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
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
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