Five minutes with… Irena Royzman


Alex Baldwin

Five minutes with… Irena Royzman

Since the formalisation of the new Biologics Price Competition and Innovation Act (BPCIA) framework in 2014, there has been a wave of patent infringement litigation, leading to a trend of innovator-versus-biosimilar disputes.

A panel of biosimilar experts will discuss the situation on this evening’s LSPN Connect, including Irena Royzman, head of life sciences at Kramer Levin Naftalis & Frankel.

LSIPR caught up with Royzman to find out more...

LSIPR: What are some general trends you have noticed in recent innovator vs biosimilar disputes?

Irena Royzman: The biosimilar industry is targeting the same few blockbuster biologic products.

Most biosimilar makers participate in the BPCIA’s patent dance (the pre-litigation information disclosures). This enables biosimilar makers to obtain valuable information prior to litigation and to be able to narrow the patents that are asserted in litigation.

Litigating manufacturing patents is definitely a trend. Innovators have asserted a variety of patents in biosimilar litigation, with manufacturing patents playing a major role. Manufacturing processes are important to the activity and composition of the biologic and are often developed (and patented) later in the life of a biologic.

Another trend of note is the uncertainty surrounding the launch of a biosimilar product.  Biosimilar makers frequently provide a 180-day notice of commercial marketing long before commercial marketing. There is also no litigation stay associated with biosimilar litigation.  Many biosimilar makers have launched at risk with litigation pending.

Biosimilar makers are filing inter partes reviews and post-grant reviews in an effort to avoid biosimilar litigation entirely.  These proceedings are frequently initiated long before a biosimilar application is filed with the Food and Drug Administration.  

Are patent thickets holding back innovation? 

Biologics are complex products and are frequently protected by a variety of patents, including patents to the biologic itself, its formulation, its manufacture (from cells lines to cell culture media and purification methods), and methods of using the biologic.

The patents don’t hold back innovation. They have the opposite effect. In fact, biosimilar makers frequently develop their own manufacturing methods and formulations in order to avoid innovator patents and obtain patents of their own to gain a competitive edge against other biosimilar makers.

What do these early cases signal for the future of biosimilar patent strategy?

Biosimilar makers are likely to continue to participate in the BPCIA’s patent dance. The 180-day notice of commercial marketing will be used strategically. With newer biologic products and litigation beginning well before the expiration of 12 years of market exclusivity, biosimilar makers are likely to participate in the patent dance and use the 180-day notice to control the number of patents that are litigated and when.  It will be important for innovators to make decisions about which patents they want to assert early on.

Patent Trial and Appeal Board proceedings will continue to play an important role in biosimilar strategy.  They will continue to be used in effort to drive settlements and resolve disputes without district court litigation.

Watch ‘Biosimilar Patent Disputes: What the Early Wave of Litigation Signals for the Future’

LSPN Connect is the membership programme for the Life Sciences—to watch this session and for more information on joining, visit

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biosimilars, patent dance, Biologics Price Competition and Innovation Act, inter partes reviews, post-grant reviews