Litigation Details for Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Docket		Date Filed	2018-02-22
Court	District Court, D. Delaware	Date Terminated	2020-10-07
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To	Christopher J. Burke
Parties	COLLEGIUM PHARMACEUTICAL, INC.
Patents	10,004,729; 7,399,488; 7,771,707; 8,449,909; 8,557,291; 8,758,813; 8,840,928; 9,044,398; 9,248,195; 9,592,200; 9,682,075; 9,737,530; 9,763,883; 9,968,598
Attorneys	Brooke E. Hazan
Firms	Shaw Keller LLP
Link to Docket	External link to docket

Details for Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-02-22				External link to document
2018-02-21	1		before the expiration of, Collegium’s U.S. Patents Nos. 7,399,488; 7,771,707; 8,449,909; 8,557,291; 8,758,813…is an action for relief from patent infringement, arising under the patent laws of Title 35, United States…Notice of Patent Certification asserting it intends to launch its copy before Collegium’s patents to its…of infringement of the Asserted Patents under the United States Patent Law, 35 U.S.C. § 271(e)(2)(A). …of infringement of the Asserted Patents under the United States Patent Law, 35 U.S.C. § 271(e)(2)(A).	External link to document
2018-02-21	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) US 7,771,707 B2; US 8,449,909 …2018 7 October 2020 1:18-cv-00300 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-02-21	107	Report and Recommendations	x27;"883 patent"), 9,968,598 (the '"598 patent") and 10,004,729 (the '"…infringement of 13 patents: United States Patent Nos. 7,771,707 (the "'707 patent"), 8,449,…"729 patent" and collectively with the other patents, "the asserted patents"). Presently…8,449,909 (the "'909 patent"), 8,557,291 (the "'291 patent"), 8,758,813 (the … "'813 patent"), 8,840,928 (the '"928 patent"), 9,044,398 (the '"	External link to document

Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Collegium Pharmaceutical, Inc. and Teva Pharmaceuticals USA, Inc. (Case No. 1:18-cv-00300) revolves around patent disputes related to Collegium's product, Xtampza ER, a extended-release oral formulation of oxycodone. Here is a detailed summary and analysis of the key aspects of this litigation.

Background

Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on responsible pain management. Xtampza ER, one of their flagship products, is designed to provide extended-release pain relief while incorporating abuse-deterrent properties.

The Litigation

The litigation began when Teva Pharmaceuticals USA, Inc. filed an Abbreviated New Drug Application (ANDA) with the FDA to market a generic version of Xtampza ER. Collegium responded by filing a patent infringement lawsuit against Teva, alleging that Teva's proposed generic product infringed on Collegium's patents.

Key Issues

• Patent Infringement: The primary issue was whether Teva's generic product infringed on Collegium's asserted patents. Collegium claimed that Teva's product would violate their intellectual property rights[1][3].
• Validity and Enforceability: Another crucial aspect was the validity and enforceability of Collegium's patents. Collegium argued that their patents were valid and enforceable against Teva's proposed generic products.

Settlement Agreement

In September 2020, Collegium and Teva reached a settlement agreement. Under the terms of this settlement:

• Consent Judgment: Teva agreed to a consent judgment confirming that their proposed generic products infringed Collegium's asserted patents and that these patents are valid and enforceable with respect to Teva's products[1].
• Confidential Details: Additional details of the settlement were kept confidential.

Impact on Collegium

The settlement was seen as a significant victory for Collegium, as it protected their intellectual property and the value of their innovation in the Xtampza ER franchise.

• Statement from Collegium: The company expressed satisfaction with the outcome, highlighting the importance of their scientific innovation in pain management[1].

Legal and Business Implications

• Protection of Intellectual Property: The settlement underscores the importance of protecting intellectual property in the pharmaceutical industry. It ensures that companies like Collegium can continue to innovate without the threat of generic competition infringing on their patents.
• Market Exclusivity: By securing this settlement, Collegium maintained market exclusivity for Xtampza ER, which is crucial for the company's revenue and competitive position.

Industry Context

The pharmaceutical industry is highly competitive, and patent litigation is common. This case illustrates the lengths to which companies will go to protect their intellectual property and maintain market share.

• Precedent: Such settlements can set precedents for future patent disputes, influencing how companies approach ANDA filings and patent infringement lawsuits.

Conclusion

The litigation between Collegium Pharmaceutical, Inc. and Teva Pharmaceuticals USA, Inc. highlights the critical role of patent protection in the pharmaceutical industry. The settlement ensures that Collegium's innovation in pain management is safeguarded, allowing the company to continue delivering differentiated products to patients.

Key Takeaways

• Patent Protection: The case emphasizes the importance of robust patent protection for pharmaceutical companies.
• Settlement Agreements: Confidential settlement agreements can resolve complex patent disputes while protecting intellectual property.
• Market Exclusivity: Maintaining market exclusivity is crucial for pharmaceutical companies to recoup investment in research and development.
• Industry Precedent: Such cases can set important precedents for future patent disputes in the pharmaceutical sector.

Frequently Asked Questions (FAQs)

Q: What was the main issue in the litigation between Collegium Pharmaceutical, Inc. and Teva Pharmaceuticals USA, Inc.? A: The main issue was whether Teva's proposed generic product infringed on Collegium's patents for Xtampza ER.

Q: What was the outcome of the litigation? A: The litigation ended with a settlement agreement where Teva acknowledged that their proposed generic products infringed Collegium's patents and that these patents are valid and enforceable.

Q: Why is this settlement important for Collegium? A: The settlement protects Collegium's intellectual property and maintains their market exclusivity for Xtampza ER, which is vital for their revenue and competitive position.

Q: How does this case impact the pharmaceutical industry? A: It highlights the importance of patent protection and can set precedents for how companies handle ANDA filings and patent infringement lawsuits.

Q: What does the settlement mean for patients? A: The settlement ensures that patients continue to have access to Collegium's innovative pain management products without the immediate threat of generic competition.

Sources:

1. Collegium Announces Settlement with Teva Resolving Xtampza ER Patent Litigation - Collegium Pharmaceutical, Inc.
2. Litigation Details for Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc. - DrugPatentWatch
3. Gaminde v. Lang Pharma Nutrition, Inc. et al - ClassAction.org (not directly relevant but included for completeness)