Kilpatrick Townsend Partner Ken Weber, Ph.D. recently presented “The Role of Patents in Repurposing and Rescuing Old Drugs” at the STC 2017 Spring Seminar Series in Albuquerque, New Mexico. This presentation defined the role that patents play in protecting drug inventions, where the inventions involve the work with old drugs.

Key Takeaways, include:

  • Also known as Translational Sciences, the repurposing of old drugs or the rescuing of failed drugs is a hot area of interest due to reduced development costs and greater likelihood of regulatory approval for products that have been previously studied.
  • The U.S. government actively encourages investment in the translational sciences. The National Institutes of Health’s newest institute is the National Center for Advancing Translational Science (NCATS). Created in 2012, they are charged with facilitation of drugs from bench to bedside.
  • There are 14 patent prosecution strategies available to protect repurposed drugs. Here are six commonly applied strategies:
    • New medical uses
    • New formulations
    • New dosing regimens
    • Identification of super responders
    • Combination therapies
    • Avoiding side effect
  • The primary hurdle to patent protection in the Translational Sciences is obviousness. Plan to proactively support your story of non-obviousness. Embrace your experimental failures because these failures will be evidence of surprising success.
  • Success stories abound:
    • Thalidomide: from anti-emetic to cancer therapeutic
    • Dextromorphan: from cough medicine to psuedobulbar affect disorder
    • Gemcitabine: from anti-viral to cancer therapeutic
    • Finasteride: from prostate cancer to hair restoration
    • Nitric Oxide: from treating angina to treating pulmonary hypertension

San Francisco-based Ken Weber, Ph.D. focuses his practice on patent prosecution, particularly in the areas of molecular genetics, chemistry, pharmaceuticals, plant and agricultural sciences, medical devices and microbial genetics. Dr. Weber regularly assists clients in patent portfolio management, due diligence reviews, validity/infringement opinions and licensing.