Patently Human

BY DANIEL KNUDSEN

Realistically, middle school biology students may end up remembering one key concept: that their genetic code consists of a huge number of genes (25,000) forming a string of molecules that exists in each and every cell of their body—a code that makes them completely unique, and impossible to replicate.

And thus, many assume that the individual parts of that code are also unique, impossible to replicate, and, for that matter, impossible to sell. It makes sense then, when many Americans are unaware of the laws that are being fought over governing how one can manipulate, market, and monopolize life itself. One example of this multifaceted issue is the recent battle over gene patenting.

The first patent issued for a genetically engineered organism was awarded to an engineer at General Electric in 1980. This controversial claim was litigated in Diamond v. Chakrabarty, in which the Supreme Court ruled in a landmark 5-4 decision that whether a product is alive is irrelevant; the cell had been manufactured, and so rights to its use are reserved to the engineer. Since then biotechnology firms have been fast to jump on the bandwagon, reserving their claim to various aspects of life at an impressive rate. From 1981 to 2013, an estimated 20 percent of known human genes were patented. These 4,000 patents do not include those on animal sequences and the processes for manipulating DNA related molecules and machinery.

Gene patenting may seem like a mess of technical terms and statistics – but its impact is very real. Gene patenting gave both public and private corporations the exclusive right to test for and use patches of genetic code. To call this a lucrative business would be an enormous understatement. For example, one of medicine’s best hopes for saving people infected with Ebola virus lies in bioengineered tobacco. The genes that code for antibodies, tiny particles normally produced by the immune system to kill targeted threats, such as viruses, can be transplanted into tobacco plants. An experimental serum made from these manufactured antibodies has proven to be highly successful treating Ebola-infected monkeys, and was given to Dr. Kent Brantly, an American doctor who nearly died from the disease. He is one of the few to recover, at a time when thousands are dying.

Innumerable other proteins and drugs can be produced through genetic engineering, and corporations have rushed to capitalize on their discoveries and protect them through patents. From a business standpoint it makes sense. Genetic products are revolutionizing medicine, and helping people in new and exciting ways—yet all that research and development grows to be very expensive very quickly. Companies patent the sequences they isolate and the products they produce in order to make up for R&D costs. Often discoveries are leased out to other laboratories, research institutions, and companies for generally very high prices.

Yet the key here is the phrase “their discoveries.” A patent protects an invention or an original thought. The system exists in order to foster new discoveries and protect innovators from the monopolies of bigger and more powerful entities. No person invented the human genome. While our individual DNA is unique, 99.99 percent of it is exactly the same across the human population. And yet, companies were able to reserve the right to access various parts of this code based solely on whether they could beat others to the US Patent Office and say, “Here it is – we found it first.”

From the standpoint of much of the non-profit research community, this was just bad science; it locked out research labs across the world from doing the work they want. The system gave an unfair advantage to large companies that could churn out patents on strings of code. Smaller labs unable to pay royalties or too slow to reserve their own tracts of human DNA found themselves locked out of a new, burgeoning field, which in turn stalled or killed discoveries and products designed solely to help sick people. According to Lori Andrews of The Illinois Institute of Technology, prior to 2013, “53 percent of genetics labs had stopped doing research due to concerns about gene patents. Forty-nine percent of American Society of Human Genetics members had to limit their research due to gene patents.” Though the scientific community generally recognizes that corporations have an inherent profit motive, genetics became a field in which one was either with or against a few powerful companies reminiscent of Gilded Age America’s robber barons.

And in terms of bioethics, the idea of leveraging control over a fundamental aspect of the human identity rings a sour note. On one hand a gene patent inherently blocks progress on therapy; on the other it implies that the organization owns a component of life. Royalties on genes can very easily be seen as extortion over a product one has a natural right to access.

As of June 13, 2013 the human gene patenting dilemma became a non-issue in the U.S. when the Supreme Court unanimously decided on the case of Association for Molecular Pathology v. Myriad Genetics. The case was a culmination of a large number of complaints by researchers and doctors who had been served cease-and-desist orders by Myriad Genetics when they tried testing for the BRCA2 breast cancer gene. Possession of the gene dramatically increases the chances a patient will at some point develop breast cancer, so detecting its presence is extremely useful for preventative treatment. The sequence was isolated and its effects determined by Myriad in 1995. The company then gained a patent for the sequence, and demanded any laboratory testing a patient for the gene pay a royalty, covering Myriad’s previous R&D costs and making them a large profit. However, the patent halted research by other groups and dramatically ratcheted up the price of the test.

The American Association for Molecular Pathology represented doctors whose practices and patients had been hurt by Myriad’s zealous protection of its patent. They alleged that DNA exists everywhere, in all of us – making it what the legal code calls “a product of nature,” and thus not patentable. Myriad responded with the argument that the process of isolating DNA is artificial and difficult, validating their patents.

The Supreme Court chose a middle ground. The Court ruled natural DNA is by definition a product of nature and cannot be patented. However, they also noted that genes created artificially can be patented, as well as many other components of the genetic code besides DNA unknown to most people without a biological science background.

The Court made the law more palatable by ruling in favor of natural uniqueness, but the decision lacked the bite many bioethicists sought. Though mankind walked away with its DNA, so to speak, the giants of the biotechnology industry gained both approval and protection to continue operating and profiting in much the same way as before.

Opinions on the case vary, yet this massive and complex issue went undetected and unimaginable by the majority of Americans. Gene patenting was a practice that for millions meant the difference between long life and early death, a practice that I believe severely stifled scientific progress.

But more importantly, gene patenting is just a microcosm of the battles yet to come. I don’t know the answer to the big questions we are about to face—the questions of personhood, privacy, and, yet again, our ability to patent the various aspects of life. Questions like whether one can patent an organism, like an engineered plant, bacteria, or animal, and even whether it is ethical to alter the genes of an unborn human. These questions do not have easy answers, and they have no precedent—the world is running full tilt into the diverse, and ethically murky field of biotechnology. As a group, society may have differing opinions, and many may fully support the freedom to alter and capitalize on life, while others may seek a world where humanity leaves cells the way it found them, and many more will have an opinion somewhere in between. However, what is certain is that for the past fifty years our rights to exploit, own, and monopolize ourselves and the staggering diversity of life around us have been determined by nine aging justices and a handful of CEOs. Americans generally don’t know the details of their bodies, cells, and DNA, but the terrifying thing is that chances are good most people only know a little less than the Court did.

Know that the law is changing, and it is up to America to decide, not just how it feels, but just as importantly whether or not it is interested. If legislators don’t pass laws to determine for the country what its stance is, they run the risk of letting a small, oligarchical group decide for us. Though the Court has good intentions, and private researchers have great knowledge, biotechnology is not law, and neither group is qualified to make decisions in both. Unless society begins to take a stand for the natural pricelessness and opportunities inherent in all living things, we risk two extremes. On one end of the spectrum, biotechnology, one of America’s best new industries, could stall out in the driveway. On the other end one can foresee corporations capable of monopolizing fundamental aspects of life and stifling the progress of medicine crucial to improving the human condition.

For now, I just consider myself lucky to have avoided living in an America that legalized patenting people.