Posts Tagged: "patentability requirements"

On Monday, March 27, the Supreme Court will hear oral argument in Amgen v. Sanofi, a case with the parties and 27 Amici, including the United States, weighing in on whether and how the Court should address the enablement requirement of Section 112 in the context of genus claims, and in particular, genus claims to antibodies in the pharmaceutical sciences. Depending on how the court focuses its analysis, the opinion could be as narrow as how the jury instruction should read for pharmaceutical antibody claims written in the form of “a binding site plus a function.” But some of the briefs invite the court to loosen the constraints of Section 112 by eliminating the requirement of enablement of the “full scope” of the claimed embodiments in favor of a test focused on the “make and use the invention” language in the statute without the “full scope of the claimed embodiments” language the courts have used for years, with implications not just for pharma but for any art that uses functional or genus claiming.

Whether or not the law recognizes a machine as the inventor-at-law, the facts are indispensable to determination of the true inventor-in-fact. In the case of Stephen Thaler’s attempt to obtain patent protection for a food container and light stick he says were independently invented by his AI machine, DABUS, the inventor-in-fact will be either Thaler or his machine. The procedural posture of Thaler v. Vidal caused the discourse to jump over the facts of how the food container and the light stick were invented by DABUS. These overlooked facts may reveal the true inventor, regardless of whether or not the type of inventor is recognized by the current law. 

Panelists at IPWatchdog’s Artificial Intelligence Masters Program today debated how artificial intelligence (AI) interacts with intellectual property protection, and how laws around who (or what) can be an inventor or creator, as well as areas like patent eligibility, will need to evolve to ensure the continued “gold standard” status of the U.S. IP system. Attorneys working on some of the biggest cases in the AI space today took part in day one of AI Masters, including Professor Ryan Abbott, who is representing Stephen Thaler in his myriad of cases involving the AI machine, DABUS, both in the United States and elsewhere, and Van Lindberg, who represented Kristina Kashtanova in their recent bid to copyright a partially AI-generated graphic novel.

In a precedential decision published Monday, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed the Patent Trial and Appeal Board’s (PTAB) decision to invalidate a pharmaceutical patent owned by the University of Minnesota. Gilead Sciences filed an inter partes review (IPR) in 2017 challenging the claims of the university’s  U.S. Patent 8,815,830 as unpatentable. The ‘830 patent covers chemical compounds that prevent the reproduction of viruses or the growth of cancerous tumors. The PTAB found that the University of Minnesota failed to provide a sufficient written description that supported the patent’s priority claim. The Board thus concluded that the patent would not guide a skilled artisan to the patent’s claims. The CAFC agreed with the PTAB’s decision and with the ruling that a 2010 patent application publication filed by Gilead was “prior art” over the university’s patent.

The United States Supreme Court is soon poised to decide the fate of the enablement requirement, and the patent community is collectively holding its breath, wondering if the Court will strike a deathblow to the biopharmaceutical industry—simultaneously making all patents harder to get and even easier to challenge than they already are. The Supreme Court does not have a strong track record of objectively getting patent issues correct, at least not from a pro-innovation standpoint, although the Justices and their supporters likely would disagree. The undeniable truth, however, is that since the Supreme Court issued its decision in eBay v. MercExchange, virtually every decision of consequence to the patent system has made patent rights weaker and patents themselves easier to successfully challenge.

A manufacturer of Radio Frequency Identification Device transponders (RFIDs), Avery Dennison Corporation, yesterday petitioned the U.S. Supreme Court to grant certiorari in its appeal of a decision upholding ADASA, Inc.’s patent for RFID technology as patent eligible. Avery Dennison is urging the Court to take up the case, which it says “illustrates the depths of the Federal Circuit’s division” and represents “the other side of the coin” in the eligibility debate, in order to balance competing perspectives. While past and present petitions to the Court on eligibility have traditionally focused on uncertainty due to the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) too-narrow view of the law and tendency to invalidate patents under Section 101, Avery Dennison’s petition takes the view that the Federal Circuit’s reading of 101 is too broad.

