DCT

1:18-cv-00300

Collegium Pharmaceutical Inc v. Teva Pharma USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00300, D. Del., 02/22/2018
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Teva is incorporated in Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's XTAMPZA® ER product constitutes an act of infringement of eleven patents related to abuse-deterrent opioid formulations.
  • Technical Context: The technology addresses the public health problem of opioid abuse by creating pharmaceutical compositions that are resistant to tampering methods used to achieve a rapid drug release, such as crushing or dissolving.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendant’s ANDA filing (No. 209431) with a Paragraph IV certification, which asserted that Plaintiff’s patents are invalid, unenforceable, and/or would not be infringed by the proposed generic products. Plaintiff’s corresponding commercial product, XTAMPZA® ER, is an FDA-approved drug recognized for its abuse-deterrent properties.

Case Timeline

Date Event
2002-07-05 Earliest Priority Date ('291, '398, '195, '200 Patents)
2004-06-12 Earliest Priority Date ('707, '909, '813, '883 Patents)
2009-12-10 Earliest Priority Date ('928, '075 Patents)
2010-08-10 U.S. Patent No. 7,771,707 Issues
2013-05-28 U.S. Patent No. 8,449,909 Issues
2013-10-15 U.S. Patent No. 8,557,291 Issues
2014-06-24 U.S. Patent No. 8,758,813 Issues
2014-09-23 U.S. Patent No. 8,840,928 Issues
2015-06-02 U.S. Patent No. 9,044,398 Issues
2016-02-02 U.S. Patent No. 9,248,195 Issues
2016-06-23 Earliest Priority Date ('530 Patent)
2017-03-14 U.S. Patent No. 9,592,200 Issues
2017-06-20 U.S. Patent No. 9,682,075 Issues
2017-08-22 U.S. Patent No. 9,737,530 Issues
2017-09-19 U.S. Patent No. 9,763,883 Issues
2018-01-09 Defendant provides notice of ANDA filing to Plaintiff
2018-02-22 Complaint Filed

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

U.S. Patent No. 7,771,707 - "Abuse-Deterrent Drug Formulations"

Issued August 10, 2010 (’707 Patent)

The Invention Explained

  • Problem Addressed: The patent describes the problem of willful abuse of sustained-release opioid analgesics like oxycodone (Compl. ¶26; ’707 Patent, col. 1:19-24). Abusers can crush or grind conventional formulations to destroy the sustained-release mechanism, making the full dose immediately available for snorting, injection, or swallowing to achieve a "high" (’707 Patent, col. 1:24-44).
  • The Patented Solution: The invention proposes modifying the drug to increase its lipophilicity (fat-solubility) by forming a salt between the drug and one or more fatty acids or amines (’707 Patent, Abstract). This modified, more fat-soluble drug is then dispersed within microparticles composed of a material that is slowly soluble or insoluble in water, such as fats or waxes (’707 Patent, col. 3:11-16). This composition prevents the immediate release of a substantial portion of the drug even if the dosage form is physically compromised (’707 Patent, col. 3:16-22).
  • Technical Importance: This approach aimed to create an abuse-deterrent formulation that resists common forms of tampering (crushing, dissolution) without requiring the inclusion of an opioid antagonist, which could produce adverse effects in legitimate patients (’707 Patent, col. 2:57-62).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and several dependent claims (Compl. ¶44).
  • Independent Claim 1 requires:
    • A solid orally administrable abuse-deterrent pharmaceutical composition of a pharmaceutically active agent prone to abuse;
    • comprising a mixture of a therapeutically effective amount of the active agent and one or more fatty acids or fatty amines present in molar excess relative to the active agent;
    • wherein the active agent comprises an effective amount of a fatty acid or fatty amine salt of the active agent.
  • The complaint reserves the right to assert other claims (Compl. ¶44).

U.S. Patent No. 8,449,909 - "Abuse-Deterrent Drug Formulations"

Issued May 28, 2013 (’909 Patent)

The Invention Explained

  • Problem Addressed: The ’909 Patent addresses the same problem of opioid abuse as the ’707 Patent: the ease with which conventional sustained-release dosage forms can be mechanically destroyed to allow for immediate drug release and abuse (’909 Patent, col. 1:23-49).
  • The Patented Solution: The patented solution is a pharmaceutical composition of solid microparticles that contain a fatty acid salt of oxycodone. The microparticles comprise the active agent, one or more fatty acids, and a carrier material selected from waxes or wax-like substances (’909 Patent, col. 17:11-18). The patent specifies that the fatty acids must be present in a molar amount that is 6.9 to 15 times that of the active agent, creating a formulation that resists tampering (’909 Patent, col. 17:19-21).
  • Technical Importance: This patent specifies a particular embodiment of an abuse-deterrent technology, defining the composition in terms of a three-part system (drug salt, fatty acid, wax carrier) and quantifying the required ratio of fatty acid to active agent.

