DCT
2:15-cv-01202
Erfindergemeinschaft Uropep GBR v. Eli Lilly Co
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Erfindergemeinschaft UroPep GbR (Germany)
- Defendant: Eli Lilly and Company (Indiana); Brookshire Brothers, Inc. (Texas)
- Plaintiff’s Counsel: Fish & Richardson P.C.
- Case Identification: 2:15-cv-01202, E.D. Tex., 07/01/2015
- Venue Allegations: Plaintiff alleges venue is proper because Defendants transact business, have committed acts of infringement, and maintain regular and established places of business in the district. The complaint further alleges that Eli Lilly has previously submitted to the court's jurisdiction in other patent cases, and that Brookshire Brothers operates 29 pharmacies within the district.
- Core Dispute: Plaintiff alleges that Defendants' sale and promotion of the drug Cialis® for the treatment of benign prostatic hyperplasia (BPH) infringes a patent directed to methods of using phosphodiesterase type 5 (PDE5) inhibitors to treat prostatic diseases.
- Technical Context: The technology involves a pharmacological method for treating BPH, a non-cancerous enlargement of the prostate gland common in aging men, which can cause urinary symptoms.
- Key Procedural History: The complaint alleges that one of the patent’s co-inventors contacted an Eli Lilly scientist in July 2011 regarding the then-pending patent application. It further alleges that Plaintiff’s counsel sent a letter to Eli Lilly in October 2014, after the patent issued, stating that sales of Cialis for BPH appear to require a license. These alleged pre-suit contacts are cited as a basis for willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 1997-07-09 | '124 Patent Priority Date |
| 2008-01-01 | FDA approves Cialis® for erectile dysfunction (approximate date per complaint) |
| 2010-12-03 | Eli Lilly files supplemental FDA application for Cialis® to treat BPH |
| 2011-07-26 | Co-inventor allegedly emails Eli Lilly scientist about the pending U.S. patent application |
| 2011-10-06 | FDA approves Cialis® for treatment of the signs and symptoms of BPH |
| 2014-07-29 | U.S. Patent No. 8,791,124 issues |
| 2014-10-09 | Plaintiff's counsel sends letter to Eli Lilly regarding Cialis® and the '124 Patent |
| 2015-07-01 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 8,791,124, "Use of Phosphordiesterase Inhibitors in the Treatment of Prostatic Diseases," issued July 29, 2014.
The Invention Explained
- Problem Addressed: The patent describes benign prostatic hyperplasia (BPH) as a condition leading to severe difficulties in micturition (urination) that often requires surgical treatment. It notes that prior pharmacological treatments, such as alpha-receptor blockers or hormonal therapies, were characterized by "very low effectiveness, a slow onset of action, or significant side-effects." (’124 Patent, col. 1:11-31).
- The Patented Solution: The invention is a method of treating prostatic diseases by administering inhibitors of specific phosphodiesterase (sPDE) isoenzymes, particularly sPDE V. These inhibitors are intended to relax the smooth muscle cells of the prostate by preventing the breakdown of the cyclic nucleotides cAMP and cGMP, which are responsible for muscle relaxation. (’124 Patent, col. 1:32-48). The patent asserts that sPDE isoforms I, IV, and V are of "particular importance in human prostatic muscles," making them a suitable target for therapy. (’124 Patent, col. 2:6-9).
- Technical Importance: This approach provided a targeted pharmacological mechanism for BPH, aiming to improve urinary function by directly affecting prostatic muscle tissue, which could offer an alternative to less effective or side-effect-prone systemic treatments. (’124 Patent, col. 2:1-6).
Key Claims at a Glance
- The complaint asserts infringement of "one or more claims" of the ’124 Patent without identifying specific claims (Compl. ¶27). The first independent claim is Claim 1.
- Independent Claim 1:
- 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 a specific, enumerated list of compounds.
III. The Accused Instrumentality
- Product Identification: The accused product is Cialis®, whose generic name is tadalafil (Compl. ¶3).
