While Alice arguably wreaked havoc for the past decade on patent plaintiffs, its reach into patents asserted by brand pharma companies was much more limited.  A patent appeal between Sonos and Google currently pending before the Federal Circuit is likely to test the bounds of the doctrine of prosecution laches.  Sonos claims it was robbed of a $32 million jury verdict after the district court found Sonos waited too long to pursue the claims asserted at trial.  Amicus briefs have poured in highlighting a veritable policy debate over prosecution laches.  Could the doctrine of prosecution laches eventually stifle patent evergreening for pharma patents in a way that Alice never could?

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?

Corcept Therapeutics has been battling for years to halt Teva’s generic for Korlym®.  Although Corcept started off with only two patents, it has been adding patents to the Orange Book ever since Teva’s ANDA was filed.  By periodically litigating those patents in piecemeal fashion, Corcept has delayed generic Korlym®’s availability to consumers at lower-cost prices.  Yet, in a recent order, the court finally called out Corcept’s delay tactics and indicated it would award attorneys’ fees.  What happened?

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?

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? 

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.

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?

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?

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?

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?

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?

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?

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?