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Generic Drug Development

Sterne Kessler’s generic drug team combines deep understanding of small molecule drug innovators’ IP with an exception ANDA litigation capability.

Sterne Kessler's generic drug team helps clients navigate the interface between patent law and the FDA approval process. Our work includes patent validity and infringement analyses; exclusivity strategies; ANDA applications and litigation; patent term extension applications; orange book listing strategies; and appeals before the Federal Circuit.

Many decades of experience helping pharmaceutical innovators protect and defend the IP surrounding their FDA-approved drugs provides Sterne Kessler with a unique and advantageous perspective on potential avenues for developing and launching generic equivalents. We understand lifecycle oriented patent portfolios, patent term extensions,and potential weaknesses in innovators' portfolios.

In Hatch-Waxman and ANDA matters, we have assembled a deep bench of experienced litigators, technical experts and attorneys and agents with extensive experience representing both brand and generic pharmaceutical companies in blockbuster ANDA matters. More than 70 of our professionals have experience in ANDA challenges.

Our body of ANDA work comprises more than 75 Paragraph IV filings and over 600 opinions. Sterne Kessler was the first firm to file an inter partes review petition as part of an ANDA dispute. Our attorneys draw on their experience from 400+ reexaminations, 50+ interference proceedings and 575+ inter partes reviews.