A number of amici weighed in this week on Novartis Pharmaceuticals’ petition to the U.S. Supreme Court asking the Justices to consider whether the U.S. Court of Appeals for the Federal Circuit (CAFC) should have been allowed to vacate the decision of a previous three-judge panel composed of different judges, thus invalidating Novartis’ patent for a dosing regimen for its multiple sclerosis drug, Gilenya. In January of this year, Novartis followed through on its September 2022 promise that it would appeal the CAFC’s June 2022 decision invalidating its U.S. Patent No. 9,187,405 to the Supreme Court, after the CAFC denied its request to rehear the case.

The U.S. Patent and Trademark Office’s (USPTO’s) announcement early last week that it is requesting public comments on artificial intelligence (AI) and inventorship indicates that changes may eventually be implemented with respect to how the Office considers inventions created, or partially created, by AI machines. The Office is asking for input on 11 questions, including “how does the use of an AI system [in the invention process]…differ from the use of other technical tools”; whether AI inventions may be patentable under current patent laws on joint inventorship; and if statutory or regulatory changes should be made to better address AI contributions to inventions.

The United States Patent and Trademark Office (USPTO) is requesting public comments on artificial intelligence (AI) and inventorship via a Federal Register Notice published today, February 14. The Office has sought comment on the topic before, but not since its decision to deny patent protection to inventions created by Stephen Thaler’s artificial intelligence (AI) machine, DABUS. That decision was upheld by the district court and U.S. Court of Appeals for the Federal Circuit (CAFC) on appeal, but the CAFC in its decision left open the possibility that inventions made by human beings with the assistance of AI may be eligible for patent protection.

The U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedential decision affirming a Delaware court’s grant of summary judgment for Elysium Health that the asserted claims of ChromaDex, Inc.’s patent on an isolated form of vitamin B3 are directed to unpatentable subject matter under Section 101. Judge Prost authored the opinion. ChromaDex sells dietary supplements embodying the patent, which it licenses from Dartmouth College, and sued Elysium for patent infringement in 2018. Elysium moved for summary judgment that the claims were invalid under Section 101 and the district court agreed, finding that the claims were directed to a natural phenomenon, specifically, “compositions comprising isolated [NR], a naturally occurring vitamin present in cow milk.”

Last October, the United States Patent and Trademark Office (USPTO) issued a Request for Comments on USPTO Initiatives To Ensure the Robustness and Reliability of Patent Rights. Responses to this request are due by this Thursday, February 2, 2023. Patent owners, especially small businesses and independent inventors, need two things of the patent system: 1) Reliability/believability. We need patents that are respected when they are issued. We do not want any doubt about their validity. 2) Flexibility. We use many different strategies during patent prosecution. Many of our strategies reflect the startup-nature of our inventions, where we are constantly working on the product-market-fit. We may need several bites at the apple to effectively protect our invention. The Request for Comments suggests several different changes to patent prosecution, none of which address small companies’ needs.

The Federal Circuit’s decision in Juno v. Kite undermines effective prosecution practice and ultimately patent enforcement. The Juno panel held that to satisfy the written description requirement, a patent needs to demonstrate to a skilled artisan that the inventors possessed and disclosed in their filing the full scope of every genus being claimed. By denying rehearing to the Federal Circuit’s 2021 decision on the scope of the written description requirement, Juno v. Kite demonstrates how once again, the courts never consider anything from a prosecutor’s point of view. Here’s why Juno v. Kite is bad for patent prosecution practice.

While working as a patent examiner at the U.S. Patent and Trademark Office (USPTO) in Art Unit 2121 (artificial intelligence, or AI) I noticed that the typical patent application that I examined had seven method claims, seven apparatus claims, and six computer-readable medium (CRM) claims. In the typical application, the method and apparatus claims were mirrors of each other, and the first five CRM claims were mirrors of claims 1-5 and the last CRM claim combined the subject matter of claims 6 and 7. While examining a typical patent application, I only had to find prior art that taught these seven unique claims to reject the entire patent application. This led me to ponder why applicants are wasting the 13 other claims included with the standard filing fee with mirrored claims. Though best practice is to have multiple statutory categories with mirror claims by the time of allowance for enforceability reasons, there is a potential advantage for the applicant to file fewer mirror claims initially.

Last week, Novartis Pharmaceuticals followed through on its  September 2022 promise that it would appeal the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) June 2022 decision invalidating its patent for a dosing regimen for its multiple sclerosis drug Gilenya to the U.S. Supreme Court, after the CAFC denied its request to rehear the case.