US embassy cable - 05ZAGREB1199

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, Intellectual Property 
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