The Legacy of Nature

Thursday’s U.S. Supreme Court ruling against the patenting of natural genes is a major milestone in patent law and has significant implications for the future of technology. For many years now, the U.S. Patent Office has allowed the patenting of natural genes, perhaps most famously the BRCA1 and BRCA2 genes which were patented by Myriad Genetics. This resulted in tests for mutations of these genes remaining exclusive to Myriad. It also kept them unnecessarily expensive – on the order of $3,000 per test. Because mutations in these two genes greatly increase the risk of breast and ovarian cancers, such tests are a valuable tool for identifying at-risk women. But the high cost prevented many from having the test, particularly within the U.S. health care system.

The U.S. Supreme Court ruled unanimously that natural genes can not be patented, saying it manifestly violates patent rules. Put simply, laws of nature, physical phenomena and abstract ideas are not patentable.

The victory is somewhat pyrrhic in that the patents for BRCA1 and BRCA2, which were filed in 1994 and 1995, will expire in 2014 and 2015, respectively. Had this decision been handed down years ago, one wonders how many lives might have been saved?

Nevertheless, this ruling has significant value looking ahead, and not only for genetics. There’s a wealth of knowledge waiting to be gained from the natural world. This knowledge will lead to significant innovations, but in the face of incorrectly interpreted patent protection, such innovation could be tremendously stifled. The natural world is a nearly boundless legacy that has been left to all of us; it would be the worst kind of injustice to have it benefit only an exclusive few. The ability to patent methods which are applied to natural genes and other natural processes will still exist. The development of synthetic DNA (cDNA)* and processes such as cloning will also still be patentable. Similarly, discoveries relevant to other fields such as nanotechnology and material science will be patentable in so far as they involve new methods and processes. But simply identifying and patenting natural phenomena will be out of bounds.

It’s important to remember that as well as granting patents for the protection of inventions, the Patent Office exists to “promote the industrial and technological progress of the nation and strengthen the economy.” This is only right in that it’s a public institution. Unfortunately, today’s ruling demonstrates the difficulty our institutions have, and will continue to have, in dealing with a rapidly changing world.

Certainly there are those who won’t be happy about today’s Supreme Court decision. But despite the changes it brings, innovators will still have plenty of intellectual property to protect and profit by. In the end, all humanity deserves to benefit from the world that gave us life and made all of this possible in the first place.

This is cross-posted to my blog at the World Future Society.



For a more in-depth analysis of this complex topic, check out Randall Mayes excellent article in the July-August issue of THE FUTURIST.

*Some types of cDNA or complementary DNA occur naturally and therefore would not be patentable under this ruling.

Who Will Watch the Watchers?

Technological advances bring all sorts of change to our world. Such change often brings with it the need for new rules and legislation. The trick is in establishing laws that create a level playing field – one which can provide us adequate protection without putting a stranglehold on new developments. For many generations, we’ve looked to our institutions for such regulation and protection. But as the pace of change quickens, these same institutions are quickly falling behind. In many respects, it can even be argued that they’re starting to generate more problems than they’re resolving.

A recent article in The Economist (“Why the rules on copyright need to return to their roots”) recaps the original intent of copyright law as a means of balancing “the incentive to create with the interest that society has in free access to knowledge and art”. But changes over the last fifty years have dramatically increased the period of copyright protection, significantly shifting this balance. Increasing the length of copyright doesn’t encourage the creation of new work, but rather it limits its “dissemination, impact and influence.” This has contributed to a business model that is far more interested in profit than the creation of art and or the fostering of knowledge. As a result, today we have individuals receiving excessive fines for DRM violations and onerous battles over what is and isn’t fair use or in the public domain. This was hardly the original intent when the concept of copyright was established.

Location of the BRCA1 gene on chromosome 17.
Location of the BRCA1 gene on chromosome 17.

The patent process is dealing with similar shortcomings that have even more serious repercussions for the public good. For nearly thirty years, human genes have been considered patentable based on nothing more than their isolation and identification. This locking up of something that is so obviously a part of our natural world should never have been allowed to happen. Awarding these patents has hogtied research, slowing advancement in fields that have directly impacted an untold number of lives. The striking down of patents on two genes by a federal judge in March will hopefully open the floodgates and lead to the challenging of thousands more human gene patents. The two genes in question in this recent case, BRCA1 and BRCA2, are closely associated with breast and ovarian cancers. The idea that women have died because of legal wranglings over these genes is repellent.

In the summer of 2008, the world saw the beginning of a massive financial crisis. The exact details are still being uncovered, but it’s evident that much of the blame can be laid at the systematic deregulation that occurred in the US over the prior decade. The institutions responsible for this loosening did not give adequate consideration to the relationships and interdependencies between the different players, not to mention the increasingly automated, electronic trading made possible by the internet.

On a slightly more amusing, yet no less frightening note, a post in the Wall Street Journal Law Blog this week, describes a few gaps in the technical grasp of some of our Supreme Court Justices. In the course of a current constitutional rights case, Justices had to inquire about the difference between “email and a pager” and whether a text sent to someone in the midst of sending to someone else would get through. “Does it say: ‘Your call is important to us, and we will get back to you?’” one Justice asked. Another had difficulty with the concept of a service provider, asking “You mean the text doesn’t go right to me?” For a body hearing cases that will increasingly be dependent on technical knowledge, such a lack of basic understanding is very disturbing.

Whether we’re talking about copyright law, gene patents or financial regulation, the point I’m trying to make is this: In these accelerating times, our institutions, our courts, our regulatory bodies need to become as nimble, informed and responsive as the industries and technologies they seek to govern. So what can we do to ensure that they’re up to the challenge?