Gene Patenting: Ethical and Legal Issues
By: Jessica Scherrer Lamb
The role of intellectual property in the health care sphere can be controversial. In a society where health care costs are a significant issue, it is easy to question whether the contributions companies make in research, development, and manufacturing justify the price protection and licensing fees patents enable. Many scientists worry that patents hinder research, either by patent holders’ direct interference or because competing companies will not invest in developing products that might infringe on existing patents. Furthermore, products derived from human tissue introduce problems of donor consent and ownership. While these issues are important in all areas of biomedical research, the idea of “gene patents” seems to raise eyebrows the highest.
Genes do not just exist in nature, but within us, determining many of our individual characteristics. Hearing that someone owns a patent on a human gene feels personal, unlike a computer or medical device patent. Most “gene patents” claim isolated molecules in labs, but these still originate from human sources, usually from donated or discarded tissue. A donor might ask “How can a patent claim my gene?” especially if that gene is unique. Furthermore, genes themselves are not inventions but the products of millions of years of evolution, so how can they be patented at all?
Courts have found that, in general, human-derived tissue products are patent-eligible, with donors having little control over subsequent uses and no rights to profits from products derived from their tissues. The courts recently affirmed that this interpretation includes genetic materials in a case involving a test for Canavan disease [i]. Because this disease is rare, the test was made possible by a relatively small group of donors who later objected to commercialization of the test. Here the connection between patents and profits becomes important in the ethical debate. If a donor makes available, through benevolence or ignorance, a material that proves extremely valuable, who has an ownership stake in that material? What needs to be disclosed to the donor? Can another entity profit over the objections of the donor? What should be done retroactively if the donation process was flawed? So far courts have favored the commercialization rights of companies and researchers, even when patients felt their informed consent to these uses was inadequate, as was the case with the Canavan donors.
So why is it legal to patent a gene? The answer to this question lies in how one defines the term “gene” and what specific compounds or methods a patent covers (or “claims”). For instance, compositions of matter are patent eligible, but products of nature are not [ii][iii]. For a product to be a novel invention and thus patentable, the process that distinguishes it from the natural form must be transformative (i.e. sufficient to transform the product from a “natural product” into “a product of man”). What qualifies as transformative is determined by the patent office and, in the case of a challenge, the courts. Gene patents do not claim parts of our chromosomes, but rather isolated copies of that DNA (say, dissolved in a tube or embedded on a plate) with an equivalent sequence. Processing and modifying the DNA in the lab is generally considered transformative, though some scientists believe that this ignores the nature of DNA. On one hand, a great deal of work goes into identifying the sequence of a gene and isolating it for laboratory use, not to mention finding a use, which is another requirement for a patent. On the other hand, both the DNA molecules in the chromosome and in the lab encode the same unique sequence and code for the same proteins.
Interestingly, the courts seem to acknowledge the molecule vs. sequence distinction while generally upholding the claims of gene patents. For example, Myriad Genetics markets patented tests to detect breast cancer-promoting mutations in patients. The patents on these tests are broad and include claims on the sorts of isolated DNA discussed above. Recently they were challenged, but the judges ruled the creative processes were transformative regardless of other considerations and allowed the patents on the isolated molecules to stand [iv]. However, the court did throw out the patent claims that involved analyzing a patient sequence through a simple comparison to a known standard. The original patent is broad enough that Myriad’s test is still protected, but the ruling seems to confirm that while the DNA molecules are protected, the sequence information encoded in that DNA is not. If someone uses a sequencing method which does not use Myriad’s patented molecules in any way, could they circumvent the patented genetic test [v]? This remains an open question.
As medical research moves forward, we ask ourselves if our current laws are adequate to cover new ethical challenges that arise. As commercial enterprises innovate, the US Patent and Trademark Office and the courts are left to interpret how current law should apply to new types of inventions. Some find these interpretations morally or analytically inadequate, especially in the area of donor consent. Some of the questions about the legality of existing gene patents, such as the scope of claims for genetic tests, have not been answered simply because there has not been a court case challenging the patents in question. These modern issues raise questions that will shape the commercial and bioethical landscapes for years to come, and the law will need to evolve to adequately answer them.