lucarista / Shutterstock.com
In the battle for marketing approval of a biosimilar version of Neupogen under the BPCIA, applicant Sandoz stymied Amgen’s chance to join the so-called patent dance. Andrew Williams of McDonnell Boehnen Hulbert & Berghoff ponders the implications.
On March 6, 2015, the US Food and Drug Administration (FDA) approved an application by Sandoz to market a biosimilar version of Amgen’s Neupogen(filgrastrim) biologic drug. Neupogen is a 175 amino acid recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF), and is often prescribed for cancer patients on chemotherapy at times when they are at most risk of infection because their white blood cell count is low. Sandoz, a division of Novartis, will market its biosimilar under the brand name Zarxio.
This is the first such application to be approved using the new biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA). Much like with the Hatch-Waxman statute for small-molecule pharmaceuticals, the BPCIA includes both an abbreviated drug approval process and a mechanism by which the parties can address any patent claims while the drug is being approved.
Nevertheless, even though Sandoz chose to avail itself of the first part of the statute, thereby reducing the time and cost required to obtain approval of its drug, it chose not to supply Amgen with a copy of its biosimilar application. This thwarted Amgen’s ability to avail itself of the statutorily-mandated patent exchanges, nicknamed the biosimilar ‘patent dance’.
Life Sciences Intellectual Property Review (LSIPR) tracks the increasing challenges for intellectual property specialists in the rapidly evolving world of life sciences. From gene patents to stem cell research, we provide the very best news and analysis.
To continue reading this article and to access 4,500+ articles, our digital magazines and special reports published for LSIPR subscribers only then you will need a subscription.
If you are already subscribed please login.
Official LSIPR subscribers include:
Allen & Overy
Arnold & Siedsma
Birch, Stewart, Kolasch & Birch LLP (BSKB)
Carpmaels & Ransford
Cooley
European Patent Office
Finnegan LLP
GH Research
Gowling WLG
George Washington Law School
HGF Limited
IQVIA
Kirkland & Ellis International LLP
Marks & Clerk
Mintz Levin
NiKang Therapeutics Inc.
Powell Gilbert LLP
Procopio, Cory, Hargreaves & Savitch LLP
Taylor Wessing
The United States Patent and Trademark Office (USPTO)
Valea AB
World Intellectual Property Office
For multi-user price options, or to check if your company has an existing subscription we can add you into for FREE, please contact Atif at achoudhury@newtonmedia.co.
If you have any technical issues please email tech support.
Sandoz, Amgen, biosimilar, patent, patent dance, BPCIA