CD: Reflecting on the last 12-18 months, what are some of the general trends you have seen in terms of intellectual property (IP) infringements arising in the life sciences sector? How would you characterise the frequency of these cases?

Bell: The trend that has most captured our attention recently is the IP litigation surrounding biosimilars. Now that biosimilars are reaching the marketplace, there are a host of IP and competition issues to be addressed in the courts, starting with patent infringement, but also including other areas, such as commercial success, pricing and contracting and competition among biologic products. The emergence of ‘biobetters’ – biosimilars that offer advantages over the original biologic – will also add depth to traditional IP considerations. In combination with indication expansion, the existence of biobetters will likely require further consideration of segmented demand, placing more attention on the ability to identify why and for what indications patients are using a particular therapy and building on the considerations raised by ‘skinny labelling’ cases.

Zullow: Over the past 18 months there has been an increase in Biologics Price Competition and Innovation Act (BPCIA) biosimilars litigation and biosimilars inter partes reviews (IPRs). One interesting aspect of BPCIA litigation is that some of the companies that traditionally developed brand-named small molecule products, and were plaintiffs in Hatch-Waxman litigation, are now developing biosimilars and finding themselves in the position of defendants in BPCIA litigation.

Oct-Dec 2018 issue

Charles River Associates

Goodwin Procter LLP

Norton Rose Fulbright Canada LLP

Willkie Farr & Gallagher LLP