In 2024, the Federal Circuit held—for the second time—that a generic pharmaceutical company could, under certain circumstances, be liable for inducing infringement of a method of use patent for a carved out indication.  Hikma, the aggrieved generic, has petitioned to the Supreme Court.  On June 23, the Supreme Court took an interest by soliciting the views of the United States.  If left to stand, the growing precedent over inducement for section viii indications may stifle investment into generic drugs.  Will the Supreme Court save lower-cost medications from inducement by skinny labels?

Axsome Therapeutics stock price rallied this week after the announcement that it had settled its patent lawsuit against Teva.  Sell-side analysts have raised the stock target now that Auvelity’s generic threat has been eliminated.  Under the terms of the settlement, Teva will not enter the market until 2038 or 2039.  Even if other generics emerge, Axsome is likely hampered from offering an earlier date.  This could make Axsome an attractive acquisition target, similar to how Intra-Cellular was recently acquired shortly after settling with a generic for its drug, Capylta.  How did Axsome accomplish such a favorable settlement?  What was Axsome’s patent strategy for Auvelity. 

The FTC recently challenged scores of pharmaceutical patents as improperly listed in the Orange Book.  This was an important because, among the many ways that BigPharma has been accused of abusing the patent system to block lower-cost generic formulations, attacking Orange Book listings has had limited success in the past.  In 2020, the First Circuit endorsed antitrust allegations against Sanofi for improperly listed patents.  More recently, the Federal Circuit issued a precedential decision limiting the scope of patents that can be permissibly listed in the Orange Book.  This is also an important decision because it is one of the few precedential decisions from the Federal Circuit to address this issue.  What are the policy implications of the Federal Circuit’s recent ruling regarding Orange Book patent listings? 

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?

Bad facts make bad law.  The case of GlaxoSmithKline’s lawsuit over Teva’s generic Coreg® drug is a case-in-point.  I previously blogged about the case here and here.  Given that the Supreme Court declined to grant certiorari, we’re now stuck with Federal Circuit precedent holding that a generic can still face liability for induced infringement of a method-of-use patent covering a section viii carved-out indication.  What will be the consequences of this?

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?

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?

The battle continues. We previously wrote about the Federal Circuit’s decision in the case (GlaxoSmithKline v. Teva) and how that case may offer Amarin another chance to bar generics from the market for Vascepa®. Sure enough, on November 30, Amarin filed suit against Hikma asserting three patents covering use of EPA to treat cardiovascular events. What are the takeaways from this suit?

Just when you think the Amarin saga to keep out generic competition is over, something else happens. In the latest development, the Federal Circuit issued a precedential decision in an unrelated case (GlaxoSmithKline v. Teva) that suggests that a generic could potentially be liable for inducing infringement of a patented indication, even though that indication has been carved out of the generic’s label. Will this decision benefit Amarin?

In Amarin’s pending Hatch-Waxman Vascepa case against Dr. Reddy’s and Hikma, we see at least obstacles to settlement at this time before resolution of the appeal: money, entry and invalidity.

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?

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?

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.

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).

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.

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?

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? 

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?