Question

In March 2010 Judge \(R\). Sweet ruled to invalidate Myriad Genetics' patents on the \(B R C A 1\) and \(B R C A 2\) genes. Sweet wrote that since the genes are part of the natural world, they are not patentable. Myriad Genetics also holds patents on the development of a direct-to-consumer test for the \(B R C A 1\) and \(B R C A 2\) genes. (a) Would you agree with Judge Sweet's ruling to invalidate the patenting of the \(B R C A 1\) and \(B R C A 2\) genes? If you were asked to judge the patenting of the direct-to-consumer test for the BRCA1 and BRCA2 genes, how would you rule? (b) J. Craig Venter has filed a patent application for his "firstever human made life form." This patent is designed to cover the genome of \(M\). genitalium. Would your ruling for Venter's "organism" be different from Judge Sweet's ruling on patenting of the \(B R C A 1\) and \(B R C A 2\) genes?

Short answer

How would you rule on patenting a direct-to-consumer test for these genes? How would your ruling for J. Craig Venter's human-made life form differ from Judge Sweet's ruling on BRCA1 and BRCA2 genes? Answer: I agree with Judge Sweet's ruling to invalidate the patenting of the BRCA1 and BRCA2 genes, as they are part of the natural world and not human inventions. Patents should only cover human-made creations or discoveries, not naturally occurring substances. For the direct-to-consumer test for BRCA1 and BRCA2 genes, I would consider it patentable if it involves a unique and inventive method of testing that required human creativity and ingenuity. My ruling on J. Craig Venter's human-made life form would be to grant the patent, as it is not a naturally occurring organism and involves human invention, which sets it apart from Judge Sweet's ruling on the BRCA1 and BRCA2 genes.

Step-by-step solution

Answering Part (a): Ruling on BRCA1 and BRCA2 Genes

Start by explaining whether you agree or disagree with Judge Sweet's ruling on invalidating the patenting of BRCA1 and BRCA2 genes, due to them being part of the natural world. Briefly explain the logic behind your opinion. Next, provide your ruling on the patentability of the direct-to-consumer test for the BRCA1 and BRCA2 genes. Explain your reasoning behind this ruling, considering factors such as the nature of the test and how it applies to the concept of patenting. Example response: I would agree with Judge Sweet's ruling to invalidate the patenting of the BRCA1 and BRCA2 genes, as they are a part of the natural world and not a human invention. Patents should only be granted for human-made creations or discoveries and not for naturally occurring substances. As for the direct-to-consumer test for the BRCA1 and BRCA2 genes, I would deem it patentable if it involves a novel and unique method of testing that required human creativity and ingenuity to develop. It is the process itself, not the genes being tested, that should be the focus of the patent.

Answering Part (b): Ruling on Patent Application for Human-Made Life Form

Discuss your ruling on J. Craig Venter's patent application for the first human-made life form, the genome of M. genitalium. Explain your reasoning behind this ruling, considering factors such as the uniqueness of the life form and whether it should be treated differently from naturally occurring genes. Lastly, compare your ruling on this patent application to Judge Sweet's ruling on the BRCA1 and BRCA2 genes. Discuss if your ruling would be similar or different, and explain the reasoning for any differences. Example response: My ruling for J. Craig Venter's "first-ever human-made life form" would be to grant the patent, assuming the creation of this organism involved significant human ingenuity, creativity, and novelty that distinguish it from naturally occurring organisms. The primary difference between this case and the BRCA1 and BRCA2 genes is that Venter's organism is not a naturally occurring part of the natural world, and thus may be eligible for patenting. However, my ruling could change depending on the details of the patent application and the extent of human invention applied in creating this organism.

Key concepts

BRCA1 and BRCA2 Genes

The BRCA1 and BRCA2 genes are well-known markers for assessing an individual's risk of developing breast and ovarian cancer. These genes belong to a class of genes known as tumor suppressors, which, when functioning properly, help to prevent the uncontrolled growth of cells that could lead to cancerous tumors. Mutations in these genes, however, can lead to a significantly increased risk of cancer, making them crucial targets for genetic testing.

The ethical and legal debate around the patentability of these genes heated up when Myriad Genetics attempted to patent them. A patent on a naturally occurring gene would give the patent holder exclusive rights to perform diagnostic tests and conduct research on these genes. However, Judge Sweet's ruling emphasized that naturally occurring substances, even when isolated from their natural environment, cannot be patented because they are not human-made inventions - a principle in patent law that preserves access to fundamental natural resources.

It's imperative to understand the distinction between patenting a discovery (the existence of a gene) versus patenting an invention (a process or method to analyze that gene). While nature cannot be patented, a novel process or application that utilizes the gene could potentially be eligible for a patent, provided it meets criteria like novelty and non-obviousness.

Direct-to-Consumer Genetic Testing

The rise of direct-to-consumer genetic testing has made it possible for individuals to gain insights into their genetic risk factors without the need for a medical professional. Companies offering these tests typically provide a kit for collecting a DNA sample (usually saliva), which is then sent to a lab where genomic data is extracted and analyzed. The results are then made available to the consumer, often through a secure online platform.

The patentability of the direct-to-consumer tests, such as the ones offered for analyzing the BRCA1 and BRCA2 genes, hinges on the uniqueness of the procedures and technologies developed to perform the testing. This encompasses the specific chemical reagents, the processes used to isolate the DNA, and the algorithms applied to interpret genetic data. If these elements are unique and non-obvious, they potentially meet the criteria for patent protection.

It is important to note that patenting a direct-to-consumer test does not restrict access to the genes themselves, but rather protects the innovative methods used to acquire and analyze genetic information. This distinction allows companies to recoup investments in research and development, while still upholding the principle that naturally occurring genes cannot be patented.

Human-Made Life Form Patenting

The notion of human-made life form patenting enters a new frontier in intellectual property law, where the creation of synthetic organisms like the one proposed by J. Craig Venter has initiated a debate on patent eligibility.

Unlike naturally occurring genes, human-made organisms that have been altered or created in a lab through significant genetic modifications could be considered for patents. This is because they can constitute a novel invention that includes human ingenuity and is not merely an abstraction of a natural phenomenon. The patent filed for the genome of M. genitalium represents an organism whose genetic material has been substantially altered or synthesized, presenting a strong case for patentability, assuming it offers novel functionalities or has been created through a non-obvious, original process.

Compared with the ruling on the BRCA1 and BRCA2 genes, a patent on a human-made organism could be justified if it is clear that the organism would not exist without human intervention. However, it's crucial to bear in mind the moral and ethical implications as well as potential environmental impacts of such patents. These factors, along with the legal requirements for patenting, inform the complex decisions faced by patent offices regarding the protection of human-made life forms.