Key Claims at a Glance

  • The complaint asserts independent claim 1 and several dependent claims (Compl. ¶47).
  • Independent Claim 1 requires:
    • A therapeutically effective pharmaceutical composition comprising solid microparticles;
    • wherein the microparticles comprise: an active agent, one or more fatty acids, and one or more carrier materials selected from waxes or wax-like substances;
    • wherein the active agent comprises a fatty acid salt of oxycodone; and
    • wherein the fatty acids are present in an amount ranging from 6.9 to 15 times the molar amount of the active agent.
  • The complaint reserves the right to assert other claims (Compl. ¶47).

U.S. Patent No. 8,557,291 (’291 Patent)

  • Technology Synopsis: The ’291 Patent claims an abuse-deterrent oral dosage form comprising microparticles. Each microparticle contains a fatty acid salt of a drug prone to abuse and a carrier material (e.g., fats, waxes), which together retard the drug's release even if the dosage form's physical integrity is compromised (Compl. ¶50).
  • Asserted Claims: At least claims 1-11, 13, and 14 are asserted (Compl. ¶50).
  • Accused Features: The Teva ANDA Products are alleged to be an abuse-deterrent oral dosage form containing the claimed microparticle composition (Compl. ¶50).

U.S. Patent No. 8,758,813 (’813 Patent)

  • Technology Synopsis: The ’813 Patent claims a method for managing pain by administering a composition of solid microparticles. The microparticles comprise an active agent (a fatty acid salt of oxycodone), fatty acids in a specific molar ratio (6.9 to 15 times the active agent), and a wax or wax-like carrier material (Compl. ¶53).
  • Asserted Claims: At least claims 1-6 and 8 are asserted (Compl. ¶53).
  • Accused Features: Teva is alleged to induce infringement by selling its ANDA Products, which when administered by patients for pain management, will practice the claimed method (Compl. ¶53).

U.S. Patent No. 8,840,928 (’928 Patent)

  • Technology Synopsis: The ’928 Patent claims a tamper-resistant composition of solid particles, where each particle comprises a solid solution of a drug and fatty acids. The patent requires that the drug and fatty acids interact ionically and that the fatty acids comprise at least 42%-69% by weight of the particle (Compl. ¶56).
  • Asserted Claims: At least claims 1-5, 17-19, 26, and 27 are asserted (Compl. ¶56).
  • Accused Features: The Teva ANDA Products are alleged to be tamper-resistant pharmaceutical compositions meeting the claimed structural and weight percentage requirements (Compl. ¶56).

U.S. Patent No. 9,044,398 (’398 Patent)

  • Technology Synopsis: The ’398 Patent claims an abuse-deterrent composition of microparticles, each comprising a lipophilic drug derivative (a drug prone to abuse and a fatty acid) and a carrier material (e.g., fats, waxes). The patent requires that the release of the drug is retarded when the composition's physical integrity is compromised (Compl. ¶59).
  • Asserted Claims: At least claims 1-11 are asserted (Compl. ¶59).
  • Accused Features: The Teva ANDA Products are alleged to be abuse-deterrent compositions containing the claimed microparticles (Compl. ¶59).

U.S. Patent No. 9,248,195 (’195 Patent)

  • Technology Synopsis: The ’195 Patent claims a method of administering an abuse-deterrent oral dosage form. The method involves orally administering microparticles that comprise a fatty acid salt of a drug and a carrier material (e.g., fats, waxes), where the dosage form retards drug release even when compromised and placed in water (Compl. ¶62).
  • Asserted Claims: At least claims 1-11 are asserted (Compl. ¶62).
  • Accused Features: Teva is alleged to induce infringement through the sale of its ANDA Products, which are intended for oral administration by patients in a manner that practices the claimed method (Compl. ¶62).

U.S. Patent No. 9,592,200 (’200 Patent)

  • Technology Synopsis: The ’200 Patent claims an abuse-deterrent oral dosage form of microparticles. Each microparticle comprises a homogenous single phase of oxycodone and one or more fatty acids, where the molar ratio of fatty acid to oxycodone is in excess of about 7:1 and the oxycodone is in the form of a fatty acid salt (Compl. ¶65).
  • Asserted Claims: At least claims 1-13, 15, 16, and 18 are asserted (Compl. ¶65).
  • Accused Features: The Teva ANDA Products are alleged to be abuse-deterrent dosage forms containing microparticles that meet the claimed compositional and ratio requirements (Compl. ¶65).

