Posts in Patents

The 2012 Supreme Court decision in Mayo Collaborative Servs. v. Prometheus Labs changed the landscape for patenting diagnostic inventions in the United States. Patent eligibility/ineligibility in the United States stems from two sources: (1) 35 U.S.C. § 101, and (2) judicially-created exclusions, including laws of nature, natural phenomena, abstract ideas, and mental processes. In Mayo, the Supreme Court struck down method of treatment claims for being directed to a law of nature. While Mayo did not create this exclusion, it significantly expanded its applicability to diagnostic-based inventions. This paper explores Federal Circuit case law on patent eligibility of diagnostic-based inventions since the Mayo decision, as well as provides practical guidance on drafting diagnostic patent claims in light of these decisions.

Activity surrounding the requests for the Supreme Court’s review of the holdings in Arthrex v. Smith & Nephew I and Arthrex v. Smith & Nephew II continues to increase. As outlined in “A Guide to Arthrex: Activity Heats Up in Petitions Pending with Supreme Court”, four petitions for writs of certiorari have been filed:  U.S. v Arthrex, No. 19-1434, Smith & Nephew v. Arthrex, No. 19-1452, Arthrex v. Smith & Nephew, No. 19-1458, and Arthrex v. Smith & Nephew, No. 19-1204.  Now, three more amicus briefs have been filed by US Inventor, TiVo and Comcast, and on July 27, an additional consolidated petition for certiorari filed by the U.S. Government and USPTO Director Andrei Iancu asked the Court to review 39 Federal Circuit rulings affected by Arthrex.

This week, the district courts saw 77 new complaints—though at least 10 are re-filings of Uniloc v. Google cases being transferred from the Eastern District of Texas to the Northern District of California by stipulation, somewhat inflating the numbers, leaving us with a relatively low filing rate of 66 bona fide new complaints this week. The Patent Trial and Appeal Board (PTAB), for its part, saw 36 filings, driven up in part by a half-dozen petitions from LEGO® and Warner Bros. against assertion vehicle MQ Gaming, LLC.

In an August 3, 2020 modified opinion, the U.S. Court of Appeals for the Federal Circuit held certain claims directed to a method of preparation to be patent-eligible at Alice Step 1. The case is Illumina Inc. v. Ariosa Diagnostics Inc., 2019-1419 (Fed. Cir. 2020), and IP Watchdog has already published a more-detailed write-up on the modified opinion that can be found here. I write separately to highlight an interesting quote from the modified opinion that may have currency, not just in biotechnology, but also in computer technology and other arts.

The U.S. Court of Appeals for the Ninth Circuit today vacated a decision of the U.S. District Court for the Northern District of California finding that Qualcomm had engaged in unlawful licensing practices and reversed a permanent, worldwide injunction against several of Qualcomm’s core business practices. In May 2019, Judge Lucy Koh issued a 233-page order finding that Qualcomm had engaged in unlawful licensing practices and ordered in part that Qualcomm “must make exhaustive SEP licenses available to modem-chip suppliers on fair, reasonable, and non-discriminatory (“FRAND”) terms and to submit, as necessary, to arbitral or judicial dispute resolution to determine such terms…[and] submit to compliance and monitoring procedures for a period of seven (7) years.” Koh’s ruling was widely criticized, and today’s unanimous opinion was a total reversal of her findings.

Rather than allowing it a quiet death, the financial services industry is making a quiet effort to keep the Covered Business Methods (CBM) Program at the Patent Trial and Appeal Board (PTAB) alive. The special interest group has reportedly enlisted Senator Richard Blumenthal (D-CT) to push for an extension of the CBM program for one year. A rider on the next COVID supplemental appropriations package, or possibly a FY 2021 Commerce Department appropriations bill, would carry the grant of CBM’s stay of expiration.

Despite their best efforts, patent practitioners may reach an impasse during negotiations with patent examiners at the United States Patent and Trademark Office (USPTO). If an applicant still desires patent protection, it can authorize the filing of a notice of appeal to the Patent Trial and Appeal Board (PTAB) and an associated appeal brief. Thus begins an ex parte appeals process in which a panel of at least three administrative patent judges (APJs) considers patentability of the rejected claims. Over the years, I’ve observed some patent attorneys and agents approach ex parte appeals as essentially a document assembly exercise: arguments from past Office action responses are pasted into a template and then submitted to the PTAB. In my view, such an approach represents a missed opportunity to present the strongest possible case for patentability. In a worst-case scenario, it may even prevent a client from securing the patent protection it deserves. To maximize clients’ chances of success, practitioners instead should approach appeals with the mindset of a strategist and advocate.

In the spring of 2018, a district court invalidated a patent claiming methods of manufacturing a pickup truck drive shaft for failure to recite patent-eligible subject matter. Industry stakeholders, scholars, and legal commenters were more than a little incredulous, since methods of manufacturing such tangible objects have long been patentable in the United States. In due course, the Federal Circuit (in a 2-1 decision) drew even more exasperation when it affirmed the district court’s holding. If the ensuing stream of bewildered blog posts, amicus briefs, and statements by public officials are anything to go by, many viewed the case as another high water mark in our uniquely American Section 101 jurisprudence…. Then, enter the July 31, 2020 re-written majority opinion in American Axle. Rather than allow the case to go to the full court for consideration, the majority decided to edit some of the troubling language from the original panel opinion.

