is capable of effectively treating BPH).
2. Lilly argues that the evidence shows that a person of skill would not know definitively, simply by looking at the structure of any particular compound, whether that compound would selectively inhibit PDE5 and effectively treat BPH. Dkt. No. 375, at 16-17. Such a high standard has never been .required for written description. If Lilly’s standard were required for written description, there would be no need to consider, in the context of enablement, whether any experimentation was undue or merely routine. See AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244 (Fed. Cir. 2003) (“That is not to say that the specification itself must necessarily describe how to make and use every possible variant of the claimed invention, for the artisan’s knowledge of the prior art and routine experimentation can often fill gaps, interpolate between embodiments, and perhaps even extrapolate beyond the disclosed embodiments, depending upon the predictability of the art.-”); see also Dkt. No. 375, at 31 (Lilly argues that the ’124 patent is not, enabled because “[t]he quantity of experimentation just to ... .identify] selective PDE V inhibitors is exceedingly high, considering that the specification of the ’124 patent fails to describe any specific compound as a selective PDE V inhibitor and'fails to disclose a representative number of- claimed species .... ”). Furthermore, the Arfad standard may be satisfied by either a representative number of species or' a common structural feature. It is the latter, not the former, that requires recognition of the compound as a member of the genus upon looking at the compound’s chemical structure.
It is also important to note that tadalafil was a known selective PDE5 inhibitor by July 1997. Therefore, to the extent that preferred selective PDE5 inhibitors were disclosed and understood by skilled artisans to work in the claimed invention due to their activity, tadalafil would" be known by skilled artisans and understood to work in the claimed invention because it’was known to have the same activity.
In any event, UroPep introduced testimony by Dr. Bell discussing how tadalafil shares a core chemical structure with compound E4021 (compound (d) in the specify cation). Dkt. No. 344, Trial Tr. at 1259-63. Lilly’s expert Dr. Rotella gave a general opinion that the chemical structure of ta-dalafil is “distinct from the other chemical classes and compounds that were presented” in the ’124 patent. Dkt. No. 343, at 760; see also id. at 758 (stating that “[t]adalafil is miles away from these structures [compounds (a)-(j) in the ’124 patent] ... in a structural sense.”). The jury was entitled to credit Dr. Bell’s testimony. Furthermore, Dr. Bell’s testimony was more specific than—and, in that regard, undisputed by—Dr. Rotella’s testimony. Lilly introduced expert testimony that PDE5 inhibitors in general have diverse structures, but Lilly did not produce evidence distinguishing between tadalafil and E4021.
3. Lilly contends that eight of the preferred compounds in the specification cannot serve as representative species because those eight compounds are excluded from claim 1, of the. 124 patent. Lilly cites no support for that proposition, and the Court sees no merit to it. Patentees may choose to exclude from the claims some embodiments supported by the disclosure. Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1355 (Fed. Cir. 2015) (“It is for •the inventor to decide what bounds of protection he will seek.”). In fact, a patentee may choose to exclude some embodiments in order to avoid double patenting problems, as happened in this case. See, e.g., In re Johnson, 558 F.2d 1008, 1019 (C.C.P.A. 1977) (written description was adequate where two specific compounds were omitted from a claim “to avoid having [the claim] read on a lost interference count”). But the compounds’ exclusion from the claims does hot mean that those individual compounds are no longer representative of other, non-excluded compounds covered by claim!.
Even if it were the case that those eight compounds could not serve as representative species, Lilly would not be entitled to relief. For one thing, zaprinast and MY5445—compounds (a) and (c) in the specification—are not excluded from claim 1, and both were identified by sufficient evidence at trial as selective PDE5 inhibitors. The jury was entitled, to find that Lilly failed to show that MY5445 and za-prinast are not representative species that fall" within the genus, and the great weight of the evidence does not support Lilly’s position on that point.
2. Common Structural Features
A reasonable jury also could have found that Lilly failed to prove by clear and convincing evidence that the written description did not disclose “structural features common to the members of the genus.” Ariad, 598 F.3d 1336, 1351. While the disclosure does not expressly discuss the common structural features of PDE5 inhibitors, UroPep presented evidence at trial that persons of skill in the art would recognize such shared features. The jury was entitled to credit that evidence and find that the knowledge of persons of skill in the art satisfied the written description requirement.
