News & Analysis as of

Subject Matter Jurisdiction › Sandoz

Dechert LLP

District of Delaware Holds that ANDA Filer’s Conversion from a PIV Certification to a PIII Certification Does Not Strip Court of...

Dechert LLP on

Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more

Womble Bond Dickinson

Courts Answer Key Questions Over the Reach of the BPCIA

Womble Bond Dickinson on

Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more

Sheppard Mullin Richter & Hampton LLP

Update: Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange...

Sheppard Mullin Richter & Hampton LLP on

In our previous blog post of November 11, 2014, we noted that Celltrion had filed a declaratory judgment action against Kennedy Trust for Rheumatology Research for invalidity of certain patents covering methods of treating...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)

McDonnell Boehnen Hulbert & Berghoff LLP on

Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a...more

4 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide