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FDA Approves Neuralink to Begin Human Trials of Brain Implants

Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device.  Recruitment for...more

BioNTech to Ship Modular mRNA Vaccine Factory to Rwanda

Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda. According to BioNTech’s press release, the...more

U.S. FDA Approves Monkeypox Treatment Formulation

(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more

Two Drugs Recalled Due to Manufacturing Issues

Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products. ...more

Presumption of Nexus for Secondary Considerations Is Improper When a Commercial Product Includes Unclaimed but Functionally...

FOX FACTORY, INC. v. SRAM, LLC - Before Prost, Wallach, and Hughes.  Appeal from the Patent Trial and Appeal Board (PTAB). Summary:  When a commercial product contains unclaimed features, a presumption of nexus between...more

Decision of PTAB to Reconsider Earlier Decision Instituting Inter Partes Review Is Not Reviewable by the Court of Appeals

BIODELIVERY SCIENCES INTL. v. AQUESTIVE THERAPEUTICS, INC. Before Newman, Lourie, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: The PTAB has the discretion to not institute inter partes...more

A Single Prior Art Reference Can Render a Patent Obvious

GAME AND TECHNOLOGY CO., LTD. v. ACTIVISION BLIZZARD INC. Before Prost, Lourie, and Wallach. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: A single prior art reference can render a patent obvious if it...more

Coda Development v. Goodyear Tire & Rubber

Federal Circuit Summary - Before Prost, Wallach, and Hughes. Appeal from the U.S. District Court for N.D. Ohio. Summary: On a Rule 12(b)(6) motion, a district court cannot judicially notice facts that are subject to...more

FDA Approves First Generic Epinephrine Autoinjectors

The United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors. According to the press release, Teva’s autoinjectors are the first generic...more

E.I. Dupont De Nemours & Co. v. Synvina C.V.

Federal Circuit Summary - Before Lourie, O’Malley, and Chen. Appeal from the Patent Trial and Appeal Board. Summary: When the ranges identified in a claimed composition overlap with the ranges disclosed in the prior...more

Cyberdyne Bringing HAL Cyborg Exoskeleton to US Market

Cyberdyne, a Japan-based robotics technology company, recently announced its collaboration with Brooks Rehabilitation and the Brooks Cybernic Treatment Center to bring its Hybrid Assistive Limb (HAL®) exoskeleton to the U.S....more

Ericsson Inc. v. Intellectual Ventures I LLC.

Federal Circuit Summaries - Before Prost, Newman, and Wallach. Appeal from the Patent Trial and Appeal Board. Summary: An unsupported expert opinion does not constitute substantial evidence to contradict a prior art...more

Da Volterra Develops Device to Combat Antibiotic Resistance

Da Volterra, a biotech company developing products in the antibacterial field, has announced results in a human clinical trial for DAV132, a product said to prevent life-treating bacterial infections during antibiotic...more

Elbit Systems Of America, LLC v. Thales Visionix, Inc.

Federal Circuit Summaries - Before Moore, Wallach, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: The PTAB is entitled to weigh the credibility of expert witnesses, and attorney argument cannot be...more

FDA Approves Prickless Glucose Monitoring System

The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients. The glucose monitoring tool will allow patients to monitor their glucose...more

The Eastern District of Texas Again Broadly Applies IPR Estoppel and Finds a Joined Party in the IPR Is Also Subject to Estoppel

A magistrate judge in the Eastern District of Texas recommended in Network-1 Technologies, Inc. v. Alcatel-Lucent USA, Inc. Case No. 6:11-cv-492 (E.D.Tex. September 25, 2017) that Hewlett-Packard (“HP”) should be estopped...more

Medtronic Receives Regulatory Approval for Surgical Navigation Device

According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons...more

Magistrate Judge Recommends IPR Estoppel Bar of Prior Art References

A magistrate judge in the Eastern District of Texas recommended in Biscotti, Inc. v. Microsoft Corp., No. 2:13-CV-01015, DI 191 (E.D. Tex. May 11, 2017) that Microsoft should be estopped from asserting invalidity grounds that...more

Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for...more

PTAB Avoids Triggering Estoppel by Issuing Concurrent Final Written Decisions

The Patent Trial and Appeal Board issued concurrent final written decisions upholding the validity of all challenged claims of U.S. Patent No. 8,141,154 in Palo Alto Networks, Inc. v. Finjan. Inc. IPR2015-01979, Paper 62...more

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