Those who are not patent attorneys may be surprised to learn that it is possible to patent the human genetic code.
In fact, approximately 20% of all human genes are patented.
The US Patent and Trademark Office (PTO) has granted patents on genes and their DNA building blocks since the early 1980s, but this practice has recently reentered public awareness due to a lawsuit (Association for Molecular Pathology v. US Patent & Trademark Office) by a breast cancer survivor against Myriad Genetics, a company that has obtained patents on two genes closely associated with increased risk for breast and ovarian cancer, BRCA1 and BRCA2. These patents make Myriad the sole provider of tests to detect those genes, at a cost of over $3,000 per test.
Patents give their owners exclusive rights to use, manufacture, or sell the patented invention for 20 years from filing of the application. In order to qualify for a patent, an invention must be new, useful, and non-obvious to an expert in the field. However, patents cannot be granted on laws of nature or theoretical phenomena, for example the Theory of Relativity. Prior to the 1980s, the PTO considered that life forms were equivalent to the laws of nature, and therefore not patentable subject matter.
However, the Supreme Court ruled in Diamond vs. Chakrabarty (1980) that a scientist could obtain a patent on a lab-created bacterium that could consume oil slicks, on the grounds that the organism did not occur in nature, and therefore was a “manufacture” or “composition of matter” under 35 USC Section 101, and not equivalent to a law of nature.
Since that time, the PTO has allowed patents not only on man-made organisms, but on entire genes, gene fragments, and even fragments of DNA. The requirements for patenting genetic inventions are that they must: identify novel genetic sequences; specify the sequence’s products; specify how the product functions in nature (its use); and enable one skilled in the field to use the sequence for its stated purpose.
Critics allege that this standard is too loose, allowing companies that merely identify a gene to patent it, even if they are unable to identify its functions or uses with any degree of specificity; which in turn hinders progress in biotechnology, because it gives a monopoly to the person who first identifies a genetic sequence, which is comparatively easy, not the person who identifies its use or purpose, which is comparatively difficult; which in turn blocks or drives up costs to develop medicines or therapies based on that gene.
This is essentially the plaintiffs’ argument in the Myriad Genetics case. The suit, filed by the American Civil Liberties Union on behalf of breast cancer patients and organizations representing scientists and technicians, argues that Myriad’s patents on the genes BRCA1 and BRCA2 exceed patent law, because genes are not patentable subject matter, and violate the the Patent and Copyright Clause and the First Amendment of the Constitution, because they impede the free flow of information, and as a result impede scientific research and interfere with medical care.
Indeed, some investors may be bypassing funding promising research in the development of genetic stem cells, because the intellectual property rights are already substantially locked up by genetic patents. Craig Venter, who as president of a for-profit company is credited with “cracking” the human genome at a fraction of the cost and time originally estimated, is reportedly focusing his current research efforts on creating biofuel-producing designer microbes, because he can patent whatever he invents in the lab without having to worry that someone has staked a patent claim to pre-existing human genetic code.
Genetic patent owners reply to the critics that the genes patented by Myriad are not equivalent to laws of nature, because they are not in the form of the genes as they occur in the human body, but rather are isolated, purified forms of those genes not occurring in nature. While the cost of the Myriad tests may be high, that is no different than the high cost of patented pharmaceutical medicines. The public accepts the inherent trade-offs of the patent system for pharmaceuticals– the inventor gets a time-limited monopoly which ensures him a profit for his investment of time, capital, and ingenuity, while the public gets full disclosure of the technology, spurring further innovation even before the patent expires, and cheaper generic versions of the medicine after the patent expires. The trade-offs are no different for genetic patents, the patent owners argue.
In this as with many other important intellectual property disputes, we see tension between open source, open information, collaborative innovation, and closed source, closed information, profit-driven innovation. With biotechnology on the verge of yielding a cornucopia of new medicines and therapies over the next 10 to 20 years, it should be fascinating to watch how this tension plays out, and whether genetic patents will drive or hinder progress in medical treatment.