Understanding the Functionality of Gene Patents

Patent X000072 was awarded to Eli Whitney for his invention of the cotton gin. Alexander Graham Bell secured patent 174,465 for the telephone, while Walter Hunt received patent 6281 for creating the safety pin [source: Bieberich].

As for patent 8,017,761, it was granted to Merck for their groundbreaking work on "RNA interference mediated inhibition of Stearoyl-CoA desaturase gene expression using short interfering nucleic acid" [source: United States Trademark and Patent Office].

However, perhaps it's not as straightforward as it seems.

Although patents are commonly associated with everyday items like toasters, tractors, and turntables, the U.S. Patent and Trademark Office has been granting patents on genetic material since 1982. Currently, there are between 3,000 and 5,000 patents on human genes in the U.S., alongside 47,000 patents related to genetic inventions [source: Cook-Deagan]. On June 13, 2013, the U.S. Supreme Court declared that naturally occurring human genes cannot be patented, though synthetic DNA or inventions replicating DNA remain eligible.

It may seem odd that corporations can claim ownership over something inherent to your body, but the reality is far more nuanced. The intricacies of gene patenting are as complex as the language of patent number 8,017,761, and the debate surrounding it is equally intricate, as we’ll explore.

History

Long before the 2013 decision prohibiting the patenting of human genes, the legal journey shaping today’s patent laws for substances produced within the human body has been far from smooth. For instance, in 1853, the Supreme Court rejected Robert Morse’s patent claim related to the telegraph, arguing that electromagnetism—a natural principle—could not be patented. Yet, in 1912, a court upheld a patent for lab-derived adrenaline, distinguishing it from its natural counterpart. Similarly, after World War II, the Supreme Court ruled against patenting a lab-created bacterial mixture, citing its natural origins [source: Darnovsky and Reynolds].

A pivotal moment in the history of genetic patents occurred in the early 20th century with the enactment of the Plant Patent Act of 1930, which granted plant breeders the right to patent new plant varieties. However, for the next five decades, courts rejected patents on "products of nature" until the groundbreaking Diamond v. Chakrabarty case, where the Supreme Court ruled that a living organism—specifically, a strain of bacteria—could indeed be patented.

This decision paved the way for the first gene patent in 1982, awarded to the University of California for a synthetic hormone related to breast development in pregnant women [source: DeGiulio]. That same year, the first patented recombinant genetic product—insulin—was introduced. The race for genetic patents intensified after the Human Genome Project announced in late 2000 that it had nearly completed mapping human DNA, sparking a surge in patent filings.

Facing an overwhelming number of patent applications for individual genes and sequences—many of which lacked a clear understanding of the genetic material's function—the United States Patent and Trademark Office (USPTO) introduced new guidelines in 2001. These rules required applicants to demonstrate "specific, credible, and substantial" uses for the genetic material to qualify for a patent [source: AMA].

While these requirements slowed the process and limited applications to those with extensive research, over 3 million genome-related patent applications have been filed to date [source: Oak Ridge National Laboratory].

Getting a Patent

To secure a patent from the USPTO, an invention must meet four key requirements: it must be practical, original, non-obvious, and fulfill the enablement criterion, which ensures that the invention is described in sufficient detail for experts in the field to replicate it. Once granted, the patent holder enjoys exclusive rights to produce, use, or sell the invention for 20 years.

In the U.S., patents are awarded based on the "first to invent" rule. If multiple parties apply for a patent on the same invention, the one who can demonstrate they created it first receives the patent. This principle fueled the surge in patent applications following the completion of the Human Genome Project, as everyone raced to claim priority.

Most genetic patents are issued by the USPTO, along with the European and Japanese Patent Offices.

For patents involving modified natural products, such as gene patents, inventors are required to submit a sample of their creation to one of the 26 global culture depositories recognized under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for Patent Procedures. It’s crucial to understand that genes qualify as altered natural products only after being extracted from the body and undergoing specific processing. The patent protection applies solely to the resulting processed product.

