Biotech and Medtech - Inventions & Patents

The increasing importance of monoclonal antibody as a therapeutic modality is exemplified by Genentech’s $256 million worth of royalty in 2007 and a projected growth of 15% to 25% in 2008 as reported by the WSJ.  The royalty income is based mostly on a single patent generally known as the Cabilly II patent which have been the subjects of my previous blogs.  The Cabilly II patent relates to the basic methods for making monoclonal antibody using recombinant DNA technology.  As such, if you are importing, selling, or manufacturing monoclonal antibody drugs in the US, the chances are you will have to pay royalty to Genentech.

The latest development in this high stake game is that Genentech and MedImmune has reached a settlement with undisclosed terms.  This litigation is rather complicated and goes back to 2003.  MedImmune had licensed certain intellectual property rights from Genentech, but challenged the validity of one of the licensed patents from Genentech. The litigation revolves around the assertion that MedImmune did not breach its license agreement with Genentech by such a challenge.  For more detail discussion please see this article from law.com.

The Cabilly Controversy

Genentech’s Cabilly II Is Revoked

I have had a life long fascination with inventions and the inventive process.  How does the inventive process work?  In an excellent article titled “In the Air, Who says big ideas are rare?” by Malcolm Gladwell published in the May 12, 2008 issue of the New Yorker, gave some insight into the inventive process.  Gladwell eloquently argues that inventions and great ideas do not occur de novo but rather such inventions and ideas predicate on knowledge that have been previously accumulated.  He also paraphrases the famous sociologist Rober K. Merton:

“A scientific genius is not a person who does what no one else can do; he or she is someone who does what it takes many others to do. The genius is not a unique source of insight; he is merely an efficient source of insight.”

Gladwell’s article suggests the notion of “multiples” in which there are numerous thinkers out there with access to the same information.  The possibility of several thinkers simultaneously coming up with the same great idea is a more frequent occurrence than we think.  Gladwell’s original article illustrates such occurrences with many fascinating case histories.

The US Patent system is based on the first-to-invent concept.  Thus, if more than one inventor files for the same invention, the patent is awarded to the person who is able to demonstrate that he is the first to reduce the invention to practice.  For patent systems in the rest of the world the first-to-file principle is followed.  In this case, regardless of the number of “multiples”, the first inventor to file takes precedent.
When there are two US patent applications or when there is a pending US application and an issued US patent of less than a year old claiming the same invention, an “interference proceeding” may be held to determine which inventor should take precedent.  “Multiples” are not uncommon in medical device inventions.  A surgeon sees a problem and comes up with a solution (invention).  Another surgeon also sees the same problem and may come up with a similar or an identical solution. 
Interference particularly in the biotech industry can be a high stake game and may drag on for years.  I have written about the Cabilly patent in a previous blog and have recently followed the story with an update.