Axsome Therapeutics stock price rallied this week after the announcement that it had settled its patent lawsuit against Teva. Sell-side analysts have raised the stock target now that Auvelity’s generic threat has been eliminated. Under the terms of the settlement, Teva will not enter the market until 2038 or 2039. Even if other generics emerge, Axsome is likely hampered from offering an earlier date. This could make Axsome an attractive acquisition target, similar to how Intra-Cellular was recently acquired shortly after settling with a generic for its drug, Capylta. How did Axsome accomplish such a favorable settlement? What was Axsome’s patent strategy for Auvelity.
Read MoreRecent 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 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 ($ABBV). The case is currently pending within the Northern District of Illinois (In Re: Humira (Adalimumab) Antitrust Litigation, No. 19-cv-1873 (N.D. Ill.)). We previously blogged about related allegations before the case was filed when Boehringer Ingelheim raised them within its biosimilar litigation against AbbVie. On June 8, 2020, the Illinois federal court dismissed the antitrust action pursuant to AbbVie’s motion to dismiss. What are the takeaways from the case?
Read MoreThe Court in AbbVie’s patent fight over Humira with Boehringer Ingelheim said that it “seems clear enough” that AbbVie had a patenting program designed to mitigate biosimilar entry for Humira®. Though AbbVie clearly danced around ways to avoid producing much of its behind-the-scenes strategizing for building a patent estate sizeable enough to practically coerce settlements, the Court has ordered AbbVie to pull up its skirt.
Read MoreBoehringer Ingelheim has been one of the lone holdouts in AbbVie’s ($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?
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