Gene Patent Purposes

Gene patents are generally classified into four types: diagnostics, functional use, processes, and compositions of matter. These patents may cover individual genes, but more commonly, they involve processes related to genetic material or short sequences of connected genes, with a focus on gene segments responsible for protein production.

In the realm of diagnostics, researchers aim to patent methods that detect genetic variations or anomalies. Often termed disease gene patents, these are primarily linked to identifying genetic markers associated with conditions like cancer, Alzheimer’s disease, and cystic fibrosis. This category becomes complex because a single gene can have multiple mutations, or a single test might examine various genes for the same condition—each unique combination of engineered mutations and tests can be patented.

Functional use patents arise from research uncovering the roles specific genes play in disease development or bodily regulation. These patents are typically granted for drugs that influence gene functionality.

Process patents are straightforward, safeguarding methods used to extract or manipulate genes. Amid the heated debate over gene patenting, these patents are considered less controversial since they protect a procedure rather than human genetic material itself.

Composition of matter patents are designed to protect "inventions" resulting from the combination of various genetic materials. These are commonly filed for drugs and vaccines, such as insulin and human growth hormone (HGH). This category of patents lies at the center of many legal disputes surrounding genetic patents, as we’ll explore further in the next section.

Legal Challenges

The core of the legal dispute over gene patenting revolves around the distinction between "products of nature" and "compositions of matter." Opponents argue that genes, being fundamental elements of our bodies, are natural and thus unpatentable. Supporters, however, claim that once a gene is extracted and altered, it becomes a "composition of matter" eligible for patent protection.

A highly publicized case in this debate involves Myriad Genetics. The company secured seven patents for the BRCA1 and BRCA2 genes, linked to breast and ovarian cancers, and created a test kit to assess a woman’s risk of developing these diseases.

In March 2010, a U.S. District Court invalidated Myriad’s patents, ruling that genetic material is inherently a product of nature. The judge dismissed the argument that genes outside the body lose their natural status, calling it "a lawyer's trick" [source: Schwartz].

However, in July 2011, the Court of Appeal for the Federal Circuit reversed this decision, stating that lab-isolated genetic material has a distinct chemical composition compared to its natural state within the body [source: Pollack].

This ruling sparked debate, with some viewing it as a green light for biotech companies, while others saw it as another chapter in the ongoing battle over genetic ownership. Ultimately, the U.S. Supreme Court ruled that isolated genes, like BRCA1 and BRCA2, cannot be patented, but synthetic creations, such as Myriad’s cDNA, are eligible for patents despite their genetic basis.

Next: The controversy surrounding gene patents extends beyond legal matters.

Ethical, Social and Economic Challenges

Beyond the courtroom, the discussion about gene patents remains highly active.

Advocates for gene patents contend that the system encourages research by allowing scientists to secure rights and recognition for their discoveries, preventing others from exploiting their work after publication. They argue that retaining these rights offers financial motivation for companies to invest in exploring genetic materials, ensuring a return on their investment for at least two decades. Without patent protection, they claim, genetic research would significantly decline.

Additionally, supporters highlight that the patent system reduces redundant efforts across research institutions. When one facility patents a discovery, it becomes publicly documented, preventing others from pursuing the same path. This transparency, inherent to the patent process, fosters collaboration and openness, enabling scientists to build on each other’s work and advance research more effectively.

Opponents of gene patenting argue that the genetic material within our bodies is a shared human resource, not the property of any laboratory, and that the ban on patenting "products of nature" clearly applies here. They also claim that when one lab holds a patent on a specific gene or gene sequence, it stifles research at other institutions due to the licensing fees required to use the patented material. The American Medical Association (AMA) supports this stance, opposing gene patenting because it "could restrict patient access to genetic testing and impede research on genetic diseases" [source: AMA].

The financial aspect of gene patenting also impacts consumers. When a single company holds the exclusive rights to a test or treatment, they essentially control a monopoly for the patent’s 20-year duration, allowing them to set prices without competition. More concerning is the possibility that, without market competition, patent holders may lack the incentive to enhance their products or address consumer needs.

One thing is certain: the realm of gene patenting is as intricate as the human body itself, and the debates and legal battles it sparks are likely to persist for many years.