Court: District Court, E.D. Texas; August 25, 2017; Federal District Court
In the patent infringement case between Erfindergemeinschaft UroPep GbR (plaintiff) and Eli Lilly and Company (defendant), UroPep claims infringement of U.S. Patent No. 8,791,124 (the ’124 patent), which covers a method for treating benign prostatic hyperplasia (BPH) using phosphodiesterase type V (PDE5) inhibitors, specifically Cialis. UroPep asserts that Lilly's marketing of Cialis constitutes induced infringement. Lilly denied the allegations and raised defenses regarding the patent's validity. Following a trial, the jury found that Lilly infringed the patent and that it was valid, awarding UroPep $20 million in damages. Lilly subsequently filed a motion for judgment as a matter of law or for a new trial, which was denied.
The ’124 patent, entitled "Use of Phosphodiesterase Inhibitors in the Treatment of Prostatic Diseases," was originally filed on July 9, 1997, and has a priority date associated with this filing. The application evolved through several stages, including an abandoned application and a continuation that resulted in U.S. Patent No. 8,106,061. The patent's specification outlines BPH as a condition in older males leading to urinary difficulties, noting prior treatment methods like surgery and drug therapy, which were often ineffective and had significant side effects. The inventors of the ’124 patent identified PDE enzymes as a new therapeutic target, explaining that inhibitors of these enzymes can enhance the relaxation of smooth muscle by preventing the breakdown of cyclic nucleotides, cAMP and cGMP. The patent also recognizes the different types of PDEs, their distribution in the body, and their varying activities in different tissues.
Prior art has identified various compounds that selectively inhibit specific phosphodiesterase (PDE) types, particularly PDE5, with tadalafil (the active ingredient in Cialis) being a well-known selective PDE5 inhibitor. Before the priority date of the ’124 patent, tadalafil and 118 other PDE5 inhibitors were recognized. The inventors of the ’124 patent conducted experiments showing that PDE1, PDE4, and PDE5 were active in human prostatic tissue and that selective inhibition of these PDEs could lead to relaxation of prostatic tissue strips. This led to the conclusion that such compounds could treat benign prostatic hyperplasia (BPH).
The patent discloses several preferred selective inhibitors of PDE1, PDE4, and PDE5, which include ten specific compounds and two classes of compounds, but tadalafil is not among those preferred. The document details methods to assess whether a compound is a selective inhibitor of the specified PDE types, indicating that suitable compounds can be used for treating BPH and other prostatic diseases.
In their original Patent Cooperation Treaty application, the patentees claimed the use of these preferred inhibitors for the treatment of prostatic diseases, including BPH. The subsequent ’061 patent, filed in 2003, focuses on methods for treating BPH by administering selective inhibitors of PDE4 and/or PDE5 from a specific group of identified preferred inhibitors. Meanwhile, in the 1980s and 1990s, companies like Pfizer and Lilly were exploring PDE5 inhibitors for various conditions, with Lilly developing Cialis for erectile dysfunction and seeking regulatory approval in 2001.
In December 2001, Lilly initiated discussions regarding potential new uses for Cialis, specifically considering its development for treating benign prostatic hyperplasia (BPH). By 2011, Lilly received FDA approval for Cialis as a BPH treatment and began marketing it, while the ’061 patent was still active. However, the claims of the ’061 patent did not encompass Cialis since tadalafil was not listed as one of the preferred selective inhibitors specified in the patent. In December 2011, the patentees filed a continuation application that resulted in the issuance of the ’124 patent. During the prosecution of this patent, claims were rejected due to nonstatutory double patenting over the ’061 patent, prompting the patentees to amend claim 1 to exclude several preferred compounds identified in the ’061 patent.
Claim 1 of the ’124 patent ultimately described a method for treating BPH using a phosphodiesterase (PDE) V inhibitor, explicitly excluding eight preferred compounds, while still including tadalafil. The ’124 patent was issued in July 2014, and in October 2014, UroPep alerted Lilly to potential infringement, but Lilly did not respond. UroPep subsequently filed an infringement action in July 2015. During the trial, evidence was presented from both parties, including expert testimonies and testimonies from Dr. Stefan Uckert, a named inventor of the ’124 patent, and Lilly employees involved in the Cialis development. Lilly did not contest the sufficiency of the evidence for infringement. UroPep successfully demonstrated that Cialis administration for BPH infringed claim 1 of the ’124 patent. The court interpreted claim 1 to necessitate administering a selective PDE5 inhibitor—defined as a compound with at least 20 times greater selectivity for PDE5 than for PDE1 through PDE4. UroPep presented evidence, including the FDA-approved Cialis drug label, which confirmed that tadalafil met this selectivity criterion.
The Cialis label indicates that five milligrams is an effective dosage for treating benign prostatic hyperplasia (BPH) and directs physicians to prescribe it for this condition. Expert testimony from UroPep's urologist, Dr. Anthony Sliwinski, confirmed that the Cialis label meets all limitations of claim 1 of the patent in question. He, along with UroPep’s medicinal chemist expert, Dr. Andrew Bell, provided detailed analyses of the label during trials. Dr. Sliwinski also testified about his professional practice of diagnosing BPH and prescribing Cialis. UroPep presented evidence that Lilly induced infringement by marketing Cialis for BPH through various materials aimed at both physicians and patients. This included substantial advertising expenditures, such as over $100 million on one television advertisement, and promotional materials that led Dr. Sliwinski to prescribe Cialis.
Lilly raised four invalidity defenses: lack of written description, lack of enablement, anticipation, and obviousness, all of which were rejected by the jury. Lilly contends these rejections justify a judgment as a matter of law or a new trial. Additionally, Lilly argues that the court improperly handled issues of claim indefiniteness, erroneous jury instructions, and evidentiary rulings. The legal standards for these motions are determined by Fifth Circuit law, with a motion for judgment as a matter of law requiring that there be no legally sufficient evidentiary basis for the jury’s verdict.
The court is required to interpret evidence favorably for the non-moving party and grants significant deference to jury verdicts, reversing only if evidence overwhelmingly supports one party's position. In considering a motion for a new trial, the moving party must demonstrate clear prejudicial error or that substantial justice was not served. The court evaluates all evidence but does not have to view it favorably for the nonmoving party and cannot grant a new trial unless the verdict contradicts the great weight of the evidence.
