DCT
1:15-cv-00474
Novartis Pharma Corp v. West Ward Pharma Intl Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novartis Pharmaceuticals Corporation (Delaware) and Novartis AG (Switzerland)
- Defendant: Roxane Laboratories, Inc. (Nevada)
- Plaintiff’s Counsel: McCarter & English, LLP
- Case Identification: Novartis Pharmaceuticals Corporation v. Roxane Laboratories, Inc., 1:15-cv-00474, D. Del., 06/10/2015
- Venue Allegations: Venue is alleged to be proper as Defendant markets and sells drug products in the District of Delaware and has agreed not to contest personal jurisdiction or venue for this action.
- Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application (ANDA) for a generic version of the cancer drug AFINITOR® (everolimus) infringes patents covering methods of using the drug to treat specific cancers.
- Technical Context: The patents-in-suit relate to methods of using the compound everolimus, an mTOR inhibitor, for the treatment of specific types of neuroendocrine and solid excretory system tumors.
- Key Procedural History: This is a Hatch-Waxman action initiated after Defendant amended its ANDA filing to include a Paragraph IV certification. The certification alleges that claims of Plaintiff's patents are invalid and, for one claim of one patent, not infringed by Defendant's proposed generic product. Plaintiff filed this complaint within the 45-day statutory window following receipt of Defendant's notification letter.
Case Timeline
| Date | Event |
|---|---|
| 2001-02-19 | U.S. Patent No. 8,410,131 Priority Date |
| 2005-11-21 | U.S. Patent No. 9,006,224 Priority Date |
| 2013-04-02 | U.S. Patent No. 8,410,131 Issued |
| 2015-04-14 | U.S. Patent No. 9,006,224 Issued |
| 2015-04-27 | Defendant sends Paragraph IV certification letter to Plaintiffs |
| 2015-06-10 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,006,224 - "Neuroendocrine Tumor Treatment," issued April 14, 2015
The Invention Explained
- Problem Addressed: The patent addresses the unmet medical need for effective treatments for patients with pancreatic neuroendocrine tumors (NETs), which have a high potential for metastasis and significant mortality, particularly after the failure of initial courses of chemotherapy ('224 Patent, col. 3:1-12).
- The Patented Solution: The invention is a method for treating this specific patient population by administering a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin, also known as everolimus ('224 Patent, col. 1:35-65). This method provides a targeted therapy, which inhibits the mTOR pathway, specifically as a monotherapy for patients whose advanced pancreatic NETs have progressed after cytotoxic chemotherapy ('224 Patent, Abstract; col. 27:27-33).
- Technical Importance: The invention provided a specific, targeted therapeutic strategy for a difficult-to-treat cancer sub-population with limited alternative treatment options ('224 Patent, col. 3:1-12).
Key Claims at a Glance
- The complaint alleges infringement of claims 1-3, with Claim 1 being independent (Compl. ¶20).
- Independent Claim 1:
- A method for treating pancreatic neuroendocrine tumors,
- comprising administering to a human subject in need thereof a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a monotherapy
- and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.
U.S. Patent No. 8,410,131 - "Cancer Treatment," issued April 2, 2013
The Invention Explained
- Problem Addressed: The patent’s background section notes the general need to expand the available treatment options for solid tumors, particularly for advanced solid tumors where existing anticancer compounds may not induce disease regression or stabilization (’131 Patent, col. 1:56-62).
- The Patented Solution: The invention provides a method for inhibiting the growth of a specific class of tumors, defined as "solid excretory system tumors," which includes tumors of the kidney and renal pelvis (’131 Patent, col. 2:28-29; col. 18:29-30). The claimed method consists of administering a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin (’131 Patent, Abstract; col. 18:26-32).
- Technical Importance: The invention identified a targeted use for a specific rapamycin derivative against tumors originating in the excretory system, a distinct class of malignancies (’131 Patent, col. 1:52-56).
Key Claims at a Glance
- The complaint alleges infringement of one or more claims, and Defendant's notice letter references claims 1-9 (Compl. ¶¶ 20, 24). Claim 1 is independent.
- Independent Claim 1:
- A method for inhibiting growth of solid excretory system tumors in a subject,
- said method consisting of administering to said subject a therapeutically effective amount of a compound of formula I
- (wherein the compound of formula I is defined in the claim as 40-O-(2-hydroxyethyl)-rapamycin).
III. The Accused Instrumentality
Product Identification
- Defendant's Abbreviated New Drug Application (ANDA) Products, which are everolimus tablets in 2.5 mg, 5 mg, 7.5 mg, and 10 mg dosage strengths (Compl. ¶15).
