The protection provided by patent rights benefits society by encouraging inventors to disclose their inventions, but these same rights can be wielded against competitors through infringement suits, causing a chilling effect on later innovation. In the field of pharmaceutical innovation, the Hatch-Waxman Act's safe harbor has provided a defense against infringement, allowing generic manufacturers to quickly bring low-cost drugs to the public while trespassing minimally on the patent holder's rights. The Act's delicate balance of benefits and burdens has been threatened by recent judicial interpretations of the provision's scope. The scope of the safe harbor has been expanded to the point that it reduces the value of patent protection for laboratory tools and methods, and in turn threatens the patent system's role in encouraging innovation in these areas.
Robert A. Jone,
Sparse Patent Protection for Research Tools: Expansion of the Safe Harbor Has Changed the Rules,
Emory L. J.
Available at: https://scholarlycommons.law.emory.edu/elj/vol63/iss3/5