Patent Valuation, Monetization and Investments

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Markman Advisors Patent Blog

by Zachary Silbersher

Posts tagged Humira
What can the Patent Office do to prune Keytruda’s patent thicket?

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.

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Why was the Humira “patent thicket” antitrust case against AbbVie dismissed?

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?

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Should the PTAB presumptively stay IPRs filed against pharmaceutical patents?

The 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.

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What are the lessons from Boehringer’s settlement with AbbVie over its Humira biosimilar?

And 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?

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AbbVie still can’t escape Boehringer’s claim that its Humira patent-thicket was wrongful.

The 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.

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Is Boehringer Ingelheim planning to launch its Humira biosimilar at-risk?

Boehringer 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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When did Mylan agree to launch its Herceptin biosimilar?

Mylan’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? 

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Did AbbVie create a wrongful “patent thicket” around Humira®?

​​​​​​​Boehringer 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®?

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Will AbbVie’s latest patent suit against Sandoz mean a Humira-biosimilar before 2023?

AbbVie ($ABBV) has commenced its latest litigation in its campaign to keep biosimilars for Humira® at bay.  On August 10, AbbVie brought suit against Sandoz ($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?

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How long can Roche keep back biosimilars for Avastin®, Herceptin® or Rituxan®?

The 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?

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Sandoz lost two IPRs challenging Humira® patents - what does this mean for other biosimilars?

Sandoz was denied institution on two IPRs against Humira® patents owned by AbbVie.  As we previously discussed, in late 2017, Sandoz filed eight different IPRs against Humira® patents.  Two of those IPRs just failed to reach institution.  What are the take-aways, for Sandoz and any other Humira® biosimilars?

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When do biosimilars launch at risk?

The 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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Sandoz’s aBLA for HUMIRA® has been accepted by FDA -- what happens next?

Sandoz, the generic arm of Novartis, has announced that its abbreviated Biologic License Application (aBLA) for a Humira® biosimilar has been accepted by FDA.  Now that Sandoz’s aBLA has been accepted for review by FDA, what happens next on the patent front? 

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