DCT
1:08-cv-00050
Alpharma Inc v. Purdue Pharma LP
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Alpharma Inc. (Delaware)
- Defendant: Purdue Pharma L.P. (Delaware)
- Plaintiff’s Counsel: Hunton & Williams LLP; Mark T. Hurt
- Case Identification: 1:08-cv-00050, W.D. Va., 11/17/2008
- Venue Allegations: Plaintiff alleges venue is proper because Defendant conducts business in the district, which has been disproportionately affected by prescription opioid abuse and therefore has an acute local interest in the subject matter.
- Core Dispute: Plaintiff seeks a declaratory judgment that its abuse-resistant opioid analgesic, ALO-01, does not infringe and that Defendant's patents related to abuse-deterrent opioid formulations are invalid.
- Technical Context: The technology concerns pharmaceutical formulations of opioid analgesics designed to deter abuse, such as by crushing for injection or taking multiple oral doses.
- Key Procedural History: The complaint alleges a history of communications between the parties, beginning in early 2007, regarding a potential business relationship. During these discussions, Defendant allegedly asserted its patent portfolio was broad enough to encompass Plaintiff's technology and threatened litigation if Plaintiff proceeded to market its ALO-01 product.
Case Timeline
| Date | Event |
|---|---|
| 1997-12-22 | Earliest Priority Date for '384, '957, '494, '066, '767, '686, '863, '635 Patents |
| 1998-07-29 | Earliest Priority Date for '088 Patent |
| 2001-05-08 | U.S. Patent No. 6,228,863 Issued |
| 2001-08-21 | U.S. Patent No. 6,277,384 Issued |
| 2002-04-23 | U.S. Patent No. 6,375,957 Issued |
| 2002-11-05 | U.S. Patent No. 6,475,494 Issued |
| 2003-09-30 | U.S. Patent No. 6,627,635 Issued |
| 2004-02-24 | U.S. Patent No. 6,696,066 Issued |
| 2004-02-24 | U.S. Patent No. 6,696,088 Issued |
| 2007-02-06 | U.S. Patent No. 7,172,767 Issued |
| 2007-09-14 | Meeting where Defendant allegedly stated its patents covered Plaintiff's technology and threatened litigation |
| 2008-06-30 | Plaintiff re-submitted a New Drug Application (NDA) for ALO-01 to the FDA |
| 2008-09-02 | U.S. Patent No. 7,419,686 Issued |
| 2008-11-17 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,277,384 - "Opioid Agonist/Antagonist Combinations"
Issued August 21, 2001 (’384 Patent)
The Invention Explained
- Problem Addressed: The patent addresses the potential for oral abuse of opioid analgesics, which occurs when a patient or addict self-administers more than the prescribed dose to achieve a euphoric effect (’384 Patent, col. 4:30-35).
- The Patented Solution: The invention is an oral dosage form that combines an opioid agonist (the painkiller) with an opioid antagonist (which blocks the opioid effect). The key is the ratio of the two drugs, which is designed to be analgesically effective at a prescribed dose but to create an "aversive experience" (such as precipitated withdrawal) in a physically dependent person who takes a higher dose (e.g., 2-3 times the normal dose) in an attempt to get high (’384 Patent, col. 5:5-32).
- Technical Importance: This approach sought to deter oral abuse by making dose escalation unpleasant for addicts, a different mechanism from earlier technologies that focused primarily on preventing parenteral (injection) abuse (Compl. ¶17, ¶27).
Key Claims at a Glance
- The complaint seeks a declaratory judgment of non-infringement of all claims, but does not identify specific claims at issue (Compl. ¶48). Independent claim 1 is representative.
- Essential elements of claim 1 include:
- An oral dosage form, comprising an orally therapeutically effective dose of an opioid agonist, and an opioid antagonist
- the dosage form having a ratio of opioid antagonist to opioid agonist that provides a combination product which is analgesically effective when the combination is administered orally
- but which is aversive in physically dependent human subjects when administered at the same dose or at a higher dose than said therapeutically effective dose
- and maintains an analgesic effect but does not increase analgesic efficacy of the opioid agonist relative to the same therapeutic dose of opioid analgesic when administered to human patients without said opioid antagonist.