The written description requirement under 35 U.S.C. § 112 mandates that a patent specification must adequately describe the invention to enable a skilled person to make and use it. This requirement has been interpreted to mean that the specification must convey that the patentee possessed the claimed invention at the time of application. In this case, the dispute centered on whether the patent adequately supported the claim of "an inhibitor of phosphodiesterase (PDE) V," defined as a selective PDE5 inhibitor with specified effectiveness. Lilly contended that the specification was insufficient, while UroPep argued that it provided enough representative examples and common structural features. Despite UroPep's objections, the court accepted Lilly's jury instruction regarding the written description requirement. Ultimately, the jury ruled that Lilly did not meet the burden of proving the patent's invalidity by clear and convincing evidence.
Lilly's post-trial motion argues for a judgment of invalidity due to inadequate written description of a selective inhibitor of PDE5, claiming that the patent fails to adequately describe representative species or structural features within the claimed genus. The Court rejects this argument, emphasizing that the inquiry into possession is objective and must consider the perspective of a person of ordinary skill in the art, rather than being confined to what is explicitly stated in the patent. The Federal Circuit's precedent indicates that the written description requirement is satisfied if enough information is provided to convince a skilled artisan that the inventor possessed the invention. The level of detail necessary can vary based on the claims' nature and the technology's complexity. Ultimately, the Court finds that there was sufficient evidence for the jury to conclude that Lilly did not meet the burden of proving, by clear and convincing evidence, that the patent did not adequately disclose representative species or common structural features necessary for understanding the claimed invention.
Lilly's argument that the patent disclosure lacked a sufficient number of representative selective PDE5 inhibitors was found unconvincing. The patent specification identifies ten specific compounds and two classes of compounds known as 'preferred selective inhibitors of PDE I, IV, and V,' providing their chemical names and structural drawings. Evidence presented at trial indicated that several of these compounds, including sildenafil, MY5446, and zaprinast, were recognized as selective PDE5 inhibitors by July 1997. Expert testimonies corroborated this, with Dr. Nicholas Terrett highlighting prior knowledge of quinazoline compounds' PDE5 inhibitory properties and Dr. David Rotella confirming sildenafil’s established selective PDE5 activity. Furthermore, the jury learned that by July 1997, hundreds of selective PDE5 inhibitors were known in the field, demonstrating a mature understanding of the technology. Dr. Rotella acknowledged that tadalafil and numerous other inhibitors were documented prior to this date, with some, like sildenafil and zaprinast, undergoing human clinical trials for other conditions. The jury could reasonably conclude that the patent disclosed a sufficient number of representative selective PDE5 inhibitors, considering the knowledge and advancements in the field at the time. The adequacy of a written description is a factual matter, evaluated by various factors, including prior art and the maturity of the science.
UroPep provided evidence suggesting that Lilly did not fulfill its burden of proof regarding the sufficiency of disclosure for selective PDE5 inhibitors in the ’124 patent. Lilly argued that the patent's mention of several species is inadequate, citing that the broader genus of selective PDE5 inhibitors is extensive, with one witness estimating the quinazoline class to contain billions of compounds. Despite acknowledging that only a fraction of these are selective PDE5 inhibitors, UroPep's expert stated that hundreds were known by 1997 and tens of thousands have been developed since. However, the court noted that there is no definitive requirement for the number of species to be disclosed to adequately describe a genus claim, as this could vary with each invention and field advancements. The specification of the ’124 patent identifies at least four known selective PDE5 inhibitors and two classes that include them, indicating to skilled artisans in the field that compounds like tadalafil would be applicable. The Federal Circuit has previously dismissed the necessity of including at least one representative compound to satisfy the written description requirement. While mentioning representative compounds can support implicit descriptions for generic claims, it is not mandatory. A disclosure of a single species may suffice if numerous others are known. Historical cases support the notion that patentees are not obligated to disclose every species within their claims.
In the case of Capon, the court highlighted that the claimed chimeric genes were created from known DNA sequences, emphasizing that the invention did not involve discovering gene function or structure, nor the identification of DNA segments linked to immune responses, which were already documented in prior art. Instead, the innovation lay in the unique combination of these DNA segments to produce a novel outcome. The Federal Circuit found that the Board of Patent Appeals erred in determining that the specifications failed to meet the written description requirement solely because they did not repeat the structure or formula of the nucleotide sequences for the claimed chimeric genes.
Comparatively, in Unocal, the written description requirement was deemed satisfied as evidence showed that skilled artisans understood the properties of petroleum sources and could modify these sources to create a desired product. Similarly, in the current context, it was recognized that numerous selective PDE5 inhibitors and their functions were already known, and the invention was not the discovery of these inhibitors but rather their application in treating prostatic diseases like BPH. The inventors did not claim the discovery of PDEs or their inhibitors, and it was confirmed by experts that existing PDE5 inhibitors could be utilized without the need for new discoveries.
The disclosure, however, did not articulate the 'novel result' of inhibiting PDE5, as the effects of such inhibition were previously established. The invention was characterized as the application of known compounds, including tadalafil, through a novel treatment method for BPH. The excerpt further notes that patents claiming a new genus or its utilization must provide detailed information, such as representative species or structural features, to adequately describe the invention, referencing several cases where claims were insufficient due to lack of characterization or disclosure of the new compounds.
When claiming to have invented a genus, the written description must disclose various species that achieve the intended result, as required by patent law. This ensures that a skilled individual in the field understands the composition of the new genus. However, if the genus is well-known and merely a component of the claim, background knowledge can suffice. In the case of Amgen Inc. v. Hoechst Marion Roussel, the Federal Circuit upheld claims involving "mammalian" and "vertebrate" cells without requiring specific examples, as these terms were familiar to those skilled in the art. Similarly, in In re Herschler, the disclosure of a single example of a steroidal agent was adequate to support claims for a novel method of delivery, given that steroidal agents were already known in the field. The court noted that if the application had pertained to novel steroidal agents, a different standard would apply. This principle is applicable across various inventions, including chemical arts, despite arguments suggesting that unpredictability in pharmaceutical chemistry necessitates the identification of representative species. The statute's requirements are uniform for all types of inventions, and while certain aspects of chemical arts may be unpredictable, that does not inherently demand the specification of representative species for a claimed genus.
