Intellectual Property Rights

The safeguarding of product trade secret, its formulations and other process parameters by law is usually covered by IPR. It includes those as patents, copyrights, industrial design rights, trademarks etc. IPR is of prime importance in the field of biologics and biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR. The very name Biosimilars calls for the occurrence of Intellectual Property rights laws and by-laws. Hence this session is of utmost interest to the attorneys and law personnel. Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of many who need them. Prices frequently exceed $100,000.

  • Pharma patent scenario
  • Criteria for patentability and patent claims
  • Critical research issues
  • Patentable subject matter
  • Recent patent disputes and litigations
  • Evaluation of highly variable drugs and drug products

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