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Territoriality In Nanotech Patents & Impact On US Manufacturing Stephen B. Maebius Foley & Lardner 3000 K St. N.W. Washington D.C. 20007 (202) 672-5569 [email protected] www.foley.com ©2004 Foley & Lardner LLP Three Areas Of Patent Law Which May Impact US Manufacturing Bayh-Dole licensing limitations Domestic patent law restricting importation Difficulties in obtaining international patent rights - may facilitate overseas production ©2004 Foley & Lardner LLP Bayh-Dole Licensing Restrictions Sec. 209(b): licensee must agree “that any products embodying the invention or produced through the use of the invention will be manufactured substantially in the United States” many nanotech patents are and will be subject to this provision, but most will not may be unclear whether end product was produced through use of the governmentsupported invention ©2004 Foley & Lardner LLP Domestic Patent Law Restricting Importation Sec. 271(g): prevents importation of a “product” made offshore by a process patented in the US Problem: Bayer v. Housey held that information made by a biotech or nanotech process is not blocked (e.g., assay using nanoarray to discover new drug identity) May encourage offshore research to discover end products not covered by US patents (Maebius & Wegner, NLJ, Dec. 24, 2001) ©2004 Foley & Lardner LLP Difficulties In Obtaining International Patent Rights Costs are prohibitive for many start-ups Not all countries have reliable enforcement systems Failure to obtain rights in other countries may encourage overseas competitors ©2004 Foley & Lardner LLP Conclusions Strong US patent system is encouraging investment in nanotech start-ups Limited manufacturing of products at this time; now mostly research jobs are being created Domestic patent law reforms may help, but only to a limited extent Need to continue push for global patent harmonization to make international patent rights affordable & effective for US nanotech businesses ©2004 Foley & Lardner LLP