A broad category of "solubilizing agents" does not necessitate specific examples if skilled individuals are aware of various solvents that can dissolve the relevant salt. In patent law, particularly within the chemical field, claims often involve established genera. For instance, in Bristol-Myers Squibb Co. v. Ben Venue Labs. Inc., independent claims regarding treating taxol-sensitive tumors included a medicament from a broad category, which did not require an absolute number of species for validity. Prior cases illustrate that patent claims can be invalidated for failing to disclose any or more than one species in emerging fields where existing knowledge does not enhance the disclosure. University of Rochester v. G.D. Searle Co. invalidated claims for COX-2 inhibitors due to a lack of known examples, while AbbVie Deutschland GmbH. Co. KG v. Janssen Biotech, Inc. reaffirmed invalidity because only a limited subgenus was disclosed. In Ariad, claims involving molecules to reduce NF-kB activity were invalidated as there were no working examples or synthesis provided, and the prior art was undeveloped. Boston Scientific Corp. v. Johnson & Johnson also upheld invalidity, highlighting the absence of structural characteristics for claimed analogs and emphasizing that a patentee cannot rely on well-known information if contradicted by the patent's own disclosures. Overall, the requirement for adequate written description does not allow for reliance on general knowledge when the patent details are inconsistent.
The required disclosure of representative compounds for satisfying the written description requirement varies based on context and existing knowledge in the field. The ’124 patent indicates that the area of PDE5 inhibitors was well-established before July 1997, supported by evidence from UroPep showing that numerous selective PDE5 inhibitors, including tadalafil, were known at that time. The law does not necessitate the inclusion of all known compounds in the patent disclosure, and it is generally preferable to avoid excessive detail.
Lilly's claims regarding the necessity of disclosing additional compounds lack legal support, as the evidence presented does not justify a ruling in their favor. Lilly incorrectly assumes that the genus encompasses all PDE5 inhibitors rather than just selective ones. They have not provided convincing evidence that a selective PDE5 inhibitor would not effectively treat BPH. Furthermore, Lilly's argument that a person skilled in the art would not be able to determine the efficacy of a compound solely based on its structure is unsubstantiated; such a stringent requirement for written description is not legally mandated. Existing knowledge and routine experimentation in the field can fill any gaps in the specification without needing exhaustive detail on every variant of the invention.
Lilly contends that the ’124 patent is not enabled due to the high quantity of experimentation required to identify selective PDE5 inhibitors, arguing the patent does not specify any such compounds nor disclose a representative number of claimed species. According to the Arfad standard, either a representative number of species or a common structural feature is necessary for enablement, with the latter requiring recognition of compounds based on their chemical structure. Tadalafil, recognized as a selective PDE5 inhibitor by July 1997, would be known to skilled artisans due to its activity, thereby fulfilling the enablement requirement. UroPep presented testimony from Dr. Bell, who noted the structural similarity between tadalafil and compound E4021, countering Lilly's expert Dr. Rotella's claim that tadalafil's structure is distinct from other compounds in the ’124 patent. The jury could credit Dr. Bell’s more specific and undisputed testimony over Dr. Rotella’s general opinion. Lilly argued that eight preferred compounds in the specification cannot be considered representative because they are excluded from claim 1; however, the court did not find merit in this argument, citing that patentees can exclude certain embodiments from claims for various reasons, including avoiding double patenting. Even if those eight compounds were not representative, Lilly would still not be entitled to relief, as zaprinast and MY5445—compounds included in the specification—were not excluded from claim 1 and were identified at trial as selective PDE5 inhibitors. The jury was justified in finding that Lilly did not demonstrate that MY5445 and zaprinast are not representative species within the claimed genus, and the evidence overwhelmingly supports this conclusion.
Lilly did not prove by clear and convincing evidence that the written description failed to disclose common structural features of PDE5 inhibitors. Although the disclosure does not specifically mention these features, UroPep provided evidence that experts in the field would recognize them. UroPep's expert, Dr. Bell, detailed the core chemical structures of several selective PDE5 inhibitors, including tadalafil and E4021, indicating that E4021 shares a chemical structure with tadalafil. The jury was justified in accepting this testimony over that of Lilly’s expert.
Lilly claimed that the case Ariad required disclosure of a structural feature common to all genus members, but the Court disagreed, stating that a patent may describe various structural features across subgenera. UroPep's evidence showed that while PDE5 inhibitors do not share a common chemical structure, they possess a common physical structure resembling an envelope, which fits into the active site of the PDE5 enzyme to inhibit its activity. Skilled artisans could modify this core structure to enhance potency and selectivity, and the jury found that UroPep presented sufficient evidence of this common physical structure, which Lilly did not effectively rebut, leading to Lilly's failure to meet its burden of proof regarding invalidity.
Additionally, Lilly contended that the disclosure’s breadth was too wide to support the specific claim for selective PDE5 inhibitors used for treating BPH. However, the Court noted that Lilly waived this argument by raising it for the first time in its motion.
A Rule 50(b) motion by Lilly will not be granted because it is based on a theory not previously disclosed in the pretrial order or presented during the trial. The pretrial order only discussed a general written description defense, and Lilly did not raise any additional arguments during the trial, which prevented UroPep from responding or building a record. Previous case law supports that a party waives arguments not presented at trial, as seen in Fujifilm Corp. v. Motorola Mobility LLC and other cited cases, where defendants were denied post-trial motions based on theories not properly introduced earlier. Lilly's claim that the Court limited its ability to present this new theory is unfounded, as the Court did not prevent any arguments from being made. Furthermore, Lilly's general assertion regarding the written description defense fails to provide adequate notice of a new theory to UroPep, thus constituting a waiver of the argument. Even if waiver were not a factor, Lilly's argument lacks merit.
Lilly argues that the patentees failed to adequately disclose the utility of selective PDE5 inhibitors for treating benign prostatic hyperplasia (BPH) in the original application from July 1997. Lilly claims the disclosure does not distinguish the utility of inhibiting PDE1, PDE4, or PDE5 for treating BPH among other conditions. However, the original disclosure, shared across the PCT application and both the ’061 and ’124 patents, explicitly describes the invention as utilizing selective inhibitors of PDE1, PDE4, or PDE5 for the treatment of BPH and other prostatic diseases. The initial paragraphs outline BPH and prior treatments, followed by a discussion of the biological mechanisms relevant to smooth muscle relaxation in the prostate, indicating the potential effectiveness of targeting PDEs. The disclosure further details the presence and functionality of PDE1, PDE4, and PDE5 in prostatic tissue and asserts that selective inhibitors of these PDEs can effectively treat BPH and related conditions. Lilly points out that the specification lacks sufficient detail to identify the claimed invention, specifically the focus on selective PDE5 inhibitors for BPH treatment, arguing that it does not provide adequate "blaze marks" for directing this choice. The case law cited suggests that merely describing a broad category of compounds without clear guidance on particular species may not meet the written description requirement.
