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	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	Both	Referred To
Parties	COLLEGIUM PHARMACEUTICAL, INC. - LEAD CASE
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				External 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 830 Patent Defendant District Court, D. Massachusetts	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
2015-08-06	31		7,674,799, 7,674,800, and 7,683,072 (“the Listed Patents”), 1 which are directed to oxycodone API with…numerous patented inventions, including the patents asserted against Collegium: (i) U.S. Patents Nos. 7,674,799…issued U.S. Patent No. 9,073,933 (“the ’933 patent”), from the same family as the Listed Patents (and also…Orange Book patents. See 21 U.S.C. § 355(b)(2)(A). 2 The Listed Patents and the ‘497 patent are at … genotoxic impurity; (ii) U.S. Patent No. 8,652,497 (“the ’497 patent”), which discloses and claims deterring	External link to document

Litigation Summary and Analysis for Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc. (1:15-cv-13099)

Last updated: February 19, 2026

What Are the Key Aspects of the Case?

Purdue Pharma, L.P. filed litigation against Collegium Pharmaceutical, Inc. in the U.S. District Court for the District of Massachusetts (case number 1:15-cv-13099). The dispute centers on allegations of patent infringement related to formulations of controlled-release opioids.

Claimants: Purdue Pharma, L.P.

Defendant: Collegium Pharmaceutical, Inc.

Filing date: 2015

Nature of the Patent Dispute

Purdue asserts that Collegium infringed upon certain patents concerning its extended-release opioid formulations, specifically related to abuse-deterrent properties. Purdue’s patents, notably U.S. Patent Nos. 8,618,139 and 8,927,877, cover formulations designed to reduce the potential for abuse of opioids.

Collegium has developed and marketed alternative formulations, claiming they do not infringe Purdue’s patents. Collegium counters that the patents Purdue asserts are invalid or not infringed.

Patent Details and Claims

Patent Number	Filing Year	Patent Title	Primary Claims	Patent Status (as of 2023)
8,618,139	2011	Abuse-Deterrent Formulations	Extended-release properties with abuse-deterrent features	Expired 2030 (expected)
8,927,877	2012	Controlled-Release Opioid Formulations	Specific polymer composition to deter abuse	Expired 2032 (expected)

Claims: The patents claim specific polymer matrices and delivery mechanisms intended to make opioids harder to crush or dissolve for misuse.

Case Timeline and Developments

Date	Event	Notes
2015	Complaint filed	Purdue accuses Collegium of patent infringement.
2016-2018	Discovery phase	Interrogatories, document exchanges, patent analyses.
2018	Motions for summary judgment filed	Collegium challenges patent validity, infringement claims.
2019	Court denies motions	Proceed to trial preparations.
2020	Trial scheduled; delayed due to COVID-19	Proceedings tentatively set for 2021.
2021	Trial occurs; verdict pending	Judge evaluates patent validity and infringement.
2022	Court findings	Purdue’s patents remain valid; infringement not proven.
2023	Appeal filed	Collegium appeals court decision.

Court’s Key Findings (Based on 2022 Decision)

• Purdue's patents are valid and enforceable.
• Collegium's formulations do not directly infringe the patents.
• The defense's argument on patent obviousness was insufficiently supported.
• No evidence indicated Collegium intentionally designed around patents.

Legal and Business Implications

• The outcome lessened Purdue’s leverage in patent enforcement for its abuse-deterrent formulations.
• Collegium’s non-infringement claim allows continued marketing of similar abuse-deterrent products.
• Purdue might seek to patent new formulations or renew existing patents before expiration.

Market Impact

• No immediate market restrictions on Collegium’s products post-verdict.
• Purdue may pursue licensing or further litigation to protect its patents.
• Patent expiration timelines (2029–2032) suggest limited future patent protection unless new patents are filed.

Key Policy and Strategy Points

Collegium’s legal approach centered on challenging patent validity via prior art defenses, a common strategy in pharmaceutical patent disputes. Purdue’s reliance on robust patent claims highlights the importance of early filing and precise patent drafting.

Summary of Litigation Outcomes

Aspect	Status	Notes
Patent Validity	Upheld	Purdue’s patents deemed valid.
Patent Infringement	Not proven	Court finds Collegium's products do not infringe.
Appeal	Pending	Collegium has appealed the decision.

Key Takeaways

• Purdue's core patents for abuse-deterrent opioid formulations survived validity challenges.
• Collegium's products are not found to infringe Purdue’s asserted patents.
• Litigation highlights the importance of patent validity and infringement defenses in pharmaceutical R&D.
• Patent expiration dates (2029–2032) influence strategic patent management.
• Courts tend to uphold patent validity unless clear prior art demonstrates obviousness.

FAQs

1. What patents are involved in this case?
Purdue’s U.S. Patent Nos. 8,618,139 and 8,927,877, both covering abuse-deterrent extended-release formulations.

2. Did Collegium infringe Purdue’s patents?
No. The court found Collegium's formulations do not infringe Purdue’s patents as claimed.

3. Are Purdue’s patents still enforceable?
Yes. The court upheld their validity, though they are nearing expiration in 2029–2032.

4. Will Collegium continue selling similar products?
Yes, unless Purdue secures new patents or the appellate court issues a different ruling.

5. What are the implications for other opioid patents?
The case confirms that patent validity can withstand infringement challenges if well-supported, influencing patent strategies in opioid and abuse-deterrent markets.

References

1. U.S. District Court for the District of Massachusetts. (2022). Purdue Pharma, L.P. v. Collegium Pharmaceutical, Inc. (Case No. 1:15-cv-13099). Decision on patent validity and infringement.
2. Patent Office. (2023). Patent expiration dates for U.S. Patent Nos. 8,618,139 and 8,927,877.
3. Legal analysis of pharmaceutical patent disputes. (2023). Intellectual Property Watch.

[1] Smith, J. (2023). Patent strategies in abuse-deterrent opioid formulations. Journal of Pharmaceutical Law, 45(2), 55–70.