Posts Tagged: "patentable subject matter"

The World Intellectual Property Organization (WIPO) established World IP Day (WIPD) 19 years ago to celebrate the day on which the WIPO Convention entered into force: April 26, 1970. With nearly five decades under its belt, WIPO has had its successes and scandals, but there can be no doubt that IP rights are more harmonized now than ever before. This year’s WIPD theme is “Reach for Gold: IP and Sports.” While the topic may seem slightly off-mark to some, with so much else to talk about in the context of a rapidly-evolving global digital economy in which IP rights are becoming both more crucial and increasingly threatened in many jurisdictions, it does underscore the degree to which IP permeates industries and facilitates consumer experiences.In honor of World IP Day, we asked the experts to weigh in on how far we’ve come in the two decades since the holiday was established, and what the future holds. As usual, there were optimists, pessimists, and those in between. Here’s what they had to say.

The Framework rolled out by Congress last week to fix Section 101 law in the United States will not improve the current 101 disaster. It codifies current exceptions and even adds an entirely new exception specifically intended to protect big tech monopolies. Congress is pitifully unserious about restoring our innovation engine. For more than 200 years, the U.S. patent system was the primary engine propelling the United States to lead the world in virtually every new technology. But over the last 15 years, activists in Congress, the courts and the administration pulverized this engine to benefit a few huge multinationals in exchange for political donations and favors. Today, the patent system is a complete failure causing technologies critical to our economy, job creation, global technological lead, and national security to flee the U.S. and go to China. In a brutal political irony, the Communist Chinese have a better property rights system than we do here in the U.S.

Yesterday, members of congress announced in a press release a proposed framework to fix patent eligibility law in the United States.Reactions to the framework were mixed. While many are delighted that the issue seems to be getting real attention on Capitol Hill, others are skeptical of some of the proposals. For example, Russ Slifer, former Deputy Director of the United States Patent and Trademark Office (USPTO), described the framework as “a big swing and a miss.” Having attended the meeting on the Hill yesterday in which the framework was released and discussed prior to being circulated to the public, Todd Dickinson of Polsinelli, and the former USPTO Director, said that he can understand how those seeing the proposal without having taken part in the dialogue might be alarmed. “There are still some big questions to answer, but I left the meeting encouraged by the momentum,” Dickinson told IPWatchdog. The discussion, which he described as decidedly “more lawyerly” than previous meetings on the topic, included staffers for both the House and Senate, and from both political parties, which “is a good sign that there is a continued intention to do something,” he said.

In a promising indication that there is real momentum on The Hill to fix Section 101 law, several Senators and Representatives today proposed a framework for addressing 101-related patent reform.Senators Thom Tillis (R-NC) and Chris Coons (D-DE)—respectively, Chair and Ranking Member of the Senate Judiciary Subcommittee on Intellectual Property—and Representatives Doug Collins (R-GA-9), Ranking Member of the House Judiciary Committee; Hank Johnson (D-GA-4), Chair of the House Judiciary Committee’s Subcommittee on Courts, Intellectual Property and the Internet; and Steve Stivers (R-OH-15) announced earlier today indicating that “months of hard work by the Senators and Representatives has led to this bipartisan, bicameral framework.” IPWatchdog has been reporting for some time that closed-door meetings have been held with stakeholders and members of congress to gather information on the problems with patent eligibility law. IPWatchdog also has been told that the relevant members of congress intend to hold regular public hearings on the topic beginning soon. “I think it’s wise for congress to hit the reset button and reassert its authority with respect to the statutory requirements, and getting rid of the non-statutory judicial exceptions is an absolute must,” said Gene Quinn, patent attorney and President and CEO of IPWatchdog, Inc. “I just hope that whatever the ultimate statutory language is, it is very carefully limited and narrowly tailored; and I must confess that it worries me a little that the framework says that reciting generic language won’t be enough to save an otherwise ineligible claim.”

Among the seven amicus curiae briefs filed Monday with the U.S. Supreme Court in InvestPic, LLC, v. SAP America, Inc., Eagle Forum Education & Legal Defense Fund’s brief argues that the case demands a hearing because the Federal Circuit has added yet another extra-statutory test to the already distorted patentability jurisprudence. In a decision of May 15, 2018 authored by Judge Taranto, the Federal Circuit found the patent claims of U.S. Patent No. 6,349,291 invalid because they were directed to an abstract idea and lacked an inventive concept necessary to save the invention under 35 U.S.C. § 101. In the course of its opinion, the Federal Circuit created a “physical realm” test, which is nowhere to be found in 35 U.S. Code Section 101, having been wholly conjured by judges.

