DCT

2:19-cv-21384

Corcept Therap Inc v. Teva Pharma USA Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-21384, D.N.J., 12/13/2019
  • Venue Allegations: Venue is based on Defendant Teva USA's registration to do business, employee presence, and business operations in New Jersey, and on Defendant Teva Ltd.'s alleged control over its U.S. subsidiary and purposeful availment of the forum.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's KORLYM® (mifepristone) product constitutes an act of infringement of a patent covering a method for administering the drug.
  • Technical Context: The technology relates to pharmaceutical methods designed to optimize the absorption and bioavailability of the drug mifepristone by administering it in conjunction with a meal.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendants' submission of ANDA No. 211436 and a corresponding Paragraph IV certification notice to Plaintiff. The certification asserts that the patent-in-suit is invalid, unenforceable, or will not be infringed by the proposed generic product. The patent-in-suit is listed in the FDA's "Orange Book" as covering Plaintiff's KORLYM® product. The complaint notes prior litigation between the parties involving related subject matter.

Case Timeline

Date Event
2011-11-18 Priority Date for U.S. Patent No. 10,500,216
2018-01-31 Earliest date of Teva's 1st Paragraph IV Notice Letter
2018-05-14 Earliest date of Teva's 2nd Paragraph IV Notice Letter
2019-01-14 Earliest date of Teva's 3rd Paragraph IV Notice Letter
2019-05-08 Earliest date of Teva's 4th Paragraph IV Notice Letter
2019-06-20 Earliest date of Teva's 5th Paragraph IV Notice Letter
2019-12-10 U.S. Patent No. 10,500,216 Issued
2019-12-13 Complaint Filed

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

U.S. Patent No. 10,500,216 - “Optimizing mifepristone absorption”

  • Patent Identification: U.S. Patent No. 10,500,216, “Optimizing mifepristone absorption,” issued December 10, 2019.

The Invention Explained

  • Problem Addressed: The patent's background section states that administration of a standard dose of mifepristone can lead to "widely varying plasma drug concentration in different patients," with differences as high as 800%, potentially rendering the dose sub-therapeutic for some individuals (U.S. Patent No. 10,500,216, col. 1:33-40).
  • The Patented Solution: The invention is a method for increasing and standardizing the absorption of mifepristone. The method involves administering the drug within a specific timeframe after a patient has consumed a meal, which is alleged to increase both the maximum plasma concentration (Cmax) and the total drug exposure (Area Under the Curve, or AUC) compared to administration in a fasted state ('216 Patent, Abstract; col. 1:47-57). This approach aims to enhance the therapeutic benefit and predictability of a given dose ('216 Patent, col. 2:18-22).
  • Technical Importance: The patented method purports to offer a solution to the problem of erratic bioavailability, a significant challenge in oral drug delivery, thereby allowing for more consistent and effective treatment ('216 Patent, col. 1:40-43).

Key Claims at a Glance

  • The complaint asserts "one or more claims" of the '216 Patent (Compl. ¶36). The patent contains one independent claim, Claim 1.
  • Independent Claim 1 requires:
    • A method for improving mifepristone absorption in a patient with Cushing's Syndrome.
    • Administering a 1200 mg daily oral dose of mifepristone for at least 7 days.
    • The administration must occur "within 30 minutes after consuming a meal."
    • The method must result in an altered pharmacokinetic profile, specifically an increase in Cmax and AUC compared to administration without food.
    • The resulting increase in AUC must be "at least 44%."
  • The complaint's broad allegation of infringing "one or more claims" suggests the right to assert dependent claims 2-4 is preserved.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Teva's Proposed Product," a generic version of Corcept's 300 mg mifepristone tablets, for which Teva seeks FDA approval via ANDA No. 211436 (Compl. ¶1).

Functionality and Market Context

  • The complaint alleges that Teva seeks to market its generic product for the same indication as Corcept's branded drug, KORLYM®: the treatment of hyperglycemia secondary to hypercortisolism in adult patients with Cushing's syndrome (Compl. ¶10). The act of infringement alleged is the submission of the ANDA itself under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶36). The infringement theory is predicated on the allegation that the proposed labeling for Teva's product will instruct physicians and patients to administer the drug in a manner that practices the method claimed in the '216 Patent.

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed, element-by-element infringement analysis or a claim chart. The infringement theory is based on the statutory act of filing ANDA No. 211436, which under 35 U.S.C. § 271(e)(2)(A) constitutes infringement if the proposed generic product, once marketed, would infringe the asserted patent (Compl. ¶36). The analysis below summarizes the infringement allegations as inferred from the complaint, which presumes the proposed label for Teva's product will instruct a method of use that meets all limitations of the asserted claims.

No probative visual evidence provided in complaint.

