DCT

1:17-cv-01131

Purdue Pharma LP v. Alvogen Pine Brook LLC

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01131, D. Del., 08/11/2017
  • Venue Allegations: Plaintiffs allege venue is proper in the District of Delaware based on general venue statutes and on Defendants' actions in a related, long-running "Consolidated Action," where Defendants have filed counterclaims and have not contested venue.
  • Core Dispute: Plaintiffs allege that Defendants' submission of Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Plaintiffs' Hysingla® ER (hydrocodone bitartrate) product constitutes an act of infringement of five U.S. patents related to controlled-release and abuse-proofed opioid formulations.
  • Technical Context: The patents relate to pharmaceutical formulations designed to provide controlled, extended release of the opioid analgesic hydrocodone for managing severe, long-term pain.
  • Key Procedural History: The complaint notes that this lawsuit is an extension of a multi-year patent dispute between the parties, designated the "Consolidated Action," which involves numerous other patents also covering Hysingla® ER. The five patents asserted in this complaint were issued in June 2017 and listed in the FDA's Orange Book after the last action in the Consolidated Action was filed, prompting this new case.

Case Timeline

Date Event
1999-10-29 Priority Date for '024 and '611 Patents
2000-10-30 Priority Date for '023 and '077 Patents
2002-06-17 Priority Date for '610 Patent
2015-06-19 Alvogen files its ANDA for generic Hysingla® ER
2015-06-23 Actavis files its ANDA for generic Hysingla® ER
2017-06-06 U.S. Patent Nos. 9,669,023 and 9,669,024 issue
2017-06-13 U.S. Patent Nos. 9,675,610 and 9,675,611 issue
2017-06-20 U.S. Patent No. 9,682,077 issues
2017-08-07 Alvogen provides Paragraph IV notice letter to Plaintiffs
2017-08-11 Complaint filed

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

U.S. Patent No. 9,669,023, "CONTROLLED RELEASE HYDROCODONE FORMULATIONS" (Issued June 6, 2017)

The Invention Explained

  • Problem Addressed: The patent's background section describes the clinical challenge of managing moderate pain with conventional immediate-release opioids, which require frequent dosing and can lead to fluctuating plasma concentrations, resulting in periods of inadequate pain relief or excessive side effects (’023 Patent, col. 1:47-51).
  • The Patented Solution: The invention is a solid oral dosage form of hydrocodone engineered to provide a therapeutic effect for at least 24 hours, making it suitable for once-daily administration (’023 Patent, col. 1:38-42). This is achieved by incorporating the hydrocodone into a controlled-release material that yields a specific pharmacokinetic profile characterized by a relatively flat serum plasma curve, where the ratio of the drug concentration at 24 hours to the maximum concentration (C24/Cmax) is between 0.55 and 1.0 (’023 Patent, Abstract; col. 2:1-18).
  • Technical Importance: This once-daily formulation aims to improve patient compliance and provide more consistent pain management by maintaining steady plasma levels of the analgesic over a 24-hour period (’023 Patent, col. 1:59-63).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the patent without specifying which ones (Compl. ¶55). Independent claims 1 and 14 are present in the patent.
  • The essential elements of independent claim 1 include:
    • A hydrocodone formulation with a pharmaceutically acceptable polymer comprising 1% to 80% of the formulation by weight.
    • An in-vitro release rate with specific percentage ranges of hydrocodone released at 1, 4, 8, 12, 18, and 24 hours.
    • An in-vivo plasma concentration profile where the C24/Cmax ratio is from 0.55 to 1.0.
    • The ability to maintain plasma concentrations in the therapeutic range for 12 hours or longer and be administrable once a day.

U.S. Patent No. 9,669,024, "CONTROLLED RELEASE HYDROCODONE FORMULATIONS" (Issued June 6, 2017)

