News & Analysis as of

Litigation Strategies FDA Approval Pharmaceutical Patents

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo®...

Venable LLP on

Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more

Venable LLP

Spotlight On: Biosimilar Litigations - June 2025

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

Fenwick & West LLP on

In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 18th, 2:00 pm PDT

Smart & Biggar on

Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Smart & Biggar

[Webinar] Cross-border IP strategies for IP owners and litigators - September 12th, 12:00 pm GMT

Smart & Biggar on

Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Prosecution Tool Kit: Implications of the BPCIA on the IP Strategies of Brand Companies and Biosimilar Developers

The enactment of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010 established for the first time ever in the US an abbreviated pathway for obtaining FDA approval of a new biological product that is deemed...more

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