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IP Update

IP Update. James R. Zanewicz, J.D. Director Office of Technology Development. OLD PCT:. Designate/Elect Contracting States Separately Mandatory international formal exam Mandatory international search Mandatory international publication (Chapter I)

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IP Update

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  1. IP Update James R. Zanewicz, J.D. Director Office of Technology Development

  2. OLD PCT: • Designate/Elect Contracting States Separately • Mandatory international formal exam • Mandatory international search • Mandatory international publication (Chapter I) • Optional International Prelim Exam (Chapter II) • Led to International Exam Report • If filed prior to 19mo from priority, National Phase at 30mo from priority • If Chapter II not filed, enter National Phase at 20mo from priority

  3. NEW PCT • Effective Jan 1, 2004 onward • FLAT International Filing Fee with universal designation and election of all PCT Contracting States automatically • Effective April 2002 Onward • Chapter I time limit changed from 20mo to 30mo from priority REGARDLESS of Chapter II Filing.

  4. NEW PCT: • SO, what does Chapter II Accomplish now? • If file a Chapter II, you can: • RESPOND to the International Search Opinion prior to issuance of the International Preliminary Report on Patentability. • Not always necessary, as you can still enter arguments at the national stage filings.

  5. Madey v. Duke University307 F.3d 1351 (Fed. Cir. 2002) • “Experimental Use Defense” • Not Available to Universities as they are “In the Business” of doing research • Aftermath: • Letters To Universities • Seems most have chosen to avoid willful infringement by NOT pointing this out to faculty • COGR is tracking letters to Universities in the wake of Madey v. Duke, so keep them informed of any issues that arise. • www.COGR.edu

  6. AIPLA Proposal • Re-establish research exemption in patent law • Exempts activities to discern and discover: • Validity of the patent and scope of protection • Features, properties, inherent characteristics or advantages of the patented matter • Methods of making or using the patented matter • Alternatives to the patented matter, including improvements and substitutes • Hence, does NOT protect University Experimental Research. (Usually geared BEYOND just getting more info about the invention itself)

  7. NIH: Publication Open Access • The Proposal States: • “NIH Funded” researchers required to provide NIG with e-copies of all manuscripts upon acceptance for publication • Then deposited in a comprehensive, searchable electronic resource, w/in 6 months of commercial publication • Policy is to “expand public access” NOT “provide open access”

  8. Tax Exempt Bonds/Research Facilities: • Only 5% can be private use in private universities, 10% in public universities: • BUT Government Research is a PRIVATE use b/c the Government gets a royalty-free non-exclusive • So far, IRS has turned a blind eye • At COGR, announced that one institution is seriously considering seeking clarification from the IRS • Could cause Major Ripples for all Universities

  9. EXPORT CONTROLS: • ITAR (International Trafficking in Arms Regulation) • Military Applications • EAR (Export Administration Regulation): • Commercial Applications

  10. What is an ITAR or EAR Export? • Sending/Taking defense article out of US • Transferring Ownership of Defense article to Foreigner • Transferring IN the US to a Foreign entity • Disclosing technical data to a foreign party • Could be EMAILING info to foreign faculty • Review and comment by YOUR faculty on a paper by foreign faculty • Grad Student to Grad Student talking • Performing defense service for the benefit of a foreign person, either on US soil or abroad

  11. Exemptions… • ITAR • Government to Government transfer • US Government Use Exports • Some things to Canada or some NATO Countries • DOD official requests within set parameters • Information in the PUBLIC DOMAIN (Generally Available) • EAR: • Publicly Available/Public Domain Info

  12. WHAT to DO? • When licensing (especially exclusive), SHIFT responsibility for compliance to the Licensee so it is out of your hands….

  13. Intellectual Property Protection Restoration Act … • HR 2344 / S1191 • Reintroduced in 2003 • Appear to still be stuck in Committee • Committee said to be weighing • States’ willingness to waive immunity (or lack thereof), even in the face of losing IP rights • Effect of losing value of IP portfolio on States • Ability to withstand Constitutional scrutiny • John Cross Article

  14. ELECTION 2004 • STEM Cells • CA added 3 billion in stem cell research over the next 10 years by passing Proposition 71 • Stem Cell co stocks rose in reaction • Look to Nancy Reagan to begin pushing here • "We heard from a number of Republican members of Congress over the past several months who indicated support for stem cell research but didn't want to break with their president during a tough election battle. So they may feel free to express their support now," said Sean Tipton, a spokesman for the American Society for Reproductive Medicine and the Campaign for the Advancement of Medical Research.

  15. Election 2004 • Voters reelected Congress’s two physicists, Representatives Vernon Ehlers (R-MI) and Rush Holt (D-NJ), as well as Representative Sherwood Boehlert (R-NY), chair of the House Science Committee. • Some are concerned about the impact of four newly elected senators who support banning all forms of human cloning • Useless post-election Info: Actor Russell Crowe announces he’d never use a stem-cell developed treatment

  16. BUSH in General • Expected to appoint a new Food and Drug Administration commissioner seen as favorable to the industry early in his second term • May also get to appoint • (Bad for us?) • Other Biotech industry stocks rose with his re-election, seen as very pro-industry • Hence, unlikely to support price cuts on drugs funded by federal research

  17. More Info: • COGR’s Web Site • www.COGR.edu • UMUC’s Site on Higher Ed Affecting Laws • http://www.umuc.edu/distance/cip/links_laws.html#pending • ITAR/EAR Info: MIT Site • http://web.mit.edu/srcounsel/resource/ • HR2344 • http://thomas.loc.gov/cgi-bin/bdquery/z?d108:HR02344:@@@L&summ2=m&

  18. Contact Info James R Zanewicz, JD Director, OTD University of Louisville LL02 Jouett Hall Louisville, KY 40292 (502) 852-2965 james.zanewicz@louisville.edu

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