The Invention Explained

  • Problem Addressed: The patent identifies the need for hydrocodone formulations that provide sustained pain relief over a prolonged period to overcome the limitations of immediate-release dosage forms ('024 Patent, col. 1:43-51).
  • The Patented Solution: The invention is a solid oral controlled-release dosage form of hydrocodone designed for twice-a-day administration, providing a therapeutic effect for at least 12 hours (’024 Patent, Abstract). The formulation is designed to produce a specific in-vivo pharmacokinetic profile, including maintaining a plasma concentration of at least 8 ng/ml from about 2 to 8 hours after administration and at least 5 or 6 ng/ml at 12 hours after administration (’024 Patent, col. 4:1-9). The detailed description explains this can be achieved using controlled-release matrices or coatings (’024 Patent, col. 8:1-col. 12:43).
  • Technical Importance: A twice-daily formulation offers improved convenience and patient compliance compared to immediate-release versions requiring more frequent dosing, leading to more stable and effective pain management over a 12-hour interval (’024 Patent, col. 3:11-17).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the patent (Compl. ¶74). Independent claim 1 is present in the patent.
  • The essential elements of independent claim 1 include:
    • An oral dosage form comprising hydrocodone that releases the drug to maintain plasma concentrations in the therapeutic range for about 12 hours or longer.
    • A requirement that hydrocodone is the only drug in the dosage form.
    • A provision of a hydrocodone plasma concentration of at least about 8 ng/ml at about 8 hours after administration.
    • A provision of a hydrocodone plasma concentration of about 5 ng/ml or greater at 12 hours after administration.
    • A limitation that the dosage form is a tablet or capsule.

U.S. Patent No. 9,675,611, "METHODS OF PROVIDING ANALGESIA" (Issued June 13, 2017)

  • Patent Identification: U.S. Patent No. 9675611, "METHODS OF PROVIDING ANALGESIA," Issued June 13, 2017 (Compl. ¶40).
  • Technology Synopsis: This patent claims a method of providing analgesia to a patient for about 12 hours. The method comprises orally administering a solid, controlled-release dosage form of hydrocodone that produces a specific in-vivo pharmacokinetic profile, including a C12/Cmax ratio of 0.55 to 0.85 (’611 Patent, Abstract).
  • Asserted Claims: Independent claims 1 and 31 are asserted (Compl. ¶¶93, 102).
  • Accused Features: The complaint alleges that Defendants' filing of ANDAs for their generic products, which will be administered according to a product label, will induce infringement of the claimed methods of providing analgesia (Compl. ¶¶94, 103).

U.S. Patent No. 9,682,077, "METHODS OF PROVIDING ANALGESIA" (Issued June 20, 2017)

  • Patent Identification: U.S. Patent No. 9682077, "METHODS OF PROVIDING ANALGESIA," Issued June 20, 2017 (Compl. ¶41).
  • Technology Synopsis: This patent claims a method of providing analgesia for about 24 hours. The method involves administering a once-daily oral hydrocodone formulation that achieves a specific in-vivo pharmacokinetic profile, including a C24/Cmax ratio of 0.55 to 1.0 (’077 Patent, Abstract).
  • Asserted Claims: Independent claims 1 and 13 are asserted (Compl. ¶¶112, 121).
  • Accused Features: The complaint alleges that Defendants, by seeking approval for a once-daily generic hydrocodone product, will induce infringement of the claimed 24-hour treatment method upon FDA approval and marketing (Compl. ¶¶113, 122).

U.S. Patent No. 9,675,610, "ABUSE-PROOFED DOSAGE FORM" (Issued June 13, 2017)

  • Patent Identification: U.S. Patent No. 9675610, "ABUSE-PROOFED DOSAGE FORM," Issued June 13, 2017 (Compl. ¶42).
  • Technology Synopsis: This patent addresses the problem of parenteral opioid abuse. The invention is a solid dosage form that contains one or more viscosity-increasing agents which, upon attempted extraction with an aqueous liquid, form a gel that is difficult to draw into or inject from a hypodermic needle (’610 Patent, Abstract).
  • Asserted Claims: Independent claims 1 and 14 are asserted (Compl. ¶¶131, 140).
  • Accused Features: The complaint alleges that the Defendants' ANDA products themselves contain the claimed abuse-proofing technology, thereby infringing the patent (Compl. ¶¶131-132, 140-141).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are the generic hydrocodone bitartrate extended-release tablets described in Defendant Alvogen's ANDA No. 208269 and Defendant Actavis's ANDA No. 208389 (Compl. ¶¶5, 6).
  • Functionality and Market Context: The products are proposed generic equivalents of Purdue's Hysingla® ER, a once-daily oral tablet for the management of severe pain requiring around-the-clock, long-term opioid treatment (Compl. ¶¶1, 6). The ANDAs seek approval to market these generic products in various dosage strengths, from 20 mg to 120 mg, prior to the expiration of the patents-in-suit (Compl. ¶¶4, 5, 6). The basis for the infringement action is the statutory act of filing an ANDA containing a Paragraph IV certification, which asserts that the patents are invalid, unenforceable, or will not be infringed (Compl. ¶44).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-chart analysis of infringement. The allegations are pleaded generally, stating that the Defendants' ANDA products are "covered by one or more claims" of each asserted patent (e.g., Compl. ¶¶55, 74). No specific product features are mapped to discrete claim limitations.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • For the ’023 Patent: The central dispute will likely be factual and evidentiary, focusing on whether the formulation described in the Defendants' ANDA filings meets the specific pharmacokinetic (PK) and in-vitro dissolution limitations of the claims. A key question for the court will be whether the bioequivalence data submitted to the FDA for the generic products demonstrates a C24/Cmax ratio falling within the claimed range of 0.55 to 1.0.
    • For the ’024 Patent: A primary point of contention may arise from a potential mismatch in scope. The ’024 Patent claims a formulation suitable for "twice-a-day" administration that provides a therapeutic effect for "about 12 hours" (’024 Patent, Abstract). However, the accused products are generics of Hysingla® ER, which is a "once-a-day" product (Compl. ¶1). This raises the question of whether a product designed and tested for 24-hour efficacy can infringe claims directed to a 12-hour PK profile.

