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Posts tagged biologic
Will Amgen’s PCSK9 loss read-through to patents covering other biologics drugs?

The long-running patent dispute between Amgen ($AMGN) and Regeneron($REGN) and Sanofi over their competing PCSK9-inhibitors (Repatha® and Praluent®) has reached another milestone.  The case also represents another milestone in the changing landscape for patents covering biologic drugs.  The Amgen decision is at least the second district court decision this year that has invalidated biologic antibody patents under the doctrine of enablement.  The earlier decision related to MorphoSys patents asserted against Janssen related to Darzalex®.  The takeaway is clear:  as biologic drugs take up a larger share of the pharmaceutical medications in the U.S., courts are making it harder for drug companies to use overly-broad patents to corner the market on a particular inhibitor.

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District of Delaware Makes it Harder to Corner the Market on Antibody Patents in MorphoSys v. Janssen

See our post in IPWatchdog. “The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.”

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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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What are the takeaways from the Remicade® antitrust decision between Pfizer and J&J?

We 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?

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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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Coherus denied institution on Enbrel® IPRs – how does that affect Sandoz?

The 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?

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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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What is the take-away from the Federal Circuit’s latest BPCIA decision?

Since 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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