NEW STANDARDS IN EFFICIENCY
Our guide to understanding ANDA litigation.
Understanding is what leads to efficiency.
The central framework that shapes generic & namebrand drug interaction is the Drug Price Competition and Patent Term Restoration Act, widely referred to as the Hatch-Waxman Act. Enacted in 1984, this pivotal legislation facilitates the development of generic drugs while also maintaining incentives for pharmaceutical companies to innovate and create. This delicate balance is at the heart of ANDA litigation.
HISTORY
The Origins and Importance of Hatch-Waxman and ANDA
The Hatch-Waxman Act arose after the landmark 1984 court case Roche Products, Inc. v. Bolar Pharmaceutical Co. Roche, the original manufacturer of the drug flurazepam, successfully sued Bolar for attempting to develop a generic version while its patents were still active. This decision spurred concerns about delays in generic drug availability, leading Congress to enact Hatch-Waxman, which allowed generic manufacturers to start the approval process before patent expiration. The Act incentivized innovation by preserving patent rights for brand-name drugs while ensuring quicker access to affordable generics through what came to be known as ANDA (Abbreviated New Drug Application).
Under the ANDA process, a generic manufacturer can seek FDA approval based on an existing drug’s safety and efficacy data. However, these approvals often trigger legal challenges from the patent holder, initiating ANDA litigation. These disputes—typically over patent infringement or validity—have significantly influenced the affordability and availability of life-saving drugs. The dynamic nature of pharmaceutical innovation means litigation volume fluctuates, with ANDA cases peaking in the mid-2010s and continuing to plateau.
“From top leadership to hands-on execution, the Intrepid team possesses a powerful blend of pharma matter expertise and grit to get the job done, resulting in flawless final production on every project we’ve collaborated on.”
Patent Attorney at AM LAW 200 Firm
IN PRACTICE
The mechanics of ANDA litigation
While the ANDA process simplifies the pathway for generic drug approval, it often leads to legal battles between brand-name and generic manufacturers. These disputes usually center around patent rights and exclusivity claims, with brand-name companies frequently alleging that generics infringe on their patents. ANDA litigation can involve various legal proceedings, such as patent infringement suits, declaratory judgments, and settlements, and these cases can be prolonged and intricate. The outcome of these disputes significantly impacts the availability of generic drugs, which in turn affects drug prices and accessibility for patients.
Once a generic manufacturer submits an ANDA, the brand-name patent holder has a 45-day window to respond. They can choose to either settle the matter or initiate a lawsuit, which triggers an automatic 30-month delay in the approval of the generic drug. However, the brand-name company risks having its patent invalidated by the court if the case proceeds.
The number of ANDA litigations has fluctuated over the years, peaking in 2014, 2015, and 2017, but has since fallen back to 2010 numbers. Given the immense volume of electronically stored data that pharmaceutical companies generate during drug development and manufacturing, the discovery process in ANDA cases is both extensive and demanding. Both generic and brand-name manufacturers must be prepared to organize and present their data efficiently, as they have limited time to respond to legal actions.
Redactions
If there is one feature that most characterizes an ANDA review, it is redactions. If you are not familiar with the format and volume of priviliged IP associated with these cases, the redaction costs can spiral.
UNIQUE CHALLANGES
Why ESI is so significant in ANDA litigation
eDiscovery in the context of ANDA litigation presents a significant challenge for all parties involved. Generic manufacturers are required to submit to patent holders all the materials they provided to the FDA during the approval process. This necessitates meticulous preservation of electronically stored information (ESI) in specific formats that align with the ANDA guidelines. Brand-name drug manufacturers, on their end, must ensure that they safeguard all ESI related to the development and regulatory approval of their products, which often encompasses a considerable amount of intricate documentation.
To effectively manage these requirements, eDiscovery providers generally employ established templates and workflows tailored for the preservation and processing of ANDA-related materials, including correspondence with the FDA and other relevant data. Familiarity with the standard ESI formats prevalent across various jurisdictions is crucial for these providers to ensure compliance and proper context in production.
Several practical aspects are essential for navigating eDiscovery within Hatch-Waxman litigation. First, eDiscovery must encompass a broad range of electronic documents linked to the drug’s development, testing, and regulatory approval. This includes all documentation that demonstrates the drug’s efficacy, safety, and uniqueness, such as experimental results, clinical trial data, communications with stakeholders, regulatory submissions, and interactions with regulatory bodies. Additionally, documents pertinent to intellectual property, including patent applications, analyses of potential patent infringements, and prior art investigations, also fall under the eDiscovery umbrella.
Given the potentially overwhelming volume of electronic documentation, effective keyword searches and data analytics become indispensable tools in ANDA litigation. By utilizing targeted keywords—such as drug names, patent numbers, and regulatory terminology—legal teams can swiftly identify the documents most relevant to the case. Advanced analytical techniques, such as concept clustering, email threading, and near-duplicate detection, can uncover relationships and patterns within the dataset. Moreover, machine learning can facilitate automatic categorization and prioritization of data through predictive coding, streamlining the identification of pertinent documents.
30%
Our reviews are, on average, thirty percent more efficient than industry benchmarks. This isn’t easy to do. It’s takes years of experience and an obsessive focus on every little mico-efficiency that can be found. But in the end, they add up to big savings.
BEST PRACTICES
ANDA litigation carries a specific set of concerns to be aware of
The Importance of Experts
Expert testimony plays a critical role in establishing patent validity, infringement, and compliance with regulatory standards in ANDA litigation. Experts in the field—often scientists, researchers, and regulatory specialists—provide insights into the technical aspects of drug development. eDiscovery processes should focus on uncovering relevant documents, such as research studies, lab reports, and regulatory submissions, that support or challenge these experts’ opinions. Accessing electronic records related to testing data, including preclinical and clinical trial information, pharmacokinetic analyses, and bioequivalence testing, is essential for constructing a robust understanding of the scientific evidence surrounding the drug in question.
International Awareness
Cross-border data considerations also complicate eDiscovery in ANDA litigation, particularly for multinational pharmaceutical companies operating across various jurisdictions. Different regions impose distinct data protection laws and regulations, making compliance with eDiscovery requirements challenging. For instance, the European Union’s General Data Protection Regulation (GDPR) strictly governs the transfer, processing, and protection of personal data. eDiscovery teams must select appropriate data transfer mechanisms that comply with applicable laws in each jurisdiction. This includes mechanisms like standard contractual clauses (SCCs), binding corporate rules (BCRs), and frameworks such as the EU-U.S. Privacy Shield.
Collaboration Effencies
Collaboration and cooperation among the parties engaged in ANDA litigation are vital for navigating the eDiscovery process efficiently. Early case assessments allow teams to understand the scope of discovery, the volume of ESI, and the relevance of various documents. Conducting “meet and confer” sessions enables parties to address discovery-related issues, share information, and negotiate how eDiscovery will be conducted. These discussions often encompass methods of preserving, collecting, and producing electronic evidence, as well as addressing potential disputes regarding privilege, confidentiality, and relevance.
In Conclusion
To achieve the ultimate goal of delivering life-saving medications to market, stakeholders achieve the best outcomes by adopting collaborative strategies, utilizing advanced technological solutions, and implementing effective data management and governance practices to evaluate and organize the substantial amounts of electronic evidence relevant to their cases.