*Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more
5/14/2024
/ Amgen ,
Amgen v Sandoz ,
Biosimilars ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Interchangeability ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Settlement
Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more
Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
On April 16, 2024, the PTAB proposed new rules (“proposed rules”) governing the Director Review process, which would remain consistent with the Interim review process currently in place, and codify those procedures....more
On April 15, 2024, Fresenius Kabi announced the U.S. launch of Tyenne® (tocilizumab-aazg), the first Actemra® (tocilizumab) biosimilar to launch in the U.S., after receiving FDA approval in March 2024 (see Fresenius Kabi’s...more
Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more
5/1/2024
/ Biden Administration ,
Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the...more
4/18/2024
/ Biocon ,
BPCIA ,
Dismissals ,
Lack of Jurisdiction ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron
On April 10, 2024, the Court granted Plaintiffs Genentech, Hoffmann-La Roche, and Biogen and Defendants Dr. Reddy’s and Fresenius Kabi’s joint stipulation of dismissal due to settlement in Case No. 1:23-cv-22485 (D.N.J.)...more
On March 27, 2024, the PTAB summarily denied Seagen’s February 14, 2024 request for Director Review of the PTAB’s January 16, 2024 Final Written Decision (“FWD”) in PGR2021-00030 related to Adcetris® (brentuximab vedotin)....more
On March 13, 2024, Regeneron appealed the PTAB Board’s (“the Board”) recent Final Written Decisions (“FWDs”) that found claims of two Regeneron patents related to EYLEA® (aflibercept) unpatentable....more
On March 13, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four additional IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade...more
On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and...more
3/15/2024
/ Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
On March 4, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade name...more
On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. The parties announced in a press release that their settlement and...more
On February 14, 2024, Seagen requested director review of the PTAB’s January 16th Final Written Decision (“FWD”) in PGR2021-00030 finding antibody-drug conjugate claims in U.S. Patent No. 10,808,039 (the “’039 patent”)...more
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche (Roche) filed a motion to voluntarily dismiss CAFC Appeals 24-1111 and 24-1115, appealing the Final Written Decisions (FWDs) in IPR2022-00578 and IPR2022-00579,...more
The new year has brought a wave of activity for EYLEA® (aflibercept) biosimilars. Following up on our previous report (EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates, December 31, 2023), in...more
On January 28, 2024 Celltrion announced the submission to the FDA of an aBLA for CT-P47, a proposed biosimilar of Genentech’s Actemra® (tocilizumab). This is the third publicly announced aBLA filing for an...more
On January 16, 2024, the PTAB issued a Final Written Decision in a post-grant review (“PGR”) of claims in U.S. Patent No. 10,808,039 (the “’039 patent”) owned by Seagen Inc. (“Seagen”). PGR2021-00030 was filed by Daiichi...more
On January 3, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a BPCIA litigation in the District of Delaware (Case No. 1-24-cv-00005 (D. Del.)) against...more