I previously blogged about the patent tussle between iRobot and SharkNinja when the dispute originally erupted in late 2019. At the time, the prevalent concern was that iRobot would secure a quick injunction against SharkNinja’s sales in advance of the critical holiday shopping season. More than two years on, what started as a single pre-emptive suit commenced by Shark Ninja has ballooned into a multi-front war over whether SharkNinja is infringing iRobot’s patents. This has involved multiple litigations filed in district court, scores of invalidity proceedings filed at the Patent Office, and an investigation commenced before the International Trade Commission. What is the status of this ongoing patent war?

I previously blogged (here and here) about the pending Hatch-Waxman lawsuit between Exelixis ($EXEL) and MSN Pharmaceuticals in connection with MSN’s prospective generic for Cabometyx®. The case has been barreling towards trial in May of this year, which would theoretically provide insight into how soon Cabometyx® may face generic competition. This trial date is important because the 30-month stay is scheduled to expire in November 2022. However, a current dispute over scheduling has called into doubt if the trial in May will proceed, and even if it does, if it will provide certainty on MSN’s entry.

The Federal Circuit issued its precedential decision within the dispute between the California Institute of Technology (“Caltech”) versus both Broadcom and Apple. (Case Nos. 2020-2222, 2021-1527 (Fed. Cir. Feb. 4, 2022)). The Court held that there is no categorical bar against considering domestic sales activities—apart from the locations of actual manufacturer, delivery and contract execution—in the course of determining the location of an accused “sale” under Sec. 271(a).

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?

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?

The battle continues. We previously wrote about the Federal Circuit’s decision in the case (GlaxoSmithKline v. Teva) and how that case may offer Amarin another chance to bar generics from the market for Vascepa®. Sure enough, on November 30, Amarin filed suit against Hikma asserting three patents covering use of EPA to treat cardiovascular events. What are the takeaways from this suit?

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.

Just when you think the Amarin saga to keep out generic competition is over, something else happens. In the latest development, the Federal Circuit issued a precedential decision in an unrelated case (GlaxoSmithKline v. Teva) that suggests that a generic could potentially be liable for inducing infringement of a patented indication, even though that indication has been carved out of the generic’s label. Will this decision benefit Amarin?

We previously blogged about Moderna Therapeutics’ ($MRNA) ongoing patent dispute with Arbutus Biopharma ($ABUS). On July 23, 2020, Arbutus prevailed in Moderna’s third IPR challenge to one of its patents, the ‘069 patent. Given that Moderna’s COVID-19 vaccine candidate is currently one of the most promising, the question is, will Moderna’s vaccine infringe Arbutus’ patents?

A number of companies have announced candidates for a COVID-19 vaccine, including Moderna Therapeutics ($MRNA), AstraZeneca ($AZN), Johnson & Johnson ($JNJ) and Novovax ($NVAX). We looked into the existing landscape of patents that cover many of the existing candidates.

A recent post on this blog by Gaston Kroub discussed the ongoing patent war between Sonos and Google. The war started when Sonos accused Google of stealing its technology and infringing its patents. Since then, the war has broadened to multiple fronts. In one interesting twist, Google commenced its suit against Sonos asserting its own patents. Gaston’s commentary provides some useful insights for why Google would do this from strategic perspective. But in this post, we raise another question: is Google a patent troll?

Amarin’s appeal of the district court’s decision invalidating the Marine patents is now fully briefed. Amarin’s reply brief is strong, but does it tip the odds in favor of Amarin prevailing on the appeal?

Hikma and Dr. Reddy’s have filed their appellate brief defending Judge Du’s decision invalidating the Marine patents. What does it say?

When 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?

On 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?

In a precedential decision that issued on May 19, ESIP Series 2, LLC v. Puzhen Life USA, LLC, the Federal Circuit confirmed that the Supreme Court’s recent Click-to-Call decision precludes judicial review of decisions by the PTAB concerning real-parties-in-interest.  recent Click-to-Call decision precludes judicial review of decisions by the PTAB concerning real-parties-in-interest.

On May 12, 2020, Amarin ($AMRN) filed its opening appeal brief in its appeal of the decision by the District of Nevada wherein the Honorable Miranda M. Du invalidated six patents that were asserted against prospective generics, Hikma and Dr. Reddy’s. What does the brief say?

The PTAB’s decision in Apple, Inc. v. Fintiv, Inc., Case No. IPR2020-00019 (Paper No. 11) has been designated precedential as of May 5, 2020. The decision outlines the factors that the PTAB will consider when determining whether petitions should be denied under § 314(a) based upon a parallel district court litigation in which the same invalidity arguments have been raised. The case implicates the balance between patent owners and patent challengers, and who carries the heavier load.

In Amarin’s pending Hatch-Waxman Vascepa case against Dr. Reddy’s and Hikma, we see at least obstacles to settlement at this time before resolution of the appeal: money, entry and invalidity.

The United States Supreme Court has issued its ruling in Thryv, Inc. v. Click-To-Call Technologies, LP. The case is either surprising or unsurprising given your palette for the changing nature of patent rights. But one thing is certain—the stripping of appellate review for institution decisions deprives litigants of valuable jurisprudence that would otherwise make the IPR process more predictable and more efficient.