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Posts tagged Teva
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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Another reason drug prices are too high: drug companies can patent an FDA mandate.

High drug prices remain in the news.  A recent precedential decision from the Federal Circuit shows that certain drug prices will stay high if drug companies can simply take a mandate from the FDA, which was not their idea, and file a patent on it, thereby cornering the market on all IP around that mandate.  The case is Endo Pharmaceuticals Inc. v. Actavis, LLC, Case No. 2018-1054 (Fed. Cir. May 3, 2019).

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Federal Circuit clarifies patent-eligibility for diagnostic method patents: Endo v. Teva and Natural Alternatives v. Creative Compounds.

The Federal Circuit has recently issued two precedential decisions that clarify when method-of-use and diagnostic patents are directed to eligible subject matter rather than natural laws.  Some clear guidelines are solidifying that should make enforcement of these principally pharmaceutical-type patents easier to handicap.

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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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Did Corcept and Teva tell the Court they are about to settle the Korlym patent dispute?

On January 10, counsel for Corcept ($CORT) filed a letter with the Court in the pending patent litigation against Teva ($TEVA) over its proposed generic for Korlym®.  (See Dkt. 49).  Within that letter, Corcept requested an extension of one week to respond to Teva’s Answer to the Amended Complaint.  Corcept’s letter further stated that the “parties are currently discussing a potential agreement that would eliminate the need for Corcept to respond to Teva’s Answer . . . .”  Is that potential “agreement” a resolution to the litigation?

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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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Can Teva’s patents block Lilly’s anti-CGRP Emgality from the market?

The anti-CGRP market is heating.  Amgen’s ($AMGN) Aimovig® received FDA approval in May 2018, and Teva’s ($TEVA) Ajovy® received approval in September.  Hot on their heels, Eli Lilly’s ($LLY) Emgality® just received FDA approval at the end of September.  The drugs will all be sold for essentially the same price of $6900 / year.  Given the tight competition, can Teva use its patents to kick anyone off the market?

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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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Can Corcept’s amended complaint hold back Teva’s generic for Korlym®?

We previously discussed Teva’s ($TEVA) motion to dismiss Corcept Therapeutic’s ($CORT) Hatch-Waxman lawsuit commenced in response to Teva’s ANDA for Korlym®.  In response to that motion to dismiss, on July 6, Corcept filed an amended complaint.  What are the implications of that?  And how does the case currently dovetail with the pending patent applications?

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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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Korlym®: Can Corcept defeat Teva’s motion to dismiss?

Earlier this year, Teva ($TEVA) filed an ANDA to distribute a generic version of Korlym®, and soon thereafter, Corcept Therapeutics ($CORT) commenced a Hatch-Waxman patent suit in federal court in New Jersey.  On June 15, 2018, Teva moved to dismiss the case.  What is this motion all about? And will Teva’s motion prevail?

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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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Can Corcept Therapeutics fend off Teva's generic for Korlym®?

Corcept Therapeutics recently received a Paragraph IV notice letter from Teva for its drug, Korlym®.  The market’s reaction crushed the stock, sending it from approximately $23 to roughly $17 within a day.  Corcept Therapeutics has essentially one drug, Korlym® (mifepristone).  But whether Teva will enter with a generic version of Korlym® any time soon depends directly on the patents that Corcept has in its arsenal.  What are those patents?  Is the market’s reaction justified?  Or is this a buying opportunity? 

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