Imron Aly, JD, partner at Schiff Hardin, LLP, explains how biosimilar developers can minimize uncertainty in patent litigation.
What are some ways that biosimilar developers can minimize uncertainty in the patent litigation process?
Sure—I’m glad you limited the question to the litigation process because in the regulatory side there is a lot of uncertainty that’s still going on. For example, just today* when it comes to Herceptin, the FDA is asking for more information before even considering the request Pfizer has made.
On the litigation side, I would focus on 2 things. One, identifying the patent landscape for the amount and number of patents that are or could be applicable and 2, identifying early experts that would be available for each of those individual patents.
Those are 2 areas where if there isn’t activity early enough, a lot of unpredictable things can happen.
*date of filming.