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 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