Functionality and Market Context
- The ANDA Products are intended to be generic versions of Plaintiff's AFINITOR® brand everolimus tablets (Compl. ¶¶ 9, 15). The act of infringement alleged is the submission of the ANDA to the U.S. Food and Drug Administration (FDA) seeking approval to market these tablets for indications that include the treatment of "advance renal cell carcinoma (RCC)" and "progressive neuroendocrine tumors of pancreatic origins (PNET)" (Compl. ¶¶ 16, 17, 22). If approved, the ANDA products would provide a lower-cost generic alternative to AFINITOR® for these indications (Compl. ¶6).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'224 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating pancreatic neuroendocrine tumors, | Defendant's ANDA seeks approval to market its products for the "treatment of adult patients with progressive neuroendocrine tumors of pancreatic origins (PNET) with unresectable, locally advanced or metastatic disease." | ¶17 | col. 27:27-28 |
| comprising administering to a human subject in need thereof a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a monotherapy | The active ingredient in the ANDA product is everolimus, which is 40-O-(2-hydroxyethyl)-rapamycin. The proposed product label will allegedly instruct for its administration as a monotherapy. | ¶¶15, 25 | col. 27:28-31 |
| and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy. | The proposed label for the ANDA product will allegedly contain instructions for use in patients with advanced tumors (unresectable, locally advanced, or metastatic) and will specify use after failure of cytotoxic chemotherapy. | ¶¶17, 26 | col. 27:31-33 |
- Identified Points of Contention:
- Validity Questions: According to the complaint, Defendant's Paragraph IV certification does not allege non-infringement of claims 1-3 of the '224 Patent but instead alleges they are invalid (Compl. ¶20). The central dispute will therefore likely concern whether the claimed method was obvious or anticipated by the prior art at the time of the invention.
'131 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for inhibiting growth of solid excretory system tumors in a subject, | Defendant's ANDA seeks approval for the indication of "treatment of advance renal cell carcinoma (RCC)," which is a tumor of the kidney, an organ of the excretory system. | ¶16 | col. 18:26-27 |
| said method consisting of administering to said subject a therapeutically effective amount of a compound of formula I | The ANDA product's active ingredient is everolimus, the compound of formula I. The proposed label will allegedly instruct its administration for inhibiting the growth of solid excretory system tumors. | ¶¶15, 29, 30 | col. 18:27-32 |
- Identified Points of Contention:
- Scope Questions: For dependent claim 4, which recites a "tumor of the renal pelvis," Defendant alleges non-infringement (Compl. ¶20). This raises the question of whether the accused indication, advanced RCC, is properly classified as a "tumor of the renal pelvis." The patent specification lists "kidney" and "renal pelvis" as separate examples of excretory system tumors, which may support an argument that the two are distinct (’131 Patent, col. 2:28-29).
- Technical Questions: The use of the term "consisting of" in claim 1 strictly limits the method to the single step of administering the compound. An issue may arise if Defendant's proposed product label instructs or permits the use of the drug in combination with other therapeutic agents for the treatment of RCC.
V. Key Claim Terms for Construction
For the ’224 Patent:
- The Term: "failure of cytotoxic chemotherapy"
- Context and Importance: This limitation defines the specific patient population eligible for the claimed treatment method. Its construction is critical for determining the scope of the claim, which will inform both the infringement analysis (i.e., whether the proposed label covers this population) and the validity analysis (i.e., what prior art is relevant).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not provide an explicit definition for the term, which may support adopting its plain and ordinary meaning as understood by a person of ordinary skill in the art.
- Evidence for a Narrower Interpretation: The detailed description discusses specific clinical trial designs, which a party might argue should be used to narrow the term to the failure of particular types or regimens of chemotherapy ('224 Patent, col. 26:10-48).
For the ’131 Patent:
- The Term: "consisting of"
- Context and Importance: This is a legal term of art that creates a strong presumption that the claim is "closed" and does not permit additional, unrecited method steps. The infringement analysis for claim 1 will depend entirely on whether Defendant's proposed instructions for use are limited solely to the administration of everolimus or if they include combination therapies.
- Intrinsic Evidence for Interpretation:
- Evidence for a Narrower Interpretation: The term itself, as used in the claim, is the primary intrinsic evidence (’131 Patent, col. 18:27). Established patent law treats this phrase as exclusionary, limiting the method to only the recited step.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). This is based on the allegation that Defendant's proposed product label for its ANDA Products will actively instruct and encourage physicians and patients to use the generic drug in a manner that directly infringes Plaintiff's patented methods (Compl. ¶¶ 25, 28, 30, 32). Knowledge is alleged based on Defendant's Paragraph IV certification and prior notification of the patents (Compl. ¶¶ 18, 20, 23).
- Willful Infringement: While the complaint does not use the term "willful," it alleges that Defendant was aware of the patents at the time it filed and/or amended its ANDA and that doing so was an act of infringement (Compl. ¶23). It specifically alleges notifying Defendant of the '224 Patent on the day it issued, establishing pre-suit knowledge (Compl. ¶18). These allegations could form the basis for a claim of willful infringement post-approval.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue for the court will be one of patentability: as raised in Defendant's Paragraph IV notice, were the claimed methods of using everolimus for treating advanced pancreatic NETs post-chemotherapy ('224 Patent) and for treating solid excretory system tumors ('131 Patent) obvious or anticipated by the prior art at the time of the inventions?
- A key question of claim construction will be the scope of the term "consisting of" in claim 1 of the '131 Patent. The outcome of the infringement analysis may depend on whether Defendant's proposed product label instructs or permits uses beyond the sole administration of everolimus, thereby potentially placing the accused method outside the claim's narrow scope.
- A further question of definitional scope relates to the '131 Patent: can "renal cell carcinoma" (the accused indication) be considered a "tumor of the renal pelvis" (the language of asserted dependent claim 4), especially given the patent specification's separate enumeration of "kidney" and "renal pelvis" as examples of excretory system tumors?