Features

The Route to Success Against Counterfeiters and Digital Pirates in the United States

Published: October 22, 2025

Chris Bolinger Astellas US LLC Brookline, Massachusetts, United States Anticounterfeiting Committee

Geoffrey Goodale Duane Morris Washington DC, United States Anticounterfeiting Committee

Adam Sgro Davis Wright Tremaine New York, United States Anticounterfeiting Committee

Straat Tenney Troutman Pepper Locke LLP New York, New York, United States Anticounterfeiting Committee

The U.S. government’s Intellectual Property Rights Center (IPRC) continues to strengthen its operations in the global fight against counterfeiting and digital piracy through two cornerstone initiatives: Operation Apothecary and Operation In Our Sites (OIOS).

These programs, spearheaded by the U.S. Department of Homeland Security’s Homeland Security Investigations (HSI), have evolved in response to the shifting dynamics of counterfeit pharmaceuticals and digital infringement, making significant strides in collaboration, enforcement, and public awareness. This article provides an overview of these operations, their recent developments, and the integral role brand owners and intellectual property (IP) professionals can play in their success.

Operation Apothecary: Safeguarding Health Through Collaborative Enforcement

History and Objectives

Established in 2004, Operation Apothecary remains a top priority for the IPRC due to the severe health and safety risks that counterfeit pharmaceuticals pose. The operation works closely with brand owners and government agencies, including U.S. Customs and Border Protection (CBP) and the Food and Drug Administration (FDA), to initiate and support criminal investigations. The IPRC shares intelligence it develops with field agents for investigative actions, leading to seizures and disruptions of counterfeit supply chains.

Expansion and Partnerships

Over the years, Operation Apothecary has expanded its collaborative framework to enhance its effectiveness. A notable evolution is the partnership with the U.S. Chamber of Commerce (CoC) through a memorandum of understanding (MOU) initiated by Pfizer and later joined by major companies such as Apple and Amazon. This MOU facilitates direct data-sharing between brand holders and the government, bypassing lengthy legal clearances and speeding up investigations.

The inclusion of trade analysts and access to export data has allowed the IPRC to identify counterfeit pharmaceutical shipments and trace them to their source. This capability was exemplified in recent training efforts conducted in countries like Colombia, Mauritius, Turkiye, and the United Kingdom, where IPRC-led programs provided local law enforcement and customs officials with crucial tools and strategies for identifying and intercepting counterfeit products.

The inclusion of trade analysts and access to export data have allowed the IPRC to identify counterfeit pharmaceutical shipments and trace them to their source.

Tactics and Private Sector Engagement

Operation Apothecary features several key strategies, including:

Targeted intelligence gathering;
Undercover purchases; and
Leveraging shared data from private-sector partners.

The operation’s partnership with companies like Pfizer has enabled faster identification of counterfeit networks and has supported training that empowers international law enforcement to act effectively.

Brand owners play an indispensable role by providing data that feeds into the IPRC’s intelligence ecosystem. Trademark attorneys can contribute by advising their clients on best practices for data-sharing agreements and encouraging proactive participation in these partnerships.

Challenges and Emerging Trends

Despite these advancements, the global scale and complexity of counterfeit pharmaceuticals remain formidable. The rise of online sales platforms and express consignment shipments has introduced new avenues for counterfeiters to exploit. Currently, an estimated 35,000 online pharmacies exist, with 96 percent operating illegally. This alarming figure underscores the importance of public education and provider training—both of which are focal points in Operation Apothecary’s upcoming initiatives.

The rise of online sales platforms and express consignment shipments has introduced new avenues for counterfeiters to exploit.

The operation aims to release consumer-facing tools and educational modules for medical professionals by the end of fiscal year 2025. These efforts will help inform providers and patients about the risks of counterfeit pharmaceuticals and guide them in making safer choices.

Operation In Our Sites (OIOS): Tackling Digital Piracy and Online Counterfeiting

Origins and Evolution

Launched in 2007, Operation In Our Sites initially targeted standalone websites selling counterfeit goods. Over time, it has shifted its focus to address the proliferation of digital piracy, particularly as it relates to entertainment, gaming, and software industries. This change reflects the evolving landscape of counterfeiting, where social media and encrypted platforms have become primary channels for infringers

International Collaboration and Tactics

The OIOS program collaborates closely with major industry associations, such as the Motion Picture Association’s Alliance for Creativity and Entertainment (ACE), and the Recording Industry Association of America (RIAA). These organizations conduct initial investigations and refer potential cases to OIOS, where HSI field offices determine the viability of full-scale investigations. The operation also benefits from a strengthened partnership with the National Cyber-Forensics and Training Alliance (NCFTA), which has facilitated comprehensive training for HSI agents across the United States.

A significant challenge for OIOS is the transnational nature of digital piracy, with many operations run from outside the United States, in regions like Asia and Eastern Europe. To address this, OIOS has partnered with the Department of Justice’s Computer Crime and Intellectual Property Section (CCIPS) to establish the Western Hemisphere Digital Piracy Working Group, which engages local stakeholders and law enforcement to build effective cross-border enforcement strategies. Recent training programs in London and Uruguay have exemplified the value of this public-private collaboration.

Adapting to New Threats

OIOS has had to pivot to respond to new threats, such as criminals’ use of encrypted platforms and anonymous domain registrations. The shift from traditional counterfeit platforms to social media-based operations has added layers of complexity to enforcement. To counter this, OIOS has focused on developing undercover investigative profiles and leveraged partnerships with online platforms to identify and remove infringing content.

The shift from traditional counterfeit platforms to social media–based operations has added layers of complexity to enforcement.

Metrics of Success

The success of OIOS is measured through metrics such as:

The number of investigations initiated;
Sites taken down; and
The volume of counterfeit goods intercepted.

However, the operation also emphasizes the importance of public awareness. Recent studies, including one by Johns Hopkins University, have highlighted gaps in the knowledge of medical professionals regarding counterfeit pharmaceuticals, reinforcing the need for comprehensive educational campaigns.

How Brand Owners and IP Professionals Can Contribute

Both Operation Apothecary and OIOS demonstrate that effective anticounterfeiting strategies rely heavily on the involvement of brand owners and their legal teams. Here are actionable steps to enhance these partnerships:

Data Sharing and Intelligence Support: Providing timely and detailed information about counterfeit activities helps the IPRC build stronger cases and identify emerging threats.
Training and Awareness Initiatives: Participating in or supporting training programs for law enforcement, customs officials, and health care providers amplifies the reach of these operations.
Public Education Campaigns: Collaborating on consumer-focused education efforts can help reduce demand for counterfeit products by informing the public of the risks involved.

Looking Ahead: Future Goals and Industry Support

The IPRC has set ambitious goals for the future, including the rollout of new training modules and public service announcements that target consumer and provider awareness. For INTA members, the opportunity to contribute to these efforts is significant. By collaborating with government initiatives, brand owners and trademark counsel can play a pivotal role in shaping a more secure marketplace.

The fight against counterfeit pharmaceuticals and digital piracy is far from over, but with continued collaboration, innovative approaches, and strong public-private partnerships, substantial progress is within reach.

Although every effort has been made to verify the accuracy of this article, readers are urged to check independently on matters of specific concern or interest. The opinions expressed in this feature are that of the author and do not purport to reflect the views of INTA or its members.