U.S. Patent No. 6,228,863 - "Method of Preventing Abuse of Opioid Dosage Forms"
Issued May 8, 2001 (’863 Patent)
The Invention Explained
- Problem Addressed: The patent addresses the parenteral abuse of oral opioid medications, which involves extracting the opioid from its dosage form and injecting it to achieve a "high" (’863 Patent, col. 3:1-10).
- The Patented Solution: The invention proposes a method where an opioid agonist and an opioid antagonist are combined in a dosage form from which they are difficult to separate. The formulation is designed to require at least a "two-step extraction process" to separate the agonist from the antagonist (’863 Patent, Abstract). The specification describes an embodiment where both drugs are soluble at a low pH, but have different solubilities at a high pH, forcing a multi-step chemical separation process (’863 Patent, col. 5:1-5).
- Technical Importance: This method aims to deter abuse by creating a significant technical hurdle for abusers seeking to isolate the pure opioid for injection, going beyond simple combinations to embed a chemical separation challenge into the dosage form itself (Compl. ¶26, ¶27).
Key Claims at a Glance
- The complaint seeks a declaratory judgment of non-infringement of all claims (Compl. ¶96). Independent claim 1 is representative.
- Essential elements of claim 1 include:
- A method of reducing the abuse potential of an oral dosage form of an opioid analgesic
- comprising combining an analgesically effective amount of an orally active opioid agonist together with an opioid antagonist into an oral dosage form
- said opioid agonist/antagonist combination being chosen such that the opioid agonist and opioid antagonist are only extractable from the dosage form together
- and at least a two-step extraction process is required to separate the opioid antagonist from the opioid agonist
- the amount of opioid antagonist including being sufficient to counteract opioid effects if extracted together... and administered parenterally.
U.S. Patent No. 6,375,957 - "Opioid Agonist/Opioid Antagonist/Acetaminophen Combinations"
Issued April 23, 2002 (’957 Patent)
- Technology Synopsis: This patent is related to the ’384 Patent and similarly describes an oral dosage form combining an opioid agonist and an opioid antagonist in a ratio designed to be aversive in abusers taking multiple doses. This patent adds the non-opioid analgesic acetaminophen to the combination (’957 Patent, Abstract).
- Asserted Claims: All claims are at issue (Compl. ¶56).
- Accused Features: The accused features are the combination of an opioid agonist (morphine) and a sequestered antagonist (naltrexone) in Plaintiff's ALO-01 product (Compl. ¶27).
U.S. Patent No. 6,475,494 - "Opioid Agonist/Antagonist Combinations"
Issued November 5, 2002 (’494 Patent)
- Technology Synopsis: This patent is related to the ’384 Patent and describes an oral dosage form combining an opioid agonist and antagonist in a ratio that is aversive to abusers. The claims focus on specific ratios for particular opioid agonists like hydrocodone and hydromorphone (’494 Patent, Abstract; claims 1-23).
- Asserted Claims: All claims are at issue (Compl. ¶64).
- Accused Features: The accused features are the combination of an opioid agonist (morphine) and a sequestered antagonist (naltrexone) in Plaintiff's ALO-01 product (Compl. ¶27).
U.S. Patent No. 6,696,066 - "Opioid Agonist/Antagonist Combinations"
Issued February 24, 2004 (’066 Patent)
- Technology Synopsis: This patent is related to the ’384 Patent family and claims oral dosage forms containing combinations of an opioid agonist and antagonist. It describes sustained-release formulations and specific ratios intended to deter oral abuse (’066 Patent, Abstract).
- Asserted Claims: All claims are at issue (Compl. ¶72).
- Accused Features: The accused features are the combination of an opioid agonist (morphine) and a sequestered antagonist (naltrexone) in Plaintiff's ALO-01 product, which is an extended-release formulation (Compl. ¶27).
U.S. Patent No. 7,172,767 - "Opioid Agonist/Antagonist Combinations"
Issued February 6, 2007 (’767 Patent)
- Technology Synopsis: This patent is related to the ’384 Patent family and claims solid oral dosage forms combining an opioid agonist with naltrexone in specific weight ratios for various opioids, intended to be analgesically effective but aversive to abusers (’767 Patent, Abstract; claims 1-2).
- Asserted Claims: All claims are at issue (Compl. ¶80).
- Accused Features: The accused features are the combination of an opioid agonist (morphine) and a sequestered antagonist (naltrexone) in Plaintiff's ALO-01 product (Compl. ¶27).
