Bristol Myers Squibb recently announced a deal to buy Karuna Therapeutics for $14 billion. Bristol Myers has touted the deal as accelerating the company’s expansion into neuroscience. Karuna’s lead asset, KarXT, is an antipsychotic that is a combination of two prior drugs, xanomeline and trospium. Analysts have reported that KarXT could surpass $6 billion in annual sales. However, that may depend on whether Karuna has protected KarXT with sufficient intellectual property. Does KarXT have strong enough patent protection to ward off generics for long enough to make Bristol Myers’ gamble pay off?
Read MoreRecent amendments to the Pandemic and All-Hazards Preparedness and Response Act (PAHPARA) authorize HHS to study alternative economic models for the pharmaceutical business that essentially divorces research and development costs from drug prices by taking away the state-sanctioned monopolies such as exclusivity periods and patents. Should pharma be forced to make money without patents? Or are there fixes to the patent system that could cut down the delay of entry of lower-cost generics?
Read MoreCorcept 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?
Read MoreIn February 2023, United States Senator Elizabeth Warren penned a letter to Kathi Vidal, Director of the USPTO, asking what the Patent Office can do to blunt Merck’s use of patents to stall entry of lower-cost alternatives for Keytruda. Unfortunately for consumers, the answer may be, not that much.
Read MoreI 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?
Read MoreTrillium 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 $25M investment in Trillium. In conjunction with developing its own two CD47-inhibitor candidates, Trillium is also building out its patent portfolio. On February 2, 2021, two additional U.S. patents issued to Trillium, including U.S. Patent Nos. 10,906,954 and 10,907,209. Will Trillium’s patents offer protection against brand competitors or eventual biosimilars?
Read MoreWhen does a pile of sand become a heap? When is a portfolio of patents too many patents? Can using too many patents to compel generics to take a later entry date turn into monopolistic conduct? These questions lurk the heart of the antitrust litigation brought by buyers of the blockbuster drug, Humira®, against its manufacturer, AbbVie ($ABBV). The case is currently pending within the Northern District of Illinois (In Re: Humira (Adalimumab) Antitrust Litigation, No. 19-cv-1873 (N.D. Ill.)). We previously blogged about related allegations before the case was filed when Boehringer Ingelheim raised them within its biosimilar litigation against AbbVie. On June 8, 2020, the Illinois federal court dismissed the antitrust action pursuant to AbbVie’s motion to dismiss. What are the takeaways from the case?
Read MoreOn June 4, the Federal Circuit issued a precedential decision holding that § 285 under the Patent Statute is inapplicable for awarding attorneys’ fees to the prevailing party in a proceeding for inter partes review. The case is Amneal Pharmaceuticals, LLC v. Almirall, LLC, Case No. 2020-1106 (Fed. Cir. Jun. 4, 2020). While the Court’s decision dispenses rather cleanly with the possibility of collecting fees for prevailing in an IPR, the Court nonetheless left open the door to collecting fees if the IPR is intimately tied to a pending parallel district court case. How much does that matter?
Read MoreWe previously blogged about the upcoming litigation trial between Amarin Pharmaceuticals ($AMRN) and Dr. Reddy’s and Hikma, which are two prospective generics for Amarin’s Vascepa®. While that blog post provided a general overview of the issues to be litigated at the upcoming trial, there are numerous other issues and questions around the upcoming trial. This post will focus on how the REDUCE-IT trial may impact Amarin’s fight with the existing generics, if at all.
Read MoreWe previously blogged about Teva’s ($TEVA) petition for post-grant review (PGR) of Corcept Therapeutics’ ($CORT) ‘214 patent. Since then, on November 20, 2019, the PTAB granted institution of Teva’s petition. The proceeding will now be litigated for another year before a final decision. On a recent earnings call, Corcept stated that it believes the standard for institution is “pretty low,” and not necessarily dispositive that Teva will prevail. Now that we have the institution decision, what can we glean from it, and how likely is that Corcept’s patent survives?
Read MoreAnd just like that, it’s over. Boehringer Ingelheim has thrown in the towel in its patent fight with AbbVie over Boehringer’s proposed biosimliar for Humira®. Boehringer was a lone hold-out among a long line of proposed biosimilars for AbbVie’s blockbuster. Boehringer’s distinction was that it had raised a unique defense, namely, arguing that AbbVie had built an unfair “patent thicket” around Humira® that was unenforceable. We previously blogged about Boehringer’s “unclean hands” defense here and here and here. Now that Boehringer has settled, what are the larger lessons for future biosimilar patent fights?
Read MoreHigh drug prices remain in the news. A recent precedential decision from the Federal Circuit shows that certain drug prices will stay high if drug companies can simply take a mandate from the FDA, which was not their idea, and file a patent on it, thereby cornering the market on all IP around that mandate. The case is Endo Pharmaceuticals Inc. v. Actavis, LLC, Case No. 2018-1054 (Fed. Cir. May 3, 2019).
Read MoreBoehringer Ingelheim has been one of the lone holdouts in AbbVie’s ($ABBV) campaign to delay biosimilar competition against Humira® until 2023. To date, AbbVie has settled with almost all proposed biosimilars for entry dates in 2023. Is Boehringer going to launch at-risk?
Read MoreMylan’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?
Read MoreThe 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 $6900 / year. Given the tight competition, can Teva use its patents to kick anyone off the market?
Read MoreBoehringer Ingelheim has claimed that AbbVie wrongfully created a “patent thicket” around Humira®, and it is delaying biosimilar competition. While that defense is unique, and may be hard to prove on its face, the FDA appears to agree with Boehringer. Did AbbVie create a wrongful “patent thicket” around Humira®?
Read MoreWe previously blogged about Pfizer’s ($PFE) antitrust lawsuit against Johnson & Johnson ($JNJ) related to Janssen’s Remicade®. In short, Pfizer launched Inflectra® in 2016, which is a biosimilar to Janssen’s Remicade®. Yet, Inflectra® has struggled to eat into Janssen’s monopoly for Remicade®. Pfizer claims that Inflectra®’s poor sales are due to anticompetitive rebate schemes by Janssen. Specifically, Janssen forced hospitals and insurers to enter exclusive arrangements and bundled-rebated programs that discouraged them from stocking or covering Inflectra®. Pfizer sued Janssen in the Eastern District of Pennsylvania. Janssen moved to dismiss, but on August 10, the Court denied Janssen’s motion to dismiss. What are the takeaways?
Read MoreNevro Corp. ($NVRO) claims to have invented pioneering technology for improving the life of individual suffering from chronic pain. Nevro’s product, the Senza® system, received FDA-approval in May 2015. Rather than relying upon opioids, the Senza® system uses innovations for spinal-cord stimulation (SCS) therapy. In 2016, Nevro sued Boston Scientific ($BSX) for copying its patents protecting its innovative SCS therapy. The case is scheduled to go to trial in November of this year, but the Court has already issued preliminary rulings that show a mixed bag of wins and losses for both parties. Where is this case heading?
Read MoreThe 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?
Read MoreThe PTAB has denied institution of two IPRs filed by Coherus Biosciences against patents covering Enbrel®’s proteins, the ‘182 and ‘522 patents. The IPRs were not filed by Sandoz, but they will most likely affect Sandoz. Sandoz already has FDA approval to market Erelzi®, which is its biosimilar for Enbrel®. And Sandoz is going to trial against Amgen in April. How do Coherus IPR decisions affect Sandoz's decision to launch at risk? Or to settle with Amgen?
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