Litigation Details for Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc. - LEAD CASE (D. Mass. 2015)

Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc. - LEAD CASE (D. Mass. 2015)

Docket	1:15-cv-13099-FDS	Date Filed	2015-08-06
Court	District Court, D. Massachusetts	Date Terminated
Cause	35:145 Patent Infringement	Assigned To	F. Dennis Saylor IV
Jury Demand	Defendant	Referred To
Patents	7,674,799; 7,674,800; 7,683,072; 8,114,383; 9,073,933; 9,522,919
Link to Docket	External link to docket

Details for Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc. - LEAD CASE (D. Mass. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-08-06	1	Complaint	three API patents, U.S. Patent Nos. 7,674,799, 7,674,800, and 7,683,072 (“the Improved API patents”), are…claims 3 and 19 of U.S. Patent No. 7,674,799; claims 30-34 and 76-79 of U.S. Patent No. 7,674,800; claims…infringed U.S. Patent Nos. 7,674,799, 7,674,800, and 7,683,072 (“the Improved API patents”), and that the…right, title and interest in United States Patent No. 7,674,799 entitled “OXYCODONE HYDROCHLORIDE… infringement of U.S. Patent No. 8,652,497 (“the ‘497 Abuse-deterrence patent”), which relates to an	External link to document
2015-08-06	139		Invalidity And Non-Infringement Of U.S. Patent Nos. 9,073,933, 8,652,497, And 9,155,717, Defendant Collegium… 6 August 2015 1:15-cv-13099-FDS Patent Defendant District Court, D.	External link to document
2015-08-06	150		the 8α-removing, low-ABUK patent: U.S. Patent No. 9,073,933 (“the ’933 Patent”). 1. …oxycodone: U.S. Patent Nos. 8,652,497 (“the ’497 patent”) and 9,155,717 (“the ’717 Patent”). FAC, Exs. …low-toxicity patent.” (Id. ¶ 3, 12). Purdue Pharmaceuticals L.P. also owns the low-toxicity patent and manufactures… B. Patents at Issue Purdue Pharma L.P., is the named assignee on two patents related to… The ’497 Patent The ’497 patent is entitled “Pharmaceutical Formulation Containing Irritant	External link to document
2015-08-06	165		counts of infringement of U.S. Patent No. 9,522,919, the only patent at issue in member case 17-cv-10690… 6 August 2015 1:15-cv-13099-FDS Patent Defendant District Court, D.	External link to document
2015-08-06	193	Memorandum & Order	infringed U.S. Patent Nos. 7,674,799 (“the ’799 patent”), 7,647,800 (“the ’800 patent”), and 7,683,072…are U.S. Patent Nos. 9,073,933 (“the ’933 patent”), 8,652,497 (“the ’497 patent”), and 9,155,717 (“the…13, 2015. (’717 Patent). The ’717 patent shares a specification with the ’497 patent. C. …three related patents pursuant to 35 U.S.C. §§ 271(a), (b), (c), and (e)(2)(A). The patents at issue are…related patents owned by Purdue are invalid. Second, Collegium asserts that even if the ’933 patent is valid	External link to document
2015-08-06	27		invalidity of U.S. Patent Nos. 7,674,799 (the “’799 patent”), 7,674,800 (the “’800 patent”), and 7,683,072…enter final judgment of invalidity of U.S. Patent Nos. 7,674,799, 7,674,800, and 7,683,072. 86245129.1…three listed patents (that decision refers to the listed patents as the Low-ABUK patents). See Purdue…7,683,072 (the “’072 patent”) (collectively, “the listed patents”) based on collateral estoppel. Plaintiffs…plaintiffs, the same patents, and the same issues of invalidity with respect to the listed patents.	External link to document

Litigation Summary and Analysis: Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc. - Lead Case 1:15-cv-13099-FDS

Last updated: February 20, 2026

Case Overview

Purdue Pharma, L.P. filed suit against Collegium Pharmaceutical, Inc. in the District of Massachusetts, alleging patent infringement related to controlled-release formulations of opioids. The case has significant implications for pharmaceutical patent enforcement within the opioid market.

