On June 25, 2021, the Biological Product Patent Transparency (BPPT) amendments to 42 U.S.C. 262(k) of the Biologics Price Competition and Innovation Act (BPCIA) took effect. Those amendments make publication of the FDA "Purple Book" mandatory; require that the Purple Book include additional information—including patent lists provided by a reference product sponsor (RPS) to a biosimilar applicant pursuant to 42 U.S.C. 262(l)(3)(A) or (l)(7)—and require that FDA update the Purple Book every 30 days.
July 12, 2021
New Legislation Requires Certain Patent Information to Be Published in FDA Purple Book for Biological Products
By: Christopher E. Loh
On June 25, 2021, the Biological Product Patent Transparency (BPPT)
amendments to 42 U.S.C. 262(k) of the Biologics Price Competition and
Innovation Act (BPCIA) took effect. Those amendments make publication
of the FDA "Purple Book" mandatory; require that the Purple Book
include additional information--including patent lists provided by a reference product sponsor (RPS) to a
biosimilar applicant pursuant to 42 U.S.C. 262(l)(3)(A) or (l)(7)--and require that FDA update the Purple Book
every 30 days.
Supreme Court Holds That Authority Exercised by Administrative Patent Judges in IPRs Is Unconstitutional and Provides for Director Review of IPR Decisions as a Remedy
By: Christopher E. Loh
On June 21, 2021, the Supreme Court in United States v. Arthrex Inc., No. 19-1434, held that the authority wielded by administrative patent judges (APJs) in inter partes review proceedings (IPRs) violates the Appointments Clause of the Constitution. The Supreme Court remedied that constitutional violation by permitting the director of the Patent and Trademark Office to directly review IPR decisions.
Supreme Court Upholds ACA for Third Time, but New Threats Loom
Ha Kung Wong spoke with Part B News about the Supreme Court's opinion in California v. Texas, upholding the Affordable Care Act (ACA) for the third time, as well as another upcoming case regarding the ACA, Kelley v. Becerra.
Spotlight On: Neulasta (pegfilgrastim) / Fulphila
(pegfilgrastim-jmdb) / Udenyca (pegfilgrastim-cbqv) /
Ziextenzo (pegfilgrastim-bmez) / NyvepriaTM (pegfilgrastimapgf)
Spotlight On: Herceptin (trastuzumab) / OgivriTM
(trastuzumab-dkst) / Herzuma (trastuzumab-pkrb) /
Ontruzant (trastuzumab-dttb) / TrazimeraTM (trastuzumab-qyyp) / Kanjinti (trastuzumab-anns)
Spotlight On: Biosimilar Litigations
Spotlight On: Rituxan (rituximab) / Truxima (rituximab-abbs) / Ruxience (rituximabpvvr)
Spotlight On: Humira (adalimumab) / AmjevitaTM (adalimumab-atto) / Cyltezo
(adalimumab-adbm) / HyrimozTM (adalimumab-adaz) / HadlimaTM (adalimumab-bwwd) / AbriladaTM (adalimumab-afzb) / Hulio (adalimumab-fkjp)
Spotlight On: Enbrel (etanercept) / Erelzi (etanercept-szzs) / Eticovo (etanerceptykro)
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, LapelgaTM, Ziextenzo, Udenyca, Fulphila, NyvepriaTM, MSB11455, and Pegfilgrastim (Lupin)), trastuzumab (Herceptin, OgivriTM, Herzuma, Ontruzant, TrazimeraTM, and Kanjinti), rituximab (Rituxan, Truxima, and Ruxience), adalimumab (Humira, AmjevitaTM, Cyltezo, HyrimozTM, HadlimaTM, AbriladaTM, and Hulio), etanercept (Enbrel, Erelzi, and Eticovo), and insulin glargine (Lantus / Lantus SoloSTAR, Basaglar, and Semglee) have been updated with activity through June 30, 2021.
