Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner discusses the millions of dollars involved in BioSimilar patenting litigation.
More In This Category
The gentleman idea goes out the window when huge amounts of money are involved because, of course, both companies have shareholders and responsibility to the shareholders. So it’s a real battle. It’s a battle royal in this circumstance. So the idea is for the patents, these people are supposed to exchange information back and forth privately, decide what patents ought to be sued, what patents are important, and they exchange lists an decide, “Okay, do you infringe, do you not infringe? Are the patents invalid?” All that sort of thing all privately. So you can imagine at each step of the way, there’s reluctance to do what you’re supposed to do. And that results in lawsuits. In fact, in the Sandoz situation just a couple of weeks ago, Sandoz got to the point where – as a first step, Sandoz is supposed to provide its biological information. The information it gave to the FDA, it’s supposed to provide that same information to the sponsor, the originator for Filigastrin. And the rule says you’re supposed to provide – the rule uses the word shall. And Sandoz said, “No. We’re not gonna do it. Sue us.” All right?
And so now there’s a big lawsuit about whether they’re supposed to take the first step or not. They haven’t even got to exchange about the patents. And it’s unbelievable what kinds of difficulties this raises.