'216 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of improving absorption of mifepristone in a patient suffering from Cushing's Syndrome, comprising Teva's proposed generic product is intended for the same patient population as KORLYM®, which includes patients with Cushing's syndrome. ¶10 col. 13:1-3
administering to the patient for at least 7 days an oral dose of mifepristone of 1200 mg per day within 30 minutes after consuming a meal, It is alleged that the proposed labeling for Teva's product will instruct a dosing regimen that meets these specific dosage, duration, timing, and food-related requirements. ¶36, ¶39 col. 13:2-5
such that the pharmacokinetics of mifepristone are altered by increasing the maximum plasma concentration (Cmax) and increasing the area under the curve (AUC) as compared to the Cmax and AUC that would result from administering mifepristone without food in the fasted state in the absence of the meal, As a bioequivalent generic, Teva's product, when administered as instructed, is alleged to produce the same pharmacokinetic alterations as the branded drug. ¶1, ¶36 col. 13:5-10
said increase in AUC being at least 44% and thereby increasing mifepristone absorption in the patient. The complaint alleges that the use of Teva's product as directed will result in the specific, quantitative increase in drug exposure recited in the claim. ¶36, ¶39 col. 13:10-12
  • Identified Points of Contention:
    • Technical Questions: A potential issue is whether the "at least 44%" increase in AUC is an inevitable consequence of following the claimed administration steps for any patient with any meal. The patent itself bases this figure on a study with a "moderate fat meal" ('216 Patent, col. 12:1-3). The defense may question whether this functional limitation is met under all conditions covered by the broad term "a meal," which could raise issues of definiteness and enablement.
    • Scope Questions: The primary dispute in an ANDA case is typically patent validity rather than infringement. However, a threshold question for infringement will be whether the final, FDA-approved label for Teva’s product contains instructions that direct users to perform all steps of the claimed method. Any deviation between the label's instructions and the claim limitations could provide a basis for a non-infringement argument.

V. Key Claim Terms for Construction

  • The Term: "a meal"

  • Context and Importance: This term's breadth is central to the scope of the claim. The claim requires a specific pharmacokinetic outcome (at least 44% AUC increase) to be achieved by administering the drug after "a meal." Practitioners may focus on this term because if the required outcome is only achieved with specific types of meals (e.g., high-fat), but not all meals, the defendant may argue the claim is invalid for lack of enablement or indefiniteness.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim uses the simple, unqualified term "a meal," which on its face does not appear to be limited to any particular type of food composition or caloric content.
    • Evidence for a Narrower Interpretation: The specification provides detailed examples of specific meals used in clinical testing, such as a "high-fat, low-fat or other type of meal," a "high-calorie" meal, and a "moderate fat breakfast (34% of total calories from fat)" ('216 Patent, col. 3:21-40). A party could argue that the term "a meal" should be construed in light of these specific examples that were shown to produce the claimed result.

  • The Term: "increase in AUC being at least 44%"

  • Context and Importance: This functional limitation is a critical potential point of dispute for both infringement and validity. The case may turn on whether this is interpreted as a required result for every individual patient on every occasion, or as an average or expected result across a patient population.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation (e.g., as an average): The patent discloses this 44% value based on clinical trial data from a group of subjects ('216 Patent, Table 1; col. 12:1-3). This may support an argument that the claim recites an expected average outcome rather than a guaranteed result in a single patient.
    • Evidence for a Narrower Interpretation (e.g., as a required outcome): The claim language "said increase in AUC being at least 44%" directly links the administration step to this specific quantitative outcome. A defendant could argue this creates a strict condition for infringement that must be met, and if not always met, the claim is invalid.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement to infringe under 35 U.S.C. § 271(b), asserting that Teva, with knowledge of the '216 Patent, will encourage direct infringement by physicians and patients through the instructions on its proposed product labeling (Compl. ¶39).
  • Contributory Infringement: The complaint alleges contributory infringement under 35 U.S.C. § 271(c), based on the theory that Teva's product is specifically designed for an infringing use and lacks a substantial non-infringing use (Compl. ¶40).
  • Willful Infringement: The complaint alleges that Teva has knowledge of the '216 Patent (Compl. ¶39), a prerequisite for willfulness. However, the complaint does not contain an explicit allegation of willful infringement or a request for enhanced damages.

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

  • A central question for the court will be one of validity: Is the claimed method, which recites a specific dosing regimen and a resulting quantitative pharmacokinetic effect, non-obvious over prior art that may teach general food effects on drug absorption or specific administration protocols for mifepristone?
  • A key issue of claim construction and validity will be whether the functional limitation "increase in AUC being at least 44%" tied to the broad term "a meal" renders the claim indefinite or not enabled. The resolution will likely depend on whether the evidence shows this outcome is consistently achieved under the conditions covered by the claim.
  • Finally, a dispositive infringement question will be one of label correspondence: Does the language of the proposed, and ultimately approved, label for Teva's generic product instruct a method of use that meets every limitation of the asserted claims, thereby constituting infringement under the specific provisions of the Hatch-Waxman Act?