On August 4, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed a decision of the U.S. District Court for the District of Delaware in Godo Kaisha IP Bridge 1 v. TCL Commc’n Tech, wherein the district court held that TCL was liable for infringement by way of its sale of LTE standard-compliant devices…. The CAFC initially said that it agreed with the district court’s ruling and reasoning, but wrote to address a question not before addressed by the CAFC case law: “who determines the standard-essentiality of the patent claims at issue—the court, as part of claim construction, or the jury, as part of its infringement analysis?”

On August 3, inventor advocacy group US Inventor filed an amicus brief with the U.S. Court of Appeals for the Federal Circuit in support of a due process argument raised in an appeal from the Patent Trial and Appeal Board (PTAB) by New Vision Gaming & Development. US Inventor’s brief raises two major points in support of New Vision’s contention that the financial incentive structure for administrative patent judges (APJs) destroys due process at the PTAB. First, the brief details data that proves the existence of an “October Effect,” which leads to inflated rates of petitioner-friendly PTAB trial institutions in response to the APJ performance review cycle at the USPTO. Second, the brief argues that APJ performance review criteria are inherently subjective in a way that incentivizes APJs to make pro-petitioner decisions to please supervisors who have budgetary responsibilities. Taken together, US Inventor contends that these factors would lead a reasonable person to question “whether the PTAB invalidates patents so frequently because its constituent APJs try to please their budget-minded bosses through revenue-enhancing decision making.”

One thing you should never say in 2020 is: “Well, at least things can’t get any worse.” They can and often do. The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. It’s also signed by 32 other state attorneys general, along with those representing the District of Columbia, Guam and American Samoa. They are demanding that the government use its authorities under the Bayh-Dole Act to march in against Gilead Sciences, the maker of the COVID-19-fighting drug remdesivir, so that it can be made more widely available at a lower cost.

Greetings; John White here. It is time for you to “Think PCT” [Patent Cooperation Treaty] anew. If the last thing you remember hearing me say about the PCT was some pneumonic about how to ensure an International Filing Date (English Applicant Requests Priority Designation!), or how to calculate an old Section 102(e) date under the FOoT/DUSE  (Fee Oath Translation/ Designate United States (publish in) English) Rule for the Patent Bar Exam: good, you still remember it! You’ve put off senility a little further by keeping these things circulating in your steel-trap like brain! (Sadly, my voice is probably still rattling around in there as well, I suppose. Sorry about that…) But, let’s move on; it is now time to really understand the use and implementation of a PCT strategy in the modern era. The world is changing rapidly!

This week, district courts saw 91 new complaints, a large portion filed by IP Edge subsidiaries, such as Karetek Holdings, LLC; Guada Technologies; Tunnel IP, LLC; Altair Logix, LLC; Coretek Licensing, LLC; and Raindrops Licensing, LLC, with the rest being Intellectual Ventures selloffs, company-to-company disputes (like the Skull Shaver, LLC v. Freedom Grooming design patent case), and some pharmaceutical filings.

There were 17 discretionary denials under Section 325; 41 PTAB petitions filed—one post grant review (PGR) and 40 inter partes reviews (IPRs)—a number buttressed largely by Amazon filing seven IPRs against VB Assets, LLC – an assertion vehicle apparently spun out of AI-voice company, VoiceBox, after Nuance purchased them last year – as well as Samsung filing five IPRs against Clear Imaging Research, LLC, an entity run by the former co-founder of Soryn IP. This was rounded out by a five-IPR battle between Monolitic Power Systems and Volterra Semiconductor over licensing semiconductor technology.

On January 9, 2019, Moderna Therapeutics, Inc. (“Moderna”) filed a petition requesting inter partes review of U.S. Patent No. 8,058,069 (the ‘069 patent) owned by Arbutus Biopharma. The ‘069 patent is directed to lipid nanoparticle technology, the same technology that Moderna is using in its efforts to develop a vaccine for COVID-19. The Patent Trial and Appeal Board (PTAB) instituted review, but in their decision last week, determined that Moderna had not shown, by a preponderance of the evidence, that claims 1-22 of the ‘069 patent are unpatentable under 35 USC § 103.

Much has been written about the uncertainty in U.S. patent law concerning laws of nature, natural phenomena, and abstract ideas following the Supreme Court’s decisions in Mayo v. Prometheus and Alice Corp Pty Ltd v. CLS Bank Int’l. A recent decision from the Enlarged Board of Appeal at the European Patent Office (the Enlarged Board), however, demonstrates that the United States is not alone in grappling with issues surrounding patent eligibility. In the case of genetically modified plants and animals, questions arise on where to draw the line between human invention and biological processes. Earlier this year, the Enlarged Board reversed a 2015 decision that had held that product-by-process patents could be sought for genetically modified plants and animals despite a patent exclusion for “essentially biological processes.”