At Maschoff Brennan, we specialize in the sophisticated intellectual property challenges that pharmaceutical companies face. Because of the Hatch-Waxman Act and the requirements that pharmaceutical companies face to obtain FDA approval for their products, patent practice in the pharmaceutical field is different than the patent practice in other technology areas.

By bringing innovative products to market, pharmaceutical companies help people live longer, higher-quality lives — and our attorneys and other professionals are dedicated to facilitating that progress. Our team provides intellectual property, litigation, transactional, and regulatory services tailored to the pharmaceutical industry. We help clients tackle business and financing pressures, regulatory scrutiny, and litigation threats on a national and international scale.

Our technical expertise is unparalleled. Most of the members of our team have advanced academic degrees, including PhDs, and many have direct industry experience, which our clients truly value. Because of both our experience representing pharmaceutical clients and our technical expertise, our team is well-positioned to help clients navigate the challenges and take advantage of the endless opportunities for growth within this important sector.

Clients in the pharmaceutical industry turn to us for:

  • Obtaining patents for new technologies

  • Strengthening patent portfolios against generic challenges

  • Developing strategies to maximize the patent life of products

  • Writing opinions and providing ongoing counseling for new and evolving products

  • Litigation services, including representation in Hatch-Waxman cases

  • Asserting IP rights to protect innovations from infringement

  • Strategically building and managing patent portfolios

  • Handling regulatory and government-related matters

  • Drafting licenses, transactions, and agreements

  • Counseling on IP management and monetization strategies

  • Advocating our client’s position in post-grant reviews, reexaminations, and reissues

Pharmaceutical Litigation

Maschoff Brennan lawyers excel at helping generic pharmaceutical companies bring their alternative versions of branded drugs to market. We have decades of experience litigating Hatch-Waxman matters on behalf of the generic industry, including disputes relating to 505(b)(2) products.

We advise generic clients on a broad range of activities, including identifying which products to target in view of market and patent considerations, preparing FDA applications with appropriate patent certifications, responding to Citizen Petitions, defending generics in U.S. federal courts against claims of patent infringement, representing generics in inter partes review (IPR) proceedings before the Patent Trial and Appeal Board, and obtaining patent protection for 505(b)(2) products.

It is critical for generic companies to keep their legal costs down in order to succeed. To do so, we staff cases for generic clients leanly, with no more than three attorneys. In addition, we utilize low-cost vendors for routine litigation work, such as document collection and review. We also aim to avoid expensive discovery fights with our adversaries, unless necessary to achieve a strategic purpose or client goal. While settlement during a 30-month stay is not always possible, we litigate strategically and aggressively in order to put the case in the best possible position for an early settlement.