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26 Fed. Cir. B.J. 307 (2016-2017)
There's a Storm a Brewin': Can the Hatch-Waxman "Safe Harbor" Provision Shield Commercial Stockpiling from a Potential Downpour of Patent Infringement Allegations?

handle is hein.journals/fedcb26 and id is 329 raw text is: There's a Storm a Brewin': Can the Hatch-Waxman Safe Harbor Provision Shield Commercial Stockpiling from a Potential Downpour of Patent Infringement Allegations? Darby T. R. Findley* Introduction The Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act (the Act), is the cornerstone for competition between brand and generic pharmaceutical manufacturers.' By striking a balance between patent exclusivity and generic production, the Act created a thriving generic market that encouraged new pharmaceutical development and increased public access to generic drugs.2 Prior to the Act's passage, two barriers prevented manufacturers from pushing generics onto the market.3 First, generic companies had to undergo * Darby T. R. Findley is a J.D./M.P.H. Candidate, August 2017, at The George Wash- ington University Law School, and received her B.A. in International Studies from Emory University in May 2013. She would like to thank her Adjunct Professor, Ryan O'Quinn, for his insight and guidance throughout the note drafting process, and her wife, Kaitlyn Findley, for her endless encouragement and support. ' Martha M. Rumore, TheHatch- WaxmanAct-25 Years Later: KeepingthePharmaceutical Scales Balanced, PHARMAcY TIMES (Aug. 15, 2009), http://www.pharmacytimes.com/pub- lications/supplement/2009/genericsupplementO809/generics-hatchwaxman-0809 archived at https://perma.cc/AC3N-GAVE. 2 See Clifford Davidson, 7he Safe Harbor Provision ofthe Hatch- Waxman - Is 7here a Hole in the Safety Net?, 4 DRUG DELIVERY TECH. no. 5 (June 2004), http://www.drug-dev.com/ Main/Back-Issues/The-Safe-Harbor-Provision-of-HatchWaxman-Is-There-429.aspx archived at https://perma.cc/B3VH-U2AM. ' See id. at 1, 5-6.

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