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 University 307 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 www.COGR.edu UMUC’s Site on Higher Ed Affecting Laws – http://www.umuc.edu/distance/cip/links_laws.htm l#pending ITAR/EAR Info: MIT Site – http://web.mit.edu/srcounsel/resource/ 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