IP Update James R Zanewicz J D Director

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

OLD PCT: l l l 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 19 mo from priority, National Phase at 30 mo from priority – If Chapter II not filed, enter National Phase at 20 mo from priority

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

NEW PCT: l 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. l Not always necessary, as you can still enter arguments at the national stage filings. l

Madey v. Duke University 307 F. 3 d 1351 (Fed. Cir. 2002) l “Experimental Use Defense” – Not Available to Universities as they are “In the Business” of doing research l 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. l www. COGR. edu

AIPLA Proposal Re-establish research exemption in patent law l Exempts activities to discern and discover: l – 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 l Hence, does NOT protect University Experimental Research. (Usually geared BEYOND just getting more info about the invention itself)

NIH: Publication Open Access l 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”

Tax Exempt Bonds/ Research Facilities: l 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

EXPORT CONTROLS: l ITAR (International Trafficking in Arms Regulation) – Military Applications l EAR (Export Administration Regulation): – Commercial Applications

What is an ITAR or EAR Export? Sending/Taking defense article out of US l Transferring Ownership of Defense article to Foreigner l Transferring IN the US to a Foreign entity l Disclosing technical data to a foreign party l – 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 l Performing defense service for the benefit of a foreign person, either on US soil or abroad

Exemptions… l 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) l EAR: – Publicly Available/Public Domain Info

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

Intellectual Property Protection Restoration Act … l HR 2344 / S 1191 – Reintroduced in 2003 – Appear to still be stuck in Committee l 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

ELECTION 2004 l STEM Cells – CA added 3 billion in stem cell research over the next 10 years by passing Proposition 71 l 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.

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. l Some are concerned about the impact of four newly elected senators who support banning all forms of human cloning l Useless post-election Info: Actor Russell Crowe announces he’d never use a stem-cell developed treatment l

BUSH in General l Expected to appoint a new Food and Drug Administration commissioner seen as favorable to the industry early in his second term l May also get to appoint – (Bad for us? ) l 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

More Info: l COGR’s Web Site – www. COGR. edu l UMUC’s Site on Higher Ed Affecting Laws – http: //www. umuc. edu/distance/cip/links_laws. htm l#pending l ITAR/EAR Info: MIT Site – http: //web. mit. edu/srcounsel/resource/ l HR 2344 – http: //thomas. loc. gov/cgi- bin/bdquery/z? d 108: HR 02344: @@@L&summ 2=m &

Contact Info James R Zanewicz, JD Director, OTD University of Louisville LL 02 Jouett Hall Louisville, KY 40292 (502) 852 -2965 james. zanewicz@louisville. edu