|St. Onge Steward Johnston & Reens LLC|
Clearing the way for a generic version
SSJR has the expertise to properly advise clients to achieve their goals without generating unnecessary litigation costs. For example, through good counsel and proper advice, SSJR secured a dismissal of a Hatch-Waxman patent infringement case against its client Sandoz. The case was initiated when GlaxoSmithKline (“GSK”) asserted that Sandoz’s generic version of GSK’s anti-nausea drug Zofran® (Ondansetron) infringed U.S. Patent No. 5,344,658. Through its work SSJR was successful in convincing GSK to dismiss its infringement case against Sandoz. The dismissal of the case with prejudice from the U.S. District Court of New Jersey cleared the way for Sandoz to sell its generic version of Zofran®.
Trial through appeal
SSJR has the resources to defend its clients from trial through appeal. For example, when Eon Labs (now Sandoz) wanted to be the first to launch a generic version of the Johnson & Johnson drug Sporanox® (itraconazole) it came to SSJR. As the first to file its ANDA with a Paragraph IV certification Eon Labs was entitled to 180 day market exclusivity if the court agreed Eon Labs’ generic product did not infringe any of the patents covering the Sporanox® product. SSJR successfully defended Eon Labs at trial and through the appeal. The victory meant Eon Labs was able to launch its product as the sole generic alternative to a market estimated at $175 million annually.
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Pharma + Biotech
Smart, creative, and quick to determine the best course of action, our pharmaceutical and biotechnology attorneys have deep insight into the regulatory, business and legal issues facing clients in the fields of generic drug manufacturing and approval. Along with vast litigation experience, they also have technical expertise in both medicinal chemistry and dosage formulation resulting from their work at brand companies, including Abbott Laboratories, Bristol-Myers Squibb, BASF Pharma, and Pfizer, Inc.
SSJR has represented clients on drugs, literally, from A to Z, including Abilify®, Actos®, Allegra®, Allegra D®, Clarinex®, Coreg®, Doryx®, Metrogel®, Naropin®, Neurontin®, Pulmicort Respules®, and Zofran®, among others.
SSJR attorneys are well versed in the subtle intricacies of Hatch-Waxman, both old and new, affecting generic drug manufacturers. SSJR possesses the expertise and resources necessary to translate complex science into a compelling, easily understood case