Patent Valuation, Monetization and Investments

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Markman Advisors Patent Blog

by Zachary Silbersher

The Theranos verdict is a reminder that patent-literacy matters.

Elizabeth Holmes, the founder of Theranos, has been convicted of securities fraud. There are many lessons and take-aways from Holmes’ story and the verdict. For one thing, fake-it-till-you-make-it may now yield concrete consequences for failure. Yet, one overlooked lesson is that the Theranos downfall illustrates a failure of patent-literacy—particularly among investors. (This is, after all, a patent blog.)

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What is at the heart of the GSK skinny-label standoff at the CAFC?

I 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?

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What is the status of the iRobot v. SharkNinja patent war?

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?

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Will Exelixis’s Cabometyx face generic competition when the 30-month stay ends in November?

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.

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Did the CAFC’s Caltech decision make finding infringing “sales” within the U.S. easier?

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).

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Will Trillium Therapeutics’ patents protect its CD47 candidate against competitors?

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?

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Will Amarin’s new cardiovascular patent lawsuit against Hikma keep out generic sales?

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?

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How will the CAFC’s Valeant v. Mylan venue case change the landscape of pharmaceutical patent litigation?

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.

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Can Amarin benefit from the GSK v. Teva decision regarding induced infringement for off-label sales?

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?

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Why Investors Need to Prepare for Disclosure of Diligence Materials in Patent Cases...

The takeaways for investors and IP owners seeking investment are clear. It is not safe to assume that a common interest exists during the investment procurement stage, especially as it relates to disclosure of privileged information to potential investors. As a result, any presentations containing privileged information made to potential investors — such as on the strength of the IP, or the potential damages at issue in a case — run the risk of being deemed discoverable.

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Markman Advisors
What Investors Need to Know About the ABA's Litigation Finance Guidance...

Ultimately, the true best practices when it comes to litigation funding of patent cases are those that best align interests between all the parties to the deal, while also respecting the boundaries of the attorney-client relationship and the ethical obligations of the lawyers involved. Moreover, interests must be aligned to prevent the litigation finance arrangement from hampering the prosecution of the case on the merits, or from serving as a hindrance (rather than aid) to settlement. Done right, litigation finance can be a critical component for a successful patent enforcement case or campaign.

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Markman Advisors
Why Should Investors Care About Apple's Lawsuit Against Koss?

For now, it is clear that these are just the opening salvos in what — absent settlement — is shaping up as a major patent war between two well-regarded names in the headphone/earbud space. Both Apple and Koss investors would do well to monitor developments in the two Apple/Koss cases, as well as any other cases involving Koss’ patents.

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Markman Advisors
What Investors Need to Know About Covid-19's Impact on the PTAB....

In the words of Lex Machina: “PTAB continued its trial flow in an effective, timely fashion. It has been reliable throughout this spring and summer, causing some parties to choose PTAB as a solution for stalled federal district court cases.” Put another way, the PTAB has risen to the Covid-19 challenge with aplomb. It is not a surprise, therefore, that the PTAB continues as a popular destination for patent disputes.

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Markman Advisors
Is Moderna’s COVID-19 vaccine using Arbutus Biopharma’s patents?

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?

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Which patents cover the COVID-19 vaccine candidates for Moderna, AstraZeneca, J&J and Novovax?

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.

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Is Google a Patent Troll?

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?

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Amarin: What does Amarin’s reply appellate brief say?

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?

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