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
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
11/23/2021
/ § 314(d) ,
Administrative Procedure Act ,
Apple ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Statutory Interpretation ,
USPTO
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
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
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
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
12/1/2020
/ AstraZeneca ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Infectious Diseases ,
Intellectual Property Protection ,
Life Sciences ,
Moderna Inc. ,
Pfizer ,
Public Health ,
Research and Development ,
Vaccinations
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
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
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
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
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, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows. ...more
2/19/2020
/ Biologics ,
Cancer ,
Declaratory Judgments ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Future Royalties ,
Intellectual Property Protection ,
IP License ,
Life Sciences ,
Novartis ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
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
2/3/2020
/ Biologics ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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
1/29/2020
/ Biologics ,
BPCIA ,
Canada ,
Cross-Border Transactions ,
Drug Distribution ,
Exports ,
Foreign Relations ,
Free Trade Agreements ,
Generic Drugs ,
Imports ,
Innovation ,
Intellectual Property Protection ,
Mexico ,
NAFTA ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PHRMA ,
Product Exclusivity ,
Trade Relations ,
Trump Administration ,
United States-Mexico-Canada Agreement (USMCA) ,
US Trade Policies
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
1/15/2020
/ Abstract Ideas ,
Denial of Certiorari ,
Diagnostic Method ,
Diagnostic Tests ,
Innovative Technology ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
SCOTUS ,
Section 101
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
1/10/2020
/ AbbVie ,
Amgen ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Commercial Marketing ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Genentech ,
Generic Drugs ,
Intellectual Property Litigation ,
Inter Partes Reexamination ,
Inter Partes Review (IPR) Proceeding ,
Interchangeability ,
Irreparable Harm ,
Life Sciences ,
Motion to Dismiss ,
Notice Requirements ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Prescription Drugs ,
Public Health Service Act ,
Regulatory Requirements
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
1/10/2020
/ AbbVie ,
Amgen ,
Amgen v Hospira ,
Applicable Manufacturers ,
Biogen Idec ,
Biologics ,
Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hospira ,
Intellectual Property Protection ,
Inter Partes Reexamination ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Expiration ,
Patent Infringement ,
Patent Trial and Appeal Board ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Safe Harbors ,
Settlement Agreements ,
USPTO