DCT
3:17-cv-05087
Eli Lilly Co v. Macleods Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Eli Lilly and Company (Indiana) and ICOS Corporation (Delaware)
- Defendant: Macleods Pharma USA, Inc. (Delaware) and Macleods Pharmaceuticals, Ltd. (India)
- Plaintiff’s Counsel: McCARTER & ENGLISH, LLP
- Case Identification: Eli Lilly and Company v. Macleods Pharma USA, Inc., 3:17-cv-05087, D.N.J., 07/12/2017
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Macleods Pharma USA, Inc. has its principal place of business there, and both defendants collaborate to market and distribute generic drugs throughout the United States, including New Jersey. The complaint also asserts specific jurisdiction based on the filing of the Abbreviated New Drug Application (ANDA), which is directed at the U.S. market, including New Jersey.
- Core Dispute: Plaintiffs allege that Defendants' submission of an ANDA to the FDA seeking approval to market a generic version of the drug Cialis® (tadalafil) constitutes an act of infringement of a patent covering a method for treating sexual dysfunction.
- Technical Context: The technology relates to pharmaceutical methods using a specific phosphodiesterase type 5 (PDE5) inhibitor at a particular dosage range to treat sexual dysfunction, a significant therapeutic market.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of an ANDA containing a "Paragraph IV certification." This certification asserts that Plaintiffs' patent is invalid, unenforceable, and/or will not be infringed by the proposed generic product. Such a filing is defined by statute as an act of patent infringement to enable adjudication of patent rights prior to the launch of the generic drug.
Case Timeline
| Date | Event |
|---|---|
| 1999-04-30 | '166 Patent Priority Date |
| 2005-09-13 | '166 Patent Issue Date |
| 2017-05-30 | Date of Defendant's Notice Letter to Plaintiffs |
| 2017-07-12 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,943,166 - “Compositions Comprising Phosphodiesterase Inhibitors for the Treatment of Sexual Dysfunction”
- Patent Identification: U.S. Patent No. 6,943,166, “Compositions Comprising Phosphodiesterase Inhibitors for the Treatment of Sexual Dysfunction,” issued September 13, 2005 (’166 Patent). (Compl. ¶30).
The Invention Explained
- Problem Addressed: The patent's background describes how prior phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, were associated with significant adverse side effects, including facial flushing, vision abnormalities, and a clinically significant drop in blood pressure when used with organic nitrates. (’166 Patent, col. 2:5-30). This limited their use in certain patient populations.
- The Patented Solution: The invention is a method of treating sexual dysfunction by orally administering a specific compound, (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino[2',1':6,1]pyrido[3,4-b]indole-1,4-dione (tadalafil), in a relatively low unit dose of about 1 to 20 mg. (’166 Patent, Abstract; col. 2:31-48). This specific dosage regimen is described as providing an effective treatment while minimizing or eliminating the adverse side effects associated with other PDE5 inhibitors. (’166 Patent, col. 2:31-41).
- Technical Importance: The claimed method offered a therapeutic option for sexual dysfunction with a different side-effect profile, potentially enabling treatment for individuals who previously experienced unacceptable side effects or were taking contraindicated medications like nitrates. (’166 Patent, col. 2:41-48).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2, 4, 5, and 7-12. (Compl. ¶38).
- Independent Claim 1 requires:
- A method of treating sexual dysfunction in a patient in need thereof
- comprising orally administering one or more unit dose
- containing about 1 to about 20 mg,
- up to a maximum total dose of 20 mg per day,
- of a compound having a specific chemical structure (tadalafil).
III. The Accused Instrumentality
Product Identification
- Defendants' proposed tadalafil tablets, which are the subject of ANDA No. 207244 submitted to the FDA for approval to market a generic version of Cialis®. (Compl. ¶1).
Functionality and Market Context
- The accused instrumentality is the future commercial manufacture, use, and sale of generic tadalafil tablets. (Compl. ¶¶33, 58). The complaint alleges that Defendants' proposed product will be a tablet containing tadalafil as the active ingredient in 2.5 mg, 5 mg, 10 mg, and 20 mg dosage strengths. (Compl. ¶39). It is further alleged that this product will be marketed to treat male erectile dysfunction, consistent with the FDA-approved label for the brand-name drug, Cialis®. (Compl. ¶¶40-41).
