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 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