In 2010, a U.S. District Judge ruled to invalidate Myriad Genetics' patents on the BRCA1 and BRCA2 genes. Judge Sweet noted 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 BRCA1 and BRCA2 genes.
J. Craig Venter has filed a patent application for his 'first-ever 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 the judge's ruling on patenting of the BRCA1 and BRCA2 genes?

Verified step by step guidance

1. Understand the key difference between the BRCA1 and BRCA2 genes and the genome of M. genitalium. The BRCA1 and BRCA2 genes are naturally occurring sequences in humans, while the genome of M. genitalium in this case is described as 'human-made,' implying it was artificially synthesized or engineered.
2. Review the legal and ethical principles surrounding patent law. In general, naturally occurring substances, such as genes found in nature, are not patentable. However, inventions or creations that are not naturally occurring, such as synthetic or engineered organisms, may be eligible for patents.
3. Consider the implications of Judge Sweet's ruling. The decision to invalidate Myriad Genetics' patents was based on the principle that genes found in nature cannot be patented because they are discoveries, not inventions. This principle would not necessarily apply to a synthetic genome, as it is not naturally occurring.
4. Evaluate the criteria for patent eligibility. For Venter's 'human-made life form,' the genome must meet the requirements of being novel, non-obvious, and useful. If the genome of M. genitalium was entirely synthesized and meets these criteria, it could be considered patentable.
5. Conclude by comparing the two cases. The BRCA1 and BRCA2 genes are part of the natural world and were ruled unpatentable, while Venter's synthetic genome, being an artificial creation, could potentially be ruled patentable under current patent laws. The ruling would likely differ based on the distinction between natural and synthetic entities.

Key Concepts

Gene Patenting

Gene patenting refers to the legal ability to claim ownership over specific genes and their sequences. The controversy arises from the balance between incentivizing innovation in genetic research and the ethical implications of owning parts of the human genome. The ruling against Myriad Genetics highlighted that naturally occurring genes cannot be patented, as they exist in nature and are not inventions.

Synthetic Biology

Synthetic biology is an interdisciplinary field that involves designing and constructing new biological parts, devices, and systems. It also includes the modification of existing natural biological systems for useful purposes. The patent application by J. Craig Venter for a human-made organism represents a significant aspect of synthetic biology, where the creation of novel life forms raises questions about ownership and the nature of biological inventions.

Natural vs. Artificial Distinction

The distinction between natural and artificial is crucial in patent law, particularly in genetics. Natural entities, such as genes found in the human body, are generally not patentable, while artificial creations, like genetically engineered organisms, may be eligible for patents. This distinction influences legal rulings and ethical considerations regarding what constitutes an invention versus a discovery in the realm of genetics.