THE PROTECTION OF PHARMACEUTICAL PRODUCTS

WHAT ?

Pharmaceutical products constitute particular entities, as they relate to public health while still representing important and divergent economic interests. Those are subject to a very specific legislation which articulates around three axes:

  • The patent system, which gives efficient protection to pharmaceutical products, as long as these are novel and inventive
  • The supplementary protection certificate (SPC), which extends the duration of the protection conferred by a patent
  • The recognition that a pharmaceutical product is useful for the treatment of orphan diseases or for pediatric usage, which gives certain benefits to the proprietor

 

WHY ?

  • A patent gives the proprietor the right to prohibit third parties from selling, offering for sale, or manufacturing, using or holding your pharmaceutical product for commercial use, in the territory protected by the patent
  • A supplementary protection certificate may extend, for a period up to five years, the duration of the protection conferred by a patent for a particular product,
  • Pharmaceutical products recognized as useful for pediatric usage may obtain an extension of six months of the corresponding supplementary protection certificate
  • Pharmaceutical products intended for the treatment of orphan diseases may obtain a commercial exclusivity reaching up to ten years and more
  • These different mechanisms are also useful to generate revenues through the grant of licences to third parties, to stimulate creativity within your company, and to valorise the results of your Research and Development

 

HOW ?

  • Recommended preliminary step: Examining freedom to practice
    Is the pharmaceutical product free of exploitation or is it covered by a third party's right which is still in force and applicable to the territory in question ?
  • First step: Examining patentability
    If the pharmaceutical product is free, is it patentable, i.e. new, inventive and susceptible of industrial application?
  • Second step: Deciding on a strategy
    If the product is patentable, and depending upon the territories in which a protection is pursued, must one initially apply for a Belgian or European patent or use the international filing system "PCT" (Patent Cooperation Treaty) ? When exactly during the innovation process, is it judicious to file a patent application? Which complementary protections/benefits are available ?
  • Third step: Implementing the strategy
    Depending on what has been decided, prosecuting the applications before the official authorities in order to obtain and secure the required rights.
  • Fourth step: Enforcing your rights
    Making sure your rights are known and respected by third parties, and introducing court actions, if necessary

 

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WHAT CAN KIRKPATRICK DO ?

  • Advise on patentability and freedom to practice
  • Define a protection strategy together, in the light of the available protection rights
  • Draft your patent applications with you
  • Represent you through all procedures from filing patent applications to the grant of the patents and their maintenance
  • Have translations made of your patents
  • Monitor your patents or any which have been filed by your competitors, and oppose them if necessary
  • Act on your behalf in cases of infringement (proceedings or negotiations)
  • Defend your interests in case of litigation or threat of adverse actions from your competitors
  • Draft and negotiate agreements (licensing, assignment, confidentiality, etc.) and take care of the registration procedures
  • Financially evaluate your patents and those of your competitors or potential commercial partners
  • Advise and give opinion on any questions relating to protection of pharmaceutical products

These services are also available for the protection of phytopharmaceutical products.