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Posts tagged protein
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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MorphoSys loses its Darzalex patent case against J&J—what happens next?

Morphosys’ ($MOR) patent trial against Janssen ($JNJ) and Genmab was headed for trial in February.  In advance of that trial, however, the parties traded numerous summary judgment motions.  On January 26, Genmab announced that the District Court granted its motion to invalidate the asserted patents.  What happens next?

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What do the Court’s December 4 rulings mean for MorphoSys' Darzalex patent case?

Earlier this week, we blogged about the series of pending summary judgment motions in MorphoSys’ ($MOR) lawsuit accusing Janssen’s ($JNJ) Darzalex® of infringing its patents.  The Court heard oral argument on December 3.  The transcript of that hearing is not currently publicly available.  The Court, however, did issue oral rulings at the end of the hearing that hit the docket on December 4.  What do the rulings mean?

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Will MorphoSys’ Darzalex patent case against Janssen make it to trial, or be stopped at summary judgment?

The Darzalex® patent case commenced by MorphoSys against Janssen is headed towards trial.  Before that, however, the parties recently filed a series of summary judgment motions, and on December 3, 2018, the Court heard oral argument.  Will the Court moot the trial by granting Janssen’s motions to invalidate the patents?

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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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Can Coherus invalidate Amgen's Enbrel® patents? Part 2

In an earlier post, we discussed the pending IPRs filed by Coherus Biosciences against Amgen’s two patents covering its Enbrel® protein (entanercept).  Whereas our earlier post summarized Coherus’s argument for why the fusion protein claimed in Amgen’s ‘182 and ‘522 patents should be found obvious by the PTAB, this post will summarize Amgen’s preliminary response. 

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Amgen asks the full Federal Circuit to reconsider its PCSK9 loss

Earlier this year, in October, the Federal Circuit vacated Amgen’s hard-earned injunction against Praluent®, the only other PCSK9 drug competing with its own, Repatha®.  The case has been remanded to the District Court of Delaware for a new trial on the validity of Amgen’s patents.  Before that could happen, however, earlier this week Amgen petitioned the Federal Circuit for en banc review of its October 5, 2017 decision that cut against Amgen.  What are Amgen's chances?

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