In 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 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 American University Law Review recently published a very timely and compelling article on the intersection between the Hatch-Waxman Act and the BPCIA, on the one hand, and post-grant proceedings at the PATB, on the other. The article, which is titled, Ships in the Night: Resolving Administrative Conflict Between FDA- and Patent-Related Legislation, American Univ. Law Review [Vol. 68:1111], (hereinafter, “Garcia & Stroud”), is authored by Carlos A. Garcia, Patent Counsel, Eli Lilly & Company, and Jonathan Stroud, Chief IP Counsel, Unified Patents Inc. The article is a comprehensive and thorough overview of how petitions for inter partes review and other post-grant proceedings may be impacting efficient resolution of patent issues for generic drugs.
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 MoreMylan’s biosimilar for Herceptin® has FDA approval since December 2017. Several months earlier, in March 2017, Mylan reached a global settlement with Roche and Genentech regarding their patents covering the drug. The terms of the settlement have not been made public, which raises the question – when did Mylan agree to launch?
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 biosimilars are biting. And they are biting at three big biologics distributed by Roche through its biotech subsidiary, Genentech. Roche currently faces pending biosimilar competition against Avastin® (bevacizumab), Roche’s biggest selling cancer drug, Herceptin® (trastuzmab), Roche’s breast-cancer drug, and Rituxan® (rituximab), Roche’s immunotherapy drug. All three drugs are involved in patent litigations. How long will these cases last? And how long can Roche keep the biosimilars out?
Read MoreSince the first BPCIA cases hit the courts a few years ago, the Federal Circuit and the Supreme Court have slowly been entangling the knots and confusions around the complicated regulatory scheme. Innovator companies and biosimilars have wrangled over the “patent dance” and the 180-days notice of commercial marketing, including what’s required, what’s not, and who can leverage a regulatory tactical advantage. A case between Amgen and Sandoz has helped resolve many of these issues, and this week, the Federal Circuit took another step towards gutting the statute. What are the take-aways?
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