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 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?

Pacira Pharmaceuticals has been busy protecting Exparel from generic competition.  For the past few years, Pacira has launched multiple patent lawsuits against Jiangsu Hengrui Pharmaceuticals, along with its regulatory agent, eVenus Pharmaceutical Laboratories.  In December 2024, Pacira acquired a new patent and immediately commenced another patent suit against Jiangsu Hengrui.  The patent is U.S. Patent No. 12,156,940, and it will not expire until 2044.  It is the parent patent in a new family, and Pacira has already filed a follow-up application to the ‘940 patent, which suggests more patents are in the pipeline.  What is the ‘940 patent?  And how successful will it be for prolonging Pacira’s monopoly pricing for Exparel?

For the past couple of years, Novo Nordisk was embroiled in patent litigation with numerous prospective generics for Ozempic.  In the fall of 2024, Novo Nordisk wrapped up existing claims and settled with numerous generics, including Mylan, Dr. Reddy’s, Apotex, Sun Pharmaceuticals, among others.  The terms of those settlement agreements, however, are confidential, leaving investors uncertain as to the expected entry date for generic Ozempic.  Novo Nordisk has two other semaglutide drugs, over which it is currently litigating different patents with generics.  What is the patent landscape for Novo Nordisk’s Semaglutide products, Ozempic, Wegovy and Rybelsus?

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? 

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?

We previously blogged about Exelixis ($EXEL) shortly before it commenced its Hatch-Waxman suit against MSN Pharmaceuticals in connection with its prospective generic for Cabometyx®. What has happened in the suit since then?

On November 5, 2020, the Federal Circuit issued a precedential decision, Vaeleant Pharmaceuticals v. Mylan Pharmaceuticals, that is likely to have a significant impact on the litigation of Hatch-Waxman cases—including the possible development of “generic-friendly” districts. In short, if this decision stands, the future of patent pharma litigation against multiple generics for the same drug will likely be spread out, difficult to consolidate, subject to multiple forums determining in parallel common issues related to infringement and invalidity. Costs for brands are likely to go up along with settlement leverage for generics. Although, exactly who wins and who loses from this decision remains to be seen.

We previously blogged about the upcoming litigation trial between Amarin Pharmaceuticals ($AMRN) and Dr. Reddy’s and Hikma, which are two prospective generics for Amarin’s Vascepa®.  While that blog post provided a general overview of the issues to be litigated at the upcoming trial, there are numerous other issues and questions around the upcoming trial.  This post will focus on how the REDUCE-IT trial may impact Amarin’s fight with the existing generics, if at all.

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 American University Law Review recently published a very timely and compelling article on the intersection between the Hatch-Waxman Act and the BPCIA, on the one hand, and post-grant proceedings at the PATB, on the other.  The article, which is titled, Ships in the Night: Resolving Administrative Conflict Between FDA- and Patent-Related Legislation, American Univ. Law Review [Vol. 68:1111], (hereinafter, “Garcia & Stroud”), is authored by Carlos A. Garcia, Patent Counsel, Eli Lilly & Company, and Jonathan Stroud, Chief IP Counsel, Unified Patents Inc.  The article is a comprehensive and thorough overview of how petitions for inter partes review and other post-grant proceedings may be impacting efficient resolution of patent issues for generic drugs.

Exelixis ($EXEL) recently received a Paragraph IV certification against its drug, Cabometyx, which is indicated for kidney cancer and as a second-line treatment for liver cancer.  The certification was sent by MSN Pharmaceuticals.  A lawsuit is likely to be filed by Exelixis against MSN within 45 days of the Paragraph IV certification.  How well-positioned is Exelixis to fight this generic challenge? 

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.

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?

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?

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?

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?

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?

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.