Discerning Signal from Noise: Navigating the Flood of AI-Generated Prior Art

Patent, , , , , , , , ,

by Dennis Crouch

This article explores the impact of Generative AI on prior art and potential revisions to patent examination standards to address the rising tidal wave of AI-generated, often speculative, disclosures that could undermine the patent system's integrity.

The core task of patent examination is identifying quality prior art.  References must be sufficiently accessible, clear, and enabling to serve as legitimate evidence of what was previously known.  Although documents are widely available today via our vast network of digital communications, there is also increasing junk in the system -- documents making unsubstantiated claims that are effectively science fiction.  Patent offices prefer patent documents as prior art because they are drafted to meet the strict enablement standards and filed with sworn veracity statements. Issued patents take this a step further with their imprimatur of issuance via successful examination.  Many of us learned a mantra that "a prior art reference is only good for what it discloses" -- but in our expanding world of deep fakes, intentional and otherwise, is face value still worth much?

In a new request for comments (RFC), the USPTO has asked the public to weigh in on these issues -- particularly focusing on the impact of generative artificial intelligence (GenAI) on prior art.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Ikorongo Challenges Federal Circuit’s Heightened “Same Invention” Requirement for Reissue Patents

Patent, , , , , , ,

by Dennis Crouch

Ikorongo Technology has filed a petition for certiorari asking the Supreme Court to overturn the Federal Circuit's heightened disclosure standard for the "same invention" requirement in reissue patents. The petitioner argues that the Federal Circuit's test, established in Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354 (Fed. Cir. 2014), directly contradicts the Supreme Court's decision in U.S. Industrial Chemicals, Inc. v. Carbide & Carbon Chemicals Corp., 315 U.S. 668 (1942). Petition for Writ of Certiorari, Ikorongo Tech. LLC v. Bumble Trading LLC, No. 23-1118 (U.S. Apr. 2024).

Reissue has long been a part of the U.S. Patent system, and today's guiding statute (35 U.S.C. 251) looks substantially the same as that enacted back in 1836.  The basic idea is that a defective patent can be "surrendered" and a new patent issued "for the same invention." 

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

The Non-Compete Ban: Impact on Patenting and Challenging Implementation

Patent, , , , ,

by Dennis Crouch

Non-compete agreements fly under the radar for most American lawyers.  One reason is that such restrictions have long been banned within legal practice. As an example, the American Bar Association (ABA) Model Rule 5.6(a) prohibits lawyers from entering into agreements that restrict their right to practice law after terminating an employment, partnership, or other professional relationship. The rule's stated aim is to protect clients' freedom to choose their legal representation, but it also ensures that lawyers can practice their profession without restriction.

The increasing prevalence of non-compete agreements in other industries has drawn increasing scrutiny from policymakers and regulators, leading to the FTC's recent rule banning most non-compete agreements across the United States.  The new rule was announced on April 23, 2024 following a 3-2 vote by the FTC Commissioners (along party lines, with Democrats in the majority). It is set to take effect 120 days later (August 21, 2024). As I discuss below, two lawsuits have already been filed seeking to derail implementation.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Without Undue Experimentation vs Without Any Experiments

Patent, , , , , , ,

by Dennis Crouch

I was rereading the Supreme Court's recent enablement decision of Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) and was struck by the Supreme Court's statement that its 19th Century decision of Wood v. Underhill, 46 U.S. 1 (1847) "establish[ed] that a specification may call for a reasonable amount of experimentation to make and use a patented invention."  This statement from Amgen is surprising because Chief Justice Taney's decision in Wood includes a seemingly contrary statement that bars any experimentation

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

SCT: False Claims Act Actions Based Upon Fraudulently Obtained Patent Rights

Patent, , , , , , , , ,

by Dennis Crouch

This post walks through a new petition for writ of certiorari involving claims that Valeant Pharma defrauded the U.S. government by using fraudulently obtained patent rights prop up its drug prices. [Read the Petition]

The False Claims Act (FCA), originally enacted in 1863 to combat contractor fraud during the Civil War, imposes civil liability on anyone who "knowingly presents" a "fraudulent claim for payment" to the federal government. 31 U.S.C. § 3729(a)(1)(A). The Act allows private citizens, known as "relators," to bring qui tam actions on the government's behalf against those who have defrauded the government. If successful, relators can recover up to 30 percent of the damages. 31 U.S.C. §§ 3730(b)(4), (d)(2).