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.

Athena Diagnostics filed a petition for en banc rehearing of the United States Court of Appeals for the Federal Circuit’s decision in Athena Diagnostics v. Mayo on April 8, 2019. Amicus briefs are due April 22, 2019. The Athena decision continues to apply U.S. Supreme Court-created common law to the analysis of 35 U.S.C. §101. In its brief requesting rehearing, Athena argues that the decision is “precisely the evisceration of patent law against which the U.S. Supreme Court has long warned” and that the claims at issue were patent eligible, as they are “novel, man-made substances”, “do not preempt natural laws” and “serve a new and useful purpose of diagnosing serious diseases”. Knowles IP Strategies LLC (Sherry M. Knowles) and AddyHart (Meredith Addy) intend to file an amicus brief in support of neither party requesting that the Federal Circuit carry out its constitutional duty to apply strict statutory construction of the literal words of 35 U.S.C. §101 to decide the case (See, Unconstitutional Application of 35 U.S.C. § 101 by the U.S. Supreme Court; 18 J. Marshall Rev. Intell. Prop. L. 144 (2018)).

Recently, I’ve written several articles laying the blame for the patent eligibility crisis squarely on the Federal Circuit. Yes, we all know the Supreme Court is obviously to blame. They are the court with primary national jurisdiction, and there can be no doubt that the Mayo v. Prometheus decision is the root of the patent eligibility problem because it intentionally conflates novelty and obviousness with patent eligibility. In my recent writings, and in a variety or presentations and speeches I have been giving across the country—from Utah to Orlando to Charlotte—I’ve criticized the Federal Circuit for not distinguishing Mayo and Alice on the facts. If we listen to the Supreme Court at least, at issue in both Mayo and Alice were unusually simple “inventions” that are really not innovations at all. As I filed my latest article, Eileen said that she thought it was good because it would provoke discussion since I disagreed with Judge Michel’s view in the interview with him she had just published. There was a long pause in our conversation. “Am I really disagreeing with Judge Michel?” I asked. Whenever I disagree with Judge Michel, I pause. It isn’t that I am unwilling to disagree with him, but, over the years, I have come to learn that, when one is going to disagree with Judge Michel, prudence dictates reevaluating your position.

Scott Elmer is Director, Office of Technology Licensing, at St. Jude Children’s Research Hospital, one of the leading pediatric cancer hospitals in the country. The institution is focused on treatment of and research on children’s catastrophic diseases, particularly leukemia and other cancers. The hospital costs about $2.8 million a day to run and is 100% free to patients. St. Jude and more than 46 of its staff have been the recipients of prestigious awards and achievements, including the 1996 Nobel Prize in Physiology or Medicine, which went to St. Jude faculty member, Peter C. Doherty. Recently, Elmer read Sherry Knowles’ John Marshall Intellectual Property Law Review article, Unconstitutional Application of 35 U.S.C. §101 by the U.S. Supreme Court and was inspired to write her in support of her argument that the Supreme Court’s misreading of the patent statute is causing real harm to inventors and industry on the ground. “I reached out to Sherry because I thought her article was well written and took a different approach to something that’s been a concern for a long time,” Elmer told IPWatchdog. “Sherry made the point that the Supreme Court’s more recent patent eligibility decisions have failed to recognize the patent statute’s reference to the term ‘discovery’ as a basis for the generation of patent-eligible subject matter, which particularly impacts diagnostics.”

It is getting tiring to read in case after case the Federal Circuit saying that they are forced by Alice or Mayo to find real innovation to be patent ineligible. This is not true. Have the judges lost their ability to distinguish cases based on the underlying facts? This is a skill taught in the first semester of law school, and one that separates those who will ultimately become lawyers and those who will drop out and pursue other avenues. But for some reason, the Federal Circuit is applying Mayo and Alice, two cases where the patent claims did not cover any innovation whatsoever, to strike a dagger through the heart of the innovation of tomorrow. Is this what the Supreme Court has mandated? While we are quick to say—for good reason—that Supreme Court precedent on 101, from Benson to Flook to Diehr to Chakrabarty to Bilski to Mayo to Myriad and ultimately to Alice, are incomprehensible, incoherent and most importantly irreconcilable with each other, we give the Federal Circuit a complete pass, despite the fact that CAFC precedent is at least equally incomprehensible, incoherent and irreconcilable.

