Gen-O

We’ve had Gen-X and Gen-Y, but now we are about to have the onslaught of a generation of people who grew up with Linux and Napster and Firefox and so many other open source technologies that I wouldn’t be surprised if this generation comes to be knows as Gen-O (for "Open").

Myriad Genetics filed a Notice of Appeal on Wednesday in the suit brought against them by the ACLU challenging the validity of the BRCA1 and 2 patents. The ACLU claimed a first round victory on March 29 when a New York district court held that genes are products of nature and therefore not patentable. My friends at Choate, Hall and Stewart have a great summary of the case in last week’s GEN.

In October of 2007, Radiohead released their album, In Rainbows using a unique pricing policy: pay what you want. Fans were able to download a complete digital version of the album and only had to pay what they thought was fair.

How exactly do these things relate? And more importantly, relate to life sciences and cleantech? We are about to experience a sea change in the way technology businesses are conducted, and it will be driven by an open souce mindset. We have, for decades, operated under the model of patent protection for technological innovations, and so far it has worked quite well. Why is the US arguably the world’s foremost center of innovation? Because there has long been a clear, consistent plan for encouraging entrepreneurship through the patent system. In the case of Radiohead, it’s copyright law that applies, but it has the same net effect. That clear path is about to get a little murky.

The music industry was caught unawares when technological innovations made violation of copyright law as simple as a click of a mouse. Radiohead’s response was unique and innovative. The life sciences industry has been seeing this coming for some time. Years ago, I served on the rare disease sub-committee of the (HHS) Secretary’s Advisory Committee on Genetic Testing. Nucleic acid patents were (and still are) under attack from the likes of Mildred Cho, Deborah Leonard and John Merz who were making the case that there was no inventive step in developing a diagnostic test based on alterations of a gene. (Wanna know the truth? 1. It’s about the money. Academicians who had a side business of testing patient samples were mad that a commercial organization could block them from performing the test in their lab, despite the fact that the commercial organization had paid to license the rights to the patents from an academic center and was incurring the cost of developing, marketing and distributing the test, not to mention those of prosecuting the patents. 2. Their stated goal was to increase “access,” but that is precisely what will not happen. Patients and physicians would somehow just know that a particular test was available in someone’s lab? Quality Control and Quality Assurance is enhanced by having numerous academic labs across the country performing the assay using different standards? 3. They went after diagnostics first because the argument is reduced to triviality if you apply the same logic to therapeutics, but I’m sure it won’t be long before they start down that path. But I digress.) Now, the successor to the SACGT, the SAC on Genomics Health and Society, is arguing for exemption from infringement for certain categories of people and is taking on genomic data sharing. Heaven help us.

The Myriad case will be overturned on appeal, but it’s a shot across the bow. The nucleic acid patent hand-wringers have an accidental ally in Gen-Oers. We will continue to see attacks on nucleic acid patents, and concurrently, will see approaches similar to that taken by Radiohead in new settings, but most commonly in industries where intellectual property rights are important to de-risk investment and to foster innovation. Do I believe we will move to abolish patents or move to a system like India or China where there is a patent system but effectively no enforcement? Clearly not. The early results from Radiohead and other similar experiments (like video games offered on a pay-what-you-want basis) were not great. Most people paid something, but it was far less on average than it would have been had they sold through traditional channels. (The analyses I’ve seen don’t account for the reduced production cost when offering the product as a download, so the net to the artists may actually be better.) However, a generation of people who grew up with an open source mindset will certainly continue to challenge the existing model, and technology industries will feel the pressure the most.

Is this a bad or a good thing? It’s a little of both. In fairness, I fully agree that there are quite a number of nucleic acid patents that have no business being around. Remember all those EST patents in the late 90s? When a point mutation in a gene is found to cause a disease, it seems to me it’s a novel and perfectly patentable discovery. After the fifth or seventh or tenth point mutation in the gene is found to cause the same disease, is it truly novel and patentable? I’d argue no. However, invalidating patents based on completely novel disease gene discoveries will result in less, not more, access to commercial products, including, and very importantly, diagnostic testing.