To prevent opportunistic lawsuits, however, Congress has sought to strike a "balance between encouraging private persons to root out fraud and stifling parasitic lawsuits"

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

UMKC School of Law Wins National Patent Application Drafting Competition

Patent

By Chris Holman

Last week the U. S. Patent and Trademark Office announced the winner of this year’s National Patent Application Drafting Competition (NPADC), the University of Missouri-Kansas City School of Law. I teach patent law at UMKC, and was privileged to travel to Alexandria with the team of UMKC students (pictured below, from left to right, Will Knutson, Mark Trompeter, Joe Hooper, and Lukas Fields) to watch them compete and ultimately triumph in the final round of the competition. I am sure a great deal of the credit for their success can be attributed to our adjunct faculty members teaching patent prosecution at UMKC, James Devaney (Shook Hardy & Bacon) and Jon Hines (Senior Patent Counsel at 3Shape).

I would encourage any law student interested in pursuing a career in patent prosecution to consider participating in the competition next year. In a nutshell,

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

What is Next for Enablement and Written Description of Antibody Claims?

Patent, , , , ,

by Dennis Crouch

I had been following the case of Teva v. Lilly for a few years.  Teva has traditionally been a generic manufacturer, but in this case sued Eli Lilly for infringing its patents covering methods of treating headache disorders like migraine using humanized antibodies that bind to and antagonize calcitonin gene-related peptide (CGRP), a protein associated with migraine pain. U.S. Patent Nos. 8,586,045, 9,884,907 and 9,884,908.  The patents cover Teva's drug Ajovy, and allegedly cover Lilly's Emgality. Both drugs were approved by the FDA in September 2018.  A Massachusetts jury sided with Teva and awarded $177 million in damages, including a controversial future-lost-profit award.

Although the jury sided with Teva, District Judge Allison Burroughs rejected the verdict and instead concluded that Teva's patent claims were invalid as a matter of law for lacking

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Supreme Court Declines to Hear Vanda’s Patent Obviousness Appeal

Patent, , , , , ,

by Dennis Crouch

The Supreme Court has denied Vanda Pharmaceuticals' petition for certiorari, leaving in place a Federal Circuit decision that invalidated Vanda's patents on methods of using the sleep disorder drug Hetlioz (tasimelteon) as obvious.

Vanda had argued in its cert petition that

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

AI Visualize and the Eligibility of Innovative AI Systems

Patent, , , , ,

by Dennis Crouch

The recent eligibility decision in AI Visualize v. Nuance, __ F.4th __ (Fed. Cir. 2024), gives me pause to consider more general eligibility issues of AI Inventions. When does the design or creation of AI system elements qualify as an eligible invention?  In his recent article, Prof. Nikola Datzov wrote what we have all been thinking: "Innovative applications of AI are everywhere we look [and are] revolutionizing our society."  Nikola L. Datzov, The Role of Patent (In)Eligibility in Promoting Artificial Intelligence Innovation, 92 UMKC L. REV. 1, 4 (2023).

In AI Visualize, the Federal Circuit

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Seeking Clarity on Comparison Prior Art: Seirus Petitions Supreme Court in Heat Wave Design Patent Dispute

Patent, , , , , ,

by Dennis Crouch

Seirus has petitioned for writ of certiorari in its long-running design patent dispute with Columbia Sportswear.  The petition asks two questions related to the comparison process for design patent infringement -- in particular, the questions focus on what can qualify as "comparison prior art" used to provide context for the infringement analysis.

Questions presented:

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Codifying Discretionary Denial of IPR Petitions

Patent, , , , ,

by Dennis Crouch

The USPTO recently released yet another Notice of Proposed Rulemaking (NPRM) -- this one focusing on codification of IPR/PGR rules associated with non-merits based "discretionary denials" of institution as well as termination due to settlement.  This is a controversial area because of that word 'discretion.'  Unrestricted discretion by government officials is concerning because of the potential for arbitrary or biased decisions, lacking transparency and accountability.  In that frame, these rules are beneficial because they structure and limit discretion - hopefully making the outcomes more predictable and justifiable.  A key note - the rules here focus primarily on procedure (separate briefing for discretionary denials) and substantive issues relating to parallel, serial, and cumulative petitions. Although this is an important step, they do not address discretionary denials associated with parallel litigation (or other outside factors) under Fintiv and subsequent director guidance. This is likely the most controversial area of discretionary denials that is being left out for now.

Congress clearly intended the USPTO to have substantial discretion

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

AI as Author: Thaler v. Perlmutter Now Before the DC Circuit

Patent, ,

by Dennis Crouch

The leading case on copyrightability of AI created works is now pending before the Court of Appeals for the District of Columbia. The case, Thaler v. Perlmutter, No. 23-5233 (D.C. Cir. 2024), centers on Dr. Stephen Thaler's attempts to register a copyright for an artistic image autonomously generated by his AI system that he has named the "Creativity Machine." The U.S. Copyright Office refused registration on the basis that the work lacked the required human authorship. Thaler filed suit challenging this determination.  The parties have now filed their briefs, along with one law professor amicus brief in support of Thaler.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

False Patent Marking as False Advertising: Overcoming Dastar

Patent, , , , , , , ,

by Dennis Crouch

The Federal Circuit is set to consider the use of terms like "patented," "proprietary," and "exclusive" in commercial advertising can be actionable under § 43(a)(1)(B) of the Lanham Act when their use is not entirely accurate. The key issue on appeal is whether the district court erred in granting summary judgment for Crocs on Double Diamond Distribution and U.S.A. Dawgs' ("Dawgs") counterclaim for false advertising under the Lanham Act.

