IPSEN BIOPHARMACEUTICALS, INC. et al. v. CONJUPRO BIOTHERAPEUTICS, INC. et al.

This case, IPSEN BIOPHARMACEUTICALS, INC. et al. v. CONJUPRO BIOTHERAPEUTICS, INC. et al., is a pharmaceutical patent infringement dispute rooted in an Abbreviated New Drug Application (ANDA) filing. The plaintiffs, IPSEN BIOPHARMACEUTICALS, INC. and IPSEN BIOPHARM LTD., are global biopharmaceutical companies focused on developing transformative medicines, particularly in oncology, rare diseases, and neuroscience. Ipsen is known for products like ONIVYDE®, a treatment for metastatic pancreatic adenocarcinoma, which utilizes liposomal irinotecan. The defendants, CONJUPRO BIOTHERAPEUTICS, INC., CSPC PHARMACEUTICAL GROUP LIMITED, and CSPC OUYI PHARMACEUTICAL CO., LTD., are part of a larger Chinese pharmaceutical group. CSPC Pharmaceutical Group Limited is a major player in China's healthcare industry, involved in research, development, manufacturing, and selling a wide range of pharmaceutical products, including innovative drugs, generics, and APIs. Conjupro Biotherapeutics, Inc. is a Princeton, NJ-based subsidiary of CSPC, focusing on preclinical and clinical research and development in oncology, cardiology, and CNS diseases. CSPC Ouyi Pharmaceutical Co., Ltd. is another subsidiary, engaged in manufacturing and marketing formulation drugs and APIs, with some facilities having U.S. FDA certification.

The core of the dispute revolves around the accused product, which is an ANDA generic version of Ipsen's ONIVYDE® (irinotecan liposome injection). ONIVYDE® is approved for the treatment of metastatic pancreatic adenocarcinoma. The asserted patent is U.S. Patent No. 11,344,552, titled "Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal irinotecan and oxaliplatin". This patent generally covers improved antineoplastic therapies for pancreatic cancer, specifically involving the administration of liposomal irinotecan in combination with oxaliplatin and 5-fluorouracil, particularly for previously untreated patients.

The case was filed in the U.S. District Court for the District of New Jersey (1:2024cv04991), a common venue for pharmaceutical patent litigation, especially ANDA cases due to the presence of many pharmaceutical companies or their registered agents in the state. The case was later consolidated with 1:2025cv13647 and administratively terminated on September 5, 2025. This case is notable as it involves Ipsen's ONIVYDE®, a critical treatment for pancreatic cancer, and potential generic competition. The patent at issue, US 11,344,552, has also been challenged in an inter partes review (IPR) proceeding, IPR2025-00505, filed by CSPC Pharmaceutical Group Limited et al. against Ipsen Biopharm Ltd. et al. on January 16, 2025, with a trial instituted on August 13, 2025. This parallel IPR proceeding highlights the defendants' multi-pronged strategy to challenge the validity of the asserted patent.

The patent infringement litigation, IPSEN BIOPHARMACEUTICALS, INC. et al. v. CONJUPRO BIOTHERAPEUTICS, INC. et al. (1:2024cv04991), concerning U.S. Patent No. 11,344,552, saw a relatively brief lifespan in the District of New Jersey, marked by its consolidation with another case and subsequent administrative termination, significantly influenced by a parallel inter partes review (IPR) proceeding at the Patent Trial and Appeal Board (PTAB).

Key Legal Developments and Outcome:

• 2024-04-15: Complaint Filed. Ipsen Biopharmaceuticals, Inc. and Ipsen Biopharm Ltd. filed a civil action alleging patent infringement against Conjupro Biotherapeutics, Inc., CSPC Pharmaceutical Group Limited, and CSPC Ouyi Pharmaceutical Co., Ltd. related to U.S. Patent No. 11,344,552.
• Initial Pleadings & Counterclaims. The defendants, Conjupro Biotherapeutics, Inc., CSPC Pharmaceutical Group Limited, and CSPC Ouyi Pharmaceutical Co., Ltd., filed an answer denying infringement and asserted counterclaims for declaratory judgment of noninfringement and invalidity of the patent-in-suit.
• 2025-01-17: Parallel PTAB IPR Filed. The defendants in the district court case – CSPC Pharmaceutical Group Limited, CSPC Ouyi Pharmaceutical Co., Ltd., and Conjupro Biotherapeutics, Inc. – filed an inter partes review petition (IPR2025-00505) against U.S. Patent No. 11,344,552 B2 at the USPTO's Patent Trial and Appeal Board.
• Case Consolidation. The district court action was consolidated with another case, 1:2025cv13647. While the specific date of the consolidation order is not readily available, it occurred prior to the administrative termination of 1:2024cv04991.
• 2025-08-14: PTAB Institutes IPR. The Patent Trial and Appeal Board instituted inter partes review for claims 1-15 of U.S. Patent No. 11,344,552 B2. This decision indicated a "reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition."
• 2025-09-05: Administrative Termination. The consolidated action, including 1:2024cv04991, was administratively terminated by the U.S. District Court for the District of New Jersey. An administrative termination in the District of New Jersey typically means the case is closed for statistical purposes but does not operate as a dismissal order. The parties usually have 60 days to file papers for dismissal, or the court may dismiss with prejudice. The institution of the IPR proceeding likely played a significant role in the court's decision to administratively terminate the district court litigation, often done to allow the PTAB process to unfold first.
• No Further District Court Developments. Given the administrative termination, the case did not proceed to substantive pre-trial motions like Markman claim construction, extensive discovery, or trial events. The final disposition as of the provided information is administrative termination, with the parallel IPR proceeding ongoing against the patent at issue.

