[UPDATE: See below for complete reading list of analysis and commentary, growing as the work comes in.]
Yesterday the United States Supreme Court issued its unanimous decision in Mayo Collaborative Services v Prometheus Laboratories, a significant intellectual property case that, according to law firm Patton Boggs LLP:
"…has widespread impact on the pharmaceutical and biotechnology industries, which have obtained thousands of U.S. patents on diagnostic tests used to determine diseases and disorders, and potential treatments and treatment dosages."
What’s at the heart of Mayo v Prometheus? Again from Patton Boggs:
"The Supreme Court held that drug metabolism is an entirely natural process and therefore the correlation between the metabolites in a patient and the thiopurine dosage was an unpatentable law of nature. Justice Breyer wrote the decision, stating ‘the relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.’ Under U.S. patent law, natural laws are not patentable by themselves, but they may be ‘transformed’ into a patentable process in certain circumstances."
[To read the entire update, see: In A Decision With Potential Widespread Impact, The Supreme Court Holds That Methods Of Personalized Pharmaceutical Dosing Are Not Patentable]
U.S. patent attorney Gene Quinn, writing on IPWatchdog, called Justice Breyer’s “the most intellectually dishonest decision I have ever read, which is saying a lot given the utter contemptuous understanding of patent law displayed by the Supreme Court over the years.” [Killing Industry: The Supreme Court Blows Mayo v. Prometheus]
Yesterday, intellectual property firm McDonnell Boehnen Hulbert & Berghoff LLP issued the following on early reaction to the decision:
"Dr. Robert Wah, Board Chair for the American Medical Association (AMA), … welcomed the Supreme Court’s decision invalidating Prometheus’ patents. Asserting that the Court had ‘prevented irreparable harm to patient care with today’s unanimous decision to invalidate two patents that gave Prometheus Laboratories exclusive rights over the body’s natural responses to illness and medical treatment,’ the AMA declared that the decision was "a clear legal victory that ensures critical scientific data remain widely available for sound patient care and innovative medical research.’"
[For entire alert, see: Early Reaction to Supreme Court Decision in Mayo v. Prometheus]
Also from MBHB:
"The general message conveyed by the Court seems to be two-fold. First, if ‘the steps in claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field,’ such claims likely encompass non-patentable subject matter. And second, the Court demonstrated general concern that ‘upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.’ How this message affects the thousands of existing patents in the field of personal medicine remains to be seen. However, going forward, patent practitioners would be wise to revisit this ruling when drafting claims to medical diagnostic methods." [Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012)]
Law firm Fenwick & West LLP tells us that the implications of this decision extend well beyond the life sciences field(s):
"For other industries as well, this decision has a clear impact. For instance, the question about whether patent-eligibility is merely a ‘coarse filter’ that should be avoided when possible is now settled—the patent eligibility analysis must be undertaken. The Court’s approach of dissecting method claims to determine which portions state laws of nature and which portions recite conventional steps is in sharp contrast with how the USPTO and courts have been analyzing claims in recent years. If such holding is extended to include the other branches of the ‘implicit exception’ to patentability that the Court references (i.e., natural phenomena and abstract ideas), then a very wide swath of science and technology areas are implicated…" [Supreme Court Issues Groundbreaking Decision Limiting the Types of Methods that are Eligible for Patenting]
Fascinating case. We’ll be posting additional commentary and analysis as it comes in. In meantime, early updates:
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