Posts Tagged: "patents"

Artificial intelligence (AI) is a field of computer science that creates software or models that mimic human reasoning or inference. Machine learning is a subset of AI which uses algorithms trained on massive amounts of data to allow the computer to learn with gradually improving accuracy without explicitly being programmed. The biopharmaceutical and healthcare fields produce massive amounts of data, including properties and characteristics of drug compounds, biological, genomic, and clinical data, efficacy of treatments, adverse events and risks, and electronic health records. The data may come from many sources, both public and proprietary. AI systems trained on such data can streamline and optimize the drug development process, including drug discovery, diagnosing diseases, identifying treatments and risks, designing clinical trials, and predicting safety and efficacy profiles, leading to increasing efficiency and reducing costs. 

The U.S. Court of Appeals for the Federal Circuit (CAFC) today affirmed a district court’s grant of summary judgment that Baxalta, Inc. and Baxalta GmbH’s Hemophilia patent claims are invalid for a lack of enablement. The court said the facts of the case are “materially indistinguishable from those in Amgen.”… While Baxalta tried to argue its screening process does not require the type of trial and error described in Amgen and instead “predictably and reliably generates new claimed antibodies every time it is performed,” the court said “this does not take the process out of the realm of the trial-and-error approaches rejected in Amgen.”

The regulatory framework for the inter partes review (IPR) process has long been the subject of criticism from both patent owners and petitioners. There is a growing consensus that the existing rules need to be revised to address loopholes and unintended consequences that have developed over the 10 years the America Invents Act (AIA) has been in effect. To that end, both the U.S. Patent and Trademark Office (USPTO) and Congress have proposed changes in the regulatory framework. While the two disparate approaches seek to change the IPR playing field, their purpose and approach are significantly different. This article discusses those similarities and differences.

Confusion and misunderstanding among some independent inventors might slow or stall progress of the excellent eligibility reform bill recently introduced by Senators Chris Coons (D-DE) and Thom Tillis (R-NC). Titled the Patent Eligibility Restoration Act (PERA), the legislation would overturn Supreme Court and Federal Circuit decisions that scrambled settled law, excluding many worthy classes of inventions, such as medical diagnostic methods and advanced computer applications.

Pfizer, Inc. and BioNTech SE on Monday hit back at competitor COVID-19 vaccine maker Moderna with inter partes review (IPR) petitions against two Moderna patents on mRNA vaccine technology at the Patent Trial and Appeal Board (PTAB). Pfizer/ BioNTech told the PTAB that Moderna’s patents include “unimaginably broad claims directed to a basic idea” and asked the Board to cancel all of the challenged claims of both patents.  

In addition to unrecoverable issues like divided infringement, it’s no secret that patents have come under increased scrutiny over the last decade. The Patent Trial and Appeal Board (PTAB) continues to invalidate patent claims at an alarming rate, defendants have ever-increasing invalidity and non-infringement arguments to make in district court, and the Supreme Court’s Alice decision on patent eligibility continues to baffle the entire patent community…. While the patent community debates the need for reform, an easy and attainable solution, and one that is within your control, is simply to strengthen the patents before they issue.

Careless naming of inventors on a patent application can create confusion and add complexity to an already intricate process. The recent case of Blue Gentian, LLC v. Tristar Prod., Inc. is a great example where failure to properly list a co-inventor resulted in the only named inventor losing their patent rights…. To avoid a case similar to Blue Gentian v. Tristar, identify all inventors carefully and have them sign an assignment agreement, which transfers their rights to a single entity, such as an individual or the company that’s going to exploit the patent.

