Pharmaceutical and biological products are subject to a dizzying array of exclusivity and patent certification provisions. Because these provisions determine whether a product can be approved — and when — it is critical for companies to thoroughly understand the written and unwritten rules that apply to them. One wrong move could cost a company tens of millions or even billions of dollars. For innovators, it could mean the difference between immediate competition and years of protection. For follow-on developers, it could mean the difference between immediate approval and years of delay. For investors, it could mean the difference between a profitable investment and a dud.

FDA Exclusivity Rules

The FDA Exclusivity Rules, however, are exquisitely complex. Most “FDA attorneys” do not even handle exclusivity issues or bother to learn the applicable rules. But Scott Lassman has been handling these issues for 25 years — nearly his entire career. It is, in fact, one of his areas of expertise — and one of his favorite areas of the law.

Over that time, Scott has seen the Exclusivity Rules evolve substantially, along with the tactics used by companies to take advantage of them. And he has played an active role in that evolution. He has successfully litigated cases involving the “late listing” of patents in the Orange Book, forfeiture of 180-day exclusivity, and the requirements for pediatric exclusivity. He also helped to shape legislation affecting exclusivity, such as the Medicare Modernization Act and the Biologics Price Competition and Innovation Act. And, most recently, he has been involved in efforts to influence FDA’s policies regarding Reference Product exclusivity applicable to biosimilars. Because the Exclusivity Rules continue to evolve, companies need counsel who not only know the history and precedents but also stay informed about important new developments and FDA’s unwritten rules.

Exclusivity Expertise

Lassman Law+Policy has expertise with the following exclusivity provisions:

  • New Chemical Entity (NCE) Exclusivity
  • New Clinical Trial (3-year) Exclusivity
  • Patent Certification Requirements
  • 30-Month Stays
  • 180-Day Exclusivity
  • Orphan Drug Exclusivity
  • Pediatric Exclusivity
  • Competitive Generic Therapy (CGT) Exclusivity
  • Reference Product Exclusivity
  • First Interchangeable Exclusivity
  • Single Enantiomer Exclusivity
  • Special Rules for “Old Antibiotics”
  • Qualified Infectious Drug Product (QIDP) Exclusivity

You are invited to contact Lassman Law+Policy for more information on the firm's counsel and advocacy in exclusivity matters. For updates and observations on the complex area of FDA exclusivity rules and practice, see the Exclusivity Blog.

Scott Lassman

Scott M. Lassman's Profile Image
Scott Lassman has nearly 30 years’ experience in FDA law and policy, both as an in-house attorney and in private practice. He provides strategic advice and advocacy to small, mid-size and large pharmaceutical, biotechnology and medical device companies, as well as the trade associations that represent them and the investors who fund them. His practice covers all aspects of FDA regulatory law, with a special focus on exclusivity, biosimilars, product approval and policy matters...

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