- Functionality and Market Context: Cialis® is a phosphodiesterase 5 (PDE5) inhibitor. The complaint states that the U.S. Food and Drug Administration (FDA) approved Cialis® on October 6, 2011, "to treat the signs and symptoms of BPH." (Compl. ¶21). Plaintiff alleges that Defendant Eli Lilly manufactures, markets, and sells Cialis® for this BPH indication, and that Defendant Brookshire Brothers, a pharmacy chain, sells and distributes Cialis® to consumers for the treatment of BPH (Compl. ¶3, 4). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'124 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for ... treatment of benign prostatic hyperplasia | Defendant Eli Lilly markets Cialis®, and Defendant Brookshire Brothers dispenses it, for the express indication of treating the "signs and symptoms of BPH." | ¶3, 21, 27 | col. 8:19-21 |
| comprising administering to a person in need thereof an effective amount of an inhibitor of phosphodiesterase (PDE) V | Cialis® is identified as a PDE5 inhibitor that is administered to patients for the treatment of BPH. | ¶3 | col. 8:21-23 |
| excluding a compound selected from the group consisting of dipyridamole, 2-(N-(4-carboxypiperidine)-6-chloro-4(3,4-(methylendioxy)benzyl)amino)quinazoline, 2,3-dihydro-8-hydroxy-7-nitro-1,4-benzodioxine-2-methanol, alpha-nitrate, 4((3,4-(methylendioxy)benzyl)amino)-6,7,8-trimethoxy-quinazoline, [and other specific compounds] | The complaint implicitly alleges that Cialis® (tadalafil), the active ingredient, is not one of the specific compounds or salts explicitly excluded by the claim language. | ¶27 | col. 8:23-41 |
- Identified Points of Contention:
- Scope Questions: The primary infringement question may turn on the scope of the claimed method. A defendant could argue that the accused product's FDA-approved indication for treating the "signs and symptoms of BPH" (Compl. ¶21) is distinct from the "treatment of benign prostatic hyperplasia" as required by the claim. This raises the question of whether a method that alleviates symptoms without necessarily reversing the underlying cellular growth of the prostate falls within the claim's scope.
- Technical Questions: The claim includes a negative limitation excluding a list of specific compounds. While the complaint implicitly alleges that tadalafil is not on this list, a potential dispute could arise if a defendant argues that tadalafil is a salt, derivative, or otherwise falls within the scope of one of the excluded chemical entities, even if not listed by name.
V. Key Claim Terms for Construction
- The Term: "treatment of benign prostatic hyperplasia"
- Context and Importance: This term defines the entire purpose of the claimed method. Its construction is critical because the accused product, Cialis®, is indicated for the "signs and symptoms of BPH" (Compl. ¶21). Whether this FDA-approved indication meets the claim limitation will be a central issue.
- Intrinsic Evidence for a Broader Interpretation: The patent specification links BPH to a list of associated symptoms, including "pollacuria (frequent micturition), nycturia (nocturnal micturition), weakened urine jet, urge incontinence (involuntary discharge of urine), [and] prostatism," which it refers to as "urge symptoms." (’124 Patent, col. 2:20-23). Plaintiff may argue this language supports a construction where "treatment of BPH" encompasses the alleviation of its associated clinical symptoms.
- Intrinsic Evidence for a Narrower Interpretation: The patent’s background section describes BPH in terms of physical changes, such as "a benign growth of the prostate gland" where "glandular portions...increase by double their volume, and the muscular and fibrous portions increase by four times their volume." (’124 Patent, col. 1:11-19). A defendant may argue this supports a narrower, more literal construction requiring an effect on the underlying physical hyperplasia, not just its resulting symptoms.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that both defendants induce infringement under 35 U.S.C. § 271(b).
- For Eli Lilly, the alleged inducement is based on providing instructions, advertising, marketing materials, and prescribing information to distributors, physicians, and consumers that direct them to use Cialis® for BPH, thereby performing the patented method (Compl. ¶29).
- For Brookshire Brothers, inducement is alleged based on selling Cialis® to consumers for BPH and providing "individualized advice and support" and "wellness counseling" that encourage its use for that purpose (Compl. ¶34).
- Willful Infringement: Willfulness is alleged against Eli Lilly based on pre-suit knowledge of the patent and the infringing activity. The complaint asserts this knowledge arose from a July 2011 email from a co-inventor to an Eli Lilly scientist about the pending patent application and an October 2014 notice letter from Plaintiff's counsel to Eli Lilly's counsel (Compl. ¶22, 23, 30).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: can the phrase "treatment of benign prostatic hyperplasia," as used in the patent, be construed to cover the defendants' alleged activity of marketing and dispensing a drug for the "signs and symptoms of BPH"? The case may turn on whether the patent's language supports a functional, symptom-based definition or requires a stricter, histological definition of treating the underlying prostate enlargement.
- A key factual question will be one of knowledge and intent related to willfulness. The court will need to determine whether the alleged 2011 and 2014 pre-suit communications put Eli Lilly on sufficient notice of infringement to support a finding that its post-issuance conduct was objectively reckless, thereby exposing it to the possibility of enhanced damages.