The disclosure adequately identifies the use of selective PDE5 inhibitors for the prophylaxis or treatment of benign prostatic hyperplasia (BPH), distinguishing it from prior cases cited by Lilly, which lacked sufficient specificity or guidance. Unlike Novozymes, where no variant matched the claims, or Boston Scientific, which failed to support claims for a subgenus due to lack of specific disclosure, the current disclosure provides a range of embodiments without the necessity of designating one as "of special interest." Lilly's argument that the failure to explicitly identify a selective PDE5 inhibitor negates the disclosure's adequacy is unfounded, as the document does describe selective PDE5 inhibitors and their therapeutic effect on prostatic tissue. The specification lists preferred inhibitors, with evidence showing that several compounds were recognized as selective PDE5 inhibitors prior to July 1997, affirming that a skilled artisan at the time would have recognized numerous selective PDE5 inhibitors.
Several PDE5 inhibitors were already undergoing human clinical trials, as noted in multiple trial transcripts. The patent specification outlines experiments indicating that selective inhibitors of PDE1, PDE4, and PDE5 can relax prostatic tissue, supporting the notion that these inhibitors are effective for treating benign prostatic hyperplasia (BPH). The specification requires that an inhibitor must be 20 times more selective for the target PDE to be deemed suitable for the invention's purpose. Prior art confirms that BPH treatment can be achieved by inducing relaxation of prostatic muscle cells. The Court found no necessity for the specification to describe the use of PDE5 inhibitors in human clinical trials to meet the written description requirement. Trial evidence suggested that a skilled person would understand the application of selective PDE5 inhibitors for BPH treatment based on the provided disclosures. Additionally, Lilly's assertion that the patent is invalid due to the exclusion of certain compounds from claim 1 was rejected; the law allows patentees to exclude compounds without the need for an explanation in the disclosure, as the inventor determines the scope of protection sought.
A disclosure does not need to justify the exclusion of certain features as long as it properly describes alternative aspects of the patented invention. The patentees of the ’124 patent previously excluded eight compounds from claim 1 to avoid double-patenting issues related to their earlier ’061 patent. Lilly argues that this exclusion cannot justify the negative limitation in claim 1 since zaprinast, included in claim 3 of the ’061 patent, was not excluded from claim 1. Lilly contends this inconsistency indicates an arbitrary division of a single invention, which is prohibited by the written description requirement. However, there is no such prohibition, and the exclusion of the eight compounds serves to narrow the claims appropriately.
The written description requirement does not forbid negative limitations unless they contradict the invention's essence. An example cited is In re Bimeda Research, where excluding an anti-infective agent contradicted the invention's goal of avoiding such agents. In contrast, the exclusion of the eight compounds in the ’124 patent aligns with the intended disclosure, allowing for other PDE5 inhibitors. Expert testimony indicated that skilled individuals would not be confused by these exclusions. Ultimately, a patentee may choose specific embodiments to claim and exclude others without needing to provide an explanation, provided the claim does not mislead skilled individuals about the covered embodiments. Consequently, the negative limitation in claim 1 does not warrant Lilly's request for judgment or a new trial.
The written description requirement under 35 U.S.C. § 112 mandates that a patent specification must clearly and concisely describe the invention and its use, enabling a person skilled in the relevant field to make and use the invention without undue experimentation. The enablement requirement has been interpreted to mean that sufficient information must be provided so that skilled artisans can practice the full scope of the claim. Factors influencing the determination of undue experimentation include the quantity of experimentation needed, guidance provided, existence of working examples, the nature of the invention, prior art status, skill level of practitioners, unpredictability of the art, and claim breadth. The burden of proof for lack of enablement lies with the challenger, requiring clear and convincing evidence.
In the case involving Lilly, the company contested the jury's acceptance of UroPep’s expert testimony regarding routine experimentation needed to assess a compound's selectivity for PDE5 versus PDE1-PDE4 for treating benign prostatic hyperplasia (BPH). Dr. Bell, a credible expert with relevant experience, testified that screening a significant number of compounds could be completed within weeks and that such screening is a common practice in the field. The jury found Dr. Bell's testimony credible and preferred it over Lilly’s expert, Dr. Rotella. Dr. Bell also noted that the field's maturity meant skilled artisans might not need extensive screening if they already had a PDE5 inhibitor.
Pfizer did not screen its compound collection in 1997 because it already possessed sildenafil. Dr. Bell testified that Pfizer utilized fractionation methods, as outlined in the T24 patent, to separate PDE isoenzymes and determine inhibitor selectivity. He referenced the Gal-wan and Nicholson articles in the ’124 patent, emphasizing that these fractionation methods were standard in the pharmaceutical industry. Lilly contended that certain selective PDE5 inhibitors may lack potency or effectiveness for treating BPH due to bioavailability issues. However, Dr. Bell asserted that the methodologies described in the ’124 patent for identifying potent PDE5 inhibitors were widely accepted in the industry. Lilly also argued that the patent's claim regarding an effective amount of PDE5 inhibitor for BPH treatment was not enabled, but Dr. Bell explained that routine dose ranging would suffice for skilled artisans to establish effective dosages. The principle of enablement is not negated by the need for reasonable experimentation. Lilly failed to present evidence showing that any potent PDE5 inhibitor studied did not treat BPH effectively. Despite Lilly's experts claiming the patent's examples were confusing and non-workable, the jury could favor Dr. Bell's testimony, which highlighted that oral formulation is generally a straightforward process. Dr. Bell pointed out that skilled artisans would be familiar with existing oral formulations of PDE5 inhibitors and relevant published data. Lilly's criticisms of the patent's enablement requirements were deemed fundamentally flawed based on this testimony.
Lilly contends that synthesizing all selective PDE5 inhibitors requires undue experimentation, which misinterprets the enablement requirement of patent law. A patent must allow a skilled artisan to practice the invention's full scope but is not bound by the time frame for achieving this. The precedent set in *In re Wands* illustrates that the process of developing monoclonal antibodies, which involves extensive screening, does not invalidate broad claims due to enablement issues. Additionally, Lilly's argument confuses the invention's practice with the regulatory requirements for FDA approval, as evidenced by *Kemin Foods* and *Mitsubishi Chemical Corp.*, which affirm that patent claims are not limited to products meeting specific safety thresholds or requiring human trials for patentability.
