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 http://holmansbiotechipblog.blogspot.com/2012/11/district-court-rejects-argument-that.html.