Apple Smartwatch Antitrust Case Survives, Showing ‘Freedom of Design’ is Not Absolute

Judge Cites ‘Associated’ Anticompetitive Conduct Claims

It’s a case that challenges the limits of the “freedom of design” usually enjoyed by companies accused of product design changes alleged to harm competition. Ordinarily, a design change is not the kind of conduct that runs afoul of the antitrust laws, but on March 21, U.S. Judge Jeffrey S. White from the Northern District of California denied Apple Inc.’s motion to dismiss an antitrust case brought against it by AliveCor Inc. The suit alleges that Apple unlawfully maintained its monopoly in the market for heart rate analysis apps by updating WatchOS, the Apple Watch operating system on which AliveCor’s heart rate analysis app runs. (AliveCor, Inc. v. Apple Inc., No. 21-cv-03958-JSW, N.D. Calif.).

Heart rate analysis apps analyze the user’s heart rate in real time using a sensor close to the user’s wrist and determine whether the user’s heart rate is normal or irregular. The app runs constantly while the device is worn and alerts the user when a situation arises requiring an ECG recording and medical analysis. AliveCor also sells an electrocardiogram-capable wrist band for the Apple Watch and related WatchOS software that analyzes reading from the band. AliveCor claims that its products—the ECG-wristband hardware and software and its heart rate analysis app—“helped change the perception of the Apple Watch from an accessory to a personal health monitoring tool.”

AliveCor calls its heart rate monitoring app “SmartRhythm.” According to AliveCor, when sales of SmartRhythm took off Apple was inspired to announce an update to WatchOS with its own heart monitoring app designed to exclude AliveCor from the U.S. market for WatchOS heart rate analysis apps.

SmartRhythm works by using data from the Apple Watch’s heart rate algorithm. According to the complaint, Apple’s update to WatchOS altered the heart rate algorithm in a way that prevents third-party developers from being able to detect heart rate fluctuations and irregularities. As a result of these changes, SmartRhythm could not provide accurate heart rate analysis, and AliveCor removed it from the market.

Consequently, Apple is a monopolist in the WatchOS heart rate analysis app market, which AliveCor claims Apple is maintaining with exclusionary design changes to WatchOS, in violation of Section 2 of the Sherman Act, California’s Unfair Competition Law, and Section 17200 of California Business and Professions Code.

The court denied Apple’s motion to dismiss AliveCor’s monopolization claim in what it characterized as the “[single brand] aftermarket for WatchOS apps.” Applying the factors enumerated by the court in Newcal Indus., Inc. v. Ikon Office Sol., 513 F.3d 1038, 1044 (9th Cir. 2008), the court found that the WatchOS app aftermarket was wholly derivative from the primary smartwatch market, the alleged restraint applied only to the aftermarket, Apple’s aftermarket power was not obtained through contract terms reached in the primary market, and that competition in the smartwatch market does not discipline anticompetitive practices in the WatchOS app aftermarket. Accordingly, the court ruled that AliveCor’s market definition met the Newcal standards for a “single product” relevant market.

Apple argued that a company that improves a product to the benefit of consumers does not violate antitrust laws “absent some associated anticompetitive conduct,” citing the leading “freedom of design” case of Allied Orthopedic Appliances Inc. v. Tyco Health Care Group LP, 592 F.3d 991, 998-99 (9th Cir. 2010). The court quoted the holding of Allied: “If a monopolist’s design change is an improvement, it is necessarily tolerated by the antitrust laws, unless the monopolist abuses or leverages its monopoly power in some other way when introducing the product.”

Apple argued that its update to WatchOS was purely a design change that benefitted users, with no associated anticompetitive conduct. It observed that AliveCor hadn’t established that consumers use Apple’s app instead of some third-party app, or that Apple rejected any third-party apps, or that no other third-party heart apps are available to Apple Watch users. But the court rejected those arguments, noting that Apple failed to provide any legal authority that would require such allegations.