U.S. Patent No. 9,682,075 (’075 Patent)

  • Technology Synopsis: The ’075 Patent claims a tamper-resistant composition of solid particles containing a drug, waxes, and a high concentration of fatty acids (42%-69% by weight). The claims recite specific parameters for particle size, release duration (6-24 hours), and the functional requirement that the composition maintains slow release even when crushed with a mortar and pestle (Compl. ¶68).
  • Asserted Claims: At least claims 1, 3-8, and 12 are asserted (Compl. ¶68).
  • Accused Features: The Teva ANDA Products are alleged to be tamper-resistant compositions that meet the claimed compositional, particle size, and functional requirements (Compl. ¶68).

U.S. Patent No. 9,737,530 (’530 Patent)

  • Technology Synopsis: The ’530 Patent claims a process for making stable abuse-deterrent oral formulations. The process involves preparing a substantially homogeneous melt of the drug, waxes, and fatty acids; forming solid microparticles from the melt; and "curing" the microparticles at a specific temperature range for a minimum of about 48 hours (Compl. ¶71).
  • Asserted Claims: At least claims 1, 7, and 10-19 are asserted (Compl. ¶71).
  • Accused Features: Teva is alleged to induce infringement because its ANDA Products are allegedly made by or covered by the claimed manufacturing process (Compl. ¶71).

U.S. Patent No. 9,763,883 (’883 Patent)

  • Technology Synopsis: The ’883 Patent claims an abuse-deterrent composition of solid microparticles comprising a fatty acid salt of a basic active agent and a carrier of waxes or wax-like substances. A key feature is the process of making the microparticles, which involves dissolving the active agent in free base form in a melt of fatty acids to form the salt in situ (Compl. ¶74).
  • Asserted Claims: At least claims 1-8 and 11-13 are asserted (Compl. ¶74).
  • Accused Features: The Teva ANDA Products are alleged to be abuse-deterrent compositions made by the claimed in situ salt formation process (Compl. ¶74).

III. The Accused Instrumentality

  • Product Identification: Defendant’s proposed Oxycodone Extended-Release Capsules, CII, in 9 mg, 13.5 mg, 18 mg, 27 mg, and 36 mg dosages, as described in ANDA No. 209431 ("Teva ANDA Products") (Compl. ¶1).
  • Functionality and Market Context: The complaint alleges that the Teva ANDA Products are generic versions of Plaintiff's commercial product, XTAMPZA® ER (oxycodone) extended-release capsules (Compl. ¶¶4, 39). It further alleges that Defendant intends to launch "essentially a copy" of XTAMPZA® ER, which is recognized by the FDA for its abuse-deterrent properties with respect to oral, nasal, and intravenous routes of abuse (Compl. ¶¶36, 37, 41). The complaint asserts that Teva’s product possesses these uniquely effective abuse-deterrent properties, which form the basis of the infringement allegations (Compl. ¶37).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'707 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a solid orally administrable abuse-deterrent pharmaceutical composition of a pharmaceutically active agent prone to abuse The Teva ANDA Products are alleged to be solid, orally administrable abuse-deterrent compositions containing oxycodone. ¶¶1, 44 col. 3:5-9
the composition comprising: a mixture of a therapeutically effective amount of the pharmaceutically active agent prone to abuse, and one or more fatty acids or fatty amines present in molar excess relative to the pharmaceutically active agent The Teva ANDA Products are alleged to comprise a mixture of oxycodone and one or more fatty acids that are in molar excess relative to the oxycodone. ¶44 col. 7:31-38
wherein the pharmaceutically active agent comprises an effective amount of a fatty acid or fatty amine salt of the pharmaceutically active agent prone to abuse The Teva ANDA Products are alleged to contain an effective amount of a fatty acid salt of oxycodone. ¶44 col. 7:41-52
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether the combination of oxycodone (a base) and fatty acids in the accused product results in the formation of a "fatty acid...salt" as required by the claim, or if it remains a physical mixture or solid solution. The definition of "salt" in this context will be critical.
    • Technical Questions: The complaint alleges, upon information and belief, that the fatty acids are in "molar excess." A key factual question will be what evidence demonstrates that the specific formulation of the Teva ANDA Products meets this quantitative limitation.