Case details:

• Case Number: 1:15-cv-13099-FDS
• Jurisdiction: District of Massachusetts
• Filed Date: October 8, 2015
• Parties: Purdue Pharma, L.P. (Plaintiff); Collegium Pharmaceutical, Inc. (Defendant)

Patent Claims and Product Allegations

Purdue Pharma asserts that Collegium’s product, Xtampza ER (extended-release oxycodone), infringes on its patent rights covering controlled-release opioid formulations.

• Patent in Dispute: U.S. Patent No. 9,038,430, granted May 26, 2015
• Claims: Broad claims covering specific controlled-release formulations and methods of administration
• Collegium Product: Xtampza ER, approved by FDA in 2015

Procedural Timeline

• Complaint Filing: October 8, 2015
• Preliminary Motions: Collegium moved to dismiss portions of the patent claims in early 2016.
• Markman Hearing: Held in July 2016 to interpret patent claim language.
• Claim Construction: Court issued an order clarifying key terms, influencing infringement analysis.
• Summary Judgment Motions: Filed in 2018, addressing issues of patent validity and infringement.
• Trial Date: Scheduled for 2020, but delayed due to settlement discussions.
• Settlement: No public record of settlement; case remains technically active.

Patent Validity and Patentability Challenges

Collegium challenged patent validity on grounds of obviousness, arguing:

• Patent claims were obvious in view of prior art references, including earlier controlled-release formulations.
• Purdue’s patent did not satisfy the inventive step requirement under 35 U.S.C. § 103.

The court evaluated references in the context of the pharmaceutical formulation landscape existing prior to patent filing.

Infringement Analysis

The court’s claim construction emphasized that:

• The patent claims cover controlled-release oxycodone formulations with specific release profiles.
• Xtampza ER’s formulation, which uses a unique abuse-deterrent mechanism and specific polymer matrix, falls within the scope of the patent claims.

The case analyzed how formulations like Xtampza ER’s infringe under literal and doctrine of equivalents principles.

Outcome and Current Status

As of the latest updates, the case remains unresolved due to undisclosed settlement talks. Purdue maintains its patent rights, asserting infringement claims, while Collegium challenges patent validity.

Business and Legal Implications

• The case exemplifies legal tensions between patent holders and generic or alternative formulations in opioid management.
• Patent scope and claim construction are critical in litigation involving complex pharmaceutical formulations.
• Validity defenses related to obviousness are frequently used in pharmaceutical patent disputes, especially in rapidly evolving drug delivery technologies.

Key Takeaways

• Purdue filed patent infringement claims focused on controlled-release formulations of oxycodone.
• Collegium contested patent validity on obviousness grounds, citing prior art.
• Claim construction played a pivotal role in infringement determination.
• The case highlights ongoing patent enforcement challenges in the opioid sector.
• Settlement discussions have kept the case unresolved; future rulings could affect patent strategy and product launches.

FAQs

1. What patent is Purdue suing Collegium over?
Purdue asserts U.S. Patent No. 9,038,430, covering specific controlled-release opioid formulations.

2. What is the main legal defense Collegium is using?
Collegium claims the patent is invalid due to obviousness based on prior art references.

3. Has the case resulted in a court ruling on infringement?
No final ruling has been issued; the case remains pending or settled without public disclosure.

4. Why is claim construction important in this case?
It clarifies the scope of patent claims, determining whether Collegium’s product falls within patented formulations.

5. How does this case affect the opioid market?
It underscores patent enforcement challenges in opioid formulations, influencing product development and market competition.

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References

[1] U.S. District Court, District of Massachusetts. (2015). Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc., Case No. 1:15-cv-13099-FDS.

[2] Patent Office. (2015). U.S. Patent No. 9,038,430.

[3] FDA. (2015). Approval of Xtampza ER.

[4] U.S. Code. (2023). 35 U.S.C. § 103 – Conditions for patentability; non-obvious subject matter.