Posts Tagged: "Mayo v. Prometheus"

WIPO Report Validates Fears About U.S. Patent Decline

Each year the World Intellectual Property Organization releases a report titled World Intellectual Property Indicators. The latest edition of the report, the 2019 version, is a look back on the filing statistics for 2018. The report is eye-opening and should be mandatory reading for policy makers and legislators in the United States. For the first time since 2009, the United States saw a decline in the number of patent applications filed. This remarkable statistic comes at a time when patent applications are growing in number across the rest of the world. And let’s not forget that 2009 was a time of particular economic crisis both in the United States and around the world due to the global financial crisis and Wall Street meltdown brought on by the housing market collapse.  

Athena v. Mayo: A Splintered Federal Circuit Invites Supreme Court or Congress to Step Up On 101 Chaos

On July 3, the Court of Appeals for the Federal Circuit denied en banc rehearing in Athena Diagnostics v. Mayo Collaborative Services. The 86-page order from the Federal Circuit includes eight separate opinions—four concurring with the en banc denial and another four dissenting from the decision. The separate opinions reflect a Federal Circuit that isn’t divided so much on the issue of the importance of Athena’s now invalidated patent claims but, rather, the application of the U.S. Supreme Court’s Section 101 jurisprudence under Mayo Collaborative Services v. Prometheus Laboratories (2012). Throughout the opinions, it seemed clear that the Federal Circuit was eager to have the Supreme Court take this case up on appeal in order to clarify Mayo’s judicial exception to laws of nature and its impact on patent claims covering medical diagnostics.

Mayo Response Brief in Athena v. Mayo at CAFC Argues Athena Claims Impede Treatment Decisions

The presently pending petition for en banc review in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC has been addressed by Sherry Knowles and Meredith Addy and is supported by a number of amicus briefs. The patent in issue has been described by the present author as a paradigm of patent eligibility, supporting the argument that en banc review is merited. Mayo has now filed its response brief, submitted on May 7, and argues that the panel’s decision invalidating the asserted claims as ineligible properly applied the two-step Alice framework in light of precedent, that the full Court need not re-examine it, and accordingly, that Appellants’ petition should be denied.

Alice Five Years Later: Hope Wanes as 101 Legislative Discussions Dominated by Big Tech

On June 19, it will be five years since the United States Supreme Court issued a decision in Alice Corp. v. CLS Bank, 134 S.Ct. 2347 (2014), which significantly changed the way courts and patent examiners evaluated patent eligibility of computer implemented innovation in the United States. While the Supreme Court ostensibly extended the patent eligibility analysis applied in the life sciences context that had previously been adopted in Mayo Collaborative v. Prometheus Labs., 132 S.Ct. 1289 (2012), even a cursory review of allowance rates from the USPTO and invalidity rates in federal courts shows that Alice changed the prevailing analysis in profound ways. We will be commemorating this anniversary on June 24-25 in Washington, DC with a dedicated event examining the damage, discussing real solutions, and offering strategies for innovators who need protection in these uncertain times (see below for more detail). Almost immediately after Alice, patent examiners started to issue new subject-matter eligibility rejections for computer implemented innovations using the abstract idea exception to the statutory categories of patent eligibility. “The ubiquity of subject-matter eligibility rejections in office actions exploded, leading many to wonder whether software implemented inventions remained patentable at all,” explained Kate Gaudry and Samuel Hayim, who have done a series of articles on IPWatchdog detailing their statistical analysis. “This effect was largely centered in business method art units of [USPTO technology center] (TC) 3600. For example, the number of allowances issued from business-method art units dropped from 24% in the months before Alice was decided to about 3% in months after.” For months there has been growing hope that a legislative fix spearheaded by a few dedicated Members of Congress would provide a solution. But in recent weeks, that hope is waning as the uncomfortable reality that big tech is dominating the discussions has started to set in.

Patent Eligibility of Medical Diagnostic Inventions: Where Are We Now, and Where Are We Headed?

In each of the recent Federal Circuit decisions on medical diagnostics inventions, Athena Diagnostics v. Mayo Collaborative Services, 2017-2508, (Fed. Cir. Feb. 6, 2019) (“Athena”) and Cleveland Clinic Found. v. True Health Diagnostics LLC, 2018-1218 (Fed. Cir. April 1, 2019; non-precedential) (“Cleveland Clinic II”), the court affirmed a district court ruling that found a medical diagnostic or a related patent invalid for being directed to ineligible subject matter. Athena and Cleveland Clinic II follow the hard stance taken by the Federal Circuit against medical diagnostics inventions, first in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015) (“Ariosa”) and next in Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352, 1361 (Fed. Cir. 2017) (“Cleveland Clinic I”). In Athena, the patent covered a method for diagnosing a disease in a subpopulation of affected individuals based on the discovery of a correlation between the disease and certain autoantibodies found only in that subpopulation. In Cleveland Clinic I, the patent claims were directed to diagnosing the risk of atherosclerotic cardiovascular disease (CVD) based on the correlation between elevated levels of a protein found in the blood and occurrence of atherosclerotic CVD. In Cleveland Clinic II, the claims were directed to methods of identifying elevated levels of the protein but did not include any recitation of the correlation…. The requirement for an improvement to the technology involved in carrying out the claimed method is a steep hurdle for the eligibility of most medical diagnosis inventions, since the essence of such inventions is applying a newly discovered correlation to deliver a practical benefit—not improving the technology used to provide the diagnosis. In this regard, medical diagnostic inventions are unique. This point was highlighted by the Athena dissent through reference to the amici curiae Five Life Sciences Patent Practitioners’ brief, which stated, “[medical] diagnostic methods . . . are so tightly bound to underlying natural laws and phenomen[a], they are especially susceptible to undue expansion of the eligibility standards…” Athena Dissenting opinion at 13.