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? 

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?

I previously blogged about the Exelixis patent dispute. The Cabometyx patent trial occurred last week (May 16). A recent note on Seeking Alpha indicates that comments from the court during the trial suggests that Exelixis may lose on the ‘776 patent, but win on the ‘473 patent. (I was one of two patent experts on the Truist call referenced in the note.) If that happens, will Exelixis still be able to secure freedom from generics through 2030 based upon the ‘439, ‘440 and ‘015 patents asserted in its second lawsuit?

Exelixis is on the eve of trial against MSN over its prospective generic for Cabometyx. Yet, there are now two separate patent litigations between the companies related to Cabometyx. Exelixis succeeded in slowing down MSN’s entry by keeping the cases separate, but an MSN victor in the upcoming trial may increase the odds of an at-risk launch.

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?

The Federal Circuit has issued a precedential decision addressing whether a patent covering a given polymorph was invalid as obvious, Grunenthal GmbH v. Alkem Laboratories Ltd.  Though the Court explained that it was not establishing a categorical rule that polymorph patents can never be obvious, the case nonetheless provides important guidelines for when a polymorph patents are likely to be invalid.  For those following Revlimid®’s patent cases, the immediate question is—does the Grunenthal case have read-through to Celgene’s polymorph patents? 

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?

Yesterday, we blogged about why the Markman hearing was cancelled in Celgene’s Revlimid® patent case against Dr. Reddy’s.  Some analysts suggested that this is a positive indication of a settlement approaching with Dr. Reddy’s and possibly with all generics.  We weigh in.

On March 23, Celgene and Dr. Reddy’s informed the Court that they jointly have resolved the single pending claim construction dispute—namely, the construction of the word “crystalline” within the two asserted polymorph patents.  What does this mean for the case?

A number of generics are moving in on Celgene's Revlimid.  Leading the pack is Dr. Reddy’s, and although Celgene has asserted numerous patents against Dr. Reddy’s proposed generic, a single issue has crystallized in advance of an upcoming Markman hearing that could make or break the case.