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Posts tagged generic
Korlym® faces another potential generic from Sun Pharma

Another generic has filed an ANDA with the FDA for a license to distribute a generic version of Korlym®.  Teva is no longer the only company seeking to sell generic Korlym®, which therefore increases the likelihood that Corcept Therapeutics ($CORT) will face a generic competitor for its main drug at some point in the future.

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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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Is Corcept’s new Korlym lawsuit a game-changer against Teva?

Corcept Therapeutics ($CORT) recently filed a new lawsuit against Teva ($TEVA) related to Teva’s proposed generic for Korlym®.  The new suit asserts three new patents that were recently listed in the Orange Book.  Are the three new patents a game-changer?

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Will Celgene and Dr. Reddy’s settle the Revlimid dispute now that Bristol Myers is at the table?

Celgene ($CELG) has announced plans to be acquired by Bristol Meyers Squibb ($BMY).  A settlement conference is scheduled in the Hatch-Waxman patent case between Celgene and Dr. Reddy’s on January 10, 2019.  Now that Bristol Meyers is at the table, will the parties be able to reach a settlement that couldn’t be reached before?

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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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Korlym: Will Teva prevail on its motion to dismiss the amended complaint?

We previously wrote about Corcept’s ($CORT) amended complaint in its Hatch-Waxman patent litigation against Teva ($TEVA) regarding Korlym®.  On July 27, Teva filed another motion to dismiss.  Corcept opposed the motion on August 21, and Teva filed its reply on August 28.  The motion is now fully briefed.  Who will prevail?

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Senator Hatch Thinks Some Industries Deserve Patents More Than Others

Senator Orrin Hatch (R-UT) recently proposed an amendment to the Hatch-Waxman Act that would significantly upset the availability of petitions for inter partes review (IPR) for generic pharmaceutical companies.  Senator Hatch appears to believe that brand pharmaceutical companies deserve patents more than others.  

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Will Corcept Therapeutics’s new patent for Korlym® help against Teva’s generic?

On April 17, 2018, a new patent issued to Corcept Therapeutics ($CORT) that covers Korlym®.  The patent is U.S. Patent No. 9,943,526 pursuant to U.S. Patent Application No. 15/133,791.  The ‘526 patent has already been added to the Orange Book.  Korlym® was already protected by two patents listed in the Orange Book, and Corcept recently commenced a Hatch-Waxman litigation against Teva asserting these two patents.  How effective is the new ‘526 patent at keeping Teva at bay?

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