Interest in entrepreneurship and start-up culture seem to be at an all-time high, especially when it comes to the tech industry. But why do so many of the best young graduates choose to work on the next sexting app rather than on an app-based algorithm for clinical patient support? It’s a question that demands an answer, and soon.
A key problem seems to be that creating your own biotech start-up today is no simple affair, especially when it comes to the legalities of it all. Although there is rapidly-growing public interest in personalized medicine, which any entrepreneur would want to capitalize on, it is precisely in this sector of biotechnology where patent laws remain murky. Without patent protection to guarantee market exclusivity, investors will be loath to fund your ideas, no matter how innovative.
Which is exactly why, two decades ago, Myriad Genetics patented the BRCA mutations associated with breast cancer, opening a controversy over gene patenting that is still ongoing. Soon after, hundreds more patent applications for genes were filed, with patenting viewed as an important tool for protecting companies’ enormous investments in product development.
This immediately triggered reactions from concerned parties, such as Professors Michael Heller (Columbia Law) and Rebecca Eisenberg (UMichigan Law), who introduced the idea that “proliferation of intellectual property rights upstream may be stifling life-saving innovations further downstream in the course of research and product development.”
But university researchers turned out to be largely unaffected, operating under an informal “research exemption” to use patented technology. Companies chose to refrain from exercising patent rights against universities since academic research could potentially increase the value of patented technologies.
Yet where did that leave an enterprising newcomer to the biotech scene, no longer shielded by university protection and fair game for more established companies? Between a rock and a hard place, according to Dr. Marc Grodman, founder of Bio-Reference Laboratories, the largest clinical laboratory operating in the Northeast. At a Congressional hearing about the effect of gene patents on innovation in genetic testing, he argued that “we are dealing with one or at most a handful of genes… once these are in… exclusive hands… neither I nor others can enter the field and use the patented genes to find other genes or improve the tests that correlate to the same disease.”
However, in 2013, the U.S. Supreme Court struck down Myriad Genetics’ patent claim, ruling that human genes cannot be patented. And with that, the gene patenting frenzy was stopped in its tracks. The U.S. Patent and Trademark Office (USPTO) became much stricter about the patenting of products derived from nature, releasing a set of harsher requirements for patentability.
Although Myriad certainly wasn’t pleased, what about the women who, unlike Angelina Jolie, couldn’t afford a genetic test that came with a $3000-$4000 price tag? Competitors rushed in the open door, and just six months later the price of the BRCA test dropped to as low as $900. This was a clear example of competition fostering innovation, and ultimately benefiting the public.
But this may all change again, and sooner than one might think. Under heavy pressure from the biotech industry at large, and personalized medicine companies in particular, the USPTO released yet another set of new guidelines in December. Meant in part to clarify previous rules, they also acted to completely remove some barriers that had been established less than a year before.
The USPTO is currently seeking public feedback on their latest interpretation of the Supreme Court rulings. Until March 16th, any member of the public may submit written comments via email, to be published online. A public forum was recently held on January 21st, allowing attendees to present their own analyses of whether or not certain natural products remained eligible for patenting under the new Supreme Court precedent. In the upcoming weeks, no doubt legions of lawyers will be ready to defend the interests of the biotech giants.
But will anyone speak for the start-ups?
The USPTO has no easy task ahead of them. But if they end up folding under the pressure of the biotech giants, it would be a sad day for innovation.
Julie Vu is a senior in the Organismic and Evolutionary Biology Department at Harvard College.
Pierre Baduel is a 3rd year graduate student in the Organismic and Evolutionary Biology Department at Harvard University.