DCT

1:17-cv-00393

Novartis Pharma Corp v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00393, D. Del., 04/07/2017
  • Venue Allegations: Venue is alleged to be proper based on Defendant's incorporation in Delaware, its registration to do business and distribute pharmaceutical products in the state, and its purposeful direction of activities toward Delaware by filing an Abbreviated New Drug Application (ANDA) with the intent to market products there.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an ANDA to the FDA seeking approval to market generic everolimus tablets constitutes an act of infringement of four patents covering specific methods of using everolimus to treat various cancers.
  • Technical Context: The dispute is in the field of oncology therapeutics, specifically concerning the compound everolimus (marketed by Novartis as AFINITOR®), an mTOR inhibitor used to treat several types of advanced cancers.
  • Key Procedural History: This lawsuit was filed under the Hatch-Waxman Act following Plaintiff’s receipt of a Paragraph IV certification notice letter from Defendant. The letter, dated February 21, 2017, asserted that claims of the patents-in-suit are invalid and/or would not be infringed by Defendant's proposed generic product. The complaint was filed within the 45-day statutory window, triggering a 30-month stay on FDA approval of Teva's ANDA.

Case Timeline

Date Event
2001-02-19 Priority Date for ’131, ’962, and ’010 Patents
2005-11-21 Priority Date for ’224 Patent
2009-03-30 FDA approves AFINITOR® (5 mg and 10 mg strengths)
2010-07-09 FDA approves AFINITOR® (2.5 mg strength)
2011-07-29 FDA approves AFINITOR® (7.5 mg strength)
2013-04-02 U.S. Patent No. 8,410,131 ('131 Patent) issues
2013-05-07 U.S. Patent No. 8,436,010 ('010 Patent) issues
2014-07-15 U.S. Patent No. 8,778,962 ('962 Patent) issues
2015-04-14 U.S. Patent No. 9,006,224 ('224 Patent) issues
2017-02-21 Plaintiff receives Defendant’s Paragraph IV Notice Letter
2017-04-07 Complaint filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,006,224 - "Neuroendocrine Tumor Treatment"

The Invention Explained

  • Problem Addressed: The patent addresses the treatment of endocrine tumors, noting that pancreatic neuroendocrine tumors (NETs) have long-term metastatic potential and that a high percentage of patients present with liver metastases at the time of diagnosis (’224 Patent, col. 3:1-6). This points to a need for effective therapies for advanced forms of the disease.
  • The Patented Solution: The invention is a specific method of using an mTOR inhibitor, everolimus, to treat a particular subset of patients: those with pancreatic neuroendocrine tumors that are "advanced" and are being treated "after failure of cytotoxic chemotherapy" (’224 Patent, col. 27:26-28; Abstract). This method involves administering everolimus as a monotherapy, targeting a specific clinical scenario.
  • Technical Importance: The patent carves out a specific patient population for a known drug, aiming to provide a targeted treatment regimen for patients with advanced disease who have already failed a prior line of therapy (’224 Patent, col. 27:26-28).

Key Claims at a Glance

  • The complaint asserts claims 1-3 of the ’224 Patent (Compl. ¶28).
  • Independent Claim 1 recites:
    • A method for treating pancreatic neuroendocrine tumors in a human subject in need thereof;
    • comprising administering to the subject a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin (everolimus);
    • as a monotherapy;
    • and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.

U.S. Patent No. 8,410,131 - "Cancer Treatment"

The Invention Explained

  • Problem Addressed: The patent background describes a general need to expand the available treatments for solid tumors, particularly for cases where existing anticancer compounds do not result in disease regression or stabilization (’131 Patent, col. 2:56-62).
  • The Patented Solution: The invention provides a method for treating a specific category of solid tumors—those of the "excretory system"—by administering everolimus (’131 Patent, Abstract; col. 3:27-29). The specification explicitly includes kidney and renal pelvis tumors within the scope of "excretory system tumors" (’131 Patent, col. 3:27-29).
  • Technical Importance: This patent claims a new use for everolimus focused on a particular organ system, thereby expanding the compound's therapeutic applications beyond its initial uses.

