Introduction
The litigation between Amgen Inc. and Hospira, Inc. is a significant case in the realm of biotechnology and patent law, particularly concerning the development of biosimilars. This article delves into the key aspects of the case, including the patents involved, the Safe Harbor provision, and the court's rulings.
Background of the Case
In 2014, Hospira, Inc. submitted a Biologics License Application (BLA) to the FDA for approval of a biosimilar to Amgen’s Epogen product, which is a recombinant human erythropoietin (EPO) used to treat anemia. Amgen subsequently sued Hospira for patent infringement, alleging that Hospira’s biosimilar development infringed two of Amgen’s patents: U.S. Patent No. 5,856,298 (the ’298 patent) and U.S. Patent No. 5,756,349 (the ’349 patent)[1][5].
Patents Involved
The patents in question relate to specific forms of EPO and aspects of their production. The ’298 patent was found to be infringed by Hospira, while the ’349 patent was not infringed. The jury determined that the asserted claims of the ’298 patent were valid and infringed, while those of the ’349 patent were valid but not infringed[1].
Safe Harbor Provision
A critical aspect of this case is the Safe Harbor provision under 35 U.S.C. § 271(e)(1). This provision protects activities that would otherwise be considered patent infringement if they are "solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs." Hospira argued that all 21 batches of its EPO biosimilar were protected under this provision because they were used for various types of testing related to the BLA submission[1].
Jury Verdict and District Court Ruling
After a trial in 2017, the jury found that only 7 out of 21 batches manufactured by Hospira were protected by the Safe Harbor defense. The jury awarded Amgen $70 million in damages. Both Hospira and Amgen moved post-trial to vacate the jury’s verdict, but these motions were denied by the district court[1][5].
Federal Circuit Appeal
Hospira appealed the district court’s denial, arguing that the jury instructions on the Safe Harbor defense were improper. Hospira contended that all batches should have been protected because they were used for testing and development as part of the BLA submission. However, the Federal Circuit upheld the jury’s verdict, reasoning that the relevant inquiry was whether each act of manufacturing was solely for a use reasonably related to submitting information to the FDA. The court emphasized that each accused activity must be evaluated separately and found substantial evidence supporting the jury’s conclusion that 14 batches were not manufactured solely for FDA-related purposes[1].
Key Findings of the Federal Circuit
- The Federal Circuit maintained that the patented inventions were methods of manufacture, and thus the focus should be on whether each act of manufacturing was for FDA-related purposes.
- Only batches used for qualifying Hospira’s manufacturing process and equipment, and those used for a mandatory pre-approval inspection by the FDA, were protected under the Safe Harbor provision.
- The remaining batches were intended for commercial use and not required for FDA pre-approval[1].
Intention vs Actual Use
The case highlights the complexity of determining the intention behind the use of patented material. The courts acknowledged that while some uses may be necessary during development stages, not all uses are strictly intended for supporting an FDA approval application. This leaves room for interpretation regarding what constitutes a use "reasonably related" to the development and submission of information under federal law[5].
Additional Litigation Context
In another related case, Amgen sued Pfizer and its affiliate Hospira for patent infringement concerning a different biosimilar product, NEULASTA (pegfilgrastim), based on U.S. Patent No. 8,273,707. Here, the defendants filed a motion to dismiss, arguing that their process did not meet the concentration limitations specified in the patent. However, the motion was denied by the court[3].
Impact on Biosimilar Development
The Amgen v. Hospira case sets a precedent for biosimilar manufacturers, emphasizing the importance of carefully evaluating each batch of drug substance to ensure it meets the Safe Harbor criteria. It underscores that not all activities during the development stage are automatically protected, and manufacturers must demonstrate that each batch was manufactured solely for FDA-related purposes[1][5].
Key Takeaways
- Patent Infringement: Hospira was found to have infringed one of Amgen’s patents related to EPO production.
- Safe Harbor Provision: Only batches manufactured solely for FDA-related purposes are protected under the Safe Harbor defense.
- Separate Evaluation: Each batch must be evaluated separately to determine if it meets the Safe Harbor criteria.
- Commercial Use: Batches intended for commercial use are not protected under the Safe Harbor provision.
- Interpretation Challenges: The case highlights the complexity in interpreting the intention behind the use of patented material.
FAQs
Q: What was the main issue in the Amgen v. Hospira case?
A: The main issue was whether Hospira’s biosimilar development infringed Amgen’s patents and whether certain batches were protected under the Safe Harbor provision.
Q: Which patents were involved in the case?
A: The patents involved were U.S. Patent No. 5,856,298 and U.S. Patent No. 5,756,349, related to forms of EPO and its production.
Q: What is the Safe Harbor provision, and how did it apply in this case?
A: The Safe Harbor provision protects activities related to the development and submission of information under federal law. In this case, only 7 out of 21 batches were found to be protected because they were used for FDA-related purposes.
Q: What was the outcome of the Federal Circuit appeal?
A: The Federal Circuit upheld the jury’s verdict, affirming that 14 batches were not protected under the Safe Harbor provision and awarding Amgen $70 million in damages.
Q: How does this case impact biosimilar development?
A: The case emphasizes the need for biosimilar manufacturers to carefully evaluate each batch to ensure it meets the Safe Harbor criteria, highlighting that not all development activities are automatically protected.
Sources
- Mintz: Federal Circuit affirms Safe Harbor ruling and $70 million award in Amgen Inc. v. Hospira, Inc.
- Big Molecule Watch: Amgen v. Hospira (epoetin alfa) Archives
- Goodwin Law: Motion to Dismiss Denied in Amgen v. Hospira BPCIA
- Unified Patents: 1:20-cv-00201 - Amgen Manufacturing Ltd et al. v. Pfizer Inc et al.
- Center for Biosimilars: Goodwin Attorneys Discuss Hospira-Amgen Infringement Case
