Patent and Data Protection in the Russian Federation. Serge SCOTTO, St.Petersburg 23052006

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Patent and Data Protection in the Russian
Federation. Serge SCOTTO,
St.Petersburg23/05/2006
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IPR

• 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

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Patent Protection
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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

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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 years

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Conditions of patentability

• An invention shall be granted legal protection if
• It is new
• Possesses an inventive step, and
• Is industrially applicable.
• Article 4. The patent Law of the Russian
  Federation
• It addresses as well trademarks / design

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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 TRIPS

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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

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Infringements

• 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
  process

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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 courts ruling to protect his
  business reputation
• Other remedies as provided under the applicable
  Russian legislation.

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Patent protection enforcement is of vital
importance for the industry.

• The patent exclusivity protects the high risk
  investment in pharmaceutical RD
• 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

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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 calculated.
• 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)

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Data protection.
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Data Exclusivity protection. Fundamental
importance for the industry

• Data generated in extensive pre-clinical and
  clinical trials is a proprietary information on
  the drugs 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 RD
• 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.

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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 period)
• 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

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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.

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Counterfeiting
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CounterfeitingState 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

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CounterfeitingWhat 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

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Conclusion.

• 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 counterfeiters
• 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.

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Official Time Frame input from project/
scientists
PRIORITY YEAR
NATIONAL APPLICATIONS
Decision point 1(3) Foreign filing. List 1 PCT
10 (or 11) National MT (US) AR CL UY VE
MY PK TW TH SA
Decision point 2(3) PCT NPE List 1 21 Countries
EPO regionally (30 states 5 extension states)
60 000 USD
25 000 USD
0 8 12 18
30/31
MONTHS
Filing date for patent application. US
Novelty search ready.
1 EURO PCT
Consider filing further applications before appl.
published
Analyze novelty search/ amend patent claims.
Analyze ISR/ amend patent claims
Update of priority application.
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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
  registration
• Non-reliance to undisclosed test or data not
  confidentiality.
• Enforcement to be specified