V. Key Claim Terms for Construction

  • For the '023 Patent:

    • The Term: "a plasma concentration profile of hydrocodone with a ratio of the plasma concentration of hydrocodone at 24 hours after administration to the highest concentration of hydrocodone during the 24 hours of from 0.55 to 1.0" (from Claim 1).
    • Context and Importance: This term is the central quantitative limitation defining the "once-a-day" character of the invention. Practitioners may focus on this term because the infringement analysis will depend entirely on whether the Defendants' ANDA data demonstrates that their products fall within this numerically precise pharmacokinetic range.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification's objective is to "provide a relatively flat serum plasma profile" (’023 Patent, col. 2:2-3), which could support an argument that the numerical range should be interpreted to achieve this functional goal, rather than as a rigid boundary.
      • Evidence for a Narrower Interpretation: The specification provides tables with specific in-vivo data for certain embodiments (’023 Patent, Table III). A party could argue that these examples define the context of the claimed range, suggesting it should be narrowly construed to cover only formulations with highly similar profiles.

  • For the '024 Patent:

    • The Term: "maintains plasma concentrations...for about 12 hours or longer" (from Claim 1).
    • Context and Importance: This term is critical because of the mismatch between the claim's "twice-a-day" context and the accused product's "once-a-day" nature. Practitioners may focus on this term because its construction could be dispositive; if "about 12 hours or longer" is construed to require a profile optimized for 12-hour dosing, a 24-hour product may not infringe.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain language "12 hours or longer" could be argued to literally encompass a 24-hour formulation.
      • Evidence for a Narrower Interpretation: The patent is consistently described as being suitable for "twice-a-day administration" (’024 Patent, Abstract; col. 4:10-14). A party could argue this repeated contextual framing limits the claim to formulations with PK profiles tailored for a 12-hour dosing interval, not a 24-hour one.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce and contribute to infringement upon approval of their ANDAs (e.g., Compl. ¶¶56, 94). The alleged basis for inducement is that Defendants will encourage infringement by doctors and patients who follow the instructions on the product labeling (e.g., Compl. ¶¶60, 98). The complaint alleges contributory infringement on the basis that the ANDA products are "especially made or especially adapted for use in the infringement" and have "no substantial non-infringing use" (e.g., Compl. ¶¶58, 59).
  • Willful Infringement: Willfulness is alleged for all asserted patents, with Plaintiffs claiming the case is "exceptional" under 35 U.S.C. § 285 (e.g., Compl. ¶¶61, 80). The basis for this allegation is Defendants' alleged knowledge of the patents and their proceeding to seek FDA approval with "no reasonable basis for believing" their products would not infringe (e.g., Compl. ¶61). For Alvogen, this knowledge is predicated on its August 7, 2017 Paragraph IV notice letter (Compl. ¶45).

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

  • A central issue will be one of bioequivalence data versus claim scope: Does the clinical data contained within the Defendants' confidential ANDA submissions demonstrate that their proposed generic products will produce the specific in-vivo pharmacokinetic profiles (e.g., C24/Cmax ratios, plasma concentrations at specific time points) required by the claims?
  • A key legal question will be one of temporal mismatch: Can claims directed to a "twice-a-day" formulation providing therapeutic effects for "about 12 hours" (as in the '024 and '611 patents) be infringed by the marketing of a generic version of a "once-a-day" product?
  • A critical technical question for the '610 patent will be one of formulation identity: Do the Defendants' ANDA products actually contain the claimed abuse-deterrent technology, namely a viscosity-increasing agent that forms an injection-resistant gel, or is there a fundamental difference in their formulation?