Key Claims at a Glance

  • The complaint asserts claims 1-9 of the ’131 Patent (Compl. ¶28).
  • Independent Claim 1 recites:
    • 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 (which is defined to include everolimus).

U.S. Patent No. 8,778,962 - "Treatment of Solid Tumors with Rapamycin Derivatives"

The Invention Explained

  • Technology Synopsis: The ’962 Patent addresses the need for treatments for solid tumors and claims a method for inhibiting the growth of non-malignant solid tumors of the brain by administering everolimus (’962 Patent, col. 2:56-62; col. 17:1-3).
  • Accused Features: Teva is accused of infringement through its ANDA seeking approval for treating patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma (SEGA), a type of non-malignant brain tumor (Compl. ¶25, ¶45).

Key Claims at a Glance

  • Asserted Claims: Claims 1-6 are asserted (Compl. ¶28). Independent claim 1 is directed to a method of inhibiting growth of non-malignant solid tumors of the brain.

U.S. Patent No. 8,436,010 - "Treatment of Solid Tumors with Rapamycin Derivatives"

The Invention Explained

  • Technology Synopsis: The ’010 Patent addresses the need for combination cancer therapies and claims a method for inhibiting the growth of solid breast tumors by administering everolimus either concomitantly or sequentially with exemestane (’010 Patent, col. 2:56-62; col. 17:46-51).
  • Accused Features: Teva is accused of infringement through its ANDA seeking approval for treating postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane (Compl. ¶26, ¶53).

Key Claims at a Glance

  • Asserted Claims: Claims 1-11 are asserted (Compl. ¶28). Independent claim 1 is directed to a method of inhibiting the growth of solid breast tumors with the combination therapy.

III. The Accused Instrumentality

Product Identification

  • The accused products are Teva’s generic everolimus tablets in 2.5 mg, 5 mg, 7.5 mg, and 10 mg dosage strengths, for which Teva filed an ANDA seeking FDA approval (the "ANDA Products") (Compl. ¶21).

Functionality and Market Context

  • The act of infringement alleged under the Hatch-Waxman Act is the filing of the ANDA itself (Compl. ¶30). The complaint alleges that if Teva's ANDA is approved, the product will be marketed and sold for the same indications as Novartis's branded drug, AFINITOR®, including advanced renal cell carcinoma (RCC), pancreatic neuroendocrine tumors (PNET), certain breast cancers, and non-malignant brain tumors (SEGA) (Compl. ¶22-26). The functionality that is alleged to be infringing is the administration of the generic drug according to the methods described in the proposed product labeling, which Novartis alleges will replicate the instructions for AFINITOR® and thereby practice the patented methods (Compl. ¶33, ¶38, ¶45, ¶53).

IV. Analysis of Infringement Allegations

'224 Patent Infringement Allegations

Claim Elements (from Independent Claim 1)

  • A method for treating pancreatic neuroendocrine tumors in a human subject in need thereof
  • comprising administering to the subject a therapeutically effective amount of... [everolimus]...
  • as a monotherapy
  • and wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy.

Identified Points of Contention

  • Scope Questions: The complaint notes that Teva’s notice letter did not deny infringement of claims 1-3 but asserted they are invalid (Compl. ¶28, ¶37). The primary dispute may center on validity rather than infringement. A key question for the court will be whether the claimed patient population—those with advanced PNET who have failed cytotoxic chemotherapy—was obvious over the prior art.
  • Technical Questions: The infringement case hinges on Teva’s proposed product label. A technical question is whether the instructions for use on Teva's label will direct physicians to administer everolimus as a monotherapy specifically to the patient population defined by the claim.

