How Gene Patents Work

Even before the 2013 ruling that human genes could not be patented, the judicial road that has led to today's laws regarding patent rights to substances made inside the human body has not always been bump-free. As an example, in 1853, the Supreme Court denied one of Robert Morse's patent claims relating to the telegraph. Their reason? Electromagnetism -- the principle on which the device worked -- was "a principle of nature" and therefore couldn't be patented. Yet, in 1912, another court ruled that the patent issued for adrenaline was valid because the distilled type treated in a lab was different from than the kind found in natural sources. Then, shortly after World War II, another ruling was handed down by the Supreme Court that rejected patent claims on a mixture of bacteria that could only be made in the lab [source: Darnovsky and Reynolds].

One definitive step leading to genetic patents was taken in the first half of the 20th century when the Plant Patent Act of 1930 was passed, allowing plant breeders to patent new types of plant life. But aside from plants, 50 years would pass with the courts disallowing the patenting of "products of nature" until the landmark court case of Diamond v. Chakrabarty, in which the Supreme Court ruled that a life form (in this case a strain of bacteria) could, in fact, receive a patent.

This was followed by the first gene patent to be issued in 1982 to the University of California for an engineered hormone involved with breast development in pregnant women [source: DeGiulio]. In the same year, the first recombinant (meaning engineered) genetic product -- insulin -- was also patented. More patents would follow, but it wasn't until the announcement near the end of 2000 that the Human Genome Project had almost completely mapped our DNA that the race to obtain genetic patents really sped up.

Because the United States Patent and Trademark Office (USPTO) was barraged with patent requests for both individual genes and gene sequences -- and in some cases, the applicants didn't even understand what the function of the genetic material was -- it issued new guidelines in 2001, stipulating that in order to apply for a genetic patent, a company or research institute needed to show "specific, credible and substantial" uses for it [source: AMA].

Although that requirement slowed things down a bit and made the patent application process available only to those who had conducted substantial research, to date, there are more than 3 million genome-related patent applications on file [source: Oak Ridge National Laboratory].

In order to have a patent issued by the USPTO, the invention must satisfy four criteria: It must be useful, novel, non-obvious, and must meet what is known as the enablement criterion, meaning that it should have a detailed enough description that anyone working in the appropriate field should be able to make use of it. When a patent is issued, though, it gives the owner 20 years during which no one else can make, use or sell the invention.

In the United States, patents are issued according to the "first to invent" principle. This means that in the event patents are requested for the same invention by separate parties, whoever can prove that they made the invention first is the one entitled to the patent. This helped contribute to the mad rush of patent applications in the wake of the completion of the Human Genome Project -- everyone wanted to be first.

The majority of genetic patents are granted by the USPTO, or the European or Japanese Patent Offices.

In the case of patents like gene patents that involve altered products of nature, the inventor must deposit a sample of their product into one of 26 worldwide culture depositories as stipulated by the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure. It is important to note that genes can count as altered products of nature only if they have been removed from the body and processed in some way. The patent applies to that processed end product.

Gene patents break down generally into four categories: diagnostics, functional use, process and compositions of matter. These patents might be on a single gene, but more often than not, they are on a process involving genetic material or on a small strand of linked genes, and they generally focus on the parts of genes involved in the production of proteins.

When it comes to diagnostics, gene researchers are looking to patent methods that test for genetic differences or abnormalities. These types of patents are occasionally referred to as disease gene patents, because they are most often associated with spotting genetic markers involved in ailments such as cancer, Alzheimer's disease and cystic fibrosis. Things get complicated in this category of gene patents because one gene can have many different mutations, or one test can analyze different genes for the same disease -- and all of the different combinations of engineered mutations and tests can be patented.

Functional use patents stem from research that discovers the roles played by various genes in causing disease in the body or in regulating bodily functions. These patents are typically issued for drugs which affect the functioning of genes.

Process patents are relatively self-explanatory and are used to protect a method by which genes are extracted or manipulated. In the furor surrounding gene patenting, these types of patents are relatively benign, as they patent a process rather than actual human genetic material.

Composition of matter patents are filed to protect "inventions" that generally stem from combining different genetic material and are typically filed for drugs and vaccines such as insulin and human growth hormone (HGH). This type of patent is at the heart of much of the legal controversy surrounding genetic patents, as we'll see in the next section.

The crux of the legal controversy over gene patenting is the debate between "products of nature" and "compositions of matter." Gene patenting opponents argue that there is no more fundamental product of nature than the genes found inside our own bodies, and therefore they are not patentable. Proponents of gene patents assert that once a gene is removed from the body and manipulated in any way it qualifies as a "composition of matter" which is legally patentable.

One of the most closely watched court cases involving these issues is the one involving Myriad Genetics. The company filed seven patents relating to genes BRCA1 and BRCA2, which are associated with breast and ovarian cancers, and it developed a test kit which helps predict a women's risk of those diseases.

In March 2010, a U.S. District Court ruled that the company's patent claims were invalid because genetic material was, in fact, a product of nature. The ruling judge called the idea that genes outside of the body were no longer products of nature "a lawyer's trick" [source: Schwartz].

However in July 2011, the Court of Appeal for the Federal Circuit overturned the lower court's decision saying that the genetic material isolated in a lab had significantly different chemical makeup than when it is found inside the body [source: Pollack].

Some say this ruling throws open the patent office doors to biotech companies while others posit that this is just one more legal tussle in the ongoing debate over who owns the rights to our genetic material -- one that was eventually decided by the U.S. Supreme Court. The court decided that a gene, even after being isolated and identified, was not eligible for a patent -- so, BRCA1 and BRCA2 could not be patented. But that the creation of something new -- in this case, Myriad's synthetic cDNA -- could be patented, even though its creation involved genes.

Next: The debate over gene patents isn't only about legal issues.

Outside of the courtroom, the debate over gene patents is still a lively one.

Proponents of gene patents argue that the system stimulates research, as scientists can retain the rights and credit for their work rather than having the results of years in the lab simply stolen by another company once findings are published. The retention of rights, they say, also provides research companies a financial incentive to explore genetic materials, as they can be assured a profit for at least 20 years from their efforts. Without gene patents, proponents argue, very little genetic research would ever take place.

They also maintain that the patenting system prevents duplication of efforts across research institutes. Once facility A has patented a finding, it becomes public knowledge and facility B does not need to head down the same research path. This component of transparency, which is integral to the patenting process, also eliminates secrecy and provides scientists access to each other's findings in a way that can propel research further, according to supporters of the gene patenting process.

The primary argument used by opponents of gene patenting is that the genetic material inside our bodies belongs to humankind, not a lab, and that the regulation prohibiting the patenting of "products of nature" certainly applies in this case. They also assert that once one lab owns a patent on a particular gene or sequence of genes, research at other labs will be hampered because of the fees that must be paid to the patent holder for use of their work in related research areas. The American Medical Association (AMA) is on this side of the issue, stating that they oppose gene patenting because "it has the potential to inhibit access to genetic testing for patients and hinder research on genetic disease" [source: AMA].

The financial component to gene patenting also has implications for the consumer. If one and only one company is allowed to patent a particular test or treatment, they effectively own a monopoly for the 20-year-term of the patent and can charge whatever they like for it. What's perhaps even more troubling is the idea that without any competition in the marketplace, a genetic patent holder wouldn't necessarily feel the need to improve their product or respond to consumer feedback.

Perhaps the only thing that is clear on this issue is that just like the human body itself, the world of gene patenting is extraordinarily complicated and the debates and legal challenges it inspires are likely to continue for years to come.