PATENT LINKAGE IN CROATIA -- TOUGH BUT

UNCLAS ZAGREB 001199 SIPDIS STATE FOR EB/IPC JOELLEN URBAN STATE PASS USTR USDOC PASS TO USPTO E.O. 12958: N/A TAGS: ETRD ECON KIPR HR SUBJECT: PATENT LINKAGE IN CROATIA -- TOUGH BUT POSSIBLE REF: A) URBAN/DETWILER EMAIL B) ZAGREB 666 SUMMARY AND ACTION REQUEST -------------- ¶1. WE APPROACHED THE HEADS OF THE CROATIAN DRUG AGENCY AND THE STATE INSTITUTE FOR INTELLECTUAL PROPERTY TO HIGHLIGHT THE ROLE THAT LACK OF PATENT LINKAGE IN THE DRUG REGISTRATION PROCESS PLAYED IN CROATIA'S REMAINING ON THE SPECIAL 301 WATCH LIST. WE SHARED THE DOCUMENT DRAFTED BY USPTO (REF A) THAT DESCRIBES THE U.S. PATENT LINKAGE SYSTEM. IN THE CASE OF THE DRUG AGENCY, WE MET CONSIDERABLE RESISTANCE TO INTRODUCING ANY SORT OF PATENT LINKAGE. THE DIRECTOR MADE CLEAR THAT HE DID NOT WANT TO "GO INTO THE PATENT BUSINESS," AND THAT HE THOUGHT THAT THE ISSUE WAS ACADEMIC NOW THAT DATA EXCLUSIVITY HAS BEEN INTRODUCED ¶2. THERE WAS A MORE OPEN ATTITUDE AT THE IP INSTITUTE, BUT MANY QUESTIONS AS WELL. WE ARE PREPARED TO PUSH AHEAD ON THIS ISSUE, BUT WILL NEED TO HAVE FURTHER EXPERT INPUT FROM WASHINGTON AGENCIES. WE PROPOSE SETTING UP A DVC WITH THE KEY PLAYERS IN CROATIA AND EXPERTS FROM USPTO AND FDA. END SUMMARY AND ACTION REQUEST. DRUG AGENCY -- WHAT LEGAL BASIS? -------------- ¶3. WE MET WITH DR. SINISA TOMIC, HEAD OF THE CROATIAN DRUG AGENCY. THIS WAS THE SECOND TIME WE HAD RAISED THE ISSUE WITH HIM (SEE REF B). AGAIN HE RAISED THE LACK OF A LEGAL REQUIREMENT TO REQUIRE PROOF OF LACK OF PATENT INFRINGEMENT. AFTER EXAMINING THE PTO DOCUMENT, TOMIC SAID HE DID NOT BELIEVE THE DRUG AGENCY HAD THE PERSONNEL, EXPERTISE OR MANDATE TO PERFORM THE "PATENT GUARDIAN" ROLE THE FDA APPARENTLY PLAYS. FINALLY, HE SAID THAT NOW THAT THERE IS A REQUIREMENT FOR THE AGENCY TO PROTECT DATA EXCLUSIVITY (BASICALLY, NO GENERIC FIRM CAN REGISTER A DRUG, PATENTED OR NOT, IF THE ORIGINAL HAS NOT BEEN ON THE CROATIAN MARKET FOR MORE THAN SIX YEARS),THE ISSUE WAS MOOT. WHEN WE ASKED ABOUT PUBLISHING MARKETING REGISTRATIONS REQUESTS ON THE INTERNET UPON FILING, AS IS APPARENTLY DONE IN ROMANIA, DR. TOMIC SAID THIS WOULD BE A VIOLATION OF BUSINESS CONFIDENTIAL INFORMATION. STATE INSTITUTE FOR INTELLECTUAL PROPERTY -- CAN DO IN THEORY, BUT... -------------- -------------- ¶4. ZELJKO TOPIC, DIRECTOR OF THE STATE INSTITUTE FOR INTELLECTUAL PROPERTY, WAS MORE OPEN. HE ASKED WHAT LAW GAVE THE FDA THE MANDATE