Laura A. Labeots 
Partner 
HUSCH BLACKWELL LLP, 120 South Riverside Plaza, Suite 2200, Chicago

Abstract

This is an article for anyone who is interested in learning more about Personalized Medicine and the legal issues surrounding it, written by someone with a deep background as both a scientist and a lawyer. The article focuses on Personalized Medicine patent law issues.  Recently, many nucleic acid-based inventions have been deemed unpatentable subject matter.  

Here new case law and USPTO Guidelines will be described, as well as strategies for patent protection of biotech inventions.

BACKGROUND

A patent gives the patent owner the right to exclude others from making, using, selling, or importing the invention.  It is difficult to patent a biotech product because such inventions are increasingly said to lack subject matter eligibility by Courts and the USPTO.  However, there are strategies that can increase the likelihood of successfully obtaining a biotech patent.

SIGNIFICANCE OF A PATENT

What is the value of a patent?  Currently, two biotech companies are contesting ownership of CRISPR gene-editing patents.  These patents allegedly are worth $1 billion and supposedly have attracted similar venture capital.  Thus, these types of patents can be highly valuable.

PATENTING PROCESS

So now we understand that biotech patents can be highly valuable, how do we get one?  The patenting process begins with filing an invention disclosure at the USPTO, which is evaluated by an Examiner according to rules called the US Code.  These rules require that the invention must involve patentable subject matter (35 USC 101); must be novel (35 USC 102); must be non-obvio ...