Recent amendments to the Pandemic and All-Hazards Preparedness and Response Act (PAHPARA) authorize HHS to study alternative economic models for the pharmaceutical business that essentially divorces research and development costs from drug prices by taking away the state-sanctioned monopolies such as exclusivity periods and patents. Should pharma be forced to make money without patents? Or are there fixes to the patent system that could cut down the delay of entry of lower-cost generics?
Read MoreIn February 2023, United States Senator Elizabeth Warren penned a letter to Kathi Vidal, Director of the USPTO, asking what the Patent Office can do to blunt Merck’s use of patents to stall entry of lower-cost alternatives for Keytruda. Unfortunately for consumers, the answer may be, not that much.
Read MoreSenator Warran recently asked what the Patent Office can do about patent thickets. Yet, the courts are in the unique position of having to contend with scores of patents asserted within a single suit. When a brand pharmaceutical company shows up with 20, 60 or 100 patents in a single suit, those challenges can be exacerbated by orders of magnitude. So, how have courts face this challenge? Regeneron’s pending patent suit against Mylan over its prospective biosimilar for Eyelea® is an interesting example.
Read MoreWhen 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 ($ABBV). The case is currently pending within the Northern District of Illinois (In Re: Humira (Adalimumab) Antitrust Litigation, No. 19-cv-1873 (N.D. Ill.)). We previously blogged about related allegations before the case was filed when Boehringer Ingelheim raised them within its biosimilar litigation against AbbVie. On June 8, 2020, the Illinois federal court dismissed the antitrust action pursuant to AbbVie’s motion to dismiss. What are the takeaways from the case?
Read MoreAnd just like that, it’s over. Boehringer Ingelheim has thrown in the towel in its patent fight with AbbVie over Boehringer’s proposed biosimliar for Humira®. Boehringer was a lone hold-out among a long line of proposed biosimilars for AbbVie’s blockbuster. Boehringer’s distinction was that it had raised a unique defense, namely, arguing that AbbVie had built an unfair “patent thicket” around Humira® that was unenforceable. We previously blogged about Boehringer’s “unclean hands” defense here and here and here. Now that Boehringer has settled, what are the larger lessons for future biosimilar patent fights?
Read MoreThe Court in AbbVie’s patent fight over Humira with Boehringer Ingelheim said that it “seems clear enough” that AbbVie had a patenting program designed to mitigate biosimilar entry for Humira®. Though AbbVie clearly danced around ways to avoid producing much of its behind-the-scenes strategizing for building a patent estate sizeable enough to practically coerce settlements, the Court has ordered AbbVie to pull up its skirt.
Read MoreBoehringer Ingelheim has been one of the lone holdouts in AbbVie’s ($ABBV) campaign to delay biosimilar competition against Humira® until 2023. To date, AbbVie has settled with almost all proposed biosimilars for entry dates in 2023. Is Boehringer going to launch at-risk?
Read More