by Youssef Rizk, Esq.
Most people are aware that having a patent on an invention, process, or business method is a powerful benefit granted by the government that creates an exclusive right of use to the inventor. Translation: “My idea, not yours! Hands off!” What people often forget, however, is that in exchange for that right, the government insists that all of the details surrounding the patentable material are revealed to the public. This requirement is an attempt to balance the individual’s right against the rights of the general public. It encourages new invention, but promises that eventually those new inventions will become accessible to the public domain (often after 20 years).
The requirements for obtaining a patent, which reflect the intent of the government to reward invention, but then to have the invention benefit the public interest are that:
1. The invention must be patentable (i.e. fall under the statutory definition of what is patentable
2. The invention must be new/novel (i.e. does not exist prior to the patent process);
3. The invention must be useful; (i.e. it needs to have a beneficial function);
4. The invention must be non-obvious (i.e. it should not be something that someone with a similar set of skills or background could come up with easily); and
5. The invention must be adequately described to the point that someone following the instructions could re-create the invention
Two recent decisions by the U.S. Supreme Court have shaken things up in the scientific community. First, there was the decision in the Mayo Collaborative Services, DBAMayo Medical Laboratories, Et al. v. Prometheus Laboratories, Inc. case where the court denied patents held by Prometheus. The patents protected a testing “method” used to determine whether or not a person’s body had absorbed too little or too much thiopurine drugs (used to treat autoimmune diseases) by analyzing the metabolites in the blood after ingenstion. The case concludes (and I am heavily summarizing the legaleze) that Prometheus could not patent a process that simply told doctors to check the levels and then compare those levels to a scale of what is considered too high or too low. The court determined that there was nothing novel about performing tests that doctors already performed, especially because the metabolites are a naturally occurring phenomena in the human body that result from metabolizing thiopurine drugs (which the drugs themselves have been in existence long before the patent). The process also did not instruct the doctors to do anything specific. For example, the (loosely paraphrased) instruction: “Check the levels of the patient’s metabolites,” was not followed with a description of how to do so. Instead it was left up to the doctor to determine the correct procedure for measuring the metabolites. This alone does not transform Prometheus’ process into anything patentable because it relies on the doctor’s innate knowledge to check the blood levels and measure them properly.
In the more recent case of Association for Molecular Pathology v. Myriad Genetics, No. 11-725, the U.S. Supreme Court did not deny the patents, but rather remanded the decision to the Appellate court for reconsideration in light of the Prometheus decision. Many in the legal community view this sort of thing as essentially a message from the Supreme Court to the Appellate court implying that they change their decision. Others feel that it may simply be that the Supreme Court needs more to go on after the Appellate Court includes Prometheus in its analysis. Regardless, the decision has many in an uproar.
For starters, in the Myriad case, the issue mainly concerns actual physical materials that Myriad patented rather than a process like that in Prometheus. Myriad’s patents are for genes found in human DNA that when examined for mutations can indicate whether or not a woman is at high risk for breast or ovarian cancer. Some argue that the Appellate court need not consider the Prometheus case because it simply has to do with a process that was poorly defined whereas Myriad has patents on actual physical materials. In opposition to that reasoning some argue that the Supreme Court intends the Appellate Court to analyze the decision not in terms of the patented subjects, but in terms of whether or not one can patent a natural phenomena.
DNA is something that occurs in nature. Patenting genes in DNA could be akin to patenting an organ found in a newly discovered insect or the liquid form of oxygen, which does not exist on Earth naturally, but is a form of a natural element. Simply put, these physical things cannot belong to any one person because no person created them. However, a unique process for using the new insect organ or creating liquid oxygen could be patentable (In Diamond v. Diehr, 450 U. S. 175, 185, the Supreme Court found that a mathematical formula itself was not patentable, but a unique process that used the formula was.). What complicates the matter is that Myriad claims that the mutations when analyzed outside the body are a new and transformative creation different from what occurs naturally. Further (and this is where Prometheus may apply more strongly), Myriad purports to have a process for determining whether or not the genes carry a mutation. The question is whether Myriad’s process to “determine if there is a mutation” is specific enough or whether it is as general as that in Prometheus.
Many bio companies consider these U.S. Supreme Court decisions detriments that create disincentives for companies or inventors to continue with their research when there is potentially no patent reward. Others consider the decisions a win for the scientific community in general because restricting access to naturally occurring phenomena or obvious diagnostic testing would impede scientific progress more greatly. The courts must consider striking a balance between the openness that benefits communal knowledge and the individual protections that reward ingenuity. Until we see how the Appellate court further analyzes the Myriad case in light of the decision in Prometheus, we will have to wait to see how these decisions ultimately affect scientific research generally and specifically with bio companies in the long run.
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Gene Patenting: Ethical and Legal Issues