This record is a partial extract of the original cable. The full text of the original cable is not available.

UNCLAS SECTION 01 OF 04 AMMAN 009748 
 
SIPDIS 
 
SENSITIVE 
 
STATE PLEASE PASS TO USTR 
STATE FOR EB/TPP/IPE - A. ADAMO 
STATE ALSO FOR NEA/ELA - M. ROSENSTOCK 
DHHS FOR FDA - M. PLAISIR 
 
E.O. 12958: N/A 
TAGS: KIPR ETRD KTIA PGOV ECON JO
SUBJECT: JORDAN'S IPR CHALLENGES AND SOLUTIONS:  PART III - 
PHARMACEUTICALS POSE FRONTIER IPR ISSUES 
 
REF: A. AMMAN 9708 
     ¶B. AMMAN 8330 AND PREVIOUS 
 
            SENSITIVE BUT UNCLASSIFIED.  FOR USG USE ONLY. 
NOT FOR INTERNET DISTRIBUTION. 
 
            THIS IS THE THIRD IN A SERIES OF CABLES ON 
INTELLECTUAL PROPERTY RIGHTS IN JORDAN.         ACTION 
REQUEST FOR USTR IN PARA 13. 
 
 
¶1.  (SBU) SUMMARY: Protection of original pharmaceutical 
formulations in Jordan is governed not by patent laws, but by 
drug registration procedures that allocate exclusive 
marketing rights for innovative drugs for five years from the 
date of approval by the Jordan Food and Drug Administration 
(JFDA).  The bilateral Free Trade Agreement (FTA) contains 
language to protect innovative pharmaceuticals under this 
registration regime, mainly in the area of data exclusivity 
and in "unfair competition" provisions.  The JFDA is just 
beginning to confront the IPR issues posed by requests for 
approvals, and protection, by innovative drug companies. 
JFDA leadership is committed to Jordanian compliance with 
international best practices, but notes that these issues are 
not easily resolved at the international level.  At present, 
unresolved pharma-related IPR issues include affording 
protection to clinical data regarding different dosages for 
the same drug submitted at different times; resolving a 
similar timing problem on data protection between limited 
government approvals for tenders versus a full market 
authorization; and protecting rights for "new uses" for 
previously approved drugs.  Beyond IPR, another FTA-related 
issue is that the JFDA's pharmaco-vigilance regulations may 
limit initial market access to innovative drugs. 
 
¶2.  (SBU) NOTE: The Embassy continues to work with individual 
U.S. drug companies, as well as the Pharmaceutical 
Researchers and Manufacturers of America (PhRMA), in pressing 
the GoJ about its compliance with FTA commitments on 
pharmaceuticals.  After some initial stumbles - including a 
court case thrown out on a technicality - there is growing 
recognition within the GoJ that more clarity is required; 
Minister of Industry and Trade Sharif Zu'bi is working with 
the JFDA and the Embassy to address these problems, and has 
underlined that the GoJ will live up to all FTA obligations. 
END NOTE AND SUMMARY. 
 
First Came the Case of the Weekly Dose 
-------------------------------------- 
 
¶3.  (SBU) International R&D-based drug firms are comfortable 
with the registration system in Jordan; to date, Embassy 
received no complaints of excessive bureaucracy or delayed 
decisions by the JFDA.  Indeed, the JFDA is given good marks 
by the drug firms for its professionalism and constant 
efforts at self-improvement.  COMMENT:  Its multi-agency 
committees, however, do not have the same reputation, being 
holdovers from a former paternalistic era of healthcare. END 
COMMENT.  During the first four years of the FTA, IPR 
protection on clinical trial data for innovative drugs 
applied to what is called "data exclusivity" by the industry. 
 
 
¶4.  (SBU)  When a company filed for protection for a 
once-a-week-dose drug in 2004 less than a year before the 
daily dosing would lose its data exclusivity protections (for 
the clinical data that, once in the public domain, would 
allow a generic firm to make the same drug and market it at 
reduced costs), however, pharmaceutical IPR problems ensued. 
The JFDA did not see why it should protect the separate data 
set referring to the once-weekly dose; in the eyes of the 
decision-taking committee, it was the same active chemical 
ingredient (the "new chemical entity" or NCE) for which the 
original patent was issued that required protection for one 
five-year term.   Rather than consult or seek a regulatory 
solution, the JFDA committee at that time was content to see 
the matter referred to the courts and to abide by a court 
decision.   The court case, however, was dismissed on a 
technicality unrelated to the substantive dispute.  To the 
JFDA, the generic company had "won." 
 
