Posts Tagged: "written description"

O’Malley Dissents from ‘Concerning’ CAFC Ruling that Biogen’s MS Drug Patent is Invalid

The U.S. Court of Appeals for the Federal Circuit (CAFC) earlier today affirmed a district court ruling that Biogen International’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Judge O’Malley dissented, arguing that the district court clearly erred in its finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effect, and that the entire analysis “might well change” if the case was remanded “for reconsideration of the record with the understanding that the patent is not about clinical efficacy” but therapeutic effect.

CAFC Reverses Massive Jury Verdict for Juno and Sloan Kettering

The U.S. Court of Appeals for the Federal Circuit (CAFC) today reversed a jury verdict for Juno Therapeutics and Sloan Kettering Institute for Cancer Research (Juno), wiping out a $1.2 billion judgment for the entities. The CAFC found that the jury’s verdict with respect to written description was not supported by substantial evidence. The case relates to U.S. Patent No. 7,446,190, owned by Sloan Kettering, which is titled “Nucleic Acids Encoding Chimeric T Cell Receptors.” The patent generally covers cancer immunotherapy technology. Juno sued Kite Pharma, Inc. for infringement of the ‘190 patent through the sale of its YESCARTA product. Kite countersued, seeking declaratory judgments of noninfringement and invalidity. The jury ultimately found in Juno’s favor and, in post-trial briefs, Kite moved for judgment as a matter of law (JMOL) on several grounds, including that the claims were not supported by sufficient written description. The district court denied JMOL and Kite appealed.

‘AISITAs’ and Written Description Requirements: Considerations and Guidance for AI Patent Applications

Artificial intelligence (AI) is everywhere, touching nearly every aspect of our daily lives, including how we work, communicate, shop, travel and more. The term “AI” is generally understood to encompass computerized systems that perform tasks ordinarily perceived as requiring some form of human intelligence. Many AI-based systems are able to recognize trends, patterns and connections, test hypotheses using available data sets, and continuously improve decision trees based on user input. As such, AI has been shown to have near endless applications, driving a surge of inventions and related patent application filings.

Written Description in the Life Sciences: The Devil is in the Details

There is a quid pro quo under the U.S. patent laws. In exchange for disclosing her invention, an inventor receives a limited monopoly. Recent developments, however, have made it harder for those in the biotechnology industry to obtain the benefit of this bargain. The written description requirement mandates that a patent specification convey to one of skill in the art that the inventors had possession of their invention as of the day they filed their patent application. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Over the last decade, three areas have proven troublesome in the life sciences.

Thought Experiment: Is Our Patent System Ready for a Potential Future of Brain Interfacing?

Currently, brain recording and/or brain stimulation is used almost entirely for medical or research purposes. Invasive surgery is generally required to read neural signals with high temporal and spatial resolution. High resolution of neural signals enables researchers to decode a brain’s underlying intentions, sensations, reactions, etc. rather reliably, if only in constrained environments. With regard to stimulation, researchers have demonstrated the ability to trigger different types of effects. For example, stimulating the reticular formation can cause a subject to become awake; stimulating the amygdala can evoke fear; stimulating the motor cortex can trigger movement; stimulating the visual cortex can cause a subject to see light flashes. However, the state of the art is neither able to decode complex and unrestrained thoughts nor cause a subject to have a particular “target” complex thought. At least not yet.