UroPep’s expert Dr. Bell gave a lengthy description of the core chemical structure found in’ a number of selective PDE5 inhibitors, including tadalafil and compound E4021 (compound (d) in' the 124 patent), as well as a number of other prior art compounds. Dkt. No. 344, Trial Tr. at 1262—63; seé generally id., Trial Tr. at 1259-68. The' patent’s disclosure of E4021 is therefore the disclosure of a species with a chemical structure shared by tadalafil. The jury was entitled to credit that testimony over the contrary testimony of Lilly’s expert. Dkt. No. 343, Trial Tr. at 758-60.
Lilly contends that Ariad requires the disclosure of a structural feature common to all members of the genus. The,Court disagrees. A patent’s specification .might identify three different structural features each found in one of three subgenera (or the same structural features may already be known in the art). The patent may claim an invention that includes a limitation to a genus- made up of those three subgenera. Under those circumstances, a person of skill in the art would be able to “‘visualize or recognize’ the members of the genus” by looking for any one of those three structural features. Ariad, 598 F.3d 1336, 1350.
in any event, UroPep presented unre-butted evidence that PDE5 inhibitors all share a common structural feature. According to Dr. Bell, PDE5 inhibitors may not all share a common “chemical” structure like the core chemical structure found in tadalafil and E4021, but all PDE5 inhibitors share a common “physical” structure. Dkt. No. 344, Trial Tr. at 1280-81. In three dimensions, that physical structure resembles an envelope: it contains a flat section, typically made up of two or more fused rings, and an attached section directed upwards. Id. at 1280. That physical structure fits into the active site of the PDE5 enzyme, inhibiting the enzyme’s activity. Id. at 1281. UroPep’s evidence indicated that skilled artisans may then add to that core physical structure to increase the PDE5 inhibitor’s potency and selectivity." See id. at 1264.
As Lilly points opt; that testimony regarding PDE5 inhibitors does not establish whether those commbri physical structures “will cause such an- interaction [with PDE5] to occur either potently or selectively.” Dkt. No. 393, at 5. UroPep, however, presented sufficient ■ evidence that- a skilled artisan' would be aware of a common physical structure shared by the members of that genus, and that a skilled artisan could make modifications to increase potency and selectivity. The jury was entitled to rely on that evidence, particularly in light of the fact that Lilly failed to rebut it in any meaningful way. Lilly therefore failed to meet its burden. to prove invalidity on that ground by clear and convincing evidence.
B. Permissible Breadth of the Disclosure
Lilly also notes that the disclosure describes the use of selective inhibitors of PDE1, PDE4, and PDE5 for the treatment or prophylaxis of BPH and a number of other conditions rélated to the prostate. Lilly argues in its motion, for the first time, that the disclosure is too’ broad to support the narrow scope of claim 1 of the ’124 patent—i.e.,, the use of selective PDE5 inhibitors for the treatment or prophylaxis of BPH.
, 1. Lilly has waived that argument. The Court will not grant a Rule 50(b) motion based on a theory that Lilly neither gave notice of in the pretrial order nor presented at trial. See Dkt. No. 251 • (pretrial order mentioned only the general written description defense); Dkt. Nos. 341-44, 346 (at no time during trial did Lilly raise such an argument in support of its written description defense). Lilly’s silence deprived UroPep at trial of any opportunity to respond to that theory and develop a record in support. See Fujifilm Corp. v. Motorola Mobility LLC, 182 F.Supp.3d 1014, 1038 (N.D. Cal. 2016) (denying motion for judgment' of invalidity as matter of law and motion for a new trial based on an obviousness theory purportedly supported by the evidence because the defendant waived that theory by .not presenting it at trial); see also Fractus, S.A. v. Samsung Elecs. Co., 876 F.Supp.2d 802, 838 (E.D. Tex. 2012) (defendant waived affirmative defense'in post-trial motion by not explicitly presenting that defense at trial, “de-priv[ing] [plaintiff] of any opportunity to substantively respond with its own testimony or evidence”); Allergan v. Barr Labs., Inc., 808 F.Supp.2d 715, 735 (D. Del. 2011) (because “defendants clearly present a different theory of obviousness post-trial than was presented at trial,” that new argument was waived; defendants could not “switc[h] horses by combining pieces of testimony .,. into new obviousness theories,” thereby depriving plaintiff of the opportunity “to mount a defense at trial to the [new obviousness] theories”). Lilly has waived that argument as a basis for the current motion, and as a basis for appeal. See Interactive Gift Exp., Inc. v. Compuserve Inc., 256 F.3d 1323, 1346-47 (Fed. Cir. 2001) (“[A] party’s argument should not be a moving target” but “should be consistent, thereby ensuring a clear presentation of the issue to be resolved, an adequate opportunity for response and evi-dentiary development by the opposing party, and a record renewable by the appellate court that is properly crystallized around and responsive to the asserted argument.”).
