Transcript FTA

SUB-REGIONAL WORKSHOP ON THE
PROTECTION OF INVENTION IN
PHARMACEUTICAL SECTOR, PATENT,
UNDISCLOSED INFORMATION AND
HEALTH POLICIES
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Organized by WIPO in Cooperation with
GCC Patent Office
Saudi Arabia, Riyadh
15-16 October, 2012
Patent, Data Protection &
Registration of Pharmaceutical
products in Oman
PHARMACIST BATOOL JAFFER SULEIMAN
BSC PHARMACEUTICAL SCIENCE, MSC CLINICAL
PHARMACOLOGY
DIRECTOR, RATIONAL USE OF MEDICINES /
WTO & FTA FOCAL POINT
MOH, SULTANATE OF OMAN
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GENERAL INFORMATION
Oman has a very good government sponsored
programs designed to increase access to
medicines
 Spending on medicines globally is expected to
exceed $ 1 trillion in 2013 reaching nearly 1.2
trillion by 2016.
 Innovation brings new therapies but also increased
spending levels to governments and private payers
 Patent expiries will reduce brand spending by $ 127
Billion through 2016

The Global Use of Medicines: Outlook Through 2016
Report by IMS Institute for Healthcare Information
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KEY 2011-2016 NUMBERS
The Global Use of Medicines:
Outlook Through 2016
Report by the IMS Institute
for Health Information
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WHAT MOHS ARE LOOKING
FOR

General availability, affordability and access to medicines

Factors to be considered:
1- Local laws and by-laws for the registration & pricing of
pharmaceutical products
Ministerial Decision No. 86/2000
2- WTO Agreements (TRIPS)
Oman’s WTO accession in Nov.2000.
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CONTINUED
3- Free Trade Agreements (FTA)
Royal Decree No. 109/2006 for the approval of
Oman-US FTA on 15 October, 2006
4- Royal Decree No. 67/2008 led to the publication
and implementation of the Patent Law on May,
2008.
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REGISTRATION OF PHARMACEUTICALS
No documents related to patent protection
 No articles related to Data Protection
 Scientific reports involve drug indication, method of
manufacture, indication, side effects (no data of clinical
trials & bioavailability studies –in most of the cases-)
 No article related to Bolar provision

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PRICING OF PHARMACEUTICALS
CIF plus 55% profit margin for the local agent
(wholesaler) including a profit margin of 22% for the
retailer
 Different systems for pricing Innovated Patented
products and Generic products
 No obligation on the ph. companies to provide
information on price reduction for off-patent
medications
 CIF price provided in the local currency of the
exporting country

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LAWS AND REGULATIONS OF IPR
The areas of IP covered by the TRIPS Agreement that
are related to medicines include:
 Patents
 Trademarks
 Undisclosed information, including trade secrets and test
data.
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PATENT PROTECTION IN TRIPS & FTA
TRIPS

Patents shall be available
for any inventions, whether
products or processes
FTA

New uses and new
methods for treatment of
particular medical
condition (Article 15.8,1b)

Patent for plants (Article
(Article 27.1)

Members may exclude
plants from patentability
(Article 27.3b)

Patent protection for 20
years from the filing date
(Article 33)
Note: The effective period of
patent protection is less than 20
years
15.8,2)

Bolar provision do not
allow commercial export
to other markets who
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allow it (article 15.8, 5)
PATENT PROTECTION IN TRIPS & FTA
TRIPS
 Does not contain an
obligation to introduce
such system
FTA
 Patent extension
compensation for not
more than 5 years for
delay in granting the
patent if granted more
than 4 years after the
filing date, or 2 years from
the request for
examination or regulatory
delay in marketing
approval (unreasonable
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delay for more than 24
months)
PATENT PROTECTION IN TRIPS & FTA
TRIPS
 No linkage or notification.
FTA
 Linkage of marketing
approval and patent (Article
15.9,4a)

Notification of the
patentee when a generic
manufacturer applies for
marketing approval (Article
15.9, 4b)
The patent system and the drug
regulatory system are separate
and independent mechanisms
Health authorities became
enforcers of medicine patents
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MARKET EXCLUSIVITY
Data exclusivity/ Market exclusivity:
 Adoption of specific periods of protection during
which health authorities cannot relay on that data to
review or grant marketing approval to a second
applicant.
 It is calculated from the date of granting marketing
approval and is independent on patent protection
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MARKET EXCLUSIVITY
TRIPS
 protection against unfair
commercial use of
undisclosed test or
other data whose
submission is required
by governments as a
condition of approving
the marketing of
pharmaceutical
FTA
 Five years for
information concerning
safety or efficacy for a
new chemical entity
(Article 15.9, 1a)
Three years for new
clinical information
(other than
bioequivalence) for
existing CE
 The periods of 5 and 3
years of protection is
also applicable when
reliance of the approval
is based on another
country

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ROYAL DECREE NO. 67/2008
Article 71 ( Enforcement Measures)
Cancellation of Marketing Approval
 MoH to pay adequately for damages (unauthorized
disclosure )
 The competitor to pay adequately for damages
(marketing of the product)
 The competitor to cease marketing of the product

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RECOMMENDATIONS FOR THE PATENT
OFFICE

Be sure that the invention is new, involves inventive
step and is industrially applicable.

Be sure that patent for new use or new methods of
use really involve inventive steps.

Avoid unreasonable delay in the issuance of a
patent.

Carefully evaluate requests for patent extension
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RECOMMENDATIONS FOR MOH

Use Bolar exception effectively

Avoid unreasonable delay in marketing approval.

Valid certificate of patent registration for the brand
drug issued by the concerned local authority or
from the GCC patent office

Undertaken letter from generic manufacturer
indicating the subject drug is off patent.

Application for marketing approval of NCE to be
submitted to MoH within three years for first
marketing else where.

Identify specific mechanisms to ensure transfer of
the technology to the country.
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RECOMMENDATIONS
Monitor and control drug pricing (reduced prices
post patent expiry).
 Consider Compulsory License if the invention is not
available in sufficient quantities or quality or at
predetermined reasonable prices in the country,
either through local manufacture or through
importation.
 An automatic waiver of data protection in case of
compulsory license. Termination of data exclusivity
following a grant of a voluntary license by the
originator
 Setting up the bases and standards to assure drug
security.
 Permission for a drug needed for serious disease or
it is considered as life saving drug.

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RECOMMENDATIONS

Three years data protection for the new use is not
for the product itself, MoH could register any
generic drug provided that the new indication is not
claimed for this generic.

Careful evaluation for requests submitted by the
originators to obtain approvals for new indications.
New therapeutic indication with unpublished
(undisclosed) data and considerable efforts is to be
considered.

Since the 5 yrs data protection is calculated from
the date of marketing approval (Registration
Certificate), MoH should prioritize registration of
unregistered pharmaceuticals imported to meet the
requirement of any health institution
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RECOMMENDATIONS
In case of public health emergency, governments should
have the right to waive off any obstacle related to data
protection.
 Amendment of Article 28 (Ministerial Decision No. 86/2000)
to be read as:
The TCR may cancel registration of any product if
the product is found to be harmful, discontinued in the
country of origin, any change introduced without prior
approval, unavailability without valid reason & not complying
with the conditions of registration and data protection should
be ceased

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RECOMMENDATIONS
4.
The provision of data protection should not be
applied for the exportation of pharmaceuticals
made by a local manufacturer.
5.
A Bolar provision allowing application for
marketing approval even during the period of data
exclusivity.
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Thank you
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