Federal Circuit Clarifies Limits of Safe Harbor Defense in Amgen v. Hospira 

December, 2019 -

Recently, in Amgen Inc. v. Hospira, Inc.,[1] the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods.

In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia.  Following a trial, a jury issued a $70 million verdict for Amgen, which was based in part on the jury’s conclusion that fourteen batches of drug substance for Hospira’s EPO biosimilar product were not covered by the Safe Harbor provision of 35 U.S.C. § 271(e)(1).  After the district court denied Hospira’s motion for judgment as a matter of law or alternatively for a new trial, Hospira appealed on a number of issues, including the jury instructions and jury findings on its Safe Harbor defense.[2]

As relevant here, 35 U.S.C. § 271(e)(1) provides that it is not an act of infringement “to make . . . a patented invention . . . 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.”  On appeal, Hospira challenged the district court’s Safe Harbor jury instructions [3] for improperly focusing the jury on the reasons why it manufactured each of the batches of EPO at issue, instead of how each batch was used or whether that use was reasonably related to developing information to support Hospira’s BLA for its EPO biosimilar.  The Federal Circuit disagreed, holding that the “jury instructions properly articulated the legal principles underlying the Safe Harbor inquiry.”[4]

The court began by explaining that each of the accused activities must be evaluated separately.  Here, because the patented inventions were Amgen’s claimed methods of manufacture, the accused activities were Hospira’s uses of Amgen’s claimed methods of manufacture.  The correct inquiry was therefore “whether each act of manufacture was for uses reasonably related to submitting information to the FDA.”[5]  Because the district court’s jury instructions correctly focused on whether “Hospira proved that the manufacture of any given batch of drug substance was reasonably related to developing information for FDA submission,” the court affirmed the district court’s denial of Hospira’s motions for JMOL and for a new trial based on the jury instructions issue.[6]

Next, Hospira argued that no reasonable jury could have found that some batches of EPO were not protected by the Safe Harbor because all of the batches at issue were ultimately used to develop and submit information in Hospira’s FDA filings.  The Federal Circuit rejected this argument as well because substantial evidence supported the jury’s finding that some of the batches at issue were not manufactured “solely for uses reasonably related to the development and submission of information” to the FDA.[7]  For instance, there was both expert and fact witness testimony that the batches at issue did not need to be manufactured to support an FDA filing.  Further, there was documentary evidence that at least some of the batches were originally designated as commercial inventory, which was probative of whether Hospira’s use of Amgen’s patented process was reasonably related to seeking FDA approval.  The court accordingly affirmed the district court’s denial of JMOL on Hospira’s Safe Harbor defense.[8]

Amgen v. Hospira suggests that in cases involving method-of-manufacture patent claims, the relevant inquiry for determining whether the Safe Harbor defense applies is why the accused infringer used the patented manufacturing methods.  Further, Amgen v. Hospira suggests that whether the acts of manufacturing were actually necessary to support a U.S. federal regulatory submission and whether the manufactured product was designated for commercial use may be probative of whether the Safe Harbor defense applies.


[1] Nos. 2019-1067, 2019-1102 (Fed. Cir. Dec. 16, 2019).

[2] Id. at 2-4.  Hospira also appealed on several other bases, including the district court’s claim construction, the evidentiary rulings regarding Amgen’s damages expert, and the denial of JMOL of noninfringement and invalidity.  Additionally, on cross-appeal, Amgen challenged the district court’s denial of JMOL of infringement of one of the patents at issue and the denial of its motion for a new trial.

[3] The final paragraph of the Safe Harbor jury instructions stated: “You must evaluate each of the accused activities separately to determine whether the Safe Harbor applies.  If you find that an accused activity was reasonably related to the development and submission of information to the FDA for the purpose of obtaining FDA approval, then Hospira has proved its Safe Harbor defense as to that activity.  If Hospira has proved that the manufacture of a particular batch was reasonably related to developing and submitting information to the FDA in order to obtain FDA approval, Hospira’s additional underlying purposes for the manufacture and use of that batch do not remove that batch from the Safe Harbor defense.”  Id. at 13.

[4] Id. at 13-14.

[5] Id. at 14-15.

[6] Id. at 15.

[7] Id. at 17 (quoting 35 U.S.C. § 271(e)(1)).

[8] Id. at 16-18.


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