¶5.  (SBU)  In early 2005, a generic company not only produced 
a daily dose of the 
contested drug, but also a weekly dose, which incontestably 
relied on data generated only for the weekly substance and 
not submitted until 2004.  COMMENT:  Some in the PhRMA 
community believe it was a breach of law for the GOJ to fail 
to uphold the FTA obligation to protect data submitted for 
the once-weekly dose, regardless of any lower court decision. 
 However, to maintain harmonious relations with its 
regulator, the aggrieved company - which continues to believe 
itself to have been wronged - decided not to pursue the case. 
END COMMENT. 
 
¶6.  (SBU) The weekly-dose case raises the general problem 
with data exclusivity and NCE's in Jordan.  For example, an 
adult dosage, a children's dose, and a pre-school or infant 
dose - each with its own set of data in support of JFDA 
approval - should receive, each in its own turn, five years 
of protection, according to the manufacturer.  But the JFDA 
can't square that proposition with its view of a single NCE 
deserving only one period of five-year protection.  As PhRMA 
and individual companies read it, the FTA appears to come 
down more strongly in favor of protections from "unfair 
competition" and to be more favorable toward data exclusivity 
in the narrowest sense, for each dose.  The main FTA 
provisions on drugs - FTA Article 4, paragraph 22 and its 
related footnotes - have yet to be interpreted in a manner 
acceptable to all, however. 
 
Then Came the non-New-Use "New Uses" 
------------------------------------ 
 
¶7.  (SBU) Addressing another drug issue, FTA Article 4, para 
22, footnote 10 reads: "...protection for 'new chemical 
entities' shall also include protection for new  uses for old 
chemical entities for a period of three years."  PhRMA 
companies interpret that to mean that when a drug has a 
proven new use, it can get an additional three years of data 
protection, at least for that new use.  Just such a drug came 
along in 2005 - it had been used as an anti-asthma therapy, 
but new clinical data showed it was also effective for those 
patients who exhibit both asthma and co-existing allergic 
rhinitis.  NOTE: The U.S. and EU have already   approved this 
new "indication" as a new approved "use".  END NOTE 
 
¶8. (SBU) The JFDA ruledthat the drug was approved for the new 
use, but not for a "new indication."  This prompted some in 
PhRMA to ask, "When is a new use not a new use?"  The JFDA 
argues that the gray area of overlapping uses does not permit 
a distinction.  However, even when innovators are permitted 
to market a "new use" and to change a patient package insert 
describing the drug including the "new use" on it, JFDA 
experts concede that they are not certain this affords every 
"protection" of the new use for an additional three years. 
Once the drug's five-year registration expires and a generic 
becomes available, it is difficult to monitor how doctors 
prescribe and patients use that generic, versus the original, 
innovative drug.  PhRMA argues that the drug should get full 
protection for the additional three years, giving it 
exclusive market access for eight years.  The JFDA is 
studying the issue further.  Embassy initially heard that the 
JFDA was drafting a 
circular to support the first, ambiguous ruling on the 
anti-asthmatic.  After the          innovator appealed, and 
when Emboffs highlighted the appeal for the JFDA DG, it 
appears the JFDA will be taking a second, harder look at what 
"protection" means. 
 
Government Tender Approval vs. Market Authorization 
--------------------------------------------- ------ 
 
¶9.  (SBU) In 2001, an innovating firm's cancer treatment was 
approved for tender in a government hospital, where most 
patients in Jordan with the relevant disease are treated. 
(In these special tender cases, a waiver is obtained from the 
traditional JFDA approval process.)  Soon afterward, the 
manufacturer filed a formal request for the drug's approval 
by the national JFDA.  This year, an Australian generic of 
the same drug turned up on the market before five years had 
elapsed from the JFDA approval.  JFDA DG Salah Mawajdeh 
explained that officials reasoned that the drug had enjoyed 
five years of data exclusivity, dating from the special 
tender bid.  The manufacturer does not agree, citing the date 
of the more recent JFDA approval as the time when the clock 
should have started ticking.  JFDA maintains that the same 
rule applies to all:  if a company gets approval under the 
tender, that's when the data exclusivity clock begins. 
 
