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