Hatch-Waxman Litigation

Tailored Legal Solutions

Each Hatch-Waxman case is unique, and our powerhouse team can provide planning and value to your case by adopting innovative approaches that aim for effective outcomes at reasonable costs. We focus on developing strategic litigation plans, including claim construction strategies, to equip clients with strong tools for negotiating favorable settlements.

Based on client needs, we conduct extensive pre-litigation due diligence, including FTOs, patent analysis, and review of regulatory filings such as ANDA filings. We assist clients in developing invalidity and/or non-infringement strategies early in the drug development process.

When cases proceed to trial, our attorneys, who are seasoned trial lawyers, have experience handling both bench and jury trials and achieving positive results for clients. We are also knowledgeable in PTAB proceedings, both as stand-alone processes and as complements to ongoing Hatch-Waxman litigation.

Experience With Both Brand and Generic Clients

Our team has represented both brand and generic companies and understands the differing business needs and litigation expectations from both perspectives. We have managed patent litigation involving various scenarios, including single ANDA first-to-file, several ANDA first-to-file, second-wave filers, single patent cases, multiple patent cases (more than 10 patents), compound patents, formulation patents, complex generics, drug-device combinations, and label carve-outs.

Diverse Team With Specialized Skills

Our team includes trial lawyers, patent prosecution professionals, and Ph.D.-level subject matter specialists. They are skilled in navigating the complexities of the drug development process, regulatory submissions, and exclusivities.

Strategic Guidance Beyond Litigation

In addition to litigation, our team provides strategic guidance on commercial operations and portfolio assessments. We strive for practical solutions while maintaining a commitment to technical and scientific proficiency across various fields, from small molecules and complex molecules to medical devices. We also engage with emerging technologies, such as artificial intelligence, and help clients integrate these innovations into their business practices.