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In Turkey, pharmaceutical merchandise for human use can’t be
marketed until they’re approved by the Ministry of Well being
(“MoH”). So as to grant
pharmaceutical license andh advertising and marketing authorization, MoH requires
pharmaceutical corporations to submit the outcomes of their
prescribed drugs’ security and efficacy checks, together with different
paperwork concerning the product.

In impact, pharmaceutical corporations should invent and develop a
pharmaceutical product by means of intensive and time-consuming
analysis and improvement actions, then present the outcomes of
the toxicological and pharmacological checks and scientific trials to
MoH with a view to commercially exploit their product. This can be a lengthy
and dear course of for introducing new or more practical therapies
for sufferers.

Generic pharmaceutical corporations, however, could submit
abridged purposes to MoH. If a knowledge exclusivity interval doesn’t
exist, they will apply for advertising and marketing authorization by referring to
the unique drug’s knowledge, with out submitting checks and
scientific trials knowledge. Offered that they show the efficacy and
security of their pharmaceutical product, the abridged utility
course of permits generic corporations to acquire the identical consequence as a
drug’s inventor with out going by means of lengthy and dear
processes. This may improve competitors available in the market by providing
extra alternative and by reducing drug costs.

Nevertheless, there’s a steadiness that must be struck by
defending the investments of drug originators. This safety is
supplied by means of mental property rights and the idea of
knowledge exclusivity within the regularity area as effectively, which permits
pharmaceutical corporations to maintain their precious take a look at and scientific
trial knowledge confidential, for a sure restricted time interval.

DATA EXCLUSIVITY IN TURKEY

The idea of information exclusivity arose in Turkish Regulation in 2005,
with the introduction of the Regulation on Licensing of Human
Medicinal Merchandise (no: 25705). This regulation was up to date in
December 2021, with the Regulation on Licensing of Medicinal
Merchandise for Human Use printed in Official Gazette no:
31686 (“Pharma Regulation”).

In accordance with Article 9 of the Pharma Regulation:

  • Information exclusivity shall apply for the reference medicinal
    merchandise, which shall be licensed for the primary time since 1/1/2005
    in one of many nations throughout the Customs Union Space.

  • The information exclusivity interval shall be six years, commencing as
    of the primary licensing date within the Customs Union Space; nonetheless,
    this era of six years is restricted with the patent time period, and
    due to this fact the patent time period can’t be prolonged by knowledge
    exclusivity.

  • There is no such thing as a formal requirement or precondition for acquiring
    knowledge exclusivity rights.

  • The safety is mechanically put in place when the advertising and marketing
    authorization is issued.

  • Information exclusivity rights of the unique product’s license
    holder is considered ex-officio by
    the Company.

  • Information exclusivity supplies originators with safety for the
    data gathered from their scientific trials and research.

  • In the course of the knowledge exclusivity interval, generic corporations can not
    use or depend on that knowledge with a view to acquire advertising and marketing authorization
    from the MoH.

Information exclusivity as an mental property proper stands
independently from patent legislation and provides the info holder sure
exclusivity rights enabling them to maintain opponents from the
marketplace for a restricted time period.

Nevertheless, Bolar Exemption brings a restrict to the applicability of
knowledge exclusivity.

BOLAR EXEMPTION IN TURKISH LAW

In accordance with Article 85/3-c of the Industrial Property Regulation
numbered 6769, trial practices, which embrace checks and experiments
crucial to ascertain a patent, are excluded from patent
safety. This exemption permits pharmaceutical corporations to make use of
the patent for scientific trials, checks, and license purposes for
generic medicine earlier than the expiration of the patent safety
interval.

This enables generic merchandise to be launched to the market
instantly after safety for the patented pharmaceutical
expires. Permitting the checks and trials to start out and run solely after
the expiration of patent safety would artificially lengthen the
20-year patent safety interval, as a result of the required checks and
trials take a very long time. The Bolar Exemption, due to this fact, permits
the discharge of generic merchandise to the market as early as doable
and permits extra seamless public entry to medication.

THE PRACTICE IN TURKEY

The Bolar Exemption is broadly accepted and carried out in
Turkey. Each the MoH and the Turkish courts don’t view scientific
checks and trials, abridged license utility and granting of
licenses as patent infringement underneath Bolar Exemption. In accordance with
established courtroom precedent and MoH follow, submitting an abridged
license utility to acquire a advertising and marketing authorization for a
pharmaceutical product doesn’t violate knowledge exclusivity
both.

In follow, MoH permits abridged license purposes referring
to an authentic product that’s nonetheless throughout the knowledge exclusivity
safety interval. In such circumstances, gross sales permission is withheld
till the top of the info exclusivity interval of the unique
product. If the MoH solely accepts advertising and marketing authorization
purposes after the expiration of the six-year knowledge exclusivity
interval, the method for a advertising and marketing authorization utility and
the MoH’s interval for evaluating the applying would begin
after six years.

In accordance with MoH, such follow would have resulted with the
knowledge exclusivity interval being virtually longer than the six years
as foreseen within the Pharma Regulation. Though there have been
unfair competitors actions introduced by knowledge holders based mostly on their
knowledge exclusivity rights, the Courtroom of Enchantment has said quite a few
instances that when generic corporations apply for authorization referring
to the unique proper holder’s knowledge throughout the knowledge
exclusivity interval, it doesn’t represent unfair competitors and
falls throughout the scope of Bolar Exemption. This helps guarantee a
steadiness of rights and pursuits between reference drug producers
and generic drug corporations.

In some circumstances, the interpretation of Bolar Exemption is even
broader. For instance, there are courtroom selections discovering that
generic merchandise for which value affirmation was obtained and
which have been listed on the Social Safety Establishment reimbursement
record fall underneath the Bolar Exemption—and due to this fact don’t
infringe.

Since Bolar Exemption is an exception, it ought to be interpreted
strictly and narrowly in keeping with the overall interpretation
rule “singularia non sunt extenda”. 
Such a large interpretation of Bolar Exemption creates an impediment
for the enforcement of patent rights for originators. Furthermore,
for the reason that value of the unique product decreases to 60% of its
precise value as soon as the generic product is launched (in keeping with
Communique on the Pricing of the Medicinal Merchandise for Human Use),
figuring out whether or not there may be patent infringement as early as
doable is important  for originators to take care of their
curiosity in contributing to the innovation.

In a current dispute topic to the choice rendered by Istanbul
Regional Courtroom of Justice sixteenth Civil Chamber within the file with the
docket quantity E. 2021/1561 Ok. 2021/1782 dated 20 October 2021, the
Istanbul IP Courtroom rendered an distinctive and promising preliminary
injunction determination, suspending the worth lower determination issued for
the unique pharmaceutical by MoH. This prevented the generic
firm from making use of for reimbursement earlier than the SSI and stopped
the generic product from being listed within the reimbursement record of
the SSI.

Nevertheless, the defendant’s objection to the choice was
partially accepted by the primary occasion courtroom by elevating the
assure quantity for the preliminary injunction. The defendant
appealed this determination as effectively, and their attraction was additionally accepted
by Istanbul Regional Courtroom of Justice, which is the best
authority to look at the preliminary injunction requests.

Though the choice of the courtroom to forestall the generic
drug from being listed within the reimbursement record of the SSI is
promising for the enforcement of pharma patents, it’s nonetheless too
early to argue that broad interpretations of Bolar Exemption have
modified in Turkey, which continues to create challenges for
originators.

The content material of this text is meant to supply a common
information to the subject material. Specialist recommendation ought to be sought
about your particular circumstances.



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