Oh, and one last thing. Did you know that Francis Collins, who has been behind this jihad against nucleic acid patents from the beginning, is an inventor on the original patent protecting the discovery of the gene for cystic fibrosis and about 20 other patents?

I'm just sayin'

The New Talent Pool

A couple of weeks ago I was invited by a group of bioscience graduate students at The University of Washington in Seattle to give a talk on making the transition from academia to industry. It's an interesting organization - a group of UW grad students across a number of bioscience disciplines who are exploring careers outside of traditional academic roles. They receive funding from a number of academic departments and bring in folks like me who have made the transition to talk about their learnings and (hopefully) provide some insights. If you have an hour to kill, you can watch the video, although the audio is pretty bad, especially at the beginning, and until the end, it's just video of my slides. Very exciting.

Prior to the talk I was meeting with Anson Fatland of the Allen Family Foundation who asked me why I agreed to schlep across the country for a 45 minute talk. I responded that I believe the children are our future. Seriously, though, these folks are the VP R&Ds, CSOs, CTOs and for some, CEOs of the next wave of bioscience companies. I'm happy to make the investment. I only hope they took away some pearls of wisdom...

At one point, it was evident that the whole investment world was largely unknown to most of the young people in the room. I wish I had this link the week before; Rob Day at Black Coral Capital, an alternative energy / cleantech investment firm, just posted a nice article on his Cleantech Investing blog that would have been helpful. It wasn't the main focus, but it gives the uninitiated a few good handles with which to figure out a little bit about how venture capital works. By the way, If you're into green/clean, it's a great blog and you can sign up for the feed (although I must say I find the GreentechMedia site impossible to navigate - at least in IE8).

Another group focused on cultivating talent is PropelCareers, whose goal is to connect employers with academic talent. They've already had some great success connecting companies and interns, some of whom have turned into FTEs at the companies where they interned.

I guess I've always tended to see the long term picture better than the here and now. Most retained recruiters wouldn't bother spending time cultivating such early stage talent, but I see it as an investment. And I fully recognize that I'm helping current and future competitors of mine, but I believe there's enough work out there for everyone, and we'll get our share.

When I was a lot younger (when emails were produced using line editors), I belonged to “The Young Scientists’ Network,” which was an Internet-based group that in effect, was a group whine about how tough it was to find meaningful employment with a PhD. There were huge debates about which side of the fence had greener grass, but for the most part, we thought rather poorly of industry. Years later, as Director of BD at Athena Diagnostics, I was galled every year at the Academy of Neurology annual meetings when a particular immunologist used to make disparaging public comments about our technical acumen. These comments came from an academic who likely had his lunch in the same fridge he kept research samples in. We consistently had the highest possible ratings from organizations like the American College of Medical Genetics, the College of American Pathologists, CLIAC, NYSDOH and more. What happens when he made a mistake in an assay? He ran the experiment again. What happens if we made a mistake? We give a doctor and patient an incorrect diagnosis; we couldn't allow it. The stakes were much higher on our side of the fence, and there’s a big difference between running an assay in an academic lab and making a commercially viable, bulletproof diagnostic assay. Most PhD candidates and post-docs simply don’t recognize that critical difference until they get a peek behind the curtain. There are data to support this. At this year’s MassBio annual meeting, a young post-doc presented a poster showing significant changes in perception about industry employment after spending a day at a biotech company. The work was supported by MassBio, and won top honors at the annual meeting of the National Postdoctoral Association. The abstract is available as a .pdf here (link to the annual meeting program book and search for "MGH"). It is important to continue to show these bright young minds that there is true purpose in taking discoveries that would otherwise sit on a shelf in a dusty corner of an academic lab and transforming them into commercial products that can help patients.

Aaahhh, it’s so touching watching them grow up.