BiologicsHQ's "Spotlight On Biosimilar Litigations" dashboard provides, at a glance, an overview of the status of U.S. biosimilar patent litigations through June 30, 2021.
IPRs and PGRs
On June 21, 2021, the Supreme Court denied Immunex's petition for writ of certiorari, Supreme Court Case No. 20-1285, appealing the decisions in Fed. Cir. Appeal Nos. 19-1749 and 19-1777, and the final written decisions in IPR2017-01884 and IPR2017-01879.
Enhertu (fam-trastuzumab deruxtecan-nxki):
On June 24, 2021, institution was denied in Daiichi Sankyo v. Seagen PGR2021-00030 and PGR2021-00042.
On June 25, 2021, the PTAB granted Chengdu Kanghong Biotechnology's requests for dismissal prior to institution decisions in PGR2021-00035 and IPR2021-00402 against Regeneron.
Neupogen (filgrastim) / Neulasta (pegfilgrastim):
On June 28, 2021, the Supreme Court granted certiorari in Amgen v. Apotex, Sup. Ct. Case No. 20-74 (appealing from Fed. Cir. Case No. 19-2171 and IPR2016-01542), vacating and remanding the case to the Federal Circuit for consideration in light of the Supreme Court's opinion in U.S. v. Arthrex.
Actemra (tocilizumab): On June 28, 2021, Fresenius Kabi filed IPR2021-01024 and IPR2021-01025 against Chugai.
Repatha (evolocumab): On June 1, 2021, Crandall Technologies and Amgen voluntarily dismissed Case No. 2:21-cv-01816 (C.D. Cal.).
Ajovy (fremanezumab-vfrm) / Emgality (galcanezumab-gnlm): On June 8, 2021, Teva filed Case No. 1:21-cv-10954 (D. Mass.) against Eli Lilly.
Praluent (alirocumab) / Repatha (evolocumab):
On June 21, 2021, the Federal Circuit denied Amgen's request for a panel rehearing and rehearing en banc of the Federal Circuit's affirmation in Fed. Cir. Appeal No 20-1074, appealing the District Court's determination in Case No. 1:14-cv-01317 (D. Del.) and consolidated Case Nos. 1:14-cv-01349 (D. Del.), 1:14-cv-01393 (D. Del.), and 1:14-cv-01414 (D. Del.) against Regeneron.
On June 21, 2021, Genentech and Centus Biotherapeutics filed a motion to dismiss Case No. 2:20-cv-00361 (E.D. Tex.) due to settlement.
aBLA Applications and FDA Activity
On June 2, 2021, Lupin announced the FDA had accepted for review its aBLA for pegfilgrastim, a proposed biosimilar of Amgen's Neulasta (pegfilgrastim).
On June 17, 2021, Amneal and mAbxience announced the FDA had accepted for review their aBLA for AlymsysTM (bevacizumab), a proposed biosimilar of Genentech's Avastin (bevacizumab).
CDER Purple Book Updates
On June 7, 2021, the FDA approved Biogen's AduhelmTM (aducanumab-avwa).
RylazeTM (asparaginase erwinia chrysanthemi (recombinant)-rywn):
On June 30, 2021, the FDA approved Jazz Pharmaceuticals' RylazeTM (asparaginase erwinia chrysanthemi (recombinant)-rywn).
by Fiscal Year
IPRs: Number of Patents and Claims Challenged
Institution and Final
Patents Subject to
IPRs and Litigations
Approved in the
Pending in the
IPRs by Reference
Patents Subject to
Biologic Drug IPRs
Biologic Drugs Most Frequently Targeted in
Serial IPR Challenges
Biologic Drug Patent
Multiple IPR Challenges
by Claim Type
Number of IPR
Biologic Drug Patent
Contact the BiologicsHQ Team
Robert S. Schwartz, Ph.D.
Ha Kung Wong
CALIFORNIA | DELAWARE | ILLINOIS | MARYLAND | NEW YORK | VIRGINIA | WASHINGTON, DC
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