Regeneron perpetuated Eylea as a blockbuster by using its patents to block entry of lower-cost generics.  When those patents neared expiration, Regeneron launched a new formulation covered by at least one patent, namely, Eylea HD.  One of those patent only recently issued, but has already been challenged by at least one prospective generic in a Post-Grant Review (PGR) proceeding before the Patent Trial and Appeal Board of the Patent Office (PTAB).  Will that challenge succeed?  

In 2023, the Supreme Court issued a decisive opinion that undermined the validity of broad functional genus claims for patents directed to biological antibodies. I published an article on IPWatchdog that examines numerous alternative strategies for patenting antibodies that can survive enablement and written description challenges, with a focus on paratope mapping with CDR-scanning technology. Go to IPWatchdog for full article.

Erasca, Inc. is a clinical stage oncology company developing drugs focused on RAS/MAPK pathway-driven cancers.  In January of this year, the company announced encouraging early clinical data for one of its candidates, ERAS-0015.  Then, in late April, the company received a letter from a potential competitor, Revolution Medicines, Inc. (“RevMed”).  The letter alleged that Erasca’s ERAS-0015 candidate infringes RevMed’s patent, that Erasca misappropriated trade secrets and that Erasca improperly compared pre-clinical data for its candidate with RevMed’s drug.  How concerned should Erasca’s investors be of RevMed’s allegations?

Biomarin’s effort to block Yuviwel, Ascendis’ TransCon CNP drug, has reached a lull.  Last year, Biomarin brought a proceeding before the International Trade Commission (ITC) to block Ascendis from importing its drug.  The ITC held an evidentiary hearing in late April of this year, and the ALJ is scheduled to issue its “final initial” determination by the end of August.  In the meantime, the Commission Investigative Staff (Staff) filed its brief following the evidentiary hearing.  Does the Staff’s findings bode well or ill for Ascendis’ hopes of keeping its Yuviwel drug on the market?

Biomarin’s campaign to block Ascendis from importing its new TransCon CNP drug is getting into the thick of it.  The Markman hearing is scheduled for February, and the evidentiary hearing is scheduled for late April.  In a prior post, I discussed the upcoming Markman hearing, which both parties are likely to rely upon to tee up arguments on infringement and invalidity.  Yet, even if Ascendis fails to prove that it does not infringe the patent, and also fails to invalidate the patent, there are two additional defenses that Ascendis could rely upon—public interest and intervening rights.  What are these defenses, and how strong are they? 

Amicus Therapeutics has been fighting off prospective generics for Galafold®.  Teva settled with Amicus in October 2024, but Aurobindo continued to fight.  The parties recently went to trial, and on November 5, they exchanged their first round of post-trial briefing.  The briefing suggests Amicus faces risk under Section 101 for at least two of its patents as well as prior art risk on all of them.  What do the briefs say?

Biomarin’s bid to block Ascendis from launching a competing drug for treating achondroplasia is nearing the merits.  Biomarin started its campaign in the International Trade Commission (ITC), and in response, Ascendis filed two district court declaratory judgment actions.  Ascendis withdrew the first DJ action, and the second one has been stayed.  The ITC case is now scheduled to hear the parties’ claim construction disputes later this month.  The outcome of that hearing, which will finally touch upon the merits of Biomarin’s infringement allegations, could prove to be a major inflection point in this dispute.  What’s at stake in the upcoming Markman hearing?     

Arbutus’ patent dispute with Moderna is nearing trial.  In anticipation of that, the parties have exchanged cross-motions for summary judgment seeking to limit the issues to be heard at trial.  This blog post will address Moderna’s most important summary judgment argument, namely, the lion’s share of its potential liability should be shifted to the Government under § 1498.  (Future posts will address the parties’ other summary judgment arguments.). I previously blogged about Moderna’s § 1498 defense shortly after this case began.

On July 16, Madrigal Pharmaceuticals announced that it had secured a new patent extending that may protect its drug, Rezdiffra, for almost another 20 years.  The company announced that the Patent Office had issued a Notice of Allowance for a pending patent application.  The press release indicated that the patent will include “claims directed to Rezdiffra’s commercial weight-threshold dosing regimen as prescribed in the FDA-approved label.”  Is this patent strong enough to protect the drug from generics until 2044?

