Posts Tagged: "Section 101"

Senators and Representatives Coons, Tillis, Collins, Johnson, and Stivers recently announced in a press release a proposed framework to fix patent eligibility law in the United States. If written as proposed in the draft framework, section 101 may do harm to the patent system. The senators and representatives are now soliciting feedback on the draft framework. They are likely to take additional action on the framework as soon as early this week. Please send the following text with any of your edits to [email protected].

USPTO Director and Under Secretary of Commerce for Intellectual Property Andrei Iancu believes that “to a large extent … if they want to, the Federal Circuit can fix the problem” with patentable subject matter under Section 101. Speaking at the 27th Intellectual Property Law & Policy Conference at Fordham Law School on April 25, Mr. Iancu said the interpretation of Section 101 is “the most important issue of substantive patent law currently.” He added: “This issue must be addressed now in the United States.” The USPTO Director said there is consensus that the state of the law is unworkable: “Recent case law has created significant confusion in this regard.” But he added: “If you look at the Supreme Court cases by themselves, those cases are not the ones necessarily that have caused the problem. In the way those cases have been interpreted in the lower courts or at the USPTO itself, we have deviated from the core message of the Supreme Court to some extent.”

On April 15, U.S. District Judge William Conley of the Western District of Wisconsin issued an opinion and order in Raytheon Company v. Cray, Inc. granting summary judgment of non-infringement to defendant Cray on two supercomputer patents that had been asserted by Raytheon. The order is the likely conclusion to a case that became an important part of the debate on proper venue in patent cases after the U.S. Supreme Court’s decision in TC Heartland, and aspects of how this case played out after venue was transferred point to the importance of that particular decision on U.S. patent litigation.

April 22 was the deadline for filing amicus briefs with the Court of Appeals for the Federal Circuit in Athena Diagnostics’ petition for an en banc rehearing by the court. The petition comes after a 2-1 panel decision in early February affirmed a district court’s ruling that patent claims covering methods of diagnosing myasthenia gravis (MG), an autoimmune disorder that causes weakness in skeletal muscles, were directed toward laws of nature and were thus unpatentable subject matter under 35 U.S.C. § 101. In an invitation to file briefs with the Federal Circuit in this case, Knowles IP Strategies Founder Sherry Knowles and AddyHart Partner Meredith Addy discussed the need for amici to hold the Federal Circuit accountable regarding its duty to apply a strict statutory construction of the literal language of Section 101 to ensure that patent eligibility cases are decided in a way that is consistent with Constitutional statutes. Knowles and Addy filed a brief on behalf of Freenome Holdings and Achillon Pharmaceuticals (discussed below). Theirs and other briefs that have now been filed raise concerns about the inability to patent life-saving diagnostic methods that are found ineligible under Section 101 using the Alice/Mayo framework simply because the invention or discovery involves monitoring natural processes.

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.

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)).

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.

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.

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.

Over the last 15 years, Congress, the courts and the USPTO have gutted the patent system. Fortunately, USPTO Director Andrei Iancu has been taking important steps to reverse some of the damage, with revised 101 guidance and changes in the Patent Trial and Appeal Board (PTAB). But the most important thing Iancu is doing is silencing the big tech “patent troll” narrative. False political narratives condense complicated issues into an object and then villainize the object. Once a villain is created, its evil can be expanded to encompass anything you don’t like. When you have pushed enough bad stuff into the moniker, you can simply state its evil name, add a few campaign contributions, and Congress will magically pass laws in your favor to kill the villain. The “patent troll” narrative has been valuable to big tech. It bought the laws they needed to perpetuate their monopolies. With Iancu silencing the “patent troll” narrative, big tech created a new one: “bad patents”.

The USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance provides that if an abstract idea represented in one or more claim elements is integrated into a practical application by other limitations in the claim, then the claim as a whole would not be directed to a judicial exception and, as such, would be considered patentable under section 101. The revised guidance states that “a claim that integrates a judicial exception into a practical application will apply, rely on or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” This would seem to be in line with the public policy underlying the judicial exception of not allowing a claim to preempt all means of achieving a desired result. Often, patent claims are drafted such as to contain claim elements directed to desired outcomes as opposed to specific ways of achieving the desired outcomes. Claim elements directed only to desired outcomes have the effect of preempting all ways of achieving the desired outcome, and, as such, are considered to “monopolize the judicial exception”. The public policy behind the judicial exception seeks to prevent the monopolization of the judicial exception by a claim reciting only the desired outcome.

The data shows that Section 101 allowances at the USPTO are on the rise after a long period of decline, but the 101 situation still remains “alarming,” said panelists during IPWatchdog’s webinar—”A Tale of Different Software Innovations: The Uneven Impact of Alice”—last Thursday, March 7. While Congress is currently considering ways to address the patent eligibility problem, the likelihood of a legislative fix this year is slim, said Bob Stoll of Drinker Biddle. “I believe we will see introduction of legislation on 101 as early as this summer, but I don’t anticipate anything being enacted,” Stoll said. “There’s a lot more going on to occupy their interests on the Hill.”

The U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. Myriad Genetics changed the landscape of what is considered patentable material in the context of genetic inventions. In the five years since Myriad, companies have pushed the boundaries of patenting certain types of genetic materials. Despite Myriad’s express statement that it was not considering “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” the courts have not yet established the contours of how much nucleotide sequences need to be altered in order to “create something new” in order to be patentable. However, as we discuss in the next section, we expect the Court to address these questions as biotechnology companies increasingly invest resources into emerging, expensive technologies involving genes and seek to protect their investments through patents.