Lilly's references to the development of Cialis and FDA approval do not pertain to the enablement of claim 1 of the ’124 patent, which necessitates significantly less experimentation. The standard for enablement does not require specific confirmatory evidence, and the absence of data confirming the effectiveness of certain PDE5 inhibitors for treating BPH does not invalidate the patent. The ’124 patent sufficiently details how PDE inhibitors function and their application for treating BPH, allowing a reasonable jury to conclude that the claim is enabled. UroPep emphasizes that evidence presented at trial supported the enablement factors from *In re Wands*.
UroPep presented evidence demonstrating that the experimentation required for its invention was routine and well within the capabilities of skilled individuals in the field. The specification of the patent provided clear guidance, working examples, and incorporated relevant prior art. The invention involved administering known compounds in a novel manner to treat benign prostatic hyperplasia (BPH), with a well-developed prior art in selective PDE5 inhibitors indicating a high level of skill in the field.
Lilly attempted to argue that the case was governed by the precedent set in Wyeth v. Abbott Laboratories, claiming that the research field was unpredictable and that the patent lacked guidance for treating BPH. However, UroPep countered with evidence that the patent did provide sufficient guidance and that the procedures for treatment evaluation were routine in the field.
Lilly also contended that the time taken to run assays constituted "undue experimentation," referencing its own lengthy FDA approval process for Cialis. UroPep rebutted this by stating that FDA approval is not necessary for patent enablement and that the amount of experimentation permissible depends on whether it is routine and guided by the specification. The court's precedent suggests that adequate guidance in a developed field negates claims of undue experimentation.
Lastly, Lilly claimed that the disclosures in the patent were obvious based on prior art. However, it failed to demonstrate that it was entitled to judgment as a matter of law or that the evidence overwhelmingly favored its position on enablement, which would warrant a retrial.
Lilly acknowledged prior knowledge that relaxing smooth muscle in the prostate alleviates urination difficulties and that PDE inhibitors can facilitate this by inhibiting PDE enzymes, which break down cAMP and cGMP. Lilly argued that it would have been obvious to a skilled individual to use a PDE5 inhibitor for treating or preventing benign prostatic hyperplasia (BPH). However, the jury found that Lilly did not meet its burden of proving obviousness by clear and convincing evidence. Testimony from Dr. ckert confirmed that the inventors identified PDE1, PDE4, and PDE5 in the prostate and established that PDE5 inhibition relaxes prostatic smooth muscle, aiding BPH treatment. Dr. Bell added that predicting the presence or functional role of specific PDEs in organs was impossible at the time. The jury also considered evidence of the commercial success of PDE5 inhibitors in treating BPH as indicative of non-obviousness. Lilly contended that prior art demonstrated the mechanisms of PDEs and the role of inhibitors, suggesting the invention should be deemed obvious. However, Lilly failed to show that it was obvious to use a selective PDE5 inhibitor for BPH, as the presence of PDE5 in the prostate was unknown at the time, and prior research indicated PDE5’s limited relevance in the bladder. The inventors of the ’124 patent conducted experiments that revealed PDE5's presence and relevance in prostatic tissue, leading to a novel treatment method. Furthermore, Lilly's key supporting reference, a 1995 article by Arthur L. Burnett, did not mention the use of selective PDE5 inhibitors for BPH or acknowledge PDE5's presence in the prostate, and Dr. Bell testified that the article suggested focusing on PDE3 inhibition instead.
Lilly references the Federal Circuit's decision in PharmaStem Therapeutics, Inc. v. ViaCell, Inc. to support its obviousness claim. However, this case differs significantly from Lilly's situation; in PharmaStem, prior art indicated a higher concentration of stem cells in umbilical cord blood than in adult blood, and the court found that the inventors merely confirmed existing knowledge, which was insufficient to avoid a finding of obviousness. In contrast, no prior art suggested that PDE5 existed in the prostate or its functional role, leading the court to determine that substantial evidence supported the jury's conclusion that Lilly did not prove the claimed invention was obvious to a skilled person at the priority date of the ’124 patent.
Regarding anticipation, Lilly argues that the jury wrongly rejected its claim that the first claim of the ’124 patent was anticipated by a prior art reference. Lilly faces a high burden to demonstrate that a rational jury could not have found a lack of clear and convincing evidence for anticipation. The reference in question is a monograph by Dr. C.S. Cheung, which was made available through a catalog to acupuncturists and interested parties. However, Lilly failed to establish that LaForgia or acupuncturists qualified as skilled individuals in the context of the patent. Moreover, the monograph discussed treatment for benign prostatic hyperplasia (BPH) and was not adequately documented in terms of its cataloging in a relevant library, which further weakened Lilly’s argument. Lilly’s anticipation claim is based on 35 U.S.C. 102(b), which pertains to prior patents or descriptions of an invention, emphasizing the need for a clear demonstration of prior publication to invalidate the patent.
A party contesting a patent on "printed publication" grounds must demonstrate that the publication in question includes all elements of the claimed invention and was publicly available more than one year prior to the patent application date. The jury in this case determined that the Cheung monograph did not anticipate claim 1 of the ’124 patent. The Cheung monograph reported a study involving 34 subjects who received a formula with various herbs, including Horny Goat Weed, which contains icariin, a PDE5 inhibitor. Lilly argued that the study showed Horny Goat Weed improved symptoms in most subjects; however, the evidence was unclear. It was uncertain whether icariin was the effective component, as multiple herbs were administered. Dr. Roehrborn, Lilly’s expert, acknowledged that other herbs might also affect symptoms. Additionally, the monograph indicated that Horny Goat Weed was an optional ingredient, raising doubts about whether it was present in the formulations of subjects who reported improvements. Furthermore, UroPep presented evidence that icariin is significantly less potent than tadalafil, suggesting that improvements in symptoms could not be definitively attributed to Horny Goat Weed.
Evidence indicated that Horny Goat Weed contains approximately 0.5% icariin, necessitating the consumption of about 1.6 kilograms (3.5 pounds) to achieve the effect of a 5 milligram dose of Cialis. The Cheung study involved subjects ingesting only 15 grams of Horny Goat Weed, suggesting that this amount of icariin would likely be insufficient to impact benign prostatic hyperplasia (BPH) symptoms or meet the “effective amount” requirement of the 124 patent.
Lilly's anticipation argument drew on Rasmusson v. SmithKline Beecham Corp., which they claimed was similar; however, the cases differ significantly. In Rasmusson, the prior art disclosed the same method for the same drug, while in this case, the jury could find that the administration method of Horny Goat Weed did not align with the PDE5 inhibitors of the 124 patent. Consequently, the jury could reasonably conclude that Lilly did not demonstrate anticipation, as the Cheung reference did not involve a sufficient dosage for therapeutic effect on BPH.
