As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at the Federal Circuit, and at the PTAB. Below is our recap of…
As we previously reported, on February 11, 2021, a three-judge panel of the Federal Circuit affirmed the District Court for the District of Delaware’s grant of Sanofi’s motion for judgment as a matter of law that the asserted claims of two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165…
As we close out another calendar year, we look back at the top legal developments of 2020 that could influence the market for biologics and biosimilars. While there were a number of case-specific decisions this past year that, undeniably, impacted the availability of biosimilars in the market, the five legal…
As we previously reported, in October 2018, Pfizer persuaded the Patent Trial and Appeal Board (PTAB) that the claims of Biogen’s U.S. Patent No. 8,821,873, directed to a method of treating lymphoma with anti-CD20 antibodies and covering the cancer therapeutic RITUXAN (rituximab), were unpatentable on obviousness grounds. After appealing to…
As previously reported, in February 2019, the Patent Trial and Appeal Board issued final written decisions in two IPR proceedings initiated by Sanofi challenging the U.S. Patent No. 8,679,487 (the ’487 patent) owned by Immunex. In IPR2017-01884, the Board held that the challenged claims of the ‘487 patent were unpatentable…
Today, in the Genentech v. Amgen BPCIA litigation concerning Amgen’s MVASI (bevacizumab-awwb) biosimilar product, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the district court’s denial of Genentech’s motions to enjoin sales of MVASI in the United States. MVASI is an FDA-approved biosimilar of Genentech’s…
We previously reported on the decision by the District of New Jersey (Cecchi, J.) to uphold the validity of U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product ENBREL” and U.S. Patent No. 8,163,522, related to ENBREL’s method of manufacture. As we reported…
Today, the Supreme Court denied three petitions for certiorari challenging the constitutionality of subjecting patents issued prior to the America Invents Act (“AIA”) to inter partes review (“IPR”). See Celgene v. Peter; Collabo v. Sony Corp.; Enzo v. Becton, Dickinson and Company. In all three underlying cases, the U.S. Court of Appeals for the Federal Circuit had…
On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals. At the PTAB, Pfizer had challenged the validity of Chugai’s patents (7,332,289 and 7,927,815) covering processes relevant to the manufacture of rituximab. In support…
This week, the U.S. Court of Appeals for the Federal Circuit issued two rulings in biosimilar-related appeals from final written decisions by the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. Genentech v. Iancu (USPTO), Nos. 19-1263, -1265, -1267, -1270 On March 26, 2020, the Federal…