Apple ignored AliveCor’s allegations that Apple abused or leveraged its monopoly power “in some other way” by changing its heart rate algorithm to make it effectively impossible for third parties to inform a user when to take an ECG. AliveCor contended that Apple’s updated heart rate algorithm, which was pushed out to all earlier Apple Watch models, did not improve user experience. Its purpose was to prevent third parties from identifying irregular heart rates and offering competing apps based on that data. “These allegations present the type of ‘associated conduct’ that makes product design changes cognizable under antitrust law. Plaintiff’s allegations plausibly establish that Apple’s conduct was anticompetitive,” Judge White held. A case management conference set for May 20.

Commentary

It is truly difficult to see how some separate, “associated” conduct by Apple other than its design change to WatchOS violates Section 2. It seems more straightforward to consider the design change itself to be a cognizable anticompetitive act. It may be time to drop the fiction maintained in Allied v. Tyco that design changes are “never” antitrust violations unless accompanied by some “other” conduct. Here, Apple has created the market itself in the form of an OS platform used by millions of consumers who depend on it to access all manner of competing complementary products. Under those circumstances, it should be uncontroversial to hold a platform operator liable under the antitrust laws for design changes that exclude competitors or foreclose participants from the market, without indulging in the fiction of “associated” conduct.

© MoginRubin LLP

The DOJ Throws Cold Water on the Frosties NFT Founders

The U.S. Attorney’s Office for the Southern District of New York recently charged two individuals for allegedly participating in a scheme to defraud purchasers of “Frosties” non-fungible tokens (or “NFTs”) out of over $1 million. The two-count complaint charges Ethan Nguyen (aka “Frostie”) and Andre Llacuna (aka “heyandre”) with conspiracy to commit wire fraud in violation of 18 U.S.C. § 1349 and conspiracy to commit money laundering in violation of 18 U.S.C. § 1956.   Each charge carries a maximum sentence of 20 years in prison.

The Defendants marketed “Frosties” as the entry point to a broader online community consisting of games, reward programs, and other benefits.  In January 2022, their “Frosties” pre-sale raised approximately $1.1 million.

In a so-called “rug pull,” Frostie and heyandre transferred the funds raised through the pre-sale to a series of separate cryptocurrency wallets, eliminated Frosties’ online presence, and took down its website.  The transaction, which was publicly recorded and viewable on the blockchain, triggered investors to sell Frosties at a considerable discount.  Frostie and heyandre then allegedly proceeded to move the funds through a series of transactions intended to obfuscate the source and increase anonymity.  The charges came as the Defendants were preparing for the March 26 pre-sale of their next NFT project, “Embers,” which law enforcement alleges would likely have followed the same course as “Frosties.”

In a public statement announcing the arrests, the DOJ explained how the emerging NFT market is a risk-laden environment that has attracted the attention of scam artists.  Representatives from each of the federal agencies that participated in the investigation cautioned the public and put other potential fraudsters on notice of the government’s watchful eye towards cryptocurrency malfeasance.

This investigation comes on the heels of the FBI’s announcement last month of the Virtual Asset Exploitation Unit, a special task force dedicated to blockchain analysis and virtual asset seizure.  The prosecution of the Defendants in this matter continues aggressive efforts by federal agencies to reign in bad actors participating in the cryptocurrency/digital assets/blockchain space.

Copyright ©2022 Nelson Mullins Riley & Scarborough LLP

French Insider Episode 12: Navigating the Metaverse with Jim Gatto [PODCAST]

Joining host Sarah Aberg is Jim Gatto. Jim joins us today to discuss the metaverse, the technology and business models involved in these virtual worlds, the role of NFTs and cryptocurrency in the digital economy, and the legal, regulatory, and governance issues that can arise when companies seek to enter that space.