Additionally, the jury might have determined that the Cheung reference did not qualify as a “printed publication” under section 102(b). A reference must be disseminated in a way that it is accessible to those skilled in the art. Testimony from Mr. LaForgia, which was the sole evidence regarding the distribution of the Cheung monograph, failed to establish that it was publicly available by July 1996 in a manner accessible to skilled individuals in the field.
Testimony indicated that a catalog with an advertisement for Dr. Cheung’s publication was sent only to those interested in his work, not to skilled individuals in the relevant field. Mr. LaForgia found the monograph in Dr. Cheung’s organization's library but lacked knowledge about its cataloging or accessibility elsewhere. There was no evidence that individuals skilled in the art were aware of or frequented the American College of Traditional Chinese Medicine. Consequently, a reasonable jury could have concluded that Lilly did not provide clear and convincing evidence to support its defense of anticipation, leading to the denial of Lilly's motion for Judgment as a Matter of Law (JMOL) on that basis, as well as the denial of Lilly's Rule 59 motion.
Lilly also argued that claim 1 of the ’124 patent was invalid for indefiniteness due to the court's claim construction requiring that the inhibitor of phosphodiesterase (PDE) V be at least 20 times more selective for PDE5 than for PDE1 through PDE4. The court had previously treated this as a legal issue and dismissed the indefiniteness argument. Lilly pointed to expert testimony from Dr. Joseph A. Beavo but the court found that it did not change its pretrial ruling. The requirement for an inhibitor to be 20 times more selective is clear, and the patent specifies methods for determining PDE5 inhibition potency. Despite Dr. Beavo's critiques of the testing protocols in the patent, the "20 times" requirement remains unambiguous, thus affirming the validity of claim 1.
Dr. Beavo's testimony does not indicate that the "20 times" selectivity requirement in the '124 patent is indefinite. He did not claim that it is impossible to determine if a compound is 20 times more selective for one PDE over another, nor did he assert that testing methods are unreliable enough to render the patent's claims unclear to skilled individuals. Even in the absence of a specific testing protocol, the "20 times" requirement would remain valid. While Dr. Beavo criticized the peak fractionation method used in the Truss article for inadequately separating PDE5 from other PDEs, he acknowledged that the method could identify PDE5 in other tissues. His criticisms did not disprove the reliability of peak fractionation for assessing PDE5 inhibitors' effectiveness. Dr. Bell testified that the testing methods mentioned in the '124 patent are common in the industry and that the fractionation methodology was standard at the time of the patent. Consequently, the Court dismisses Lilly's argument that Dr. Beavo's testimony invalidates the selectivity requirement for indefiniteness. Additionally, Lilly claims entitlement to judgment as a matter of law (JMOL) based on the claim constructions provided by the Court to the jury, but does so without specificity or supporting arguments regarding the terms “prophylaxis,” “a person in need thereof,” and “effective amount.”
Lilly's assertions regarding the term "inhibitor of phosphodiesterase (PDE) V" have been deemed erroneous, and the Court will not revisit prior claim construction rulings. Lilly has not presented new arguments in its JMOL (Judgment as a Matter of Law) motion concerning these constructions. Specifically, the Court previously addressed Lilly's contestation of the term "inhibitor of phosphodiesterase V" in a March 3, 2017 order. For the terms "a person in need thereof" and "effective amount," Lilly did not propose alternative constructions but argued they were indefinite. Regarding "prophylaxis," the Court adopted Lilly's suggested definition, which Lilly later agreed upon. A party cannot introduce new claim construction disputes post-trial, especially if previously endorsed.
In its motion for a new trial, Lilly raised multiple grounds, including a specific request related to Jury Instruction on Enablement concerning Claim 1 of the 124 patent, which addresses a method for treating benign prostatic hyperplasia (BPH). Lilly sought an instruction stating that the patent must enable both treatment and prophylaxis, which the Court declined, citing three reasons: the trial evidence primarily focused on treatment, the overlapping nature of treatment and prophylaxis in the patent, and potential confusion that a specific instruction could cause the jury.
The Court noted that the trial primarily focused on treatment rather than prophylaxis, with limited discussion of prophylaxis framed within the context of treatment. Testimony from Dr. Roehrborn highlighted that determining the effective dosage of a PDE5 inhibitor for BPH treatment was challenging, and he stated that the patent did not provide information on the effective amount for prophylaxis. He further explained that studying prophylaxis would be complex and require extensive time and resources due to the variability in patient responses. Throughout the trial, prophylaxis and treatment were treated as interconnected processes. The Court had previously recognized that the T24 patent did not draw a clear distinction between prophylaxis and treatment for BPH, indicating that medication could serve both purposes depending on the physician's assessment of the patient's condition. Consequently, the overlapping nature of these terms did not warrant separate jury instructions for invalidity analysis, as it would likely confuse jurors given the trial's presentation. Lilly's proposed jury instruction aimed to clarify that the patent specification must enable the full scope of the claim, which the Court confirmed had already been addressed in its instructions.
A valid patent must provide a clear description enabling a skilled person to make and use the invention without undue experimentation. Lilly argues that claim 1 of the ’124 patent is invalid due to insufficient description. To prove invalidity for lack of enablement, Lilly must show by clear and convincing evidence that the patent does not enable the full scope of the invention. The Court's charge already included the principle Lilly sought to clarify, allowing Lilly to argue non-enablement during closing arguments, which it did not do. Consequently, the motion for a new trial based on insufficient instruction regarding prophylaxis enablement is denied.
Lilly also asserts that the Court should have instructed the jury that laws of nature are not patentable. The Court rejected this request because Lilly did not challenge the patent under 35 U.S.C. § 101. Although Lilly acknowledged not raising a section 101 challenge, it sought an instruction that a natural phenomenon cannot be patented, using the example of oxygen's necessity for fire. This example was tied to Lilly's argument on anticipation, not unpatentability. During trial discussions, Lilly requested clarification regarding the relevance of discovering PDE5 in the prostate but did not formally request a section 101 instruction. The Court declined to provide this instruction, emphasizing that introducing a section 101 defense at this stage was inappropriate since Lilly had not previously raised it.