Lilly complains that its failure to raise that defense was due to the Court’s having urged Lilly to make its oral Rule 50(a) -arguments “in bite-size form.” Dkt. No. 346, Trial Tr. at 1391. The Court, however, did not cut counsel off nor prevent Lilly from raising its new theory. Cf. Blackboard, Inc. v. Desire2Learn, Inc., 574 F.3d 1371, 1380 (Fed. Cir. 2009) (noting that the defendant’s Rule 50(a) motions were cursory and the court quickly took them under advisement, but that the defendant preserved the arguments because “it [was] clear from the context that neither the court nor [the plaintiffs] attorneys needed any more enlightenment about [the defendant’s] position on those issues.”). Even though Lilly had given no indication at trial that it was relying on any theory of invalidity based on an overbroad disclosure, Lilly nonetheless chose to move on its written description defense based solely on the statement: “The Rule 50 motion would be also on written description, that the evidence meets the clear and convincing evidentiary standard to show that the inventors did not possess the full scope of the claim.” Dkt: No. 346, Trial Tr. at 1392. Although Rule 50(b) is construed liberally, such a general statement is not sufficient to provide notice to UroPep of Lilly’s entirely new theory. See Navigant Consulting, Inc. v. Wilkinson, 508 F.3d 277, 288 (5th Cir. 2007) (court “may excuse ‘technical noncompliance’ when the purposes of [Rule 50(a)] are satisfied,” which are “to enable the trial court to re-examine the question of evidentiary insufficiency ás a matter of law if the jury returns a verdict contrary to the movant, and to alert the opposing party to the insufficiency before the case is submitted to the jury.”); see also Blackboard, 574 F.3d at 1379-80 (purpose of Rule 50(a) is “to alert the court to the party’s legal position and to put the opposing party on notice of the moving party’s position as to the insufficiency of the evidence.”) (citing Navigant, 508 F.3d at 288-89). Lilly therefore waived its post-trial argument that the disclosure is too broad to support claim 1.
2. Setting aside the waiver issue, Lilly’s argument fails on the merits. According to Lilly, the patentees did not appreciate the utility, of using selective PDE5 inhibitors to treat BPH in July of 1997; therefore,, the patentees, failed to adequately disclose that narrowed invention, which is the subject of claim 1 of the ’124 patent. Specifically, Lilly complains that the disclosure does not differentiate among the utility of inhibiting PDE1, PDE4, or PDE5 for any of the listed conditions, including BPH. See Dkt. No. 393, at 13. Lilly is wrong.
The original disclosure—shared by the PCT application, the ’061 patent, and the ’124-patent—describes the invention as the use of selective inhibitors of PDE1, PDE4, or PDE5 for treating BPH and other prostatic diseases. The first two paragraphs describe the condition of BPH and prior art methods of treatment. ’124 patent, col. 1,11. 9-31. The next two paragraphs set forth the biological mechanism of inducing smooth muscle relaxation in the prostate, which prior art methods had unsuccessfully targeted. Id., col. 1, 11. 32-52. The disclosure then explains how PDEs work in the body generally, and posits that targeting PDEs may prove successful if such PDEs are present and functional in the prostate. Id., col. 1, line 53 through col. 2, line 5. Finally, the subsequent two paragraphs discuss the inventors’ work in discovering that PDE1, PDE4, and PDE5 are present and functional in the prostate; that selective inhibitors of those PDEs would allow for relaxation of prostatic tissue; and therefore that selective inhibitors of those PDEs would be effective for the prophylaxis and treatment of BPH and other prostatic diseases. Id., col. 2,11. 6-28; see also id., col. 7, 11. 11-34 (describing experiments showing the effectiveness of the use of selective inhibitors of PDE1, PDE4, and PDE5).
Lilly points to a later portion of the specification, where th