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Posts tagged Novartis
Is Novartis’ S1P modulator titration patent a “roadblock” to Celgene’s ozanimod?

While Bristol Myers ($BMY) proposed acquisition of Celgene’s ($CELG) remains in question by activists questioning Revlimid®’s pending patent cliff, a new patent angle emerges.  A Credit Suisse analyst recently identified a patent owned by Novartis ($NVS) that could purportedly act as a “roadblock” to Celgene’s MS drug ozanimod.  Is this true?

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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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What is Regeneron’s exposure from Novartis’ patent case against blockbuster Eylea®?

Novartis has filed a patent lawsuit against Regeneron seeking damages for sales of Eylea® and Zaltrap®.  On March 19, 2018, Novartis sued Regeneron in the Southern District of New York, White Plains Division, for infringing U.S. Patent No. 5,688,688.  The ‘688 patent claims gene expression constructs for the expression of polypeptides in mammalian cells.  How strong is Novartis’ case, and what is Regeneron’s exposure?

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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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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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