When does a pile of sand become a heap? When is a portfolio of patents too many patents? Can using too many patents to compel generics to take a later entry date turn into monopolistic conduct? These questions lurk the heart of the antitrust litigation brought by buyers of the blockbuster drug, Humira®, against its manufacturer, AbbVie ($ABBV). The case is currently pending within the Northern District of Illinois (In Re: Humira (Adalimumab) Antitrust Litigation, No. 19-cv-1873 (N.D. Ill.)). We previously blogged about related allegations before the case was filed when Boehringer Ingelheim raised them within its biosimilar litigation against AbbVie. On June 8, 2020, the Illinois federal court dismissed the antitrust action pursuant to AbbVie’s motion to dismiss. What are the takeaways from the case?
Read MoreBoehringer Ingelheim has claimed that AbbVie wrongfully created a “patent thicket” around Humira®, and it is delaying biosimilar competition. While that defense is unique, and may be hard to prove on its face, the FDA appears to agree with Boehringer. Did AbbVie create a wrongful “patent thicket” around Humira®?
Read MoreAbbVie ($ABBV) has commenced its latest litigation in its campaign to keep biosimilars for Humira® at bay. On August 10, AbbVie brought suit against Sandoz ($NVS) asserting that two of AbbVie’s patents will be infringed by Sandoz’s proposed biosimilar. Sandoz is the fifth biosimilar to throw its hat in the ring. Does this increase the odds of the US market seeing a biosimilar for Humira® before 2023?
Read MoreThe biosimilar statute, Biologics Price Competition and Innovation Act (BPCIA, was passed in 2010. Since then, drug companies have been filing biosimilar applications with FDA. And even though, FDA has approved only nine biosimilar drugs today, an interesting trend may be emerging: biosimilars may be more willing to launch at-risk than small-molecule generics.
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