Partner Ben Katzenellenbogen was quoted in, “Skilled in the Art: Hatch Wants to Limit Pharma IPRs, but Not Yet,” an article published by Law.com.
Excerpt: “The Hatch-Waxman Integrity Act would force generic drug applicants challenging brand pharma patents to choose between the traditional district court litigation that bears Hatch’s name, or inter partes review at the patent office.
Knobbe Martens partner Ben Katzenellenbogen, who represents generics in Hatch-Waxman litigation, said the text of the amendment doesn’t seem so much about choosing a patent validity forum, but rather about requiring generics to give up the abbreviated pathway to FDA approval if they choose IPR.
If generic applicants are required to recreate all of the clinical trials and research necessary for regulatory approval, then IPR “likely would not present a meaningful choice in most cases,” he said.
Katzenellenbogen also notes the PTAB isn’t as hard on pharma patents as on other technologies, holding all challenged claims unpatentable in fewer than half the final written decisions on Orange Book patents.“
