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December 9, 2020
LATEST NEWS
2020 Analysis on PTAB Contested Proceedings
By: Justin Oliver
Venable Fitzpatrick released its annual statistical report on
AIA trialsbefore the USPTO’s Patent Trial and Appeal Board,
including stats forIPRs, PGRs, and CBMs. The in-depth study
analyzes the types ofarguments that succeed more often than others
and the trends over timein PTAB decisions.
The analysis has again shown the advantage of obviousness
challenges over anticipation challenges forIPRs, along with a
corresponding downward trend in the use of anticipation challenges.
Additionally, thereport shows a slight uptick in IPR
unpatentability findings (the chance of a claim being found
unpatentableis now about 50%). For PGRs and CBMs, the analysis
further confirms the dominance of patent eligibilitychallenges.
This year’s analysis also shows another increase in the success
rate for motions to amend.
Venable Fitzpatrick presents this analysis to provide
practitioners additional data points in order to makeinformed
decisions throughout the AIA trial process.
Spotlight On: Neulasta® (pegfilgrastim) / Fulphila®
(pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) /Ziextenzo®
(pegfilgrastim-bmez) / Nyvepria™ (pegfilgrastim-apgf)
Spotlight On: Herceptin® (trastuzumab) /
Ogivri™(trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) /
Ontruzant® (trastuzumab-dttb) / Trazimera™ (trastuzumab-qyyp) /
Kanjinti®(trastuzumab-anns)
Spotlight On: Biosimilar Litigations
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Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) /
Ruxience® (rituximab-pvvr)
Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto)
/ Cyltezo®(adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) / Hadlima™
(adalimumab-bwwd) /Abrilada™ (adalimumab-afzb) / Hulio®
(adalimumab-fkjp)
Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) /
Eticovo® (etanercept-ykro)
Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine
recombinant) / Basaglar®(insulin glargine) / Semglee™ (insulin
glargine)
BiologicsHQ's "Spotlight On" product dashboards provide, at a
glance, an overview of the status of U.S.patent proceedings. The
dashboards concerning pegfilgrastim (Neulasta®, Lapelga™,
Ziextenzo®,Udenyca®, Fulphila®, Nyvepria™, and MSB11455),
trastuzumab (Herceptin®, Ogivri™, Herzuma®,Ontruzant®, Trazimera™,
and Kanjinti®), rituximab (Rituxan®, Truxima®, and Ruxience®),
adalimumab(Humira®, Amjevita™, Cyltezo®, Hyrimoz™, Hadlima™,
Abrilada™, and Hulio®), etanercept (Enbrel®,Erelzi®, and Eticovo®),
and insulin glargine (Lantus® / Lantus® SoloSTAR®, Basaglar®, and
Semglee™) havebeen updated with activity through November 30,
2020.
BiologicsHQ's "Spotlight On Biosimilar Litigations" dashboard
provides, at a glance, an overview of thestatus of U.S. biosimilar
patent litigations through November 30, 2020.
ReadMoreNews
UPDATES
IPRs and PGRs
Myozyme® / Lumizyme® (alglucosidase alfa):
On November 9, 2020, the Supreme Court denied the writ of
certiorari in Duke University v. Biomarin, Sup. Ct.19-1475,
appealing the decisions in Fed. Cir. Case Nos. 16-1106 and 18-1696
from the PTAB's decision inIPR2013-00535.
Litigations
Lantus® (insulin glargine recombinant):
On November 2, 2020, the District Court entered final judgment
in Sanofi v. Mylan Case No. 2:17-cv-09105(D.N.J.). On November 19,
2020, Sanofi filed Fed. Cir. Appeal No. 21-1262.
Avastin® (bevacizumab):
On November 12, 2020, Genentech filed Case No. 2:20-cv-00361
(E.D. Tex.) against Centus Biotherapeutics,Fujifilm, and Kyowa
Kirin relating to proposed biosimilar FKB238 (bevacizumab).
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Biosimilar- Related IPR
Petitions
Biosimilar-Related IPR Petitions by Fiscal Year
Biosimilar-Related IPR Petitions
by Quarter
Biosimilar-Related IPRs by Reference
Biosimilar-Related IPRs: Number of Patents
Status of Biosimilar-
Enhertu® (fam-trastuzumab deruxtecan-nxki):
On November 13, 2020, Daiichi Sankyo and AstraZeneca filed
declaratory judgment Case No. 1:20-cv-01524(D. Del.) against
Seagen.
aBLA Applications and FDA Activity
FKB238 (bevacizumab):
On November 12, 2020, Genentech listed in a district court
complaint that an aBLA for Centus Biotherapeutics,Fujifilm, and
Kyowa Kirin's FKB238 (bevacizumab) had been accepted by the FDA on
November 18, 2019. FKB238 (bevacizumab) is a proposed biosimilar of
Genentech's Avastin® (bevacizumab).
SB11 (ranibizumab):
On November 18, 2020, Samsung Bioepis and Biogen announced the
FDA had accepted for review an aBLAfor SB11 (ranibizumab), a
proposed biosimilar of Genentech's Lucentis® (ranibizumab).
AVT02 (adalimumab):
On November 19, 2020, Alvotech announced the FDA had accepted
for review an aBLA for AVT02(adalimumab), a proposed biosimilar of
AbbVie's Humira® (adalimumab).
CDER Purple Book Updates
Danyelza® (naxibamab-gqgk):
On November 25, 2020, the FDA approved Y-Mabs Therapeutics'
Danyelza® (naxitamab-gqgk).
Non-U.S. Biosimilars / Follow-On Biologics
Nyvepria™ (pegfilgrastim-apgf):
On November 23, 2020, Pfizer announced that Nyvepria™
(pegfilgrastim-apgf), a biosimilar of Amgen'sNeulasta®
(pegfilgrastim) was approved in the E.U.
STATISTICS
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Product
and Claims Challenged
Related IPRs
Biosimilar-Related IPRs: Institution and Final
Written Decision Outcomes
Biosimilar-Related Litigations
by Year
Biosimilar Applications
Pending in the United States
Patents Subject to Biologic Drug IPRs
and Litigations
Biosimilar- Related
Litigations
Patents Subject to Biosimilar-Related
IPRs and Litigations
Biologic Drug
IPR Petitions
Biologic Drugs Most Frequently Targeted in Serial IPR
Challenges
Biosimilar-Related Litigations
by Reference Product
Biosimilars Approved in the
United States
Biologic Drug IPRs by Reference
Product
Biologic Drug Patent Multiple IPR Challenges
by Claim Type
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Number of IPR Challenges Per
Biologic Drug Patent
Robert S. Schwartz, Ph.D. Chair +1 212.218.2298
[email protected]
Ha Kung Wong Partner +1 212.218.2571 [email protected]
Contact the BiologicsHQ Team
CALIFORNIA | DELAWARE | ILLINOIS | MARYLAND | NEW YORK |
VIRGINIA | WASHINGTON, DC
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