The Criticality of Patents to Innovation: The Short Story of Expanse Bioinformatics

When I am teaching patent bar review, I often include anecdotes and stories to help make a rule, or some aspect of the statute, stick a little better in the memory of students. And, humor is often a part of the story; bearing in mind the threshold to be a humorous patent guy is low…very, very low!

In reading the various patent forums back and forth about new PTO rule packages, proposed statutory reform, or some new SCOTUS decision, it is not often clear why or what makes a difference; especially to the lay person who is our collective client. Why do these patent related things we so passionately discuss matter to the clients we serve, from whatever stripe they come: large, small, university, government, etc.? Time for a story – to make it stick a little better: why patents are critical to the individual inventor who hopes to help create our collective future. This story is familiar to all who are doing patent prosecution.

Charles Eldering, PhD, of ExpanseBio.com, is an inventor whom I have gotten to know. As a part of that relationship, I have helped his company obtain a portfolio of, by now, 27 patents on methods and systems to achieve the goals of personalized medicine. These patents relate to improving health and longevity, via lifestyle modification, based on patterns of information turned up at the crossroads of your genetics and lifestyle, as well as identifying genetically personalized treatments to cure disease. Simply put: by specifically changing how you live based on your genetics, you can enhance your prospects for a long healthy life. A crystal ball, as it were, for your own personal medical future. Bioinformatics is very interesting stuff, about which I was blithely unaware until I started to work on this project.

So how does an inventor come up with stuff like this? Is it because they are just very bright (Einstein, Tesla), been at it a long, long time (Edison, Bell), or are just relentless (Edison again, and the Wright Brothers)? Or, how about, none of the above. You see, the process of inventing is unknowable until it occurs. You cannot really plan ahead; you might foster it a bit, here and there, but ultimately it is the harnessing of an insight that others have missed, and exploiting that insight.

Charles hails not from the medical side of this but, instead, comes from the information side.  His background is electrical engineering and physics with industrial experience in telecom  including exposure to communication channels and information theory.  He had experience in working with the transmission of signals in noisy environments and is familiar with long and complex codes used to transmit images from spacecraft or launch codes to nuclear submarines. These codes spread the important information out over long messages which make the underlying image or command unrecognizable in the transmitted signal, but which allow for error-free recovery at the receiving side.  Further, he had experience in data mining as it related to predictive patterns for potential advertising. Does anything yet sound like personalized medicine? No.

[PLI]

But, here is the wrinkle, the insight: in reading popular press articles about the human genome, Charles reckoned that the genome was just another large complex code, perhaps unlike the ones he already dealt with but a code nevertheless; and, if patterns could be identified in this code and correlated with the lifestyle choices of a specific person, it could provide useful information as to how that person might pursue their life. This, he believed, could be accomplished by recognizing patterns in the code but without reconstructing the complete message, which in this case would be how the entire genome of an individual expresses itself.  It could answer the simple question: why do identical twins suffer from different maladies and die at different times from different diseases? Sounds simple, right?

So, Charles starts speaking with and interviewing people steeped in genetics and biology and, what do you know, finds his eventual co-inventor, also a PhD (but in Cellular and Molecular Medicine), and also a former patent examiner! They determined that a key to accomplishing the idea was amassing the genetic information in the form of whole genome data or Single Nucleotide Polymorphisms (SNPs), collecting information about lifestyle patterns (where you live, what you do, what you eat, etc.), and correlating that sea of information with good and bad health outcomes. Health outcomes are determined by behavior as much as by genetics. The link appears to be epigenetics, which are environmentally induced changes to the genetic information which can prevent genes from expressing without changing the underlying genetic code. Unfortunately, epigenetic maps are currently unavailable so we are left with collecting behavioral data for the time being. It is when and how the genetic and behavioral factors blend that creates specific outcomes, i.e., smoking plus genetic disadvantages equals bad outcomes. This is why George Burns, despite smoking cigars (since birth it seems), lived to about 100 with no negative implications from the cigars (nor the alcohol). But, alas, others are not so lucky.

But, this is a lot of data, billions of discrete data points in the genome for even one person; let alone a small population of people. Plus, to see patterns emerge, you needed to look at these data sets and further compare healthy folks with unhealthy folks. Thus, Charles and his co-inventor did theoretical research studies to determine how to get through vast quantities of data to obtain useful results. As with any inventing process, the core concepts were developed quickly, the details took years to determine.

In pursuing the invention they did not need to conduct thousands of experiments on data and how to create genetic and behavioral databases; instead they concentrated on figuring out the best way to make use of the data provided/collected by others. And, ta da, after 7 years of research and over 100+ discrete patent filings, the 27 patent portfolio covers: 1) genetic and lifestyle correlated  prevention and/or treatment for a disease; 2) drug and behavioral changes to enhance health and longevity; and 3) use of genetic information to create social networks or make product recommendations.  Essentially, specific recommendations on how to make the best of the genetic hand you’ve been dealt.

Charles and his co-inventor, Andrew Kenedy, determined that data mining of genetic and behavioral data would revolutionize a person’s perspective on health. In the same way that public access and use of the internet changed our lives by providing the infrastructure for information to be collected and connections to be made in ways that had not been possible previously; genetic databases and lifestyle correlations will be the next layer of information to be explored and used through the internet. This information can better your life; change your life. And, thanks to smartphones, it will all commence from the palm of your hand.

Okay, so why the story? Well, in Charles estimation, patents are an absolutely critical part of the prospects for his company’s success. That is, the business plan for Expanse Bioinformatics, like so many bio and bio-linked companies, would struggle mightily to exist without them. He believes the US economy has several pillars; manufacturing, finance, and innovation as embodied in intellectual property. IP is what advances the economy over to the next generation. To Charles, this is the equivalent of manufacturing: manufacturing property. The patents are fundamental to make this process work. And, Charles is worried. The patent system is under broad attack post AIA; with the PTO itself overturning 90% of patents being challenged in Inter Party Review. The proposed statutory reform is piling on. SCOTUS is at yet another crossroads with respect to software implemented methods with CLS: is what Charles has been inventing (along with literally thousands of others working with computer implemented methods) off for another round of potential confusion, uncertainty, and delay post decision? Is Charles right to be worried? I think so.

The overarching point of this story: although unique to Charles and Expanse, it is a familiar tale retold by inventors and their companies over and over again and has been for 200 plus years. The patent system is, has been, and will remain a vital engine of economic motivation and growth if preserved intact. At the moment, that preservation is at risk.