Describe the problem with BioSimilar patenting and litigation

Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner explains how litigation is making BioSimilar patenting difficult.

Contact Jim Nelson

Email: [email protected]

Phone: (612) 373-6939


Well, in order to understand the problems with biosimilar litigation, you have to take a step back to the generic pharmaceutical litigation involved in Hatch-Waxman. And the scenario for the Hatch-Waxman lawsuit is that if a generic pharmaceutical company wants to produce a generic pharmaceutical, then the pharmaceutical company looks at what we call the Orange Book, and it’s a book that’s produced by the FDA and it has a listing of all the patents that cover the originator, the sponsors of pharmaceutical. And then the generic company has to decide, “All right. Am I gonna say that these patents are invalid? Am I gonna say that my drug, although it’s the same primary compound, it’s different in some respects from what the patents describe and so I don’t infringe? Or I’m gonna wait until the patents expire?” You have to decide these things.

And then you send a letter to the originator, to the sponsor, and the sponsor then has a certain period of time, 45 days, in which to sue you under the Hatch-Waxman Act. And this is all court regulated and FDA regulated. And the FDA is responsible for putting all those patents in this so-called Orange Book. The FDA is responsible for keeping track of the litigation. The FDA is responsible for keeping track of the ANDA filer; in other words, the pharmaceutical company that wants to make the generic. Well, the FDA said, “You know what? This is a lot of busy work for us. We don’t like this litigation stuff. We want to get out of here.”

So when it came time to do the Biologicals Act, the Biologicals Price and Competition Act, the FDA said very vigorously, “We don’t want to be part of the process to decide what the patents are, who can sue, how long it is. So we want out of it.” And so the congress said, “Okay, fine. You’re out of it. We’re gonna change the program.” So as a result, the program is all private. There is the quagmire. It’s extremely difficult. So as you can imagine, you have two parties who want to sell this expensive product, and they want to make huge amounts of money. Huge amounts of money. And so there’s a battle royal from the very beginning. And if it’s private, if it’s not regulated by the courts or by the FDA, you know that it’s a pissing contest. Pardon me, but that’s what it is. It’s just back and forth and back and forth and it’s unbelievable.