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Law360: Supreme Court Amgen Ruling's Major Effect On Enablement

Eight months ago, the U.S. Supreme Court interpreted the enablement requirement in the May 18, 2023, Amgen Inc. v. Sanofi decision.[1] Although the court did not change the law, affirming the U.S. Court of Appeals for the...more

Northern District of California Dismisses Challenge to PTAB’s Fintiv Factors

On Nov. 10, 2021, the Northern District of California granted the United States Patent and Trademark Office’s (USPTO) motion to dismiss a lawsuit brought by Apple and co-plaintiffs challenging the Patent Trial and Appeal...more

ChromaDex Milk Vitamin Formulation Patents Soured by Section 101

On Sept. 21, 2021, the U.S. District Court for the District of Delaware granted Elysium’s motion for summary judgment that two ChromaDex formulation patents were directed to patent-ineligible subject matter under 35 U.S.C. §...more

United States Calls for Supreme Court to Deny Petition for Certiorari Challenging Fintiv Factors

On Oct. 28, 2021, the Solicitor General filed a brief in opposition to Apple’s petition for a writ of certiorari in Apple Inc. v. Optis Cellular Tech., LLC et al. (No. 21-118). The government argued that the Federal Circuit...more

The Supreme Court Upholds the Doctrine of Assignor Estoppel While Clarifying Its Scope

On June 29, 2021, the Supreme Court, in Minerva Surgical, Inc. v. Hologic Inc., et al., upheld the doctrine of assignor estoppel, vacated the judgment of the Federal Circuit and remanded for further proceedings consistent...more

Third-Generation Vaccines Take Center Stage in Battle Against COVID-19

The biopharmaceutical industry is at the forefront of COVID-19 news due to major advances in vaccine development. Now, more than a year since the first case of COVID-19 and nearing a year since daily life has been upended by...more

Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19

SARS-CoV-2, the virus that causes COVID-19, is a novel coronavirus never before seen in humans. To date, it has caused 60,000 deaths in the United States – 56,000 of those in the last month alone. There does not yet exist an...more

A Therapeutic Solution for COVID-19: Repurposing Existing Drugs

For decades, antiviral drugs have been used to combat viral infections, including HIV/AIDS and influenza. Now they are a source of hope in the fight against the COVID-19 pandemic....more

BioPharma Develops Needed RNA and Antibody Tests for COVID-19

SARS-CoV-2, the virus that causes COVID-19, has been called an “invisible enemy.” It has spread through communities and across the globe, thanks in part to its ability to shed off of infected individuals for days before and...more

Biopharmaceutical Industry Fights COVID-19 Pandemic with Innovation and Speed

The COVID-19 pandemic has created unprecedented challenges for almost every industry. Most acute is the clinical challenge facing overwhelmed and underequipped hospitals and health care workers....more

US Biosimilar Market Expands As BPCIA Turns 10

The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market. The BPCIA, signed into law...more

CAR T-Cell Therapy Takes Off and Brings on Patent Litigation

CAR T-Cell therapy, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows.  ...more

BPCIA Scope Widens: 2020 Spending Bill Moves Chemically Synthesized Polypeptides to Biologic Status

Buried in a 2020 spending bill passed in December 2019 is a provision that amends the definition of “Biological Product” in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and thereby expands the products...more

USMCA: Implications for Biologics and Innovation

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more

Supreme Court Won’t Take Up Patent Eligibility for Medical Diagnostics

The cloud of uncertainty over patent eligibility of patents for medical diagnostic methods remains. On Monday, the Supreme Court declined the opportunity to revisit patent eligibility under its two-step Mayo test when it...more

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