TO MAINTAIN AN "ORANGE BOOK" AS DESCRIBED IN THE PTO PAPER. THE HEAD OF THE PATENT DEPARTMENT NOTED THAT FIVE OR SIX YEARS AGO, THERE HAD BEEN A PROPOSAL TO REQUIRE THAT THE DRUG AGENCY CHECK FOR PATENTS BEFORE ISSUING MARKETING AUTHORIZATION, BUT THE PROPOSAL HAD NEVER MADE IT INTO THE LAW ON DRUG REGISTRATIONS. TOPIC CONFIRMED THAT SHOULD THE DRUG AGENCY ASK FOR A RULING ON THE EXISTENCE OF A PATENT, THE INSTITUTE COULD GIVE IT ("THAT'S OUR JOB.") HOWEVER, HE NOTED THAT THE AGENCY WOULD VERY LIKELY NOT BE ABLE TO GIVE A CLEAR CUT ANSWER ABOUT THE DATE OF EXPIRING OF A PATENT, BECAUSE FIRMS CAN FILE FOR A SUPPLEMENTARY PATENT CERTIFICATE. ALSO, THE ISSUE OF PROCESS PATENTS WOULD COMPLICATE MATTERS (MOST OF THE PATENT DISPUTES WE KNOW OF CONCERN "PROCESS PATENTS," IN WHICH ONLY THE PROCESS, NOT THE PRODUCT, IS PROTECTED, THUS THE GENERIC FIRMS UNIFORMLY ARGUE THEY DEVISED A NEW PROCESS TO GET TO THE IDENTICAL DRUG). ¶5. ONE OF THE ATTORNEYS PRESENT AT THE MEETING ALSO SAID THAT THE DRUG AGENCY WOULD HAVE DIFFICULTLY TURNING DOWN MARKETING AUTHORIZATIONS BASED SOLELY ON THE EXISTENCE OF A PATENT HELD BY ANOTHER PARTY. "THE INFRINGEMENT IS WHEN THE COPY IS SOLD -- THERE IS NO LEGAL REASON SOMEONE CANNOT FILE FOR MARKETING AUTHORIZATION EARLY, IN ORDER TO PUT THE DRUG ON THE MARKET AS SOON AS THE PATENT EXPIRES." THERE WERE SEVERAL QUESTIONS ABOUT HOW THE PROCESS WORKS IN THE U.S. -- WHAT HAPPENS IF THE FILER IGNORES THE ORANGE BOOK? DOES THE FDA REFUSE TO ISSUE THE REGISTRATION? UPON WHAT LEGAL BASIS DOES THE FDA REFUSE REGISTRATION? COMMENT AND ACTION REQUEST -------------- ¶6. WE BELIEVE THAT THE GOVERNMENT OF CROATIA MAY BE OPEN TO INTRODUCING PATENT LINKAGE, IF THE SYSTEM IS AS SIMPLE AND EASY TO IMPLEMENT AS POSSIBLE. THE DRUG AGENCY WILL NOT WANT TO DO MORE THAT ASK FOR AN "OK" FROM THE IP INSTITUTE. THE INSTITUTE WILL WANT TO RESTRAIN ITSELF PURELY TO PATENT ISSUES, NOT COMMERCIAL ISSUES. WHILE WE FREQUENTLY REMIND THE GOC THAT JUST BECAUSE THE EU DOES (OR DOES NOT) DO SOMETHING DOESN'T MEAN THAT SOMETHING IS GOOD ENOUGH FOR US, IT WOULD BE HELPFUL IF WE COULD POINT TO A PATENT LINKAGE OPERATION IN THE EU. ALSO, THE PTO DOCUMENT RAISES A FAIR NUMBER OF QUESTIONS, MANY OF THEM QUITE TECHNICAL. THEREFORE, WE REQUEST THAT A DIGITAL VIDEO CONFERENCE BE SET UP, PROBABLY IN SEPTEMBER, WITH EXPERTS FROM USPTO AND THE FDA AND COUNTERPARTS FROM THE CROATIAN IP INSTITUTE AND DRUG AGENCY. FRANK