IV. Analysis of Infringement Allegations
The complaint alleges that Defendants will induce infringement of the ’166 Patent because the label for the proposed generic product will instruct physicians and patients to administer it in a manner that practices the patented method. (Compl. ¶¶41, 44, 50). No probative visual evidence provided in complaint.
'166 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a method of treating sexual dysfunction in a patient in need thereof | Defendants' proposed product will be marketed to treat male erectile dysfunction, a form of sexual dysfunction, consistent with the FDA-approved label for Cialis®. | ¶41 | col. 14:65-66 |
| comprising orally administering one or more unit dose | Defendants' proposed product is a tablet for oral administration. | ¶39 | col. 14:67-68 |
| containing about 1 to about 20 mg ... of a compound having the structure [tadalafil] | Defendants' proposed product will be tablets containing tadalafil in dosage strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg, which fall within the claimed range. | ¶39 | col. 14:68-15:15 |
| up to a maximum total dose of 20 mg per day | Defendants' marketing and product label are alleged to be consistent with the Cialis® label, which directs administration within this maximum daily dose. | ¶41 | col. 15:1-2 |
- Identified Points of Contention:
- Scope Questions: The complaint presents a direct mapping of the proposed product's characteristics to the claim limitations. A potential point of contention in such cases often centers on the interpretation of "about" if a dosage fell near the boundary of the claimed range, but the dosages alleged here (2.5, 5, 10, and 20 mg) fall squarely within it.
- Technical Questions: The primary question is not one of technical operation but of inducement. What evidence will establish that Defendants' proposed product label will instruct users to perform the claimed method? The complaint alleges this will be consistent with the existing Cialis® label (Compl. ¶41), which will be a key piece of evidence.
V. Key Claim Terms for Construction
The Term: "about 1 to about 20 mg"
Context and Importance: This term defines the core dosage range of the invention. Its construction is critical to determining the scope of the claim. Practitioners may focus on this term to confirm that the defendants' specific proposed dosages are captured and to understand the permissible variance from the recited numerical endpoints of 1 and 20.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The repeated use of the word "about" in the specification when describing the dosage range suggests that the inventors did not intend for the numerical values to be strict, exact limits. (’166 Patent, Abstract; col. 2:61-62).
- Evidence for a Narrower Interpretation: The specification provides specific examples and data for dosages within this range (e.g., 2 mg, 5 mg, 10 mg, and 25 mg are tested in a clinical study), which a party could argue cabins the reasonable scope of "about." (’166 Patent, col. 8:10-12). The claims themselves recite the specific "1 to ... 20 mg" range.
The Term: "sexual dysfunction"
Context and Importance: This term defines the medical indication for the claimed method. Its scope determines the types of conditions covered by the patent. The complaint focuses on male erectile dysfunction, but the patent may support a broader meaning.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification explicitly states that "Specific conditions that can be treated by the present invention, include, but are not limited to, male erectile dysfunction and female sexual dysfunction, particularly female arousal disorder." (’166 Patent, col. 3:7-10). Dependent claims 2 and 3 separately recite "male erectile dysfunction" and "female arousal disorder," respectively, suggesting the parent term "sexual dysfunction" in claim 1 is broader than either alone.
- Evidence for a Narrower Interpretation: The detailed clinical examples provided in the patent focus exclusively on the treatment of male erectile dysfunction. (’166 Patent, col. 7:57–col. 8:64). A party might argue the term should be construed in light of these specific embodiments.
VI. Other Allegations
- Indirect Infringement: The complaint is premised on induced infringement. It alleges that Defendants, by filing an ANDA for a generic version of Cialis®, have taken a substantial step to encourage, recommend, or promote infringement. (Compl. ¶¶57-58). Knowledge of the patent is established by Defendants' Notice Letter and Paragraph IV certification. (Compl. ¶¶33, 36). Intent to induce is alleged based on the act of seeking FDA approval to market a product with a label that will instruct users to perform the patented method. (Compl. ¶¶41, 44, 50).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be patent validity: The infringement theory in an ANDA case often relies on the generic product's label mirroring the innovator's label, thereby mapping onto the patent claims. Consequently, the core of the dispute will likely shift to the invalidity arguments (e.g., obviousness, lack of written description) that Defendants asserted in their Paragraph IV certification and will raise in their answer.
- A key evidentiary question will be one of inducement: Assuming the patent is valid, does the specific language in the Defendants' proposed product labeling, as submitted to the FDA, actively instruct or encourage medical professionals and patients to administer the drug in a manner that meets all the limitations of the asserted method claims?