Fuzzy Patent Logic

Over the past week, month, year (you name it!), we’ve read too much about the trials and tribulations of patent litigation. The latest, involving Pfizer and Roche, has the latter suing Pfizer for infringing on upwards of 40 Roche patents in Pfizer’s development of a trastuzumab biosimilar. This is pretty common these days, and even the number of patents involved fails to surprise. Yet, other competitors may reach the market before Pfizer; it has not yet filed for a 351(k) approval with the Food and Drug Administration (FDA) or the European Medicines Agency.

BR&R Logo Transparent1.5-21-2017

This does not apply to other potential players. Celltrion cleared the Roche patent lawsuits in April 2017, enabling it to sell its trastuzumab biosimilar in its home country of Korea. This does not necessarily apply to sales in other countries, however.

Positive results were announced for a pivotal phase 3 study of Pfizer’s trastuzumab biosimilar PF-05280014 in Europe in September. These results will likely form the clinical backbone of its 351(k) application.

First launched in 1998, principal patent expiration of Herceptin in the US should be 2018 or 2019 and was 2014 in Europe. It may be assumed that Amgen/Allergan will wait for patent expiration before marketing their product in the US and subsist on sales in Europe in the meantime.

A similar but more protracted situation exists with Abbvie’s Humira®, for which competition will be fierce once the patents expire fully in 2023 (if they are not found to be invalid earlier). Amgen settled with Abbvie to obtain a global license from the originator’s manufacturer, applying to sales after this time. However, Amgen’s biosimilar will still have to compete with severals once the patents expire or are ruled invalid.

I’d like to post others’ opinions as to how the marketshare wars will play out when some patent agreements are made and others are not. What do you think will happen on the Herceptin front?

Leave a Reply