Patents… in brief.

We just started the second round of KGI’s intellectual property class and we had the Chief Patent Counsel from the Novartis Institutes come in show us the latest and greatest in biotech IP.  Here are some of my more interesting notes on his presentation:

• A patent is nothing but the right to exclude others
  • Which is to say, the right to sue
• Patents revolve around “quid pro quo” (this for that) in terms of “monopoly for disclosure”
• There are eight ways to extend patent life in the life sciences:
  • Composition, Indication, Synthesis, Formulation, Dosing, Prodrugs, Polymorphs, and Pharmacogenomics
• The Hatch-Waxman Act can give you years on top of your patent, based on the following formula:
  • 0.5*(Date of NDA – Date of IND – Days of NonDiligence) + (Date of Patent Approval – Date of NDA – Days of NonDiligence
  • These are measured in days, and cannot exceed an extension of more than 5 years, or 14 years over the date of Patent Approval.
• For small-mols (think CDER), the FDA has the Orange Book that lists all drug exclusivities (including orphan drug status) in one place.
• Rarely does the USPTO get small-mol applications reviewed in the given 30 months (usually approx. 3 years+)
  • Persistence (read: being incredibly annoying) is a tried and true technique for making approvals go faster.
• The US is the only country that bases patents on first to invent, not first to file.  So keep your lab notebooks.
• A great, cheap way to timestamp your “invention in progress” is to send it to yourself in a well-sealed envelope by your local USPS.  Then tuck it away somewhere safe.

~ by bioscigrad on March 25, 2008.