Sloppy Government IP Protection Hinders Scientific Discovery

Sloppy Government IP Protection Hinders Scientific Discovery
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Intellectual property (IP) protection affects virtually every product under the sun. From the design of Adidas Shoes to the coding behind Microsoft Word, to best-selling novels, IP protection is critical to a thriving economy. Conservative estimates place the value-added of IP on the American economy at nearly $1 trillion annually, but these calculations overlook an important contributor to growth - expectations of future innovation. In particular, breakthroughs in cutting-edge gene editing technology and the pharmaceutical development process on the whole will likely add additional trillions of dollars to the American economy in coming decades. In addition to curing expensive diseases, genetic advancements could resurrect extinct species, create healthier foods, and boost the efficiency of agriculture. The dividend of molecules currently brewing in the test tube can be gargantuan, if the right IP incentives are in place to foster more breakthroughs.

Take, for instance, that strange-sounding acronym, CRISPR, that’s been all over the news lately. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a revolutionary gene-editing tool that can be used to engineer new crops, control mosquitoes, and even turn cancer cells into “turncoats” against other cancer cells, thereby shrinking tumors. McKinsey analysts explain that, “With CRISPR/Cas9, we can go into cells to modify DNA in a way that's comparable to editing a document.” Scientists have known about the potential for gene-editing sequences since the late 1980s, but until this decade, scientists couldn’t test the CRISPR bacterial defense system on genetic information. Then, in 2012, researchers from the University of California (UC) Berkeley got CRISPR to work its magic on DNA contained in a test tube.

Shortly thereafter, they applied for a patent to safeguard their gene-editing breakthrough. Unfortunately, flaws in the American patent system kept the university from capitalizing on their groundbreaking application. Broad Institute, a joint research venture of Massachusetts Institute of Technology (MIT) and Harvard, rushed to take the technology and apply it to whole mammalian cells. They succeeded in editing these cells’ genes, and sought the lucrative CRISPR IP that UC Berkeley had already applied for. Despite UC Berkeley’s straightforward claim of “getting there first,” the Patent Trial and Appeal Board (PTAB) awarded the patent to Broad Institute. In justifying their successful application, Broad Institute came up with the unreasonable claim that, even though UC Berkeley was the first to find that CRISPR works, Broad’s advancement was novel enough that it deserves the lion's’ share of future royalties.

Due to PTAB’s reckless disregard for legal precedent and inconsistent IP protection standards, patents deemed “too broad” often go by the wayside without regard for the original innovators behind a technology. PTAB paid no heed to UC Berkeley’s patent application, leading to a multi-year protracted legal battle with Broad Institute over discovery rights. And keep in mind, every day of unnecessary litigation means a day that these potentially life-saving discoveries aren’t used.

Last month, the Patent and Trademark Office (PTO) finally reversed course and decided to grant UC Berkeley two patents, but they’re still fairly minor compared to the patents still enjoyed by the Broad Institute. Crucially, UC Berkeley’s patents only cover CRISPR RNA experimentation, instead of the broader DNA applications that their scientists discovered 6 years ago.

The bizarre decision-making by PTAB highlights a problem with IP protection in early stages of scientific research. The scientific discovery process is gradual and step-wise, with small discoveries found along the way by different companies and organizations. The PTO has already issued more than 60 patents on minor scientific advances related to CRISPR, further infringing on the rights of the original discoverers of the technology. And this presents a large problem for intellectual property- by constantly minimizing the value of original breakthroughs, the government is diminishing incentives for innovation. With an avalanche of narrow patents being issued, pharmaceutical companies will have a difficult time getting the various permissions to move forward with their products.

In solving this issue, stronger IP protection by the federal government is key. If PTAB had similar safeguards to District Courts in protecting patents and ensuring due process, then innovation would have a green light to flourish. Technologies like CRISPR can save millions of lives, but only if elected officials craft the right systems with the right incentives in place.

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