'909 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A therapeutically effective pharmaceutical composition comprising solid microparticles The Teva ANDA Products are alleged to be pharmaceutical compositions comprising solid microparticles. ¶47 col. 4:3-5
wherein the microparticles comprise: a. an active agent, b. one or more fatty acids, and c. one or more carrier materials selected from the group consisting of waxes or wax-like substances and mixtures thereof The Teva ANDA Products are alleged to be composed of microparticles containing oxycodone, fatty acids, and wax-based carrier materials. ¶47 col. 8:22-51
wherein the active agent comprises a fatty acid salt of oxycodone The active agent in the Teva ANDA Products is alleged to be a fatty acid salt of oxycodone. ¶47 col. 8:1-3
and the one or more fatty acids are present in an amount ranging from 6.9 to 15 times the molar amount of active agent The Teva ANDA Products are alleged to contain fatty acids in a molar ratio relative to oxycodone that falls within the claimed range. ¶47 col. 8:45-51
  • Identified Points of Contention:
    • Scope Questions: Similar to the '707 Patent, the nature of the interaction between the oxycodone and fatty acids (i.e., whether it forms a "fatty acid salt") will likely be a point of dispute.
    • Technical Questions: The complaint alleges the accused product meets the specific molar ratio of 6.9 to 15. The infringement analysis will depend entirely on factual evidence from the composition of the Teva ANDA Products. The complaint itself does not provide the specific evidence for this allegation.

V. Key Claim Terms for Construction

  • The Term: "fatty acid...salt" (from '707 Claim 1 and '909 Claim 1)

  • Context and Importance: The determination of whether the accused product infringes hinges on whether the interaction between the basic drug (oxycodone) and the acidic excipient (fatty acids) creates a "salt" in the claimed sense. A defendant may argue that its product is merely a solid solution or physical mixture, whereas the plaintiff will contend that an ionic interaction sufficient to form a salt occurs, particularly in a melt-based formulation process.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The '707 Patent specification describes the formation of a salt via a melt process where the active agent in free base form is added to molten fatty acid, suggesting the term could cover salts formed in situ rather than requiring a pre-formed salt as a starting ingredient (’707 Patent, col. 7:41-52).
    • Evidence for a Narrower Interpretation: The claims distinguish between the "active agent," "one or more fatty acids," and the resulting "fatty acid salt," which could suggest these are distinct components. A defendant might argue this structure implies a more formal, complete ionic bond is required than what might occur in a homogenous melt.

  • The Term: "molar excess" (from '707 Claim 1)

  • Context and Importance: This term provides a quantitative but open-ended limitation. Its construction is important for determining the boundary of infringement. Practitioners may focus on this term because while the '909 Patent provides a specific numerical range (6.9 to 15), the '707 Patent’s broader term requires interpretation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term itself simply means a molar ratio greater than 1:1 of fatty acid to active agent. The specification states the concentration of fatty acids is "one to fifteen times the molar amount of the active agent, preferably two to ten times" (’707 Patent, col. 3:8-13), providing context for what the inventors considered to be an effective excess.
    • Evidence for a Narrower Interpretation: A defendant could argue that the term must be read in light of the patent's purpose of creating an abuse-deterrent effect. If a very slight molar excess (e.g., 1.1:1) does not confer the properties described in the specification, a court might be persuaded to construe "molar excess" to require an amount sufficient to achieve that function, potentially narrowing the claim's scope.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant will induce infringement by selling the Teva ANDA Products with labeling that will instruct physicians and patients to administer the drug for the management of pain, thereby practicing the asserted method claims (e.g., ’813 Patent, Compl. ¶53; ’195 Patent, Compl. ¶62). A general count for inducement and contributory infringement alleges that Teva's actions, including its labeling, will intentionally cause infringement by patients and manufacturers (Compl. ¶¶77, 79).

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

  • A core issue will be one of chemical identity: Does the combination of oxycodone base and fatty acids in the accused generic product, as manufactured, result in the formation of a "fatty acid salt" as construed from the patent claims, or does it constitute a non-infringing physical mixture or solid solution?
  • A second central issue will be evidentiary and quantitative: Will discovery reveal that the formulation of the Teva ANDA Products meets the specific quantitative limitations of the asserted claims, such as the "molar excess" ('707 Patent) and the specific molar ratio ranges (e.g., 6.9 to 15 in the '909 Patent)?
  • Finally, a key question for the case will be validity: As raised by Defendant’s Paragraph IV certification, the court will have to determine whether the claimed inventions—combining known pharmaceutical components like opioids, fatty acids, and waxes to achieve abuse-deterrence—would have been obvious to a person of ordinary skill in the art at the time of the invention.