U.S. Patent No. 7,419,686 - "Opioid Agonist/Antagonist Combinations"
Issued September 2, 2008 (’686 Patent)
- Technology Synopsis: This patent is related to the ’384 Patent family and claims oral dosage forms of opioid agonists and antagonists. It focuses on ratios that maintain analgesia but do not increase it, while providing an aversive effect in physically dependent subjects (’686 Patent, Abstract).
- Asserted Claims: All claims are at issue (Compl. ¶88).
- Accused Features: The accused features are the combination of an opioid agonist (morphine) and a sequestered antagonist (naltrexone) in Plaintiff's ALO-01 product (Compl. ¶27).
U.S. Patent No. 6,627,635 - "Method of Preventing Abuse of Opioid Dosage Forms"
Issued September 30, 2003 (’635 Patent)
- Technology Synopsis: This patent is related to the ’863 Patent and describes a method for reducing abuse potential by combining an opioid agonist and antagonist in a dosage form that requires at least a two-step extraction process to separate them. This patent specifically claims sustained-release dosage forms (’635 Patent, Abstract; claim 1).
- Asserted Claims: All claims are at issue (Compl. ¶104).
- Accused Features: The accused features are Plaintiff's ALO-01 product, which uses a "proprietary naltrexone sequestering technology" and is an extended-release formulation (Compl. ¶27, ¶29).
U.S. Patent No. 6,696,088 - "Tamper Resistant Oral Opioid Agonist Formulations"
Issued February 24, 2004 (’088 Patent)
- Technology Synopsis: This patent describes an oral dosage form containing a sequestered opioid antagonist that is not substantially released when administered intact but is released upon tampering. The invention focuses on the ratio of antagonist released after tampering versus that released from an intact form (’088 Patent, Abstract).
- Asserted Claims: All claims are at issue (Compl. ¶112).
- Accused Features: The accused features are Plaintiff's ALO-01 product, which contains a "sequestered opioid antagonist" (naltrexone) that is "immediately released" when the product is crushed or chewed (Compl. ¶27).
III. The Accused Instrumentality
Product Identification
The accused product is Plaintiff's ALO-01, an opioid-based pain medicine (Compl. ¶27).
Functionality and Market Context
ALO-01 is described as an extended-release oral formulation of the opioid agonist morphine, indicated for moderate to severe pain (Compl. ¶27). Its key feature is the inclusion of a "sequestered opioid antagonist called naltrexone" using a "proprietary technology" developed by Plaintiff (Compl. ¶27). According to the complaint, when ALO-01 is taken as directed, it provides pain relief. However, if it is abused by crushing or chewing, the naltrexone is "immediately released, mitigating the euphoric effects of the morphine" (Compl. ¶27). Plaintiff alleges that ALO-01 will be one of the first prescription opioid pain medicines of its kind and will provide an important public health benefit (Compl. ¶27, ¶28).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’384 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An oral dosage form, comprising an orally therapeutically effective dose of an opioid agonist, and an opioid antagonist... | ALO-01 is an oral dosage form containing the opioid agonist morphine and the opioid antagonist naltrexone. | ¶27 | col. 5:21-25 |
| ...which is analgesically effective when the combination is administered orally... | ALO-01 is alleged to provide "long lasting pain relief" when taken as directed. | ¶27 | col. 5:25-27 |
| ...but which is aversive in physically dependent human subjects when administered at... a higher dose... | When ALO-01 is crushed or chewed (simulating abuse), the sequestered naltrexone is released to mitigate the euphoric effects of morphine. This functionality is what Defendant allegedly claims infringes its patents. | ¶27, ¶36 | col. 5:27-32 |
Identified Points of Contention
- Scope Questions: A central issue may be the construction of "aversive." The complaint alleges ALO-01 "mitigat[es] the euphoric effects of the morphine" (Compl. ¶27). The infringement analysis will question whether merely reducing a "high" constitutes an "aversive experience," a term which the patent links to effects like "precipitated abstinence syndrome" (’384 Patent, col. 5:24-26).
- Technical Questions: The complaint does not specify whether ALO-01 is intended to be aversive only in physically dependent subjects, as required by the claim. The court may need to consider evidence on whether mitigating euphoria in a non-dependent abuser meets the claim limitation directed specifically to effects in a "physically dependent" individual.