Jim Gatto is a partner in Sheppard Mullin’s Washington, D.C. office, where he leads the  Blockchain & Fintech Team, Social Media & Games Team, and Open Source Team. Jim’s practice focuses on blockchain, interactive entertainment, digital art, AI, and online gambling. He advises clients on IP strategies, development and publishing agreements, licensing and technology transaction agreements, and tech regulatory issues. Jim has been involved with blockchain since 2012 and has been recognized as a thought leader by leading organizations including as a Cryptocurrency, Blockchain and Fintech Trailblazer by the National Law Journal.

Sarah Aberg is special counsel in the White Collar Defense and Corporate Investigations Group in Sheppard Mullin’s New York office. Sarah’s practice encompasses litigation, internal investigations and white collar defense.  Her areas of focus include financial services and securities, as well as corporate fraud in a variety of industries, including technology, construction, and non-profits.  Sarah’s regulatory practice encompasses market regulation, foreign registration and disclosure requirements, supervisory procedures, and sales practices.  Sarah represents corporations, financial services companies, and associated individuals in connection with investigations and regulatory matters before the U.S. Department of Justice, the Securities and Exchange Commission, the Commodity Futures Trading Commission, FINRA, the New York Stock Exchange, the New York State Department of Financial Services, and the New York Attorney General’s Office.

What We Discussed in This Episode:

  1. What is the Metaverse?
  2. How Do Metaverses Differ from Earlier Virtual Worlds?
  3. What Role Do NFTs Play in the Digital Economy?
  4. Investing in a Metaverse: What are the Risks?
  5. What are Legal, Regulatory, and Tax Considerations?
  6. What Governance Issues Exist for Brands Operating in a Metaverse?
  7. What are the Inflationary and Deflationary Aspects of the Virtual Economy?
  8. How Might Blockchain and Cryptocurrency Alter International Financial Transactions?
  9. Is the World Moving into a Virtual/Digital Economy?

How Businesses Can Use LinkedIn Company Newsletters in Their Marketing Efforts

LinkedIn has added what I think is the most helpful tool in a long time for businesses to engage with and bring value to their followers – the ability for LinkedIn Company Pages to publish email newsletters right through LinkedIn.

This underscores the importance of having a company page and how it can be used as a content hub for marketing and recruiting your business.

Linked Company Page newsletters are available to businesses with more than 150 followers that actively maintain their LinkedIn presences.

You can create a LinkedIn Company Page newsletter in three simple steps:

  1. Create: Start writing an article on and select “Create a Newsletter.” Give it a title, add a header image (it prompts you with the dimensions) and cut and paste your text. You can add hyperlinks and images for each article too.
  2. Publish: When you publish your newsletter it will post to your feed and LinkedIn will notify your followers. They can opt in to receive email and in-platform notifications when you publish new content.
  3. Review performance: View the analytics of each newsletter sent out and see the number of subscribers. The number increases pretty quickly which is awesome. And it’s opt in so you don’t have to worry about GDPR rules.

There’s a lot of opportunity here because it is a new feature (for companies – it’s been available to individuals for a short time) and most companies don’t know about it yet (and certainly aren’t using it yet), so being an early adopter is to your benefit.

Even if you send out an email newsletter, you should still utilize the LinkedIn platform to send out a newsletter because you will reach a different audience and cast a wider net for your content.

In addition, people are opting into this newsletter, so it’s not building an audience from scratch, and if you haven’t ever sent out an email newsletter, this is a great way to start. If email marketing programs and CRM management tools overwhelm you, this is a great way to test out the waters.

It’s also really easy to repurpose content you already have. I would include hyperlinks to your website or blog with the full text (in order to keep the newsletter short and to drive traffic to your site).

You can embed links from YouTube into the newsletter to play. Check out my LinkedIn newsletter to see how it looks.

