Patent Valuation, Monetization and Investments

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Markman Advisors Patent Blog

by Zachary Silbersher

Posts tagged $TEVA
Korlym: What do the post-trial briefs say about what happened at trial?

In late September, Corcept Therapeutics finally went to trial against Teva in the parties’ long-running patent dispute over Teva’s prospective generic for Korlym.  The Hatch-Waxman litigation between the two companies has been waging since 2018.  Numerous patents have come in and out of the case over that time.  Yet, by the time of the trial a few weeks ago, Corcept had narrowed its case down to alleging Teva’s infringement of only two patents: U.S. Patent No. 10,195,214 and 10,842,800.  The parties’ post-trial brief have been filed.  What do they say?

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What is at the heart of the GSK skinny-label standoff at the CAFC?

I previously blogged about the surprising case, GlaxoKlineSmith v. Teva (GSK), where the Federal Circuit held that a generic pharmaceutical company can, under the right circumstances, be liable for inducing infringement of a method-of-use pharmaceutical patent despite carving out the patented indication from its label. The decision at first spooked the generic pharmaceutical industry, but was then followed by two additional opinions—one related to a panel rehearing, followed by another one, which issued on February 11, 2022, denying a hearing en banc, which included a fiery dissent. These decisions show clear disagreements among the Judges at the Federal Circuit. What is at the heart of this dispute?

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Korlym: A review of the PTAB’s institution decision for Teva’s PGR of the ‘214 patent.

We previously blogged about Teva’s ($TEVA) petition for post-grant review (PGR) of Corcept Therapeutics’ ($CORT) ‘214 patent.  Since then, on November 20, 2019, the PTAB granted institution of Teva’s petition.  The proceeding will now be litigated for another year before a final decision.  On a recent earnings call, Corcept stated that it believes the standard for institution is “pretty low,” and not necessarily dispositive that Teva will prevail.  Now that we have the institution decision, what can we glean from it, and how likely is that Corcept’s patent survives?

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Can Amarin’s patents protect Vascepa from generics?

Amarin Pharmaceuticals ($AMRN) will be going to trial soon to protect Vascepa® against generic competition.  Amarin has asserted 15 claims from six patents against ANDAs filed by Hikma, Dr. Reddy’s and Teva.  What are the issues to be addressed at trial?

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Will Teva’s PGR against Corcept’s ‘214 patent covering Korlym be instituted?

The saga over Corcept Therapeutics’s ($CORT) patent battles against prospective generics for Korlym® is approaching another stage.  We previously discussed Teva’s ($TEVA) petition for post-grant review (PGR) of the ‘214 patent.  Corcept has filed its preliminary response to Teva’s PGR, and the PTAB is scheduled to decide whether or not to institute the PGR by about November 23, 2019.  The ‘214 patent is potentially the strong patent Corcept is currently wielding against generics, since it arguably does read upon Korlym®’s label.  Now that the papers are in, what are the odds Teva’s PGR is instituted? 

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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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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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