’863 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of reducing the abuse potential... comprising combining an... opioid agonist together with an opioid antagonist into an oral dosage form... | ALO-01 is an oral dosage form combining the agonist morphine with the antagonist naltrexone to reduce the likelihood of abuse. | ¶27 | col. 4:51-54 |
| ...said opioid agonist and opioid antagonist are only extractable from the dosage form together... | The complaint describes the naltrexone in ALO-01 as "sequestered," suggesting it is physically combined with the morphine in a way that prevents easy separation. | ¶27 | col. 4:58-63 |
| ...and at least a two-step extraction process is required to separate the opioid antagonist from the opioid agonist... | ALO-01 uses a "proprietary technology" to sequester the naltrexone. The dispute arises from Defendant's alleged assertion that this technology is covered by its patents, which describe methods like pH-based differential extraction. | ¶27, ¶36 | col. 4:55-58 |
Identified Points of Contention
- Scope Questions: The primary dispute will likely center on the meaning of "at least a two-step extraction process." The question for the court will be whether this term is limited to the chemical extraction methods disclosed in the patent (e.g., using different pH levels) or if it can be construed more broadly to cover other physical or mechanical sequestering mechanisms.
- Technical Questions: The complaint does not provide any technical detail on how ALO-01's "proprietary technology" for sequestering naltrexone actually works. A key evidentiary question will be whether this mechanism, once revealed, functions in a manner equivalent to the claimed "two-step extraction process."
V. Key Claim Terms for Construction
Term from the ’384 Patent: "aversive... in a physically dependent subject"
- Context and Importance: The definition of this term is critical because it defines the functional outcome required to infringe. The dispute may turn on whether ALO-01's alleged "mitigation" of euphoria meets this standard.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent states the goal is to make the combination "unacceptable (aversive) in a different population (e.g., physically dependent subjects)" (’384 Patent, col. 5:29-30), which could be argued to encompass any effect that deters abuse.
- Evidence for a Narrower Interpretation: The patent explicitly links the "aversive" experience to "precipitated abstinence syndrome" (’384 Patent, col. 5:24-26), suggesting a specific physiological reaction is required, not just a blunting of the desired euphoric effect.
Term from the ’863 Patent: "at least a two-step extraction process"
- Context and Importance: This term defines the core technical mechanism of the invention. Whether ALO-01's "sequestering technology" infringes will depend entirely on how broadly this term is construed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is general and does not specify the nature of the "steps." It could be argued to cover any formulation requiring two distinct actions (e.g., a physical step followed by a chemical step) to separate the drugs.
- Evidence for a Narrower Interpretation: The specification provides a detailed example of a two-step process based on dissolving both drugs in acid and then separating them using a "high pH solution" where their solubilities differ (’863 Patent, col. 4:63-67, col. 5:1-5). A defendant could argue the claim should be limited to this disclosed chemical process or equivalents thereof.
VI. Other Allegations
- Indirect Infringement: The complaint is for a declaratory judgment of non-infringement of Plaintiff's own product, ALO-01. The focus is on direct infringement, and no facts related to inducement or contributory infringement are alleged (Compl. ¶48, ¶56, etc.).
- Willful Infringement: As this is a declaratory judgment action, willfulness is not directly at issue. However, Plaintiff seeks a declaration that the case is "exceptional" under 35 U.S.C. § 285 and an award of attorneys' fees (Prayer for Relief ¶4). The basis for this appears to be the allegation that Defendant is aware of Plaintiff's product development and is using its patent portfolio to "intimidate and threaten Alpharma from entering the market" despite Plaintiff's belief of non-infringement and/or invalidity (Compl. ¶36, ¶40, ¶42).
VII. Analyst’s Conclusion: Key Questions for the Case
This declaratory judgment action appears to center on two fundamental questions of technology and claim scope.
- A core issue will be one of functional scope: Does ALO-01's alleged function of "mitigating the euphoric effects of morphine" meet the standard of causing an "aversive experience in a physically dependent subject" as required by claims in the '384 patent family? The distinction between merely reducing a drug's desirability and causing a truly negative physiological reaction will be a critical point of contention.
- A key evidentiary question will be one of technical equivalence: Does ALO-01's proprietary "sequestering technology" operate in a way that infringes claims requiring a "two-step extraction process" or a "tamper resistant" formulation, as recited in the '863 and '088 patent families? Given the lack of technical detail in the complaint, the case will likely require significant discovery into the actual mechanism of ALO-01 to resolve whether there is a fundamental mismatch in technical operation.