Hatch – Waxman

Navigating the complexities of the Hatch-Waxman (Drug Price Competition and Patent Term Restoration) Act’s provisions requires more than just legal expertise—it demands a partner who understands the complex intersection of patent law, regulatory compliance, and cutting-edge science. With nearly two decades of Hatch-Waxman experience, our team has successfully guided some of the world’s leading pharmaceutical companies through high-stakes initiatives resulting from the Act.

From managing Paragraph IV certifications to ensuring FDA compliance and securing patent term extensions, we offer comprehensive support tailored to the unique challenges and opportunities presented by the Hatch-Waxman Act. Discover how our proven strategies and deep expertise can position your company for success in a competitive and highly regulated landscape.

Intellectual properties are strategic assets that drive revenue, deter competition, and attract investment. At Carlson Caspers, we understand the unique challenges of complex industries when defending these assets or challenging competitors’ claims, mitigating risks, and taking full advantage of the provisions of legislation like the Hatch-Waxman Act.

With deep technical expertise and innovative approaches, we have become trusted counsel for Hatch-Waxman matters to many companies across the following sectors:

• Medical Devices
• Pharmaceuticals, Biosimilars, and Nutraceuticals
• Polymers, Chemicals, and Compositions

Whatever your industry, we will craft highly effective Hatch-Waxman strategies that support your objectives—protecting your IP and positioning your business for success.

Carlson Caspers provides end-to-end support for every stage of Hatch-Waxman matters, from patent strategy to litigation and appeals. Our approach combines technical expertise with a thorough understanding of the pharmaceutical industry’s legal and regulatory landscape. We tailor our services to meet your business objectives while addressing the unique challenges posed by Hatch-Waxman compliance and litigation. These include:

• Patent Portfolio Assessment: Evaluating patent strength, identifying vulnerabilities, and applying for patent term extensions to maximize exclusivity periods.
• Design-Around Strategies: Enabling our clients to maximize innovation while minimizing infringement risks.
• Paragraph IV Certifications and Pre-Litigation Preparation: Assisting generic manufacturers in filing ANDAs, including detailed bioequivalence data and Paragraph IV certifications, while preparing brand-name manufacturers to defend their patents in litigation.
• Trial and Appeal Representation: Delivering end-to-end support for high-stakes litigation, including cases involving Orange Book patent listings and market exclusivity challenges.
• Regulatory Compliance Support: Advising your team on FDA requirements, Citizen Petitions, and Good Manufacturing Practices (GMPs) to ensure adherence to regulatory standards.
• Additionally, we consider the Act’s broader effects on healthcare providers, insurers, and supply chain stakeholders, ensuring that you are well-positioned for long-term success.

In short, our attorneys are skilled in developing solutions that deliver measurable results. Whether you seek market exclusivity or pursue generic approvals, our team can help you secure a favorable outcome.

Hatch-Waxman litigation carries significant legal risks and represents critical business decisions that can have a tremendous impact on your company. At Carlson Caspers, we integrate technical expertise with a deep understanding of the regulatory and market dynamics unique to the pharmaceutical industry and as influenced by Hatch-Waxman.

We act as an extension of your team, collaborating closely with in-house counsel and subject-matter experts to create tailored strategies that align with your business goals.

We emphasize prevention and early resolution, using insights from years of experience to craft proactive measures that protect your IP positions before issues arise. When disputes occur, we act swiftly, focusing on effective and efficient results and solutions outside the courtroom.

We also understand the pressures of managing resources. By balancing thorough preparation with efficient execution, we reduce financial and operational burdens, ensuring your team can focus on innovation while we safeguard your hard-won patents.

Our team has represented leading pharmaceutical companies, including Sun Pharmaceuticals, Teva Pharmaceuticals USA, Inc., Hetero Labs Ltd., Dr. Reddy’s Laboratories, Glenmark Pharmaceuticals, Alembic, and Shilpa Medicare Ltd.

We have also assisted clients in seeking FDA approval to commercialize cost-effective generic alternatives for a wide range of high-profile products, including Tecfidera®, Sensipar®, Imbruvica®, and OxyContin®.

These successes highlight our ability to navigate the complex challenges of Hatch-Waxman litigation while delivering favorable outcomes. Notable examples include:

• Forest Labs, et al. v. Teva Pharmaceuticals USA, Inc., et al. (memantine extended-release): Represented Teva in litigation concerning seven patents related to Namenda XR®. The court invalidated six patents for indefiniteness before trial, and the firm secured a favorable settlement on the remaining patent post-trial.
• Sepracor v. Teva Pharmaceuticals USA, Inc. (eszopiclone): Acted for Teva as a first-filer in challenging patents covering Lunesta®. The firm achieved a favorable settlement, resolving the matter without proceeding to trial.
• Takeda Pharmaceutical Company Limited, et al. v. Sun Pharma Global FZE, et al. (lansoprazole ODT): Defended Sun Pharma in a patent lawsuit regarding Prevacid® SoluTab™. The Federal Circuit affirmed the lower court’s ruling of non-infringement, leading to case dismissal.
• Alcon v. Watson (olopatadine): Represented Watson in Paragraph IV litigation over ophthalmic formulations of olopatadine (Pataday®). The case was favorably settled after trial proceedings.

With unmatched industry and legal experience in navigating the complexities of Hatch-Waxman compliance and litigation, Carlson Caspers is uniquely qualified to help your company obtain favorable outcomes under the provisions of the Hatch-Waxman Act.

Carlson Caspers distinguishes itself from other firms through deep expertise in intellectual property law and a proven ability to succeed in high-stakes situations like Hatch-Waxman compliance and litigation. Our trial-tested attorneys combine industry-specific knowledge with innovative strategies to ensure favorable outcomes inside the courtroom and out.

Carlson Caspers distinguishes itself from other firms through deep expertise in intellectual property law and a proven ability to succeed in high-stakes situations like compliance with the Hatch-Waxman Act and litigation under its provisions.

But what truly sets us apart is our client-first approach. We align our strategies with your business priorities. By working seamlessly with your team, we provide unmatched counsel tailored to your needs. From navigating complex litigation to crafting proactive protection measures, we deliver an unwavering commitment to your success.