Stockpiling Biologics Under Hatch-Waxman Protection

By Paul Dietze, Whitney Remily, Scott Cunning, C. Kyle Musgrove and Yongjin Zhu (October 23, 2017, 11:47 AM EDT) -- A recent biosimilars litigation raises issues regarding the scope of the 35 U.S.C. § 271(e)(1) safe harbor provision and whether it protects commercial stockpiling. Amgen Inc. et al. v. Hospira Inc., No. 1:15-cv-839 (D. Del., Sept. 25, 2017). Hospira is seeking approval to market a biosimilar version of Amgen's erythropoeietin ("EPO") anemia treatment. Hospira had manufactured 21 lots of EPO between 2013 and 2015. These lots numbered in the tens of millions of doses. Prior to trial, Hospira filed a motion for summary judgment arguing that its activities were protected by the safe harbor provisions of 35 U.S.C. § 271(e)(1)....

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!