Patent and Data Protection in the Russian Federation by nyf51324


									Patent and Data Protection in the
Russian Federation.

Serge SCOTTO, St.Petersburg

   The true value of the pharmaceutical industry
    resides not in the manufacturing, but in the
    intellectual property.

   Protection of the incentive to discovery investment

   Russia has a long standing history in discovery
    with its scientific and academic capabilities

Patent Protection:

What does the patent do?
   “A patent provides protection for the invention to the
    owner of the patent. The protection is granted for a
    limited period, generally 20 years”.
    Source: World Intellectual Property Organization

   Most of innovative molecule reach the market 12 years
    in average, after the patent has been filled.
   It needs 3-5 years to develop the new treatment pattern
    in a given country.
   Denying protection rights leads to depriving patients of
    innovative treatment

The term of the Russian Patent.

“The term of an invention patent shall be 20 years
  from the date of receipt of the application by the
  Federal executive authority on intellectual
  property” .

The term of the Russian patent for a medicine
  may be extended for a maximum period of 5

Conditions of patentability
          An invention shall be granted legal protection if

1.   It is new
2.   Possesses an inventive step, and
3.   Is industrially applicable.

Article 4. The patent Law of the Russian Federation

     It addresses as well trademarks / design

International Patent agreements of the
Russian Federation

    The Eurasian Patent Convention
    The Patent Cooperation Treaty
    The Russian Patent Law is currently
     consistent with the provisions of

     The Russian Patent Law.
     Historical perspective.
   Patent Law of the Russian Federation of September 23, 1992
      This statute creates the framework of Russian Patent Law. It describes the
       requirements for patent protection and the rights granted to owners of
       invention patents, utility model patents and industrial design patents.
      Patent filled under former USSR automatically remain in force in the
       Russian Federation, if re-registered before Dec.31,1993

   Substance Patent Law is introduced : October 14, 1992

   Changes and amendments to the Patent Law of the Russian Federation
    effective 11 March 2003.
      Removal of the exhaustive list of subject matter makes possible provision
        of protection for inventions which were not patentable before
      Inventions such as methods of treating humans are considered as
        patentable in the Russian Federation
      The term of a patent for a medicine may be extended up to the maximum
        period of five years

   Importation into Russia,manufacture, utilization,
    offering for sale or storage for any such purpose of
    a product that incorporates the patented invention
   Performance of any of the above acts in regard to
    the product obtained directly by employing the
    patented process
   Use of a process that employs the patented

  Rights of the patent holder
The patent holder has the right to demand:
 Cessation of patent infringement

 Compensation for the losses in compliance with
  the civil legislation of the Russian Federation
 Publication of the court’s ruling to protect his

  business reputation;
 Other remedies as provided under the applicable

  Russian legislation.

    Patent protection enforcement is of
    vital importance for the industry.
   The patent exclusivity protects the high risk investment in
    pharmaceutical R&D
   It provides the innovator a return on investment for a
    limited patent period of time
   The patent legislation must allow to cover the novelty that
    is subject to protection ( new chemical entity, process,
    indication, form…)
   Its importance has significantly increased since the
    publication of the MoH decree ( February 17, 2006 ) on
    INN prescription along the reimbursement system for the
    separate categories of citizens with State social help
    The Russian Patent Law.
    The current state of affairs.
   Until now, the Russian Civil Court and the practice
    of relevant codes have not provided clear criteria
    on how the losses of patent holder should be
   Penalties for IP violation have to be significantly
    increased as today the issue is left to the courts’
    discretion – limited expertise -
   Patent infringement have to be recognized by
    MoH before marketing authorization approval,
    given the long juridical procedure of a court case.
    (Rospatent / MoH coordination)                      12
Data protection.

