As we previously reported, Amgen and Hospira both filed motions asking the Court to partially set aside the jury verdict in the Amgen v. Hospira litigation. In its motion, Hospira had asked the Court to set aside the jury verdict as to its accused batches under the § 271(e)(1) safe harbor, and as to certain findings on infringement and invalidity of the ‘298 patent. Amgen’s motion petitioned the Court to reverse the finding that Hospira did not infringe the ‘349 patent. Both parties have now filed responses opposing the other’s motion.
Amgen’s Answer Opposing Hospira’s Renewed JMOL
In its response, Amgen argues in favor of the jury verdict with respect to several findings, including the status of the safe harbor batches, infringement of the ‘298 patent, validity and non-obviousness of the ‘298 patent, and Hospira’s alternative motion for a new trial.
A. Safe Harbor Batches
According to the brief, Hospira made 21 additional batches of drug substance after making 5 batches for clinical trials and process validation (“PPQ”). Amgen’s response argues that the jury reasonably concluded that 14 of those 21 batches were not related to seeking FDA approval: although Hospira had designated them for use in the final stage of drug validation, the continued process verification (“CPV”), Amgen maintains that this step is part of routine production during commercial manufacture and should not be subject to the safe harbor. According to the brief, CPV is not required by the FDA and is an ongoing process.
The brief argues that to the extent the 14 batches in question were used as part of PPQ, Hospira tested them only because it had already made them, as no more than 5 batches were clinically necessary.
Finally, Amgen counters Hospira’s argument that its biosimilarity testing on these later batches was reasonably related to seeking FDA approval. According to the brief, biosimilarity testing need only be performed on multiple product batches, as opposed to substance batches, and the product batches could have been made from a single, existing substance batch.
Amgen states that the jury verdict as to infringement of the ‘298 patent should be upheld because the jury’s findings were consistent with how the Court construed the claims of the patent.
C. Validity and Non-obviousness
Amgen argues that the prior art did not inherently anticipate its patent, as nothing in the prior art at issue necessarily taught or would result in carrying out the processes disclosed by its claims. Amgen argues that while the methods in the prior art could arguably be used to achieve those processes, they do not do so as a matter of certainty. Amgen also argues that its claims were nonobvious, because the prior art at issue did not cover every element of its patent claims, and in any event, the claims in the patent yield unexpected results.
D. Motion for New Trial
With respect to Hospira’s motion for a new trial on these issues, Amgen suggests that the new draft FDA guidance would not have changed the outcome of the last trial. The new guidance stated that BLA applicants should test 10 drug product batches as part of the approval process, but did not require a set number of drug substance batches. According to the brief, Hospira did in fact test 10 product batches from 4 substance batches that the jury already found to fall within the safe harbor, and therefore the current jury findings are consistent with the new guidance.
Hospira’s Response Opposing Amgen’s Renewed JMOL
In its response, Hospira argues that the jury’s findings as to the ‘349 patent were well-supported because Amgen failed to provide sufficient evidence of infringement. It contends that Amgen’s infringement arguments relied on experimental testing methods that Amgen had not shown were comparable to the testing methods employed to measure the drug characteristics listed in the claims of the ‘349 patent. Furthermore, the two testing methods produce results in different forms, which could not be readily converted absent additional validation. According to the brief, Amgen’s test results therefore provided circumstantial evidence but not direct evidence of infringement, and according to Hospira, this provided the jury ample grounds on which to find non-infringement.
Hospira’s Opposition to Prejudgment and Postjudgment Interest
Hospira also filed a motion contesting both the prejudgment and postjudgment interest rulings on the $70M in damages that the jury awarded for Hospira’s fourteen infringing batches. With respect to prejudgment interest, Hospira argues that it should be calculated from the date each batch was made instead of the date the parties would have entered into a royalty agreement. Furthermore, according to the brief, it would be inappropriate to calculate interest based on a lump sum rather than per batch due to the evolving regulatory landscape of biosimilars. Hospira claims that it not only did not regularly manufacture and sell its product after the date of first infringement, but also did not know exactly how many batches it would need for testing given the changing FDA guidance. With respect to postjudgment interest, Hospira argues that the shift from prejudgment to postjudgment interest should occur on the date the judgment on the jury verdict was entered rather than on the later date of final judgment. In addition, Hospira maintains that postjudgment interest does not accrue on prejudgment interest until an order quantifying the prejudgment interest is entered.
Stay tuned to the Big Molecule Watch for further coverage of this case.