Narrative Opinion Summary
In this case, Janssen Biotech, Inc. and New York University filed a lawsuit against Celltrion Healthcare Co. Ltd., Celltrion Inc., and Hospira, Inc. under the Biologics Price Competition and Innovation Act (BPCIA) for patent infringement regarding biosimilar products. The patents in question were U.S. Patent No. 6,284,471 (the '471 patent) and U.S. Patent No. 7,598,083 (the '083 patent), both associated with the drug Remicade. The court consolidated the actions and ruled the '471 patent invalid due to obviousness-type double patenting, referencing the Federal Circuit's decision in Gilead Sciences, Inc. v. Natco Pharma Ltd. Despite pending reexamination by the PTO, the court granted Celltrion's motion for a final judgment under Rule 54(b), allowing for an immediate appeal. This decision aligns with the BPCIA's objective to expedite patent litigation, ensuring a more affordable biosimilar market entry. The court denied Janssen's request for a litigation stay, prioritizing the reduction of market uncertainty and the public interest in accessible treatment options. The case proceeds with unresolved issues surrounding the '083 patent and Celltrion's BPCIA compliance, with Janssen intending to appeal the court's ruling on the '471 patent.
Legal Issues Addressed
Application of Federal Rule of Civil Procedure 54(b)subscribe to see similar legal issues
Application: The court granted Celltrion's motion for final judgment under Rule 54(b), allowing for an immediate appeal given the distinct nature of the '471 patent issues.
Reasoning: The court must now decide whether to authorize an immediate appeal concerning the ’471 patent while considering judicial administrative interests and equities.
Invalidity of Patent under Obviousness-Type Double Patentingsubscribe to see similar legal issues
Application: The court found the '471 patent invalid due to obviousness-type double patenting, a decision influenced by the Federal Circuit's precedent in Gilead Sciences, Inc. v. Natco Pharma Ltd.
Reasoning: The court's August 19, 2016, Order confirmed that the '471 patent, issued on September 4, 2001, is not patentably distinct from U.S. Patent No. 6,790,444 (the '444 Patent), which expired on July 11, 2011.
Patent Reexamination and Judicial Proceedingssubscribe to see similar legal issues
Application: Pending reexamination by the Patent and Trademark Office does not affect the court’s decision on the '471 patent's invalidity.
Reasoning: Pending reexamination by the Patent and Trademark Office will not influence the court’s decision on the patent's invalidity.
Role of Biologics Price Competition and Innovation Act (BPCIA)subscribe to see similar legal issues
Application: The BPCIA aims to expedite patent infringement resolutions for biosimilars, and the court's decision to allow an immediate appeal aligns with this goal.
Reasoning: The BPCIA mandates that biosimilar developers disclose relevant patent information promptly, requires patent holders to sue for any alleged infringement quickly, and limits recovery to reasonable licensing fees unless infringement is pursued without delay.