Orrin Hatch: “In the 1990 Supreme Court decision of Lilly v. Medtronic, the Court held in an opinion written by Justice Scalia that…”

“In the 1990 Supreme Court decision of Lilly v. Medtronic, the Court held in an opinion written by Justice Scalia that the Bolar amendment also applies to some other FDA-regulated industries such as medical devices. While you need to read the opinion for yourself to see how this not-so-obvious result was accomplished, as coauthor of the bill, I did take note of Justice Scalia's observation that: No interpretation we have been able to imagine can transform section 271(e)(1) into an elegant piece of statutory craftsmanship. Mr. President, ouch! But the Medtronic decision has only limited significance and it is still fair to say that the generic drug industry enjoys a head start that virtually no other type of generic manufacturers could even imagine--the ability to make and use on-patent products for commercial purposes. The head start granted to generic drug firms by the Bolar amendment was an integral part of the balance of the 1984 law and must be kept in mind when I next discuss the closely related patent challenge provisions of the bill. But before I discuss these provisions, I want to first emphasize that the central feature of the Hatch-Waxman law thankfully remains unscathed by the pending legislation.”