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’ve previously written about Arbutus’ patent disputes with Moderna and Pfizer.  In Arbutus’ case against Pfizer, the court recently conducting a claim construction hearing.  Before that hearing, Pfizer argued that many of Arbutus’ patents are “indefinite.”  The court held it was premature for Pfizer to make this argument, but Pfizer nonetheless established that when the case reaches summary judgment, it will rely upon the doctrine of indefiniteness to prevail against Arbutus.  What is indefiniteness in patent law?  Are Arbutus’ patents indefinite?  How viable is Pfizer’s “indefiniteness” defense?

On August 26, Moderna issued a press release announcing it will be filing suit against Pfizer and BioNTech for patent infringement. Both Moderna and Pfizer/BioNTech sell Covid-19 vaccines that is based upon mRNA technology. Moderna is accusing Pfizer/BioNTech’s Covid-19 vaccine, Comrinaty®, of infringing Moderna’s patents covering certain features of Moderna’s mRNA technology. (At the time of publishing this post, Moderna’s complaint had not yet been filed. Once the complaint is filed, I will update the post.)

As I previously blogged here and here, Moderna has been tagged with two patent-infringement lawsuits directed to its LNP technology for delivering its mRNA vaccine for Covid. Moderna has now lodged its first defense two each suit—and in each case, it’s the same. Moderna claims that both plaintiffs, including Arbutus/Genevant and Alnylam, have each sued the wrong party. Moderna contracted with the U.S. Government to provide the vaccine, and pursuant to that contract, Moderna claims that the Government agreed to bear the brunt of any residual patent liability. Will the Government have to pick up the tab for Moderna’s patent infringement?

The LNP patent battle lines are being drawn. In the past several weeks, Arbutus has sued Moderna, Alnylam has suedboth Moderna and Pfizer, and in the latest, Acuitas Therapeutics has sued Arbutus and Genevant. What can we expect from the Acuitas lawsuit?

Moderna faces a new patent lawsuit related to its Covid vaccine. On March 17, Alnylam Pharmaceuticals commenced two separate patent lawsuits—one against Moderna and another against Pfizer. Both suits claim that the Covid manufacturers’ vaccines are infringing a patent owned by Alnylam. So what are Alnylam’s lawsuits all about?

On March 7, Moderna updated its patent-pledge with respect to enforcement of its IP rights for its Covid vaccine. In short, Moderna pledged that it will never enforce its patents against Covid vaccines manufactured within certain middle and low-income countries, but may enforce them against vaccines in other countries, such as the US. What are the take-aways from the pledge?

Trillium Therapeutics is a clinical stage immune-oncology company that focuses on cancer treatments, and in particular, treatments that inhibit CD47. Trillium is among a group of drug candidates exploring CD47 targeting agents that are attracting investment from Big Pharma. Pfizer recently announced a $25M investment in Trillium. In conjunction with developing its own two CD47-inhibitor candidates, Trillium is also building out its patent portfolio. On February 2, 2021, two additional U.S. patents issued to Trillium, including U.S. Patent Nos. 10,906,954 and 10,907,209. Will Trillium’s patents offer protection against brand competitors or eventual biosimilars?

Uniqure ($QURE) and Spark Therapeutics ($ONCE) are squaring off over who will soon provide the best haemophilia B gene therapy.  Meanwhile, the companies have acknowledged that intellectual property issues may be critical to which drug will come out on top.  Will the patent issues cloud either drug’s commercial performance?

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? 

We previously blogged about Pfizer’s ($PFE) antitrust lawsuit against Johnson & Johnson ($JNJ) related to Janssen’s Remicade®.  In short, Pfizer launched Inflectra® in 2016, which is a biosimilar to Janssen’s Remicade®.  Yet, Inflectra® has struggled to eat into Janssen’s monopoly for Remicade®.  Pfizer claims that Inflectra®’s poor sales are due to anticompetitive rebate schemes by Janssen.  Specifically, Janssen forced hospitals and insurers to enter exclusive arrangements and bundled-rebated programs that discouraged them from stocking or covering Inflectra®.  Pfizer sued Janssen in the Eastern District of Pennsylvania.  Janssen moved to dismiss, but on August 10, the Court denied Janssen’s motion to dismiss.  What are the takeaways?

The biosimilars are biting.  And they are biting at three big biologics distributed by Roche through its biotech subsidiary, Genentech.  Roche currently faces pending biosimilar competition against Avastin® (bevacizumab), Roche’s biggest selling cancer drug, Herceptin® (trastuzmab), Roche’s breast-cancer drug, and Rituxan® (rituximab), Roche’s immunotherapy drug.  All three drugs are involved in patent litigations. How long will these cases last? And how long can Roche keep the biosimilars out?

FDA’s Commissioner Scott Gottlieb said today that a “rigged” system between drug firms and insurers is stifling entry for less-expensive biosimilars.  Gottlieb stated that certain payment arrangements “raise another, perhaps even more insidious barrier to biosimilars taking root in the U.S., and gaining appropriate market share.”  Is J&J’s exclusionary contract scheme to discourage competition with Pfizer’s biosimilar for Remicade® a poster child for what Gottlieb is lamenting?  Pfizer recently sued Janssen over that very question, and the federal court is scheduled to decide a motion answering that question very shortly. 

Gilead’s new HIV drug, Biktarvy®, has received FDA approval.  Almost immediately, Gilead was hit with a patent-infringement lawsuit by ViiV Healthcare, which is owned by GSK, along with Pfizer and Shionogi.  What is Gilead’s exposure?

The biosimilar statute, Biologics Price Competition and Innovation Act (BPCIA, was passed in 2010.  Since then, drug companies have been filing biosimilar applications with FDA.  And even though, FDA has approved only nine biosimilar drugs today, an interesting trend may be emerging: biosimilars may be more willing to launch at-risk than small-molecule generics.

A recent decision by the PTAB denying institution of an IPR related to Rituxan(R) shows that disagreements exist within the PTAB over the precise standard that must be met for institution.