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Tecfidera(®): an approach for repurposing.

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Area of Science:

  • Pharmaceutical Sciences
  • Intellectual Property Law
  • Drug Repurposing

Background:

  • Dimethyl fumarate has a long history of use for psoriasis.
  • Tecfidera(®), an oral formulation of dimethyl fumarate, is approved for multiple sclerosis.
  • Patent strategies are crucial for pharmaceutical lifecycle management.

Purpose of the Study:

  • To analyze Biogen Idec's patent coverage strategy for Tecfidera(®).
  • To examine patenting approaches for repurposed drugs.
  • To assess the competitive landscape of fumarate formulations.

Main Methods:

  • Case study analysis of Biogen Idec's patenting of Tecfidera(®).
  • Survey of recent US, EP, and PCT patent applications for fumarate formulations.
  • Review of intellectual property and regulatory exclusivity mechanisms.

Main Results:

  • Biogen Idec secured patents on pharmaceutical formulations and specific dosages for multiple sclerosis treatment.
  • Other companies are actively developing competing fumarate formulations.
  • Secondary patenting and regulatory data exclusivity are key strategies.

Conclusions:

  • Repurposed drugs can be protected through formulation and dosage patents.
  • Patent strategies are vital for extending drug lifecycles and managing competition.
  • Regulatory data exclusivity offers an additional layer of protection beyond patents.