Lilly did not raise section 101 as a defense in its answer, and there was no basis for such a defense throughout pretrial proceedings or during the jury trial. An instruction regarding this defense would have confused the jury and unfairly prejudiced UroPep. Lilly's proposed jury instruction, suggesting that the discovery of a natural law cannot be a basis for patent protection, was misleading; the Supreme Court has established that the discovery of a natural phenomenon can be patentable if applied to achieve a useful result. Furthermore, Lilly's request to instruct the jury that the discovery of PDE5's role in the prostate was irrelevant to patentability was incorrect. Instead, such discoveries can be integral to the patentability analysis, especially when applied to treat prostatic diseases. The Supreme Court's precedents indicate that a patent must apply a law of nature in a manner reflecting a new and useful process. Consequently, the Court's refusal to give Lilly's proposed jury instruction was not a legal error.
Regarding the Bunnage references, UroPep successfully moved to strike a reference Lilly intended to use for its invalidity defense, arguing it was not timely disclosed. This reference included a Patent Cooperation Treaty application and an earlier UK application related to Pfizer Inc. Lilly had initially disclosed the PCT application but failed to disclose the UK application until after the deadline for presenting prior art. As a result, UroPep's motion to strike was warranted due to Lilly's untimely disclosure of invalidating prior art.
Lilly withdrew its designation of the Bunnage PCT Application as prior art, arguing instead for its admissibility to demonstrate "simultaneous invention," a secondary factor in assessing obviousness. The Court ruled against this, stating that Lilly's failure to disclose the Bunnage UK Application in its invalidity contentions and the late introduction of the simultaneous invention theory violated a Discovery Order, thereby barring its use at trial. However, Lilly was allowed to use the evidence for impeachment if UroPep presented contradictory testimony.
Lilly reiterated its position, asserting that the Bunnage applications should have been admissible. The Court noted that Lilly did not disclose the Bunnage UK Application until January 2017, after the invalidity contentions and expert reports were exchanged, and only mentioned using the applications for simultaneous invention shortly before trial. The Court found no valid reason to admit the Bunnage UK Application, as doing so would have prejudiced UroPep, preventing them from adequately responding.
Regarding the Bunnage PCT Application, while it was listed in Lilly’s initial contentions, it was not discussed in expert reports, and the simultaneous invention theory was disclosed too late. The Court emphasized that Lilly failed to meet its obligations under the Discovery Order, which required disclosure of legal theories and factual bases. Consequently, the Court maintained its decision to exclude both Bunnage applications from Lilly’s affirmative case. Lilly also raised an issue concerning the Court's refusal to allow the use of these applications during the cross-examination of Dr. Bell.
Lilly's argument centers on Dr. Bell's deposition and trial testimony regarding Pfizer's identification of benign prostatic hyperplasia (BPH) as a target for PDE5 inhibitors. During the deposition, Dr. Bell confirmed that Pfizer had recognized this potential, referencing a patent application filed in 1998 and its earlier priority date of April 25, 1997, which predates the filing of the ’124 patent. Lilly highlighted passages from the Bunnage PCT Application indicating BPH as a therapeutic use for selective PDE5 inhibitors, which Dr. Bell acknowledged.
At trial, UroPep inquired whether other PDE5 inhibitors, like sildenafil, could treat BPH, to which Dr. Bell affirmed. However, UroPep did not ask about Pfizer's consideration of patenting sildenafil. Lilly later questioned Dr. Bell regarding Pfizer's prior patent claims for sildenafil's use in treating BPH before 1997, but UroPep objected due to a previous court order limiting discussion of the Bunnage applications, which led to a ruling allowing only limited inquiry. Dr. Bell stated his knowledge of sildenafil's use for BPH came from a 2014 paper, and he speculated that Pfizer began investigating sildenafil for BPH after their initial FDA submission in September 1997.
Pfizer's inquiry into the use of sildenafil for treating benign prostatic hyperplasia (BPH) prior to September 1997 is central to the dispute between Lilly and UroPep. Dr. Bell, a key witness, stated he had no knowledge of such inquiries before that date. Lilly attempted to impeach Dr. Bell by misrepresenting his deposition testimony, claiming he could recall the date after having his memory refreshed. UroPep objected, arguing that Dr. Bell's deposition answers were based on documents provided by Lilly, not his independent recollection. The court questioned Lilly's rationale for using these documents to refresh Dr. Bell's memory, drawing a distinction between refreshing recollection and merely reading from a document. Ultimately, the court ruled that there was no evidence Dr. Bell had an independent recollection that could be refreshed by the documents, concluding that Lilly's arguments to question Dr. Bell about the documents were flawed. The court noted Dr. Bell may have seen the Bunnage PCT Application but likely had no knowledge of the earlier Bunnage UK Application or its April 1997 reference. Thus, Lilly's attempt to use the Bunnage applications did not successfully refresh Dr. Bell's memory regarding the priority date.
The use of the Bunnage applications was deemed inappropriate as it would distort the refreshing recollection procedure under Rule 612 of the Federal Rules of Evidence. Rule 612 permits a witness to refresh their memory with a writing only if it actually aids recall, not to implant specific responses. The court retains discretion to withhold documents if they may prompt a witness to testify from “false memory” rather than their independent recollection. In this instance, the Bunnage applications were not used to refresh Dr. Bell’s memory but rather to introduce the priority date of April 25, 1997 by having him repeat it, which violates Rule 103(d) that aims to prevent inadmissible evidence from influencing the jury. The court highlighted the concern of introducing otherwise inadmissible evidence under the pretext of refreshing recollection. Furthermore, at Dr. Bell’s deposition, the Bunnage applications were shown to him to “educate” him, leading to his agreement on the priority date. At trial, questions posed by Lilly appeared designed to elicit responses based on the deposition materials or to set up for impeachment if Dr. Bell’s testimony did not align with the content of the applications.
Dr. Bell's testimony indicated that Pfizer scientists began exploring sildenafil for treating benign prostatic hyperplasia (BPH) in September 1997. Lilly attempted to challenge his credibility by referencing the Bunnage applications, which is deemed an improper impeachment strategy. Courts have cautioned against using impeachment to introduce inadmissible evidence, as it circumvents evidentiary rules. Specific case law supports the notion that impeachment should not serve as a means to present substantive evidence that is otherwise inadmissible. In Dr. Bell's case, Lilly's impeachment effort was flawed for two reasons: it aimed to utilize the content of an inadmissible document and failed to demonstrate any inconsistency between Dr. Bell's deposition and trial testimonies. During trial, Dr. Bell confirmed that Pfizer began investigating sildenafil for BPH after its initial FDA submission in September 1997 and denied prior exploration. His responses were consistent with his earlier acknowledgment of the Bunnage applications, which mentioned the potential of PDE5 inhibitors for various medical conditions, including BPH.
