A series of recent Supreme Court cases have left the state of patent law in flux, and what happens next is really anyone’s guess. The Court’s decisions in Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Association For Molecular Pathology v. Myriad Genetics, Inc. have resulted in scores of patent applications being rejected that would previously have passed muster.
The Supreme Court essentially held that certain claims were unpatentable under 35 USC 101 because they recite or involve laws of nature/natural principles, natural phenomena, and/or natural products.
In Mayo, a company sought to patent a method for determining the ideal dosage of thiopurine drugs for treating autoimmune diseases. The inventors discovered that the drug was most effective when the concentration of a particular metabolite in a blood sample fell within a certain narrow window. The Court found this discovery unpatentable because the relationship between a metabolite concentration and the optimized dosage was a “law of nature” and thus failed the 35 USC 101 subject matter patent test. Without specifying, it reasoned that more would be necessary to transform the relationship into a patent-eligible application of a natural law.
In Myriad, the Supreme Court held that a naturally occurring DNA fragment is a product of nature and not patent eligible merely because it has been isolated while cDNA is patent eligible because it is not naturally occurring.
In interpreting these recent rulings, the USPTO (United States Patent and Trademark Office) issued its own guidelines of what is now patentable and what is not. Unfortunately, these guidelines, if left standing, would have a dramatic effect on all testing being conducted to find new cures and vaccines. Large pharmaceutical corporations invest millions of dollars in research and development on the premise that if a new cure is developed, they will reap a windfall. If it is now unclear whether such future medicines would even be patentable, pharmaceutical companies will not take the risks in time or expense to keep looking to fight diseases.
Moreover, the guidelines’ departure from internationally accepted norms of patentability with regard to industrial, agricultural, and pharmaceutical preparations of naturally-derived substances, compositions, and processes has the potential to seriously impair the scientific advances of U.S. universities over universities in Europe and Japan which provide broader patent protection to inventors. This could lead to the United States falling behind in this important area of research, one that has significant implications on drug discovery and development.
After taking comments from attorneys like myself and those in the pharmaceutical and medical community, the USPTO is currently revising its guidelines. Hopefully, we will soon have a much clearer and less restrictive 35 USC 101 test implemented so that companies will once again be given strong incentive to find cures.
Silvia Salvadori, PhD.
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