Drug Approval Process as Market Access Barrier? 
--------------------------------------------- -- 
 
¶10.  (SBU) Adding to manufacturers' concerns, the JFDA 
includes an extra layer of safety to its drug approval 
process by requiring that a drug be on the open market in one 
of seven countries with high safety standards for a full year 
before it can receive a formal approval in Jordan.  As the 
JFDA speeds up its approval process - it is aiming for 90 
working days from submission to approval - that leaves the 
innovator's drug off the market for at least half a year. 
PhRMA companies deem this a technical barrier to market 
access. 
¶11.  (SBU)  For its part, the JFDA argues that clinical 
trials may be statistically significant, but are still 
conducted on limited numbers of patients, and cannot equal 
population-wide use of a drug where rare side effects are 
seen over the course of a year.  The one-year public use 
monitoring safety requirement is already a compromise on 
safety concerns, according to the JFDA;  some in Jordan would 
like the period to be as long as five years.  A remaining 
concern for companies is that they might lose access to 
Jordan's growing, sophisticated medical tourism population 
during a critical time when a competing drug is already on 
the market.  Firms wonder     why - if the drug is the best 
available - Jordanians should be denied its use when it is 
already approved in major, safety-conscious countries. 
 
Next Steps: Trade Minister Zu'bi Takes Action 
--------------------------------------------- - 
 
¶12.  (SBU) NOTE: In exchanges with the JFDA and the Ministry 
of Industry, embassy has emphasized that the GOJ needs to 
abide scrupulously by its FTA commitments regarding 
pharmaceuticals.  Most recently, we stressed to the JFDA that 
more bilateral consultation might be in order, given that FTA 
commitments should be part of Jordan's legal-regulatory 
framework.  The USAID AMIR program has already tasked legal 
consultants to conduct a gap analysis over the next month to 
study where relevant legislation might be lacking.  Since 
July, the Embassy has asked the JFDA to consider having the 
High Committee for Drugs that rules on Directives regarding 
drug approvals and IPR issues include wider representation of 
the innovator firms by having a PhRMA representative among 
three private sector members on the committee.  A review of 
the law that establishes the committee's membership is also 
needed.  Minister of Industry and Trade Sharif Zu'bi took on 
board in early December Econ/C's suggestion that he consider 
whether the ministry might join the High Committee, given the 
growing influence of international trade and trade 
commitments on the country's overall drugs regime.  END NOTE. 
 
¶13.  (SBU) On December 8, Minister Zu'bi conducted a meeting 
with JFDA Director General Mawajdeh to review pharmaceuticals 
IPR and access issues raised by the FTA.        Zu'bi invited 
Econ/C and Econoff to join the meeting, during which Zu'bi 
made a firm commitment to reach clear understandings on 
pharmaceutical IPR protections in line with the FTA.  Zu'bi 
told Econ/C that Jordan wished to be consistent with 
international best practices and adhere to the FTA.  He 
requested that the USG furnish his ministry with position 
papers outlining any concerns.  Jordan will follow those best 
practices identified, he said.  If any process is not in line 
with FTA obligations, Jordan will rectify the situation. 
Zu'bi referred the matter to the JFDA, and offered to help if 
his further intervention is needed.  JFDA's Mawajdeh 
suggested that the JFDA could speak directly to USG technical 
experts if that would help resolve FTA-related pharmaceutical 
matters.  He noted that the JFDA has held digital video 
conferences with U.S. FDA colleagues, and offered to make his 
team available via this format to any concerned USG agencies. 
ACTION REQUEST FOR USTR: Please advise on next steps in 
furnishing requested U.S. position papers on pharma IPR 
issues to the GOJ. 
 
¶14.  (SBU) COMMENT: Over the past 18 months, circumstances 
have created a critical mass of test cases related to the 
FTA-mandated data exclusivity and "unfair competition" 
protections.  Taken together, these issues now command 
high-level attention in the Ministries of Trade and Health, 
and in the JFDA.  Embassy will follow up on developments over 
the next months in the run-up to the FTA Joint Committee. 
END COMMENT. 
 
¶15.  (U) Next installment on IPR:  Enforcement. 
 
RUBINSTEIN 
 
 
 
RUBINSTEIN