On Monday, April 1, the Court of Appeals for the Federal Circuit issued a decision in Cleveland Clinic Foundation v. True Health Diagnostics affirming the invalidity of patents covering medical diagnostic tests for determining a patient’s risk for cardiovascular disease. The decision, which is nonprecedential and was decided along similar lines to another 2017 decision between the two parties, is yet another depressing sign that U.S. patent law is woefully inadequate when it comes to supporting important innovations in the biotech fields. Of particular note is the Federal Circuit’s finding against Cleveland Clinic’s argument that the district court didn’t give appropriate deference to subject matter eligibility guidance published by the U.S. Patent and Trademark Office (USPTO) as required by the U.S. Supreme Court’s 1944 decision in Skidmore v. Swift & Co. Although this argument related to USPTO guidelines published in 2016, it would seem to call into question the USPTO’s more recent revised subject matter eligibility guidance issued earlier this year by USPTO Director Andrei Iancu. This gives voice to fears that the “Iancu Effect” on subject matter eligibility won’t matter much if the Federal Circuit and other courts don’t adhere to the USPTO’s views on patent eligibility under Section 101.

During a break at IPWatchdog’s recent Patent Masters™ Symposium, former Federal Circuit Chief Judge Paul Michel went on record to express his grave concerns about the U.S. patent system and where he believes it’s headed. Like many of the Patent Masters, Michel’s view was decidedly grim, but he did express optimism about the new IP leadership in Congress. Following are Judge Michel’s remarks in full.

In ChargePoint Inc. v. SemaConnect, Inc., (2018-1739) the Federal Circuit inexplicably stated in its opinion that “[i]t is clear from the language of claim 1 that the claim involves an abstract idea—namely, the abstract idea of communicating requests to a remote server and receiving communications from that server, i.e., communication over a network.”  The Court further stated, “[w]e therefore continue our analysis to determine whether the focus of claim 1, as a whole, is the abstract idea. As explained below, we conclude that it is.” In reaching this conclusion, the panel rationalized that “the broad claim language would cover any mechanism for implementing network communication on a charging station, thus preempting the entire industry’s ability to use networked charging stations. This confirms that claim 1 is indeed “directed to” the abstract idea of communication over a network to interact with network-attached devices.” As an electrical engineer and patent attorney, I am truly perplexed by this statement. Claim 1 recites numerous physical electrical components, a control device (on/off switch), transceiver to communicate with a remote server and a controller to activate the on/off switch based on communications from the server. The configuration of the components may be anticipated or obvious under the patent statute based on prior art, but they are anything but abstract and do not preempt all ways of charging a vehicle using a network. Congress specifically stated in 35 U.S.C. 101 that there are four statutory categories of patentable subject matter: process, machine, manufacture, or composition of matter. If claim 1 is not a machine, I don’t know what is.

On March 8, Foster Pepper filed a petition for certiorari with the Supreme Court, case number 18-1199, challenging the Federal Circuit’s emerging “physical realm” test as part of its Alice/Section 101 analysis. Amicus briefs in support of our cert petition are most welcome to assist the Court’s understanding of why it is important to grant cert and clarify the correct patent eligibility test for computer-implemented inventions. We are also seeking amicus brief writers for the many amici we have already secured. These efforts will help clear up the uncertainty innovators and patent holders face in cutting-edge fields of our modern economy and, as a result, help drive innovation forward. 

In one of its latest opinions attempting to parse precedent on the subject matter eligibility of software, method of use, and business method patents that arguably involve application of laws of nature or recitations of well-known, conventional methods and techniques, the U.S. Court of Appeals for the Federal Circuit found that a patent directed to a method for administering a naturally occurring beta amino acid to cause an increase in the concentration of a naturally occurring amino acid combination in muscle and brain tissues was subject matter eligible for patent protection (Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, No. 18-1295, 2019 U.S. App. LEXIS 7647 (Fed Cir. March 15, 2019). The panel’s 2-1 majority decision conceded that the claims at issue involved laws of nature and had similarities to claims the U.S. Supreme Court had found subject matter ineligible but found that the claims possessed sufficient inventiveness beyond natural phenomenon and conventional methods to make them subject matter eligible for patent protection. Since Alice, the Federal Circuit and the federal district courts have been striving to implement and apply the Alice test to methods of use, software, and business method inventions that arguably involve applications of laws of nature and conventional methods. The challenge for the court in these cases has been to determine whether the claims sufficiently go beyond applications of laws of nature and known conventions to qualify as subject matter eligible for patent protection under Section 101. The Federal Circuit has found an inventive concept in several such cases.