Biomarin Pharmaceutical sells Voxzogo, which is indicated for treatment of a genetic condition known as achondroplasia, which is the leading cause of short-limbed dwarfism.  Ascendis Pharma has applied to the FDA for license to sell a competing drug, TransCon CNP. Hoping to stifle Ascendis’ path to the market, Biomarin has launched an ITC case seeking to block Ascendis from importing its drug into the US. For now, Ascendis is relying upon a safe harbor defense. Can Biomarin use its Orange Book patents to preemptively block a competing drug from Ascendis?

Merck recently announced that it will be acquiring Verona Pharma.  The deal is slated to potentially offset losses as Merck’s blockbuster Keytruda gives way to generic competition.  Verona’s principle drug is Ohtuvayre, which is an inhaled treatment indicated for chronic obstructive pulmonary disease (COPD).  Ohtuvayre was approved in June 2024 in the U.S., and it has received five years of NCE exclusivity.  Merck has high hopes for Ohtuvayre, and some analysts have suggested the drug to reach $4 billion a year.  The drug is only protected by four patents, including a polymorph patent that expires in 2031, but could receive another five years of PTE.  Is that enough to protect Merck’s acquisition of Verona? 

Elon Musk wants to “delete” all intellectual property law.  Yet, Tesla has roughly 13,000 patents and pending applications worldwide.  Patents can provide a unique lens for investors to view a company since patent applications can reveal material information about crowded art or the lack of prototypes.  Tesla’s trillion dollar valuation is based in large part on robotaxis.  So how many patents does the company have for its robotaxis?

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?

I’ve blogged several times about the ongoing patent dispute between Arbutus and Moderna.  The case is nearing the end of expert discovery and is headed for trial towards the end of 2025.  A recent discovery dispute between the parties highlighted an important issue to watch as the case nears trial.  The dispute concerns Arbutus’ testing of Moderna’s vaccine—Moderna claims that the parameters used to setup the testing may have been faulty.  Does Arbutus have a testing problem, or Moderna grasping for straws in the face of troubling test results?

Pfizer is currently attempting to fend off generics for Vyndamax and Vyndaqel.  Both drugs indicated for treatment of cardiomyopathy caused by transthyretin amyloidosis.  Both contain the same active ingredient, tafamidis, but one is a salt form.  Vyndamax contains the free acid form of tafamidis, whereas Vyndaqel contains the meglumine salt of tafamidis. Pfizer has patents for both drugs, expiring as early as 2025 and as late as 2035. How long can Pfizer keep out generics?

Merck is planning to sell a subcutaneous version of its blockbuster Keytruda that can be injected rather than administered intravenously.  Yet, standing in the way of that is a growing portfolio of patents recently acquired by Halozyme Therapeutics.  In 2024, Halozyme was awarded numerous patents covering modified PH20 hyaluronidase polypeptides.  Merck immediately went to the Patent Office and filed petitions for the patents to be cancelled.  What is the likelihood Merck’s patent challenges will succeed?  Or Merck will be compelled to sign a license for Halozyme’s patents. 

It is not news that GLP-1 agonists sold by Novo Nordisk (semaglutide) and Eli Lilly (tirzepatide) are surging in demand and could become one of the influential drugs ever.  That demand contributed to a shortage of the active ingredients in Lilly’s and Novo Nordisk’s drugs.  During that time, drug compounders stepped into meet the supply the brands couldn’t provide.  The FDA recently announced those drug shortages were over.  The compounders sued the FDA, the brands intervened, and the cases are proceeding on an expedited basis.  What’s the status of the cases?  And, even if the drugs are returned to the shortage list, can Novo Nordisk and Lilly resort to their patents to maintain their GLP-1 monopolies?

Soleno Therapeutics is anxiously awaiting FDA approval on its extended-release formulation of diazoxide choline (DCCR), which is indicated for treating Prader-Willis syndrome (PWS). Soleno’s drug has already received breakthroughdesignation status from FDA, as well as orphan drug designation.  Together, that suggests that if Soleno’s drug is approved this month, it will receive FDA-approved exclusivity for seven years.  Yet, after that, which patents does Soleno have that it can use to delay entry of generics?

Acadia has been embroiled in a patent dispute with MSN Pharmaceuticals over a generic version of Acadia’s Parkinson’s Disease drug Nuplazid® (pimavanserin).  The lawsuit boiled down to a single dispute over a single legal issue concerning a single patent.  In December 2023, the district court ruled in favor of Acadia.  The case is now on appeal before the Federal Circuit. What are the chances of MSN prevailing on appeal?