The plaintiffs, IPSEN BIOPHARMACEUTICALS, INC. and IPSEN BIOPHARM LTD., are represented by counsel from Saul Ewing LLP and Sterlington LLP.

Here is the identified counsel:

Saul Ewing LLP

• Charles Michael Lizza
  • Role: Lead Counsel
  • Firm & Office Location: Saul Ewing LLP, One Riverfront Plaza, Suite 1520, Newark, NJ 07102
  • Relevant Experience: Lizza is listed as counsel on the initial complaint for patent infringement. His email address is provided on the complaint as clizza@saul.com.
• William C. Baton
  • Role: Lead Counsel
  • Firm & Office Location: Saul Ewing LLP, One Riverfront Plaza, Suite 1520, Newark, NJ 07102
  • Relevant Experience: Baton is listed as counsel on the initial complaint for patent infringement. His email address is provided on the complaint as wbaton@saul.com.
• Sarah Ann Sullivan
  • Role: Lead Counsel
  • Firm & Office Location: Saul Ewing LLP, One Riverfront Plaza, Suite 1520, Newark, NJ 07102
  • Relevant Experience: Sullivan is listed as counsel on the initial complaint for patent infringement. Her email address is provided on the complaint as sarah.sullivan@saul.com.
• Alexander Lee Callo
  • Role: Lead Counsel
  • Firm & Office Location: Saul Ewing LLP, One Riverfront Plaza, Suite 1520, Newark, NJ 07102
  • Relevant Experience: Callo is listed as counsel on the initial complaint for patent infringement. His email address is provided on the complaint as alexander.callo@saul.com.

Sterlington LLP

• Brian V. Slater
  • Role: Of Counsel
  • Firm & Office Location: Sterlington LLP, One World Trade Center, 85th Floor, New York, NY 10007
  • Relevant Experience: Slater is listed as "OF COUNSEL" on the initial complaint for patent infringement. His email address is provided on the complaint as brian.slater@sterlingtonlaw.com.
• Gregory B. Sephton
  • Role: Of Counsel
  • Firm & Office Location: Sterlington LLP, One World Trade Center, 85th Floor, New York, NY 10007
  • Relevant Experience: Sephton is listed as "OF COUNSEL" on the initial complaint for patent infringement. His email address is provided on the complaint as gregory.sephton@sterlingtonlaw.com.

The counsel of record representing the defendants in IPSEN BIOPHARMACEUTICALS, INC. et al. v. CONJUPRO BIOTHERAPEUTICS, INC. et al. (1:2024cv04991) are likely from Fox Rothschild LLP, based on their representation of the defendant entities in an inter partes review (IPR) proceeding concerning the same patent, U.S. Patent No. 11,344,552. The IPR (IPR2025-00505) lists CSPC Pharmaceutical Group Limited, CSPC Ouyi Pharmaceutical Co., Ltd., and Conjupro Biotherapeutics, Inc. as petitioners.

While direct PACER access for the district court case is not available to confirm appearances, the following attorneys from Fox Rothschild LLP were noted as successfully instituting IPR trials for CSPC, including one against the '552 patent:

• Howard S. Suh

  • Role: Partner, Lead Counsel (in IPR)
  • Firm: Fox Rothschild LLP, New York, NY
  • Note: Led the Fox Rothschild team in successfully instituting IPR trials for CSPC Pharmaceuticals, including a challenge against U.S. Patent No. 11,344,552.

• Joe Chen

  • Role: Associate, Counsel (in IPR)
  • Firm: Fox Rothschild LLP
  • Note: Part of the team that successfully instituted IPR trials for CSPC Pharmaceuticals, including for the '552 patent.

Other Fox Rothschild attorneys noted as part of the team for the '552 patent IPR case include:

• Luke Toft
• Erxin Du
• Kenneth MacPhail

These attorneys are involved in patent litigation, particularly in post-grant proceedings before the USPTO's Patent Trial and Appeal Board (PTAB), which is relevant experience for a parallel district court patent infringement case.

It is common for firms handling IPRs for a client to also represent them in related district court litigation. However, without direct access to the district court's docket for case 1:2024cv04991, these appearances cannot be definitively confirmed as of the current date.