DCT
1:17-cv-10690
Purdue Pharma LP v. Collegium Pharmaceutical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., and Rhodes Technologies (collectively, "Purdue") (Delaware, New Jersey)
- Defendant: Collegium Pharmaceutical, Inc. ("Collegium") (Virginia)
- Plaintiff’s Counsel: Jones Day
- Case Identification: 1:17-cv-10690, D. Mass., 04/21/2017
- Venue Allegations: Venue is alleged to be proper in the District of Massachusetts based on Defendant’s principal place of business being located within the district, as well as prior admissions of proper venue by the Defendant in related litigation.
- Core Dispute: Plaintiff alleges that Defendant’s Xtampza® ER extended-release oxycodone capsules infringe a patent directed to highly purified oxycodone hydrochloride compositions.
- Technical Context: The technology concerns the manufacturing of oxycodone hydrochloride, a widely used opioid analgesic, with specific low levels of certain process-related chemical impurities.
- Key Procedural History: The complaint follows a series of prior patent litigations between the same parties concerning Defendant's Xtampza® ER product and other Purdue patents. Defendant received FDA approval for its New Drug Application (NDA) for Xtampza® ER in April 2016 and began commercial sales in June 2016. The patent-in-suit issued in December 2016, four months prior to the filing of this complaint.
Case Timeline
| Date | Event |
|---|---|
| 2004-03-30 | Earliest Priority Date for ’919 Patent |
| 2016-04-26 | FDA approves Collegium's NDA for Xtampza® ER |
| 2016-06-20 | Collegium announces commercial launch of Xtampza® ER |
| 2016-12-20 | U.S. Patent No. 9,522,919 Issues |
| 2017-04-21 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,522,919 - "OXYCODONE COMPOSITIONS"
The Invention Explained
- Problem Addressed: The patent's background describes the chemical synthesis of oxycodone, which often begins with a compound called thebaine. The process of oxidizing thebaine to create an intermediate compound can also create unwanted "overoxidized products," specifically an impurity known as 8,14-dihydroxy-7,8-dihydrocodeinone (’919 Patent, col. 2:5-10). This impurity can carry through the manufacturing process and result in the final oxycodone drug product containing another undesirable impurity, 14-hydroxycodeinone, at levels the patent states were previously greater than 100 parts per million (ppm) (’919 Patent, col. 2:10-19).
- The Patented Solution: The invention is a final oxycodone hydrochloride composition, and the process to make it, that is defined by a very low level of a specific impurity. The patent claims compositions where the ratio of the impurity 8α,14-dihydroxy-7,8-dihydrocodeinone to the active ingredient, oxycodone HCl, is 0.04% or less (’919 Patent, Claim 1). The specification explains that achieving such low impurity levels can involve steps like hydrogenation under specific conditions to reduce the unwanted compounds (’919 Patent, col. 3:1-9, Fig. 1).
- Technical Importance: Achieving high levels of purity is a critical objective in pharmaceutical manufacturing to ensure drug safety, stability, and compliance with regulatory standards (’919 Patent, col. 2:19-23).
Key Claims at a Glance
- The complaint asserts independent claims 1, 4, 12, and 18 (Compl. ¶25, ¶28).
- Independent Claim 1:
- An oxycodone HCl composition
- comprising oxycodone HCl and 8α,14-dihydroxy-7,8-dihydrocodeinone,
- wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone HCl is 0.04% or less as measured by HPLC.
- Independent Claim 4:
- A pharmaceutically acceptable formulation
- comprising oxycodone HCl and 8α,14-dihydroxy-7,8-dihydrocodeinone,
- wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone HCl is 0.04% or less as measured by HPLC.
- Claims 12 and 18 are substantially similar to claims 1 and 4, respectively, but add the further limitation that the composition or formulation must also contain "less than 100 ppm of 14-hydroxycodeinone" (Compl. ¶25, fn. omitted; ’919 Patent, col. 36:1-12). The complaint does not assert any dependent claims.
III. The Accused Instrumentality
Product Identification
Xtampza® ER oxycodone extended-release capsules, available in 9 mg, 13.5 mg, 18 mg, 27 mg, and 36 mg dosages (the "Collegium Products") (Compl. ¶1).