The past year has provided decades’ worth of developments across law and policy in the areas of artificial intelligence (AI) and machine learning (ML) technologies. If 2022 was the breakthrough year for accessible AI, then 2023 can so far be deemed as the first year of likely many more to come in the era of an AI inquisition. “After years of somewhat academic discourse,” reflects Dr. Ryan Abbott, “AI and copyright law have finally burst into the public consciousness—from contributing to the writer’s strike to a wave of high-profile cases alleging copyright infringement from machine learning to global public hearings on the protectability of AI-generated works.” Both the U.S. Copyright Office (USCO) and the U.S. Patent and Trademark Office (USPTO) are in active litigation over the eligibility of generative AI outputs for statutory protection. Additionally, both offices have held numerous webinars and listening sessions and conducted other methods of collecting feedback from the public as they work through policy considerations surrounding AI.

Texas has long been home to the busiest patent courts in the country. In the Eastern District, Judges Rodney Gilstrap and Roy Payne have for the last decade-plus seen more patent cases than any other judges in the country. Since taking the bench in 2018, Judge Alan Albright in the Western District has had the most active patent docket, taking 18% of all patent cases in 2022, for example. Much has been written about the judges’ perceived unwillingness to grant transfer motions in patent cases (and resulting challenges to the Federal Circuit) and disfavor of staying cases pending inter partes review. These factors suggest that a defendant in these courts have few options to stay or transfer their case.

The PREVAIL Act addresses current rules that enable gamesmanship at the Patent Trial and Appeal Board (PTAB) by huge corporations against small inventors, startups and other patent owners, and that increase invalidation rates. It introduces standing requirements, establishes a clear and convincing evidence standard to invalidate a patent, ensures a code of conduct is put in place for administrative patent judges (APJs), and more. While these changes are well-intended, due to the PTAB’s perverse incentive structure, the PREVAIL Act will only be marginally effective, and may have no real effect at all.

Scott McKeown is one of the preeminent Patent Trial and Appeal Board (PTAB) practitioners in the country, founder and author of PatentsPostGrant.com, Co-Chair of the IPWatchdog PTAB Masters program, and a good friend. Recently, Scott decided to make a change, leaving Ropes & Gray and joining Wolf Greenfield & Sacks and becoming the first partner resident in Wolf’s new Washington, DC, offices. Given the news, I took the opportunity to invite Scott to IPWatchdog headquarters for an interview.

On August 2, inventor advocacy group US Inventor held a webinar on provisions of the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act that are intended to curb abuses impacting small business patent owners at the Patent Trial and Appeal Board (PTAB). While most panelists on the virtual call acknowledged that the PREVAIL Act wouldn’t solve every problem threatening the U.S. innovation ecosystem’s most vulnerable members, there was widespread agreement that the bill would have beneficial impacts if enacted. The webinar was US Inventor’s second on the PREVAIL Act following a virtual call last week with law professor Adam Mossoff and C4IP General Counsel Jamie Simpson.

The U.S. Court of Appeals for the Federal Circuit (CAFC) today affirmed a district court’s dismissal of Realtime Data, LLC’s patent infringement claims based on invalidity of the asserted claims under 35 U.S.C. § 101. In a previous ruling, the CAFC sent the case back to the district court asking for a more fleshed out Section 101 analysis. Judge Pauline Newman dissented to today’s judgment, calling current eligibility jurisprudence a “morass” and saying she would have remanded the case for determination of validity under Section 112, or possibly Sections 102 and 103.

On Friday, July 28, President Biden announced a new Executive Order titled “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs.” Rumors that the Administration was considering extending the deeply flawed Department of Energy (DOE) policy (see “More DOE Bureaucracy Equals Less Innovation” to all agencies had been swirling for months. Luckily, the new Executive Order doesn’t do that, but how it will be applied is subject to a convoluted interagency process, so it will be months before we see if it’s meeting its intended goal or not.

On July 25, the U.S. Court of Federal Claims (CFC) issued a ruling in Pulnikova v. U.S. dismissing monetary damages claims for alleged violations of 42 U.S.C. § 1983 by patent examiners and officials at the U.S. Patent and Trademark Office (USPTO). Although the CFC expressed its sympathy for the inventor’s frustrations, including the pro se filing of “appeal-books” containing thousands of pages responding to office actions, the court added that it lacked subject matter jurisdiction to award the type of damages sought.