JORDAN FDA DECISION ON OSTEOPOROSIS DRUG GENERIC

C O N F I D E N T I A L SECTION 01 OF 02 AMMAN 000725

SIPDIS

STATE FOR NEA/ARN
STATE ALSO FOR EB/TPP/MTA/IPC - P. QUIGLEY
PASS TO USTR FOR E. SAUMS
USDOC 4110/ITA/MAC/OAC/TCC/JSTRADTMAN
USDOC 4520/ITA/MAC/OME/NWIEGLER

E.O. 12958: DECL: 01/25/2014
TAGS: ETRD KIPR PREL JO
SUBJECT: JORDAN FDA DECISION ON OSTEOPOROSIS DRUG GENERIC
RAISES IPR CONCERNS

REF: AMMAN 460

Classified By: DAVID M. HALE, CDA. REASONS: 1.5 (B,D)


1. (C) SUMMARY: Jordan appears on a collision course with
Merck Sharp and Dohme over MSD's osteoporosis drug, FOSAMAX
OW, which a Jordanian drug firm called JOSWE is marketing as
a generic after receiving permission last September from the
Jordan Food and Drug Administration (JFDA). After informal
discussions with the JFDA failed last fall, and an MSD court
case was dismissed on a technicality in January, MSD plans to
go back to court. According to PhRMA's regional rep, the
association could file a recommendation to return Jordan to
the Special 301 Watch List. END SUMMARY.

Court Rules Against MSD
--------------


2. (C) The gist of MSD's complaint revolves around clinical
data protection and the difference between the FOSAMAX
(aldenomax) daily and weekly formulations. Smaller, daily
doses of FOSAMAX are already being sold as generics in
Jordan, the five-year registration period having expired.
When MSD registered the once-weekly (OW) dose in June, 2001,
it expected a five-year protection of the registration, which
includes protection of the proprietary clinical data on which
the application was based. However, the JFDA and its
internal committees appeared to have allowed the
OW-formulation clinical data to be used prematurely by
generic manufacturer Jordan Sweden Medical and Sterilization
(JOSWE). As MSD said in a letter to the Ambassador, the JFDA
was misinterpreting the application of data protection
(afforded by both Jordanian law and WTO obligations) by
maintaining that Jordan's FDA law only covered new chemical
entities with novel active ingredients, a decision MSD
labeled as having "severe negative implications" for the
innovative pharmaceutical industry. (NOTE: The bilateral
Free Trade Agreement (FTA),Article 4, para 22 not only
states Jordan's affirmative obligation to protect such
clinical data from unfair commercial use, but also the
simple, direct responsibility to "protect such information
against disclosure." END NOTE.)


3. (C) MSD initially tried to address this informally with
the JFDA and senior Jordanian trade officials. They also
approached JOSWE to see if a mutually agreeable solution is
possible. When these steps failed, MSD filed a complaint in
Jordan courts in late 2003. According to Ramsey Morad, MSD
Jordan Country Director, the court ruled January 14 that the
MSD complaint did not specify the offending party or the
substance of the case (a JFDA Technical Committee had
approved JOSWE's "LF-1" form request to register the generic,
but these key details were missing) and therefore threw the
case out. MSD plans to go back to court using its
London-based regional office (MSD/UK) as a new plaintiff and
correcting the technical deficiencies. Morad said that JOSWE
does not know that MSD is "going after them again" and that
MSD will not quit in defending its right to five years of
exclusive marketing for the OW formulation. MSD is asking
that the JOSWE product be de-registered. Morad states that
MSD does not know what the JFDA's exact ruling on the JOSWE
application was. The court case, if it had been allowed to
proceed, would have helped ascertain the facts through
discovery.


4. (U) NOTE: Most pharmaceuticals patented outside Jordan
are placed for registration with the JFDA, which affords five
years of exclusive marketing protection. Although a patent
offers 20 years of protection in Jordan and/or the patent
protection of the country of origin, representatives for
major pharmaceutical companies say that the economics of the
2-3 year application process in this market justify the
five-year protection, which would generally match the
remaining exclusivity of the same drug in the U.S. END NOTE.

Embassy Advocates for MSD
--------------


5. (C) In a letter and subsequent conversations with Deputy
PM and Minister of Industry and Trade Halaiqa, the Ambassador
has advocated that the case should have been resolved through
regulatory relief. Instead, the GOJ unnecessarily allowed it
to escalate into a costly court case that will lead potential
investors to look twice at Jordan. We have repeatedly
expressed the opinion that the matter can still be resolved
by GOJ action. PhRMA's regional rep, Samir Mansour, said
January 20 that PhRMA may pursue Special 301 action against
Jordan if this case is not resolved in MSD's favor. He also
said that this is part of what he sees as a pattern of weak
enforcement of IPR laws.

Royal Interest
--------------


6. (C) Morad told Econoff that King Abdullah used the
occasion of a WEF business luncheon in Davos last week to
speak directly to an MSD rep. The King reportedly told Jeff
Keprecos, MSD External Affairs Director for Europe, the
Middle East and Africa, that he had heard about the Merck
case. Morad said that Keprecos interpreted the King's
questions about the case as being generally supportive. The
King reportedly said that he wanted to create a good
regulatory environment in Jordan. At the King's request, MSD
is sending a file on the case to the royal court this week.

Comment
--------------


7. (C) This case illustrates the level of complexity of IPR
cases in Jordan and the need to get the government to rise to
a new level of commitment in dealing with them. DPM Halaiqa
told the Ambassador (septel) that he thought the JFDA was
given too wide a mandate under Jordan's FDA law. It would
appear the JFDA is using that mandate to continue a trend of
leaning toward support of Jordan's generics manufacturers
where possible, and even where the facts would not appear to
support their position.


8. (C) At the same time, at a business luncheon at WEF on
January 24, Mazen Darwazeh, chairman of industry leader Hikma
Pharmaceuticals, boasted of Jordan's position in the region
with a mature group of companies accessing a market of 300
million, capable of conducting clinical trials. He also
reportedly boasted of Jordan's adherence to international IPR
agreements. Jordan's adherence to the highest IPR standards
is critical to the aspirations of the industry, which has
prospered since Jordan joined the WTO. Several PhRMA firms
have entered into joint agreements with local companies.
This and other progress will be jeopardized if Jordan doesn't
get its legal and regulatory house in order. END COMMENT.
HALE