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 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 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 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 MoreWe previously blogged about Pfizer’s ($PFE) antitrust lawsuit against Johnson & Johnson ($JNJ) related to Janssen’s Remicade®. In short, Pfizer launched Inflectra® in 2016, which is a biosimilar to Janssen’s Remicade®. Yet, Inflectra® has struggled to eat into Janssen’s monopoly for Remicade®. Pfizer claims that Inflectra®’s poor sales are due to anticompetitive rebate schemes by Janssen. Specifically, Janssen forced hospitals and insurers to enter exclusive arrangements and bundled-rebated programs that discouraged them from stocking or covering Inflectra®. Pfizer sued Janssen in the Eastern District of Pennsylvania. Janssen moved to dismiss, but on August 10, the Court denied Janssen’s motion to dismiss. What are the takeaways?
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 MoreThe PTAB has denied institution of two IPRs filed by Coherus Biosciences against patents covering Enbrel®’s proteins, the ‘182 and ‘522 patents. The IPRs were not filed by Sandoz, but they will most likely affect Sandoz. Sandoz already has FDA approval to market Erelzi®, which is its biosimilar for Enbrel®. And Sandoz is going to trial against Amgen in April. How do Coherus IPR decisions affect Sandoz's decision to launch at risk? Or to settle with Amgen?
Read MoreFDA’s Commissioner Scott Gottlieb said today that a “rigged” system between drug firms and insurers is stifling entry for less-expensive biosimilars. Gottlieb stated that certain payment arrangements “raise another, perhaps even more insidious barrier to biosimilars taking root in the U.S., and gaining appropriate market share.” Is J&J’s exclusionary contract scheme to discourage competition with Pfizer’s biosimilar for Remicade® a poster child for what Gottlieb is lamenting? Pfizer recently sued Janssen over that very question, and the federal court is scheduled to decide a motion answering that question very shortly.
Read MoreSandoz recently prevailed in court against Amgen by showing it does not infringe a patent covering two of Amgen’s drugs, Neulasta® and Neupogen®. No biosimilar has yet to receive FDA approval for Neulasata® within the U.S. Sandoz recently announced successful Phase 1 data indicating it may be getting closer. Further, other biosimilars for Neulasta® are in the works. Given that Neulasta® accounts for a third of Amgen’s sales, will Amgen’s recent loss in its case against Sandoz read-through to other biosimilars?
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.
Read MoreIn February 2016, Amgen brought suit against Sandoz in connection with its proposed biosimilar for Amgen’s Enbrel® blockbuster. The case is on a relatively fast track, currently scheduled to go to trial later this year in April. Some investors have inquired about whether Sandoz has a strong obviousness-type double-patenting invalidity defense for the ‘182 patent.
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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