Data Exclusivity protection.
Fundamental importance for the
   Data generated in extensive pre-clinical and clinical trials
    is a proprietary information on the drug’s safety, quality
    and efficacy
   The generation of these data is extremely expensive and
    time-consuming process.
   Thus, protection of confidentiality of these data is of
    crucial importance as it maintains the economic incentives
    for the industry to further the pharmaceutical R&D
   DE is granted regardless of whether the product is still
    protected by a patent.
   Therapeutic equivalence of generics cannot rely on
    originator data but be proven.
    Data protection.
    The current state of affairs.
   Pre-clinical and clinical trail data of innovator company
    that are submitted in confidence to the Russian
    regulatory body are not maintained exclusive to the
    originator for a fixed period of time (Market exclusivity
   TRIPS art.39.3 protects from “unfair commercial use” of
    undisclosed test data to support application for generic
    product approval or new use of product.
   Non-reliance to originator data – Non disclosure of data to
    third party as per Art 39.3 and enforcement to be part of
    DE legislation
   Lack of a definite period of market exclusivity in Russia –
    11 years in EU
    What needs to be done.
   Continue a proactive dialogue with the Russian authorities
    so that:
   Legal provisions and enforcement for the confidentially of
    registration files and data exclusivity for innovative medicine
    that safeguard innovator companies are implemented
   Definitive and respected market exclusivity period is
    introduced by Law – Compound being aligned with
    WTO/TRIPS 39.3
   Dialogue along the preparation of the new amendments to
    the Law on Medicine that will include Data Exclusivity
    clause – Duma hearing planed in June 2006.


    State of affairs.
   USD 250-300 Mio.
   Av.70% Counterfeited are produced in RF and
    30% smuggled from India – China – Pakistan.
   Federal Law No 122-FZ . August 22, 2004
   Progress
       2002: 178 batches – 62 trademark
       2005: 107 batches – 41 trademark
           Counterfeited products became more difficult to distinguish
   Confidence of physicians and patients
   Reputation of products / treatment and companies
   Russian Federation and WTO

    What needs to be done.
   Systematic counterfeiting identification and uprooting to
    manufacturing sources should be addressed by
    inspecting systematically retail outlets. Checking goods
    at the border is not adequate as the majority of
    counterfeited products are produced in RF.
   Tougher penalties commensurate with the losses, to
    counterfeiters producers up till retailers must be imposed
    by the Russian Law (Civil Code, Administrative Code,
    Criminal Code)
   Clear procedure must be established involving all
    authorities concerned in expediting any case of
    counterfeiting as deterrent to further infringements

   In preparation of WTO accession, IPR issues are being
    addressed in various inter-governmental working group.
   Positive Court cases addressing trademark patents
    infringement were successful, however long lasting and for a
    symbolic compensation
   Lately RF Government has initiated aggressive action against
   Prosecution need resources and funds for implementation
   Severe sanctions to IPR infringers should prevent breaches.

   The industry must partner with RF legislators on the
    development of a clear and unambiguous IPR legislation
    through enhancing communication and understanding with the
    RF authorities.
  Official Time Frame – input from project/ scientists
                  PRIORITY YEAR
 Decision point 1(3): Foreign filing.         Decision point 2(3): PCT          NATIONAL
                                              NPE                               APPLICATIONS
 List 1: PCT + 10 (or 11) National:
                                              List 1: 21 Countries + EPO
 MT; (US) AR; CL; UY; VE;
                                              regionally (30 states + 5
 MY; PK; TW; TH; SA                           extension states)

         ~25 000 USD                                          ~60 000 USD
          0                     8        12                     18               30/31

 Filing date for       Novelty search
 patent application.   ready.                                                     1 EURO PCT
 US                                        Consider filing further
                                           applications before appl.
 Analyze novelty search/                   published
 amend patent claims.
                                                                         Analyze ISR/ amend
                                                                         patent claims
                       Update of priority application.
    On going action.
   Amendment to Russian Law on Medicine is
    being prepared. Its contains a set of art.
    concerning data exclusivity
       6 years of data exclusivity
       Accelerated procedure with regards to generic
       Non-reliance to “undisclosed test or data” not
       Enforcement to be specified


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