Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
Here are our picks of some legal developments to keep an eye out for in the new year: 1. Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s...more
As we previously reported, currently pending before the Federal Circuit are consolidated appeals from five final written decisions of the Patent Trial and Appeal Board (Board) in inter partes review (IPR) proceedings finding...more
As we previously reported, Sandoz appealed the PTAB’s decision not to institute an IPR regarding AbbVie’s U.S. Patent No. 9,512,216, which relates to a method for treating moderate to severe chronic plaque psoriasis using...more
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more
On November 11, 2017, Pfizer, Inc. filed a petition for inter partes review (IPR) of Biogen and Genentech’s US Patent No. 8,545,843, which relates to a method of treating vasculitis with rituximab. (IPR2018-00086.) On May 31,...more
Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more
Here are some updates since our last IPR update: HUMIRA - On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). ...more
Today Sandoz filed IPR2018-00002, directed to AbbVie’s U.S. Patent No. 9,512,216. According to the petition, the ’216 patent claims a subcutaneously-administered dosing regimen for the anti-TNF-a antibody adalimumab, the...more
The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more
Sandoz has filed two petitions for IPR challenging Abbvie patents related to use of an antibody identified in the petitions as Humira® (adalimumab): IPR2017-01987 challenging U.S. Patent 8,911,737, directed to methods of...more
Sandoz has filed a petition for inter partes review of AbbVie’s U.S. Patent No. 8,802,100 (IPR2017-01823), which claims stable formulations of an anti-TNFa antibody identified in the petition as Humira® (adalimumab). Sandoz...more
I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same...more
The Patent Trial and Appeal Board (the “Board”) issued a final written decision in an inter partes review determining Claims 1-5 of U.S. Patent No. 8,889,135 owned by Abbvie Biotechnology Ltd. unpatentable as obvious...more
The PTAB has issued Final Written Decisions in IPRs filed by Coherus against two of Abbvie’s patents, IPR2016-00188 (U.S. Patent No. 9,017,680) and IPR2016-00189 (U.S. Patent No. 9.073,987), finding the challenged claims...more
The PTAB has issued a Final Written Decision in IPR2016-00172, filed by Coherus, finding Abbvie’s U.S. Patent 8,889,135 unpatentable as obvious over the prior art. The ‘135 patent is directed to methods of treating rheumatoid...more
Coherus Biosciences has filed two petitions for inter partes review of Abbvie’s U.S. Patent 9,085,619. (IPR2017-01008 and IPR2017-01009). Coherus recently filed four other petitions for inter partes review of the ‘619...more
Samsung Bioepis, Biogen, and Fujifilm Kyowa Kirin Biologics are seeking to invalidate some of AbbVie’s patents related to Humira® (adalimumab) before the UK High Court of Justice. The patents at issue relate to methods of...more
Yesterday, Coherus filed its Petitioner Reply in IPR2016-00188 (U.S. Patent 9.017,680), IPR2016-00189 (9,073,987), and IPR2016-00172 (U.S. Patent 8,889,135)...more
The PTAB has denied institution of inter partes review of Abbvie’s U.S. Patent No. 9,114,166, finding that Petitioner Coherus had not established a reasonable likelihood that it would prevail in showing the unpatentability of...more
To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price...more
The Board has instituted IPR2016-00408 and IPR2016-00409 on AbbVie Biotechnology’s U.S. Patent No. 8,889,135, which covers methods of treating rheumatoid arthritis with a human anti-tumor necrosis factor a antibody. This...more