Functionality and Market Context
The accused products are extended-release oral capsules containing the opioid analgesic oxycodone (Compl. ¶1). The complaint alleges that Collegium commercially launched the products in the U.S. following FDA approval of its New Drug Application (NDA) (Compl. ¶20, ¶21, ¶32).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
Claim Chart Summary
The complaint alleges infringement based on the chemical makeup of the Collegium Products. The core allegation is that these products meet the specific purity profile defined in the claims of the ’919 Patent.
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An oxycodone HCl composition | The Collegium Products are extended-release capsules containing oxycodone HCl. | ¶1, ¶25 | col. 1:57 |
| comprising oxycodone HCl and 8α,14-dihydroxy-7,8-dihydrocodeinone, | The complaint alleges, upon information and belief, that the Collegium Products comprise an oxycodone hydrochloride composition that contains the specified impurity, 8α,14-dihydroxy-7,8-dihydrocodeinone. | ¶25, ¶28 | col. 2:5-10 |
| wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone HCl is 0.04% or less as measured by HPLC. | The complaint alleges, upon information and belief, that in the Collegium Products, the ratio of the specified impurity to oxycodone HCl is at or below the 0.04% threshold required by the claim. | ¶25, ¶28 | col. 2:5-10 |
Identified Points of Contention
- Factual Question: The central dispute appears to be factual and evidentiary. The complaint alleges "upon information and belief" that the accused products meet the claimed purity limitations (Compl. ¶25). This raises the question of what definitive chemical analysis of the Xtampza® ER capsules will reveal regarding the precise ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone HCl.
- Scope Question: A potential point of dispute may arise from the use of "composition" in claims 1 and 12 versus "pharmaceutically acceptable formulation" in claims 4 and 18. This raises the question of whether the claimed ratio limitation applies to the active pharmaceutical ingredient (API) alone, the final drug product including excipients, or both.
V. Key Claim Terms for Construction
- The Term: "composition" / "pharmaceutically acceptable formulation"
- Context and Importance: The asserted independent claims are split between these two terms. The accused product is a final dosage form, which is typically described as a "formulation." The construction of these terms will determine whether the claims cover just the drug substance (API) or the substance combined with excipients in the final product. Practitioners may focus on this distinction to argue that testing results from the API versus the finished capsule lead to different infringement outcomes.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader/Overlapping Interpretation: The patent title itself, "Oxycodone Compositions," and the first sentence of the complaint suggest the terms may be used broadly (Compl. ¶1). The patent’s detailed description also refers to "an oxycodone hydrochloride composition (e.g., oxycodone hydrochloride API)" (’919 Patent, col. 6:40-42), suggesting "composition" can refer to the API, while the asserted "formulation" claims clearly cover the final drug product.
- Evidence for a Narrower/Distinct Interpretation: A party could argue the terms are distinct. The patent discusses testing "a final pharmaceutical dosage form" separately from the API, which could suggest a "formulation" is distinct from a "composition" if the latter is interpreted to mean only the API (’919 Patent, col. 6:3-5).
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement and contributory infringement (Compl. ¶34). The factual basis for inducement is identified as Collegium's "labeling and manufacturing process," which allegedly causes patients and manufacturers to infringe (Compl. ¶35).
- Willful Infringement: Willfulness is alleged based on Collegium’s continued marketing and sale of the accused products after the ’919 Patent issued on December 20, 2016, which allegedly provided Collegium with knowledge of the patent and its infringement (Compl. ¶37, ¶38).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to center on highly technical, factual questions of chemical purity. The key questions for the court will likely be:
- A primary evidentiary question: Does a chemical analysis of Collegium's commercial Xtampza® ER product demonstrate that it meets the specific quantitative limitations of the asserted claims, particularly the "0.04% or less" ratio of the 8α,14-dihydroxy-7,8-dihydrocodeinone impurity as measured by HPLC?
- A secondary question of claim scope: Is there a legally significant distinction between the "composition" recited in claims 1 and 12 and the "pharmaceutically acceptable formulation" recited in claims 4 and 18, and how does that distinction apply to infringement allegations against a finished drug product?