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Posts tagged Mylan
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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If Hatch-Waxman cases are governed by TC Heartland, will that lead to “generic friendly” districts?

Mylan ($MYL) recently prevailed on a motion to dismiss for improper venue in a pending Hatch-Waxman case for the drug Eliquis®.  Mylan successfully argued that Delaware was an improper venue under the recently test for venue in patent cases enunciated by the Supreme Court in TC Heartland.  What are the implications of TC Heartland governing venue in all Hatch-Waxman cases?  Will it lead to “generic friendly” judicial districts?

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Roche prevails on two IPR challenges to Herceptin patents—does it matter?

We previously wrote about Roche’s encroaching biosimilars for Ritxuan®, Herceptin®, and Avastin®.  This week, Roche prevailed on two IPRs covering patents for Herceptin®, but lost a third IPR covering another patent for the same drug. What does this mean? 

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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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Will the Federal Circuit’s tribal immunity decision in St. Regis Mohawk Tribe v. Mylan make it to the Supreme Court?

The Federal Circuit has sided against the Tribe and Allergan.  On July 20, the Federal Circuit affirmed the decision by the Patent Trial and Appeal Board that denied the motion by the St. Regis Mohawk Tribe to terminate a series of inter partes review proceedings commenced by Mylan ($MYL) against patents listed in the Orange Book for Allergan’s ($AGN) drug Restasis®.  What are the takeaways from this decision?

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Takeaways from the Tribe’s Oral Argument at the Federal Circuit: St. Regis Mohawk Tribe v. Mylan

On June 4, 2018, the Federal Circuit heard oral argument in Allergan’s effort to assert tribal immunity at the PTAB to shut down six IPRs against its Restasis® patents.  The St. Regis Mohawk Tribe has appealed the PTAB’s prior decision that it cannot assert its immunity as a basis to terminate the IPRs.  While there was no clear indication for how the three-judge panel at the Federal Circuit would rule, there were some interesting exchanges revealing how the Court views these types of transactions, and how viable they may be in the future.

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Will Amgen's latest Neulasta® patent loss against Sandoz read-through to other biosimilars?

Sandoz 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?

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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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Notable points from the Tribe's Reply Brief in Restasis® briefing before the PTAB.

The problem with these arguments is that even if they are all true (which is questionable,) they are besides the point.  The issue at stake is whether renting sovereign immunity to evade having to defend the validity of your patent is either permissible or should be permissible.  Indeed, Judge Bryson admonished Allergan for being “conspicuously silent about the broader consequences of the course it has chosen.”  (Allegan v. Teva, Dkt. 522 at 4-5).  Mr. Saunders op-ed in The Wall Street Journal is equally silent. 

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