This case began back in 2006

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

What I’m reading from academic journals

Patent, , , , , , , , ,

I'm always on the lookout for interesting new scholarship related to intellectual property and innovation policy. The following are a few of the articles that I've been delving into this past week:

  • James Hicks, Do Patents Drive Investment in Software?, 118 NW. U. L. REV. 1277 (2024).
  • Ana Santos Rutschman, From Myriad to Moderna: The Modern Pharmaceutical Company, ___ Texas A&M University Journal of Property Law ___ (2024) (forthcoming).
  • John Howells, Ron D Katznelson, Freedom to Operate analysis as competitive necessity—the Selden automobile patent case revisited, Journal of Intellectual Property Law & Practice (2024).
  • Christa Laser, Scientific Educations Among U.S. Judges, ___ American University Law Review ___ (2025) (forthcoming).
  • Garreth W. McCrudden, Drugs, Deception, and Disclosure, 38 BERKELEY TECH. L.J. 1131 (2024).

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

The Use of Mandated Public Disclosures of Clinical Trials as Prior Art Against Study Sponsors

Patent, , , , , , , , , ,

By Chris Holman

Salix Pharms., Ltd. v. Norwich Pharms. Inc., 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024)

Human clinical trials play an essential role in the discovery, development, and regulatory approval of innovative drugs, and federal law mandates the public disclosure of these trials. Pharmaceutical innovators are voicing concern that these disclosures are increasingly being used as prior art to invalidate patents arising out of, or otherwise relating to, these trials, in a manner that threatens to disincentivize investment in pharmaceutical innovation. A recent Federal Circuit decision, Salix Pharms., Ltd. v. Norwich Pharms. Inc., illustrates the concern.  In Salix, a divided panel upheld a district court decision to invalidate pharmaceutical method of treatment claims for obviousness based on a clinical study protocol published on the ClinicalTrials.gov. website. The case garnered amicus curiae briefs filed by several innovative pharmaceutical companies in support of the patent owner, Salix Pharmaceuticals.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Proposed Changes to Patent Law’s Proper Venue Statute: Venue Equity and Non-Uniformity Elimination Act of 2024

Patent, , , , , ,

by Dennis Crouch

Law school civil procedure courses spend very little time on proper venue because, in most cases venue is proper so long as the district court has personal jurisdiction over the defendant. However, in a quirk of history, Congress created a patent-law specific venue statute in the 1800s that severely limits where a patent case can be filed. See 28 U.S.C. 1404(b). A newly proposed bill, S.4095, sponsored by Republican Senators McConnell, Cotton, and Tillis, would moderately expand the scope of proper venue and resolve some indeterminacy regarding foreign defendants.  Although the proposal does not create a right to immediate appeal, it does set a standard for mandamus that would seem to permit immediate relief of erroneous transfer denials for improper venue. This portion of the bill is entitled

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

New USPTO Director Review Rules

Patent, , , , , ,

by Dennis Crouch

The USPTO has published a notice of proposed rulemaking (NPRM) to formalize the process for Director Review of PTAB decisions. These proposed rules come in response to the Supreme Court's decision in United States v. Arthrex, Inc., 141 S. Ct. 1970 (2021), which underscored the necessity for the USPTO Director to have the ability to review PTAB decisions to comply with the Appointments Clause of the U.S. Constitution.  Of course, the USPTO has been operating under an interim procedure for Director Review that began soon after Arthrex, but has been updated a couple of times.  The NPRM closely follows the most recent version of the interim rules.

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.

Patentee’s Unclean Hands

Patent, , , , , , ,

by Dennis Crouch

The Federal Circuit's new decision in Luv'N'Care, Ltd. (LNC) v. Laurain and EZPZ, relies on the doctrine of unclean hands to deny relief to the patentee (Laurain and EZPZ), affirming the district court's judgment.  The appellate panel also vacated and remanded the district court's finding that LNC failed to prove the asserted patent is unenforceable due to inequitable conduct during prosecution, as well as its grant of summary judgment one of the asserted patents was invalid as obvious.  U.S. Patent No. 9,462,903. The case here involves bowls/plates attached to a mat to help avoid spills and for easy cleanup. 22-1905.OPINION.4-12-2024_2300689.

Unclean Hands: The doctrine of unclean hands is an equitable defense that bars a party from obtaining relief when they have engaged in misconduct

To continue reading, become a Patently-O member. Already a member? Simply log in to access the full post.