Here are some content ideas for what you can include in your LinkedIn Company Page Newsletter:

  • Article snippets with links to your latest blog posts or client alerts
  • Links to past webinars (provide a synopsis too)
  • Links to recent podcasts and videos (with shownotes)
  • Recent case studies
  • Q&As with your employees
  • Highlights of your community service/pro bono work
  • Announcements of your recent hires
  • Recent press coverage (this would be the only place where I would recommend including self-promotional items in the newsletter – the rest of it should be client-focused)
  • Upcoming events/webinars – this is a great way to promote them
  • Open jobs – why not promote them through this newsletter? It’s a competitive job market
  • News about your diversity and women’s initiatives programs – clients care a lot about this

Check out this new feature and let me know what you think of it. With nearly 800 million people on LinkedIn and the fact that your competitors are very likely not using it yet, it’s at least worth trying out.

Copyright © 2022, Stefanie M. Marrone. All Rights Reserved.

Google to Launch Google Analytics 4 in an Attempt to Address EU Privacy Concerns

On March 16, 2022, Google announced the launch of its new analytics solution, “Google Analytics 4.” Google Analytics 4 aims, among other things, to address recent developments in the EU regarding the use of analytics cookies and data transfers resulting from such use.

Background

On August 17, 2020, the non-governmental organization None of Your Business (“NOYB”) filed 101 identical complaints with 30 European Economic Area data protection authorities (“DPAs”) regarding the use of Google Analytics by various companies. The complaints focused on whether the transfer of EU personal data to Google in the U.S. through the use of cookies is permitted under the EU General Data Protection Regulation (“GDPR”), following the Schrems II judgment of the Court of Justice of the European Union. Following these complaints, the French and Austrian DPAs ruled that the transfer of EU personal data from the EU to the U.S. through the use of the Google Analytics cookie is unlawful.

Google’s New Solution

According to Google’s press release, Google Analytics 4 “is designed with privacy at its core to provide a better experience for both our customers and their users. It helps businesses meet evolving needs and user expectations, with more comprehensive and granular controls for data collection and usage.”

The most impactful change from an EU privacy standpoint is that Google Analytics 4 will no longer store IP address, thereby limiting the data transfers resulting from the use of Google Analytics that were under scrutiny in the EU following the Schrems II ruling. It remains to be seen whether this change will ease EU DPAs’ concerns about Google Analytics’ compliance with the GDPR.

Google’s previous analytics solution, Universal Analytics, will no longer be available beginning July 2023. In the meantime, companies are encouraged to transition to Google Analytics 4.

Read Google’s press release.

Copyright © 2022, Hunton Andrews Kurth LLP. All Rights Reserved.

Chinese APT41 Attacking State Networks

Although we are receiving frequent alerts from CISA and the FBI about the potential for increased cyber threats coming out of Russia, China continues its cyber threat activity through APT41, which has been linked to China’s Ministry of State Security. According to Mandiant, APT41 has launched a “deliberate campaign targeting U.S. state governments” and has successfully attacked at least six state government networks by exploiting various vulnerabilities, including Log4j.

According to Mandiant, although the Chinese-based hackers are kicked out of state government networks, they repeat the attack weeks later and keep trying to get in to the same networks via different vulnerabilities (a “re-compromise”). One such successful vulnerability that was utilized is the USAHerds zero-day vulnerability, which is a software that state agriculture agencies use to monitor livestock. When the intruders are successful in using the USAHerds vulnerability to get in to the network, they can then leverage the intrusion to migrate to other parts of the network to access and steal information, including personal information.

Mandiant’s outlook on these attacks is sobering:

“APT41’s recent activity against U.S. state governments consists of significant new capabilities, from new attack vectors to post-compromise tools and techniques. APT41 can quickly adapt their initial access techniques by re-compromising an environment through a different vector, or by rapidly operationalizing a fresh vulnerability. The group also demonstrates a willingness to retool and deploy capabilities through new attack vectors as opposed to holding onto them for future use. APT41 exploiting Log4J in close proximity to the USAHerds campaign showed the group’s flexibility to continue targeting U.S state governments through both cultivated and co-opted attack vectors. Through all the new, some things remain unchanged: APT41 continues to be undeterred by the U.S. Department of Justice (DOJ) indictment in September 2020.

Both Russia and China continue to conduct cyber-attacks against both private and public networks in the U.S. and there is no indication that the attacks will subside anytime soon.

Copyright © 2022 Robinson & Cole LLP. All rights reserved.

GDPR Privacy Rules: The Other Shoe Drops

Four years after GDPR was implemented, we are seeing the pillars of the internet business destroyed. Given two new EU decisions affecting the practical management of data, all companies collecting consumer data in the EU are re-evaluating their business models and will soon be considering wholesale changes.

On one hand, the GDPR is creating the world its drafters intended – a world where personal data is less of a commodity exploited and traded by business. On the other hand, GDPR enforcement has taken the form of a wrecking ball, leading to data localization in Europe and substitution of government meddling for consumer choice.

For years we have watched the EU courts and enforcement agencies apply GDPR text to real-life cases, wondering if the legal application would be more of a nip and tuck operation on ecommerce or something more bloody and brutal. In 2022, we received our answer, and the bodies are dropping.

In January Austrian courts decided that companies can’t use Google Analytics to study their own site’s web traffic. The same conclusion was reached last week by French regulators. While Google doesn’t announce statistics about product usage, website tracker BuiltWith published that 29.3 million websites use Google Analytics, including 69.5 percent of Quantcast’s Top 10,000 sites, and that is more than ten times the next most popular option. So vast numbers of companies operating in Europe will need to change their platform analytics provider – if the Euro-crats will allow them to use site analytics at all.

But these decisions were not based on the functionality of Google Analytics, a tool that does not even capture personally identifiable information – no names, no home or office address, no phone numbers. Instead, these decisions that will harm thousands of businesses were a result of the Schrems II decision, finding fault in the transfer of this non-identifiable data to a company based in the United States. The problem here for European decision-makers is that US law enforcement may have access to this data if courts allow them. I have written before about this illogical conclusion and won’t restate the many arguments here, other than to say that EU law enforcement behaves the same way.

The effects of this decision will be felt far beyond the huge customer base of Google Analytics.  The logic of this decision effectively means that companies collecting data from EU citizens can no longer use US-based cloud services like Amazon Web Services, IBM, Google, Oracle or Microsoft. I would anticipate that huge cloud player Alibaba Cloud could suffer the same proscription if Europe’s privacy panjandrums decide that China’s privacy protection is as threatening as the US.

The Austrians held that all the sophisticated measures taken by Google to encrypt analytic data meant nothing, because if Google could decrypt it, so could the US government. By this logic, no US cloud provider – the world’s primary business data support network – could “safely” hold EU data. Which means that the Euro-crats are preparing to fine any EU company that uses a US cloud provider. Max Schrems saw this decision in stark terms, stating, “The bottom line is: Companies can’t use US cloud services in Europe anymore.”

This decision will ultimately support the Euro-crats’ goal of data localization as companies try to organize local storage/processing solutions to avoid fines. Readers of this blog have seen coverage of the EU’s tilt toward data localization (for example, here and here) and away from the open internet that European politicians once held as the ideal. The Euro-crats are taking serious steps toward forcing localized data processing and cutting US businesses out of the ecommerce business ecosystem. The Google Analytics decision is likely to be seen as a tipping point in years to come.

In a second major practical online privacy decision, earlier this month the Belgian Data Protection Authority ruled that the Interactive Advertising Bureau Europe’s Transparency and Consent Framework (TCF), a widely-used technical standard built for publishers, advertisers, and technology vendors to obtain user consent for data processing, does not comply with the GDPR. The TCF allows users to accept or reject cookie-based advertising, relieving websites of the need to create their own expensive technical solutions, and creating a consistent experience for consumers. Now the TCF is considered per-se illegal under EU privacy rules, casting thousands of businesses to search for or design their own alternatives, and removing online choices for European residents.

The Belgian privacy authority reached this conclusion by holding that the Interactive Advertising Bureau was a “controller” of all the data managed under its proposed framework. As stated by the Center for Data Innovation, this decision implies “that any good-faith effort to implement a common data protection protocol by an umbrella organization that wants to uphold GDPR makes said organization liable for the data processing that takes place under this protocol.” No industry group will want to put itself in this position, leaving businesses to their own devices and making ecommerce data collection much less consistent and much more expensive – even if that data collection is necessary to fulfill the requests of consumers.

For years companies thought that informed consumer consent would be a way to personalize messaging and keep consumer costs low online, but the EU has thrown all online consent regimes into question. EU regulators have effectively decided that people can’t make their own decisions about allowing data to be collected. If TCF – the consent system used by 80% of the European internet and a system designed specifically to meet the demands of the GDPR – is now illegal, then, for a second time in a month, all online consumer commerce is thrown into confusion. Thousands were operating websites with TCF and Google Analytics, believing they were following the letter of the law.  That confidence has been smashed.

We are finally seeing the practical effects of the GDPR beyond its simple utility for fining US tech companies.  Those effects are leading to a closed-border internet around Europe and a costlier, less customizable internet for EU citizens. The EU is clearly harming businesses around the world and making its internet a more cramped place. I have trouble seeing the logic and benefit of these decisions, but the GDPR was written to shake the system, and privacy benefits may emerge.

Copyright © 2022 Womble Bond Dickinson (US) LLP All Rights Reserved.
For more articles about international privacy, visit the NLR Cybersecurity, Media & FCC section.

Fitness App Agrees to Pay $56 Million to Settle Class Action Alleging Dark Pattern Practices

On February 14, 2022, Noom Inc., a popular weight loss and fitness app, agreed to pay $56 million, and provide an additional $6 million in subscription credits to settle a putative class action in New York federal court. The class is seeking conditional certification and has urged the court to preliminarily approve the settlement.

The suit was filed in May 2020 when a group of Noom users alleged that Noom “actively misrepresents and/or fails to accurately disclose the true characteristics of its trial period, its automatic enrollment policy, and the actual steps customer need to follow in attempting to cancel a 14-day trial and avoid automatic enrollment.” More specifically, users alleged that Noom engaged in an unlawful auto-renewal subscription business model by luring customers in with the opportunity to “try” its programs, then imposing significant barriers to the cancellation process (e.g., only allowing customers to cancel their subscriptions through their virtual coach), resulting in the customers paying a nonrefundable advance lump-sum payment for up to eight (8) months at a time. According to the proposed settlement, Noom will have to substantially enhance its auto-renewal disclosures, as well as require customers to take a separate action (e.g., check box or digital signature) to accept auto-renewal, and provide customers a button on the customer’s account page for easier cancellation.

Regulators at the federal and state level have recently made clear their focus on enforcement actions against “dark patterns.” We previously summarized the FTC’s enforcement policy statement from October 2021 warning companies against using dark patterns that trick consumers into subscription services. More recently, several state attorneys general (e.g., in Indiana, Texas, the District of Columbia, and Washington State) made announcements regarding their commitment to ramp up enforcement work on “dark patterns” that are used to ascertain consumers’ location data.

Article By: Privacy and Cybersecurity Practice Group at Hunton Andrews Kurth

Copyright © 2022, Hunton Andrews Kurth LLP. All Rights Reserved.

New Poll Underscores Growing Support for National Data Privacy Legislation

Over half of all Americans would support a federal data privacy law, according to a recent poll from Politico and Morning Consult. The poll found that 56 percent of registered voters would either strongly or somewhat support a proposal to “make it illegal for social media companies to use personal data to recommend content via algorithms.” Democrats were most likely to support the proposal at 62 percent, compared to 54 percent of Republicans and 50 percent of Independents. Still, the numbers may show that bipartisan action is possible.

The poll is indicative of American’s increasing data privacy awareness and concerns. Colorado, Virginia, and California all passed or updated data privacy laws within the last year, and nearly every state is considering similar legislation. Additionally, Congress held several high-profile hearings last year soliciting testimony from several tech industry leaders and whistleblower Frances Haugen. In the private sector, Meta CEO Mark Zuckerberg has come out in favor of a national data privacy standard similar to the EU’s General Data Protection Regulation (GDPR).

Politico and Morning Consult released the poll results days after Senator Ron Wyden (D-OR) accepted a 24,000-signature petition calling for Congress to pass a federal data protection law. Senator Wyden, who recently introduced his own data privacy proposal called the “Mind Your Own Business Act,” said it was “past time” for Congress to act.

He may be right: U.S./EU data flows have been on borrowed time since 2020. The GDPR prohibits data flows from the EU to countries with inadequate data protection laws, including the United States. The U.S. Privacy Shield regulations allowed the United States to circumvent the rule, but an EU court invalidated the agreement in 2020, and data flows between the US and the EU have been in legal limbo ever since. Eventually, Congress and the EU will need to address the situation and a federal data protection law would be a long-term solution.

This post was authored by C. Blair Robinson, legal intern at Robinson+Cole. Blair is not yet admitted to practice law. Click here to read more about the Data Privacy and Cybersecurity practice at Robinson & Cole LLP.

For more data privacy and cybersecurity news, click here to visit the National Law Review.

Copyright © 2022 Robinson & Cole LLP. All rights reserved.

New Tools in the Fight Against Counterfeit Pharmaceuticals

The explosive growth of internet pharmacies and direct-to-consumer shipment of pharmaceuticals has provided increased access to, and reduced the cost of, important medications. Unfortunately, these same forces have increased the risks that counterfeit medicines will make their way to consumers, endangering patient safety and affecting manufacturers’ reputation in the public eye.

While the Food and Drug Administration attempts to police such misconduct through enforcement of the Food, Drug, and Cosmetics Act (FDCA), the resources devoted to enforcement are simply no match for the size and scope of the counterfeiting threat. Fortunately, pharmaceutical manufacturers are not without recourse, as several well-established tools may be used in the right circumstances to stop counterfeiters from profiting from the sale of knock-offs.

Experienced litigators can use the Lanham Act and the Racketeer Influenced Corrupt Organizations (RICO) Act to stop unscrupulous individuals and organizations from deceiving customers with counterfeit versions of trademarked drugs. Until recently, these legal weapons – including search warrants, seizures, forfeitures, and significant penalties – were typically wielded only by the government and only in criminal prosecutions.

As one recent case demonstrates, however, many of the tools that law enforcement has used for years to combat counterfeiters are also available to pharmaceutical manufacturers. In Gilead Sciences, Inc. v. Safe Chain Solutions, LLC, et al., the manufacturer of several trademarked HIV medications filed a civil complaint, under seal, alleging violations of the Lanham Act and RICO against scores of individuals and companies that were allegedly selling counterfeit versions of these drugs to patients across the country.

By deploying private investigators and techniques typically used by law enforcement, Gilead was able to gather a substantial amount of evidence before even filing the case. The company then used this evidence to secure ex parte seizure warrants and asset freezes, allowing it to locate and seize thousands of counterfeit pills and packaging before they could be shipped to unsuspecting consumers. Through the seizure of the financial proceeds of the alleged counterfeiting, Gilead prevented the dissipation of assets. If the company can successfully prove its RICO case, it stands to recover treble damages and attorneys’ fees as well.

Manufacturers of trademarked pharmaceuticals may consider using these and other tools to tackle the threat posed by counterfeiters. By drawing upon the experience and skills of trained litigators – particularly counsel who previously deployed these tools on behalf of the government while serving as federal prosecutors – companies can proactively protect their intellectual property and the consumers who depend on their products.

© 2022 BARNES & THORNBURG LLP