Introduction
The litigation between Purdue Pharma L.P. and Collegium Pharmaceutical, Inc. is a complex and multifaceted case that involves several key aspects of patent law, particularly in the context of pharmaceutical products. This article will delve into the details of the case, including the patents in dispute, the legal proceedings, and the significant rulings that have shaped the outcome.
Background and Patents in Dispute
The dispute centers around several patents held by Purdue Pharma L.P., including U.S. Patent Nos. 9,073,933, 8,652,497, 9,155,717, and 9,693,961. These patents relate to abuse-deterrent, extended-release oxycodone formulations, a critical area given the opioid crisis[3].
District Court Proceedings
The litigation began in the District Court of Massachusetts, where Purdue Pharma L.P. sued Collegium Pharmaceutical, Inc. for patent infringement related to Collegium's product, XTAMPZA ER. Collegium filed a motion for summary judgment on several grounds, including the invalidity of the patents and non-infringement.
Claim Construction and Summary Judgment
The court issued a Memorandum and Order on claim construction, which was crucial for determining the scope of the patents. Collegium argued that the '933 patent was invalid under issue preclusion due to a previous judgment in the Southern District of New York. However, the court found that the patentability of certain claims had not been litigated previously and thus were not subject to issue preclusion[2].
Non-Infringement Arguments
Collegium also argued for summary judgment of non-infringement, citing differences in the claim limitations and the doctrine of equivalents. The court found that while Purdue may have disclaimed certain products, it was unclear whether they had surrendered all other forms of oxycodone, including Collegium's oxycodone myristate. The court ultimately denied summary judgment on non-infringement grounds due to genuine fact disputes[4].
Post-Grant Review (PGR) Proceedings
In parallel to the district court proceedings, Collegium initiated a post-grant review (PGR) before the Patent Trial and Appeal Board (PTAB) challenging the validity of Purdue's U.S. Patent No. 9,693,961. The PTAB instituted the PGR and had a statutory deadline to issue a Final Written Decision (FWD) within one year, extendable by six months for good cause.
Statutory Deadline and Jurisdiction
The PTAB extended the deadline by six months until April 4, 2020, due to Purdue's bankruptcy proceedings. However, the PTAB did not issue the FWD until November 19, 2021, nearly 18 months after the extended deadline. Purdue argued that the PTAB lost its jurisdiction to issue the FWD due to the missed deadline. The PTAB rejected this argument and issued the FWD, finding all claims of the '961 patent invalid for lack of an adequate written description and anticipation[1][3].
Federal Circuit Appeal
Purdue appealed the PTAB's decision to the Federal Circuit, arguing that the PTAB's failure to meet the statutory deadline deprived it of jurisdiction. The Federal Circuit ruled that the statutory provisions did not specify consequences for non-compliance with the deadline, and thus, the PTAB retained its authority to issue the FWD even after the deadline had passed. This ruling was based on 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].
Key Rulings and Implications
- Retention of Jurisdiction: The Federal Circuit's ruling that the PTAB retained its jurisdiction despite missing the statutory deadline is significant. It clarifies that the absence of specified consequences in the statute means the PTAB's authority is not automatically revoked[1].
- Invalidity of Patents: The PTAB's finding that all claims of the '961 patent were invalid due to lack of an adequate written description and anticipation is a substantial blow to Purdue's patent portfolio. This ruling underscores the importance of meeting the requirements for patentability, particularly in the context of pharmaceutical formulations[3].
Impact on Pharmaceutical Industry
The case has important implications for the pharmaceutical industry, particularly in the development and protection of abuse-deterrent formulations. It highlights the challenges companies face in navigating both district court litigation and PTAB proceedings simultaneously. The ruling on jurisdiction also sets a precedent for how statutory deadlines are interpreted in post-grant review proceedings.
Conclusion
The litigation between Purdue Pharma L.P. and Collegium Pharmaceutical, Inc. is a complex interplay of patent law, jurisdictional issues, and the nuances of pharmaceutical product development. The Federal Circuit's decision on the PTAB's jurisdiction and the invalidity of Purdue's patents have significant implications for both parties and the broader pharmaceutical industry.
Key Takeaways
- The PTAB retains its jurisdiction to issue a Final Written Decision even if it misses the statutory deadline.
- The absence of specified consequences in the statute for non-compliance with timing provisions means federal courts will not impose coercive sanctions.
- Pharmaceutical companies must carefully navigate both district court and PTAB proceedings to protect their patents.
- Meeting the requirements for patentability, such as adequate written description and non-anticipation, is crucial for maintaining patent validity.
Frequently Asked Questions (FAQs)
What was the main issue in the Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc. case?
The main issue was whether the Patent Trial and Appeal Board (PTAB) retained its jurisdiction to issue a Final Written Decision after missing the statutory deadline.
Which patents were involved in the dispute?
The dispute involved several patents, including U.S. Patent Nos. 9,073,933, 8,652,497, 9,155,717, and 9,693,961, all related to abuse-deterrent, extended-release oxycodone formulations.
What was the outcome of the post-grant review (PGR) proceedings?
The PTAB found all claims of the '961 patent invalid for lack of an adequate written description and anticipation.
How did the Federal Circuit rule on the PTAB's jurisdiction?
The Federal Circuit ruled that the PTAB retained its jurisdiction despite missing the statutory deadline because the statute did not specify consequences for non-compliance.
What are the implications of this case for the pharmaceutical industry?
The case highlights the importance of meeting patentability requirements and navigating both district court and PTAB proceedings. It also sets a precedent for interpreting statutory deadlines in post-grant review proceedings.
Cited 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.
- United States District Court for the District of Massachusetts. "Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc." Case 1:15-cv-13099-FDS Document 193, September 28, 2018.
- JD Supra. "Purdue Pharma L.P. v. Collegium Pharmaceutical, Inc." JD Supra, January 8, 2024.
- Robins Kaplan LLP. "Purdue Pharma L.P. v. Collegium Pharm., Inc." Generically Speaking: Hatch-Waxman Bulletin, September 28, 2018.
- Casetext. "Purdue Pharma L.P. v. Collegium Pharm., Inc." Casetext.