'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 The complaint alleges Teva seeks approval for its ANDA Products for the treatment of adults with advanced renal cell carcinoma (RCC), which is a tumor of the kidney, an organ of the excretory system. ¶22, ¶38 col. 3:27-29
said method consisting of administering to said subject a therapeutically effective amount of... [everolimus] The administration of Teva's ANDA Products, which contain everolimus, for the treatment of RCC as will be instructed on the product's label is alleged to meet this limitation. ¶21, ¶38 col. 18:35-45

Identified Points of Contention

  • Scope Questions: A central dispute will likely involve the term "consisting of." This is highly restrictive language that generally prohibits any additional, unrecited steps or components. The question will be whether Teva's proposed method of use, as described on its label, includes any other active steps that would place it outside the scope of a method "consisting of" administering everolimus.
  • Technical Questions: While RCC is a kidney cancer, and the kidney is an excretory organ, the court may need to resolve whether the specific type of cancer covered by Teva's proposed label falls squarely within the patent's definition of "solid excretory system tumors" as understood by a person of ordinary skill in the art at the time.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The Term: "advanced tumors after failure of cytotoxic chemotherapy" (’224 Patent, Claim 1)

  • Context and Importance: This term defines the specific patient population for the claimed method. The construction of this phrase is critical because it sets the boundary of infringement. A narrow definition might exclude patient groups covered by Teva's proposed label, while a broad one would expand the patent's reach. Practitioners may focus on this term because it is a clinical limitation that may not be explicitly defined in the specification, leaving it open to interpretation based on extrinsic evidence and the understanding of a skilled artisan.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not appear to provide a specific, limiting definition of "advanced" or "failure of cytotoxic chemotherapy," which may suggest the terms should be given their plain and ordinary meaning in the clinical context, potentially covering a wide range of disease progression and prior treatment outcomes.
    • Evidence for a Narrower Interpretation: The specification discusses specific clinical trials used to demonstrate efficacy (’224 Patent, col. 25-26). A party could argue that the term should be interpreted in light of the patient populations in those specific trials, which could lead to a narrower construction.

The Term: "consisting of" (’131 Patent, Claim 1)

  • Context and Importance: This is a legal term of art in patent law that creates a "closed" claim, meaning the claimed method must not include any other active steps beyond what is recited. Its construction is central because if Teva's proposed product label instructs for any additional active therapeutic steps alongside the administration of everolimus, it may fall outside the claim's scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party might argue that "consisting of" only excludes other active pharmaceutical ingredients and does not exclude routine clinical steps or the administration of supportive care agents, which would not be considered part of the "method for inhibiting growth."
    • Evidence for a Narrower Interpretation: The patent uses the more open-ended term "comprising" in other claims and contexts (e.g., ’131 Patent, col. 4:51-54, discussing pharmaceutical combinations), while deliberately choosing "consisting of" for claim 1. This contrast suggests the patentee intended a highly restrictive meaning, precluding any other active treatment steps whatsoever.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all four patents, stating that Teva's proposed product labeling will actively instruct and encourage physicians and patients to administer the generic drug in a manner that directly infringes the claimed methods (Compl. ¶33, ¶38, ¶45, ¶53). The complaint also alleges contributory infringement for the ’131, ’962, and ’010 patents, asserting that the ANDA Products are a material part of the patented methods, are not a staple article of commerce suitable for substantial non-infringing use, and are especially made or adapted for an infringing use (Compl. ¶42-43, ¶50-51, ¶57-58).
  • Willful Infringement: The complaint does not explicitly use the word "willful." However, it alleges that Teva was aware of the patents-in-suit at the time it filed its ANDA and that the filing itself was an act of infringement (Compl. ¶31). This establishes pre-suit knowledge, which is a prerequisite for any potential future claim of willfulness.

VII. Analyst’s Conclusion: Key Questions for the Case

  • A central issue for the court will be one of validity. As Teva’s notice letter challenges the validity of numerous asserted claims (Compl. ¶28), the litigation will likely focus on whether the claimed methods of using everolimus for specific patient populations and indications were obvious or lacked adequate written description and enablement in view of the state of the art when the patents were filed.
  • A second key issue will be one of claim scope and interpretation. The dispute over the ’131 patent will likely turn on the restrictive "consisting of" language, raising the question of whether Teva's proposed label describes a method that is truly a monotherapy or includes other active steps. For the ’224 patent, the focus will be on the clinical definition of "advanced tumors after failure of cytotoxic chemotherapy" and whether Teva's intended market falls squarely within that definition.