A Hard Choice For Abbreviated Biologics License Applicants

By Stacie Ropka, Ted Mathias and Drew Hillier (February 4, 2019, 2:36 PM EST) -- Much like the Hatch-Waxman Act provides a pathway for approving generic small-molecule drugs and litigating patent disputes about those drugs, the Biologics Price Competition and Innovation Act provides the same for follow-on biologic drugs. Although the BPCIA was enacted in 2010, to date only a handful of biologics have been the subject of BPCIA litigation. Much of that early litigation has focused on the availability of declaratory judgments as a mechanism to resolve patent disputes concerning follow-on biologics. In addressing those issues, courts have affirmed the primacy of the BPCIA's processes for framing patent disputes, commonly known as the "patent dance," and limited the use of declaratory judgments to avoid the patent dance. Below we discuss why these decisions leave applicants filing abbreviated biologics license applications, or aBLAs, with a clear strategic choice that they must make soon after filing their applications....

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!


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!