Can the 271(e)(1) Safe Harbor Help DuPont Escape its $1 Billion Verdict?

Professor Holman has an interesting new post on his blog involving the ongoing battle between Monsanto, E.I. DuPont, and Pioneer HI-Bred.  Earlier this year, a jury concluded that DuPont owed Monsanto $1 billion in reasonable royalty even though DuPont had only done research on its potential product and had never brought it to market.

In post verdict briefing, DuPont is raising an important question of the scope of the Hatch-Waxman Safe Harbor (271(e)(1)).  That statute might be called a “fair use” statute in the way that it identifies a class of unauthorized uses of a patented invention and excuses those uses from infringement liability.   In particular, the statute allows unlicensed use of a patented invention for purposes “reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

Holman notes that the district court has issued a judgment rejecting the safe harbor for these GM foods.  However, certain food additives do count as drugs under FDA rules.  The interesting thought is that a greater regulatory scheme monitoring the use of genetically modified organisms would likely result in a broader safe harbor.  In my view, the safe harbor is unlikely to apply because GMO foods have been classified in the GRAS category – Generally Regarded as Safe. Holman sees some potential that the Federal Circuit would arrive at the opposite conclusion.

Read: Holman, District Court Rejects Argument that Hatch-Waxman Safe Harbor Applies to Genetically Modified Crops at


4 thoughts on “Can the 271(e)(1) Safe Harbor Help DuPont Escape its $1 Billion Verdict?

  1. 2

    If DuPont wants to dispense with their Genetically Modified Organisms as Generally Regarded as Safe, they may have other issues down the line.

    BTW, $US 1B when no product has been sold !?!?! I call that (un)fair abuse (by the court).

    If patents are to PROMOTE the arts, where is the logic in such a decision ?!

  2. 1

    This is an interesting case.
    Patent infringement is defined by statute as: “whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.”

    What is the case law basis or theory here for $1 billion in patent infringement damages just for doing research? The small amount of “makes” or “uses” in doing the research?
    If so, what is the legal basis for $1 billion in damages for that? Did the trial produce credible evidence that an arms length license negotiation for the statutory “not less than a reasonale royalty” for a license limited t just doing research generate that large a royalty payment?

Comments are closed.