At Maschoff Brennan, our litigators bring decades of experience litigating Hatch-Waxman matters and have helped guide the world’s most successful generic pharmaceutical companies in bringing their versions of best-selling and well-known drugs to market. Our knowledge and understanding of the complex interplay between business considerations and regulatory concerns facing pharmaceutical companies today shape the legal solutions and winning strategies we consistently provide clients.
In addition to high-stakes litigation under the Hatch-Waxman Act, we pursue and defend inter partes reviews and other post-grant proceedings. Moreover, we provide clients with strategic counseling and advice regarding settlement and other negotiations, as well as prepare pre-suit analysis, Paragraph IV and opinion letters, and settlement and license agreements. We routinely advise clients on the antitrust issues arising from settling ANDA patent litigation.
We also help clients navigate the Food and Drug Administration’s (FDA) complex regulatory framework to secure FDA approval for traditional Abbreviated New Drug Applications (ANDAs) and for 505(b)(2) New Drug Applications.
We have successfully helped our clients bring to market generic versions of the following products:
AMRIX (Cyclobenzaprine HCI)
BIAXIN XL (Clarithromycin)
CONCERTA (Methylphenidate Hydrochloride)
EXELON patch (Rivastigmine)
PATANOL (Olopatadine HCI)
Wellbutrin XL (Bupropion XL)
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 3 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.