On August 14, 2025, Genentech filed BPCIA litigation No. 2:25-cv-14648 (D.N.J.) against Shanghai Henlius Biotech (“Henlius”) and Organon alleging infringement of 24 patents by Henlius / Organon’s proposed Perjeta®...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
As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....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
The 2011 America Invents Act (AIA) provided a variety of new ways to administratively challenge patents, including the now widely used inter partes review (“IPR”) procedure. In two recent appeals of IPR decisions, Genentech...more
The PTAB remains a busy venue for biologics patents. Here are some IPR updates from the weeks since our last IPR update...more
The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more
On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved the use of Ocrevus (ocrelizumab) in treating multiple sclerosis (MS). Ocrevus is a new biologic and is the first drug approved by the FDA to treat...more
The PTAB has instituted inter partes review of Genentech’s U.S. Patent 7,622,115, granting Hospira’s petition in IPR2016-01771. According to the institution decision, the patent is directed to methods for treating cancer in...more
The PTAB has instituted IPR2016-01837, in which Hospira challenges Genentech’s U.S. Patent 7,807,799. The institution decision extends to all challenged claims, claims 1-3 and 5-11. ...more
Hospira filed two petitions for inter partes review of Genentech’s U.S. Patent 7,371,379 (IPR2017-00805) and U.S. Patent 6,627,196 (IPR2017-00804). According to the petitions, these patents are directed to methods of treating...more
It has been four years since the first inter partes review proceedings were filed in the United States. The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the...more
As we previously reported, over the past year several petitions requesting Inter Partes Review (IPR) of patents that claim foundational inventions for biologic drug production were filed. Here we discuss the scope of two of...more
On September 9, 2016, Hospira filed a petition for an IPR of U.S. Patent No. 7,622,115, owned by Genentech. The ‘115 patent claims methods of treating various cancers with bevacizumab, which is marketed by Genentech under...more