District Court Case Highlights Nuances Associated with Determining If a Generic or Biosimilar Applicant Is Entitled to Protection of the Non-Infringement Safe Harbor

September 11, 2018


A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar product. By way of background, 35 U.S.C. § 271(e)(1) recites in part that: "It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States 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 or veterinary biological products." The 271(e)(1) safe harbor, which provides a defense to patent infringement under certain circumstances, was enacted to facilitate bringing generic drugs (and now new biosimilars) to market. But determination of when the infringement safe harbor applies—and when it does not—can, in some instances, be unclear.

Amgen v. Hospira

Hospira manufactured 21 batches of its EPOGEN biosimilar over a two-year period in anticipation of gaining U.S. Food and Drug Administration (FDA) licensing approval for its biosimilar. Amgen sued Hospira alleging infringement of U.S. Patent Nos. 5,856,298 (the '298 patent) and 5,756,349 (the '349 patent), which cover methods of manufacturing EPOGEN.1,2

In September 2017, a jury found that Hospira infringed claims 24 and 27 of the '298 patent. Specifically, the jury found that only seven of the 21 batches were covered by the 271(e)(1) safe harbor and awarded Amgen $70 million in damages.3 Factors in determining safe harbor eligibility included: intent, whether the FDA required the testing that Hospira performed, and the number of batches made relative to FDA's testing requirements.4

In a post-judgment motion, Hospira alleged that no reasonable jury could find that the safe harbor did not protect each of its 21 biosimilar batches. Hospira argued that each batch was used for one or more of:

  • biosimilarity testing;
  • updating product specifications;
  • process validation;
  • stability testing; or
  • continued process verification;

that these uses met the safe harbor provision; and that the jury had impermissibly focused on Hospira's intent in manufacturing the batches.5

The district court found Hospira's arguments unpersuasive with respect to all batches. The district court opined that, while not determinative, intent can be a relevant factor in deciding whether an activity is reasonably related to obtaining FDA licensing. However, once it is determined that the activity is reasonably related to obtaining an FDA license, intent or alternative uses are irrelevant to its qualification to invoke the safe harbor.6

The district court further noted that "adopting Hospira's interpretation of the safe harbor defense would allow a party to manufacture drug substance batches earmarked for commercial inventory without infringing, so long as the party used each of those batches for at least one test to generate data of the type used by the FDA in determining whether to approve the drug…"7 "Essentially, Hospira's interpretation allows a single 'token' submission of information derived from a potential infringing act to exempt that act from infringement, without regard to the realities surrounding the potentially infringing act."8


Biosimilar manufacturers should take note that Amgen v. Hospira9 makes clear that while intent is not determinative, it can be considered by the fact finder in determining whether otherwise infringing activity is protected by the safe harbor.10 Evidence of intent regarding drug substance batches can include, e.g., how the batches are described in documents or communications with the FDA and how the batches are labeled. For questions regarding the safe harbor, or any biosimilar-related question, please contact Vern Norviel, David Hoffmeister, Lou Lieto, or any member of the patent and innovation strategies or FDA/life sciences practices.

Angela Grant and Charles Andres contributed to the preparation of this WSGR alert.

1 Amgen v. Hospira, Case No 15-839, D Del 2017, Op. at 25-27.
2 Patented method claims can add significant value to a biologic portfolio.
3 Amgen v. Hospira, Case No 15-839, D Del 2017, Op. at 25-27.
4 A relevant portion of the jury instructions recited "Hospira's additional underlying purposes for the manufacture and use of [a] batch do not [automatically] remove that batch from the safe harbor provision."
5 Amgen v. Hospira, Case No 15-839, D Del 2017, Op. at 5-6.
6 Id. at 26.
7 Id. at 26.
8 Id. at 27.
9 As of this writing, no appeal has been lodged but the final appeal date has not yet passed.
10 Intent is not a factor in determining direct infringement of a patent.