Background of the Dispute
The litigation between Purdue Pharma L.P. and Collegium Pharmaceutical, Inc. revolves around patent disputes related to abuse-deterrent, extended-release oxycodone formulations. Purdue Pharma, known for its opioid products, had been engaged in a series of legal battles to protect its patents against Collegium's similar products, particularly XTAMPZA ER.
Patent Dispute and Infringement Claims
Purdue Pharma filed a lawsuit against Collegium Pharmaceutical in the U.S. District Court for the District of Massachusetts, alleging infringement of several related patents. The patents in question include U.S. Patent Nos. 9,073,933 ('933 patent), 8,652,497 ('497 patent), and 9,155,717 ('717 patent)[5].
Key Patents and Claims
- U.S. Patent No. 9,073,933 ('933 patent): This patent is central to the dispute and involves claims related to the formulation of oxycodone hydrochloride.
- U.S. Patent Nos. 8,652,497 and 9,155,717 ('497 and '717 patents): These patents claim the addition of an irritant to deter abuse.
District Court Proceedings
Claim Construction and Summary Judgment
In the District Court of Massachusetts, the case involved several key issues:
- Claim Construction: The court issued a Memorandum and Order on claim construction, defining five disputed claim terms. This was crucial in determining the scope of Purdue's patents[5].
- Summary Judgment: Collegium moved for summary judgment on several grounds, including invalidity of the '933 patent under issue preclusion, non-infringement due to lack of literal infringement and equivalence, and non-infringement of the '497 and '717 patents because its product did not contain an irritant[5].
Non-Infringement Arguments
Collegium argued that its product, XTAMPZA ER, did not infringe Purdue's patents for several reasons:
- Oxycodone Myristate vs. Oxycodone Hydrochloride: Collegium contended that oxycodone myristate, the active ingredient in XTAMPZA ER, was not the equivalent of oxycodone hydrochloride, the active ingredient in Purdue's product[2][5].
- Irritant Patents: Collegium argued that its formulation did not contain an irritant, which was a key claim in the '497 and '717 patents. The court found that the prosecution history of the patents indicated that Purdue had surrendered claims to excipients that could also function as irritants[2][5].
Post-Grant Review (PGR) Proceedings
Institution of PGR and Statutory Deadlines
Collegium initiated a post-grant review (PGR) challenging Purdue's U.S. Patent No. 9,693,961, which is directed to opioid formulations designed to prevent or deter abuse. The Patent Trial and Appeal Board (PTAB) instituted the PGR and had a statutory deadline of one year to issue a Final Written Decision (FWD), with a possible six-month extension for good cause[1][4].
Extension and Delay
Due to Purdue's bankruptcy proceedings, the PTAB granted a six-month extension until April 4, 2020. However, the Final Written Decision was not issued until November 19, 2021, nearly 18 months after the extended deadline. Purdue argued that the PTAB's failure to meet the statutory deadline resulted in a loss of jurisdiction[1][4].
Federal Circuit Appeal
Jurisdiction and Statutory Deadlines
Purdue appealed the PTAB's decision to the Federal Circuit, arguing that the Board's failure to comply with the statutory deadline deprived it of the authority to issue a Final Written Decision. The Federal Circuit, however, ruled that the Board retained its jurisdiction despite missing the deadline. The court cited Supreme Court precedent that federal courts will not impose coercive sanctions for non-compliance with statutory timing provisions if the statute does not specify such consequences[1].
Arguments and Ruling
Purdue presented several arguments based on the statutory language, including the use of "shall" and "requiring" in 35 U.S.C. § 326(a)(11), but the Federal Circuit rejected these arguments. The court concluded that the Board's jurisdiction did not expire with the passage of the statutory deadline[1].
Key Takeaways
- Patent Jurisdiction and Deadlines: The Federal Circuit's decision clarifies that missing statutory deadlines in PGR proceedings does not automatically result in the loss of the PTAB's jurisdiction.
- Infringement Claims: Collegium successfully argued non-infringement based on differences in active ingredients and the absence of irritants in its formulation.
- Bankruptcy and Stay: The case highlights the complexities introduced by bankruptcy proceedings and their impact on patent litigation timelines.
FAQs
Q: What was the main issue in the PGR proceedings between Purdue Pharma and Collegium Pharmaceutical?
A: The main issue was whether the PTAB's failure to meet the statutory deadline for issuing a Final Written Decision resulted in a loss of jurisdiction.
Q: How did the Federal Circuit rule on the jurisdiction issue?
A: The Federal Circuit ruled that the PTAB retained its jurisdiction despite missing the statutory deadline, as the statute did not specify consequences for non-compliance.
Q: What were the key patents involved in the dispute?
A: The key patents included U.S. Patent Nos. 9,073,933, 8,652,497, and 9,155,717, related to abuse-deterrent oxycodone formulations.
Q: Why did Collegium argue that its product did not infringe Purdue's patents?
A: Collegium argued that its product, XTAMPZA ER, used oxycodone myristate instead of oxycodone hydrochloride and did not contain an irritant, thus not infringing Purdue's patents.
Q: How did bankruptcy proceedings affect the litigation timeline?
A: Bankruptcy proceedings led to an automatic stay of the PGR, which was later lifted, contributing to the delay in the PTAB's Final Written Decision.
Sources
- Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. "Board's Failure to Meet Statutory Deadline to Issue Final Written Decision Does Not Result in Loss of Board's Jurisdiction." At the PTAB Blog, July 16, 2024.
- Robins Kaplan LLP. "Purdue Pharma L.P. v. Collegium Pharm., Inc." Generically Speaking: Hatch-Waxman Bulletin, September 28, 2018.
- The FDA Law Blog. "Is a Hatch-Waxman 30-Month Stay Terminated if the Dismissal of a Patent Infringement Action is Later?" March 28, 2017.
- JD Supra. "Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc. (Fed. Cir. 2023)." January 8, 2024.
- Casetext. "Purdue Pharma L.P. v. Collegium Pharm., Inc., 335 F. Supp. 3d 149." September 28, 2018.