Dr. Bell's interpretation of Pfizer's interest in using sildenafil for treating a specific condition could reasonably be seen as indicating a greater commitment to treating BPH, rather than just acknowledging its potential efficacy. Lilly’s attempt to use the Bunnage applications for impeachment was ineffective, as it would not contradict Dr. Bell's testimony and could prejudicially sway the jury regarding the validity of the ’124 patent by suggesting it was invalidated by the Bunnage UK Application. The Court found that introducing these materials at trial would not be mitigated by a limiting instruction, as UroPep did not open the door for such evidence. Lilly’s arguments regarding impeachment and refreshing recollection were deemed inappropriate for this case, as they attempted to introduce inadmissible evidence through cross-examination.
Regarding the cross-examination of Dr. Rotella, UroPep challenged his testimony by referencing a patent he co-invented, aiming to highlight similarities to the ’124 patent. Lilly argued this cross-examination was improper and prejudicial, warranting a new trial. However, there was a pre-trial agreement that allowed for questioning on matters discussed during Dr. Rotella's deposition, including obviousness, despite his trial testimony focusing on written description and enablement. Dr. Rotella is associated with U.S. Patent No. 6,087,368, which involves quinazolinone compounds used for treating cGMP-related conditions like erectile dysfunction.
UroPep did not introduce the ’368 patent as evidence but utilized it to cross-examine Dr. Rotella regarding his opinions on the invalidity of UroPep’s ’124 patent. Lilly contested that UroPep's use of the ’368 patent was inappropriate, claiming it did not contradict Dr. Rotella's testimony. However, the court found that the omission of BPH from the ’368 patent, which includes a variety of conditions treatable with PDE5 inhibitors, suggests that as of 1998, Dr. Rotella and the patent's inventors did not consider BPH a viable treatment target. This omission raises questions about Dr. Rotella's assertion that it would have been obvious to apply PDE5 inhibitors to treat BPH in 1997.
Regarding written description and enablement, Dr. Rotella's invalidity opinions relied on the lack of quantitative clinical data in the T24 patent; however, he conceded during cross-examination that the ’368 patent also lacked such data. This absence potentially undermines his argument that clinical data is necessary for adequately describing and enabling the invention. Lilly maintained that the list of conditions in the ’368 patent was not exhaustive and that its omission of BPH was therefore negligible. They also argued that the two patents could be distinguished by the detailed disclosures and narrower claims of the ’368 patent compared to the ’124 patent.
Lilly posited that any shortcomings in Dr. Rotella’s ’368 patent were irrelevant since the validity of the ’124 patent is independent of the ’368 patent’s status. Nevertheless, UroPep's cross-examination aimed to illustrate similarities between the patents, potentially impacting the jury's perception of Dr. Rotella's credibility. Finally, Lilly expressed concerns about the limited trial time to adequately explain complex concepts of medicinal chemistry and patent law, suggesting that UroPep's arguments were presented too simplistically for the jurors to fully understand.
The parties agreed to conduct a five-day trial, with Lilly seeking 14 hours of trial time. The Court informed them that accommodating 14 hours for both sides would be challenging and proposed 12 hours each, which was accepted without objection. During the trial, Lilly had the chance to address issues from UroPep’s cross-examination of Dr. Rotella and utilized this opportunity effectively. The Court dismissed Lilly’s late assertion of inadequate time to respond to cross-examination issues, noting that Lilly successfully incorporated four affirmative defenses, extensive testimony on damages, and information on Cialis's development within the allotted time. Consequently, Lilly's motion for judgment as a matter of law and a new trial was denied, and the case was directed to be closed.
Additionally, the document addresses patent claims, detailing that following an amendment to the 124 patent, the examiner rejected claims as anticipated by the '061 patent, leading to a terminal disclaimer from the patentees. The claims of the T24 patent were subsequently allowed. Lilly's only infringement challenge suggested that doctors might prescribe Cialis for benign prostatic hyperplasia (BPH) without a proper diagnosis. However, Dr. Sliwinski testified about his diagnostic process, allowing the jury to reasonably conclude his experience was typical. Lilly further argued against UroPep’s experts regarding zaprinast, a PDE5 inhibitor mentioned in the 124 patent, but relied on evidence not presented to the jury, rendering their arguments ineffective in challenging the jury's findings.
Results and error margins presented in the exhibits are inadequate to substantiate Lilly's invalidity claim, particularly given the established understanding among skilled professionals and publications recognizing Zaprinast as a selective PDE5 inhibitor. Lilly’s reference to a 2007 review by Dr. Rotella to argue that a PDE4 inhibitor shares a core structure is irrelevant, as that portion was not discussed at trial and served a different purpose. The relevant disclosure significantly details benign prostatic hyperplasia (BPH) treatment using specific PDE inhibitors, particularly in the context of relaxing prostatic muscles. The court has previously addressed these points in a post-trial memorandum, noting that the prosecution history contradicts Lilly's theory by indicating that the patentees amended their claims to exclude all PDE inhibitors previously patented for treating BPH. Additionally, Lilly's expert, Dr. Roehrborn, cited relevant articles on PDE5 inhibitors in his works, referencing the experiments noted in the ’124 patent. The case applies the pre-AIA version of section 102(b) since the patent application predates the 2013 amendments. Although Lilly indicated a willingness to present evidence regarding the Cheung publication's availability in libraries, no such evidence was submitted at trial. The written description requirement necessitates that a person of ordinary skill recognizes the full scope of the claimed invention as possessed by the inventor at the filing date. Lilly proposed an instruction based on inherent anticipation law, which the court noted had not been used outside that context. Lastly, the court has also thoroughly addressed Lilly's section 101 argument in its post-trial memorandum.
Lilly retracted the Bunnage applications as prior art after UroPep clarified their legal status concerning the '124 patent. The Bunnage PCT Application, filed in November 1998, was submitted after the '124 patent's priority date of July 9, 1997, disqualifying it as prior art. Although the Bunnage UK Application was filed in April 1997, it was unpublished and thus did not meet the criteria under 35 U.S.C. 102(e). During his deposition, Dr. Bell did not recall the priority date of the Bunnage UK Application independently but learned it when Lilly's counsel presented the applications to him, seeking to "educate" him on the date. Consequently, the Bunnage applications did not enhance Dr. Bell's memory at the deposition nor would they assist him at trial; he merely accepted the date as presented. His recollection was not independently refreshed; he was guided to the date, which he acknowledged as plausible without having reviewed the initial documents.
