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Unpublished Paper
Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry
ExpressO (2009)
  • Michelle L. Ethier, DePaul University College of Law
Abstract

Pharmaceutical product hopping is a relatively new phenomenon in which a brand-name pharmaceutical company tactically reformulates a drug and patents the reformulation in an attempt to avoid competition by a generic competitor. When viewed in the context of the Hatch-Waxman framework, product hopping can effectively eliminate generic competitors from the market, thereby implicating § 2 of the Sherman Act. In addressing antitrust liability, this Note advocates a per se legal approach to product hopping so long as the hop is supported by a valid patent. Although some have argued that deference to the United States Patent and Trademark Office and the resultant presumption of validity for issued patents is undeserved, such deference is necessary to ensure a consistent approach to product hopping, to avoid type I errors that could trigger a chilling effect on pharmaceutical innovation, and to prevent additional litigation which would erode patent rights, diminish value, and delay innovation.

Keywords
  • Hatch-Waxman,
  • pharmaceutical,
  • generic drug,
  • product hopping,
  • antitrust,
  • Sherman Act
Disciplines
Publication Date
March 3, 2009
Citation Information
Michelle L. Ethier. "Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry" ExpressO (2009)
Available at: http://works.bepress.com/michelle_ethier/1/