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
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
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
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