Posts Tagged: "innovation"

An important part of any patent portfolio manager’s work is to understand which patents are likely to be implemented in real-world technology. We can think of the process of matching patents to products as having three levels of progressively precise analysis. The investment in time and resources required to arrive at useful documentation at each level increases as the level of analysis increases.  Accordingly, access to higher levels of product matching analysis will tend to enable higher monetary returns if the associated documentation can be brought to bear effectively in the intellectual property marketplace. To begin with a bit of background, there is a strong correlation between the value of a patent and the likelihood that the technology it describes is instantiated in real-world commercial products. Any methodologies that can provide insight into this likelihood therefore provide information on the value of a patent.

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 Cir. April 1, 2019; non-precedential) (“Cleveland Clinic II”), the court affirmed a district court ruling that found a medical diagnostic or a related patent invalid for being directed to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.

A company must be strategic in any business decision it makes in order to ensure that it takes the necessary measures to avoid liability for its actions. With respect to patent infringement, and specifically willful patent infringement, the different approaches to determining which measures to take and when to take such measures have been repeatedly challenged in light of a number of court decisions in recent years. To set the scene, the Federal Circuit held in Underwater Devices Inc. v. Morrison-Knudsen Co., 717 F.2d 1380 (1983) that a potential infringer has an affirmative duty to exercise due care to determine whether or not he or she is infringing. This placed the burden on the potential infringer to seek competent counsel and obtain either a non-infringement opinion or invalidity opinion prior to undertaking the possible infringing activities. This would prevent a finding of willful infringement and treble damages.

This week in other IP news, recently released data shows that worldwide revenues for music copyright exceeded $28 billion in 2017, up $2 billion over 2016; reports surface about the  “reverse patent trolling” issue in China; Google retains Williams & Connolly for Supreme Court battle with Oracle despite Shanmugam exit; the Copyright Office holds roundtable discussions on detecting online copyright infringement; Twitter takes down a tweet from President Donald Trump after a copyright complaint; “KINKEDIN” trademark for computer dating site successfully opposed in the UK by LinkedIn; EU antitrust regulators are petitioned to look into Nokia patent licensing practices; and loss of patent exclusivity leads to major job cuts at Gilead Sciences. 

Senators Thom Tillis (R-NC) and Chris Coons (D-DE) have written U.S. Patent and Trademark Office (USPTO) Director Andrei Iancu raising a concern about what can really only fairly be characterized as the weaponization of the Patent Trial and Appeal Board (PTAB). Although the USPTO has vehemently disagreed that there is a problem over the years, everyone in the industry familiar with post grant challenges knows there is a very serious problem with serial challenges. Indeed, there appears to be a concerted effort—perhaps even collusion—to challenge the patents of certain patent owners over, and over, and over, and over again.

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)).

Earlier today, the United States Court of Appeals for the Federal Circuit overruled the determination of the Patent Trial and Appeal Board (PTAB) in three separate IPR proceedings. The Federal Circuit found the claims of U.S. Patent Nos. 7,742,053, 6,897,871, and 7,327,369 (i.e., the Unified Shader Patents) patentable on appeal. ATI Technologies ULC v. Iancu (Fed. Cir. April 11, 2019). The question at issue was whether ATI Technologies was diligent from the moment of conception through to the constructive reduction to practice. There was no question that ATI’s conception had pre-dated the prior art of concern. Upon reading this decision, it is difficult to understand exactly why or how the PTAB could get this issue so wrong. Indeed, this decision exemplifies why many criticize the PTAB as an institution.

In their latest letter weighing in on intellectual property issues, Senators Thom Tillis and Chris Coons have expressed their concerns about the effects of “serial” inter partes review (IPR) petitions on the U.S. patent system.In March, the senators sent a letter to Karyn Temple, Register of Copyrights, to ask a series of questions about the Copyright Office’s ability to handle the likely impact of Fourth Estate Public Benefit Corp. v. Wall-Street.com, LLC. Today’s letter was addressed to USPTO Director Andrei Iancu and similarly asked Iancu to respond to a list of five pointed questions about the Office’s willingness to take action on serial IP challenges.

On the afternoon of Wednesday, April 3, the Senate Committee on the Judiciary’s Subcommittee on Intellectual Property held a hearing titled Trailblazers and Lost Einsteins: Women Inventors and the Future of American Innovation. The day’s discussion on the U.S. Patent and Trademark’s recent report on gender disparity in patenting rates covered much of the same ground as the House Intellectual Property Subcommittee’s hearing on the same topic from the previous week, although a new witness panel was able to provide some fresh perspective on the issues. However, there were arguably some instances where the witnesses either supported or acquiesced to policies that damage the patenting prospects for at least some female inventors.

Patents are often referred to as monopolies. But that is a fundamental misunderstanding of how patents work to enhance competition. The truth is that a patent is a natural anti-monopoly. In a functioning patent system, inventions become investible assets when they are patented, and the value of the invention increases as market demand increases. Because of the direct relationship between market demand and patent value, a patented invention can attract enough investment to compete with entrenched incumbents in the market for the invention. This effect introduces new competitors into the market who are protected against incumbents for a long enough period that they can survive after the patent expires. Thus, patents act to increase competition by introducing new competitors into the market and thereby create competitive markets. But perhaps even more important, some inventions deliver a strong dose of creative destruction to monopolistic incumbents who did not innovate fast enough, causing those companies to fail and clearing the market of dead weight, thus opening the market to innovative new companies. Patents are the ultimate anti-monopoly in a free market. But for this to work, the market must function undisturbed by crony laws and regulations. A patent must be a presumed valid “exclusive Right.”

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.”

The Senate has a busy schedule related to tech and innovation topics for the week of April 8, including hearings on prescription drug pricing, broadband Internet coverage maps developed by the U.S. government, free speech on social media and tech platforms, and clean energy innovations to address climate change. The Senate Environment Committee also has a business meeting this week to discuss a piece of legislation that would support innovation in direct air carbon capture. This week’s tech and innovation lineup at the House of Representatives is a bit lighter, although there are hearings looking at a proposed bill to restore net neutrality, as well as a review of the 2020 budget request for the National Institute of Standards and Technology. Elsewhere, the Brookings Institution hosts events on EU-U.S. digital data collaboration and the impact of automation on the future of work, and the Information Technology and Innovation Foundation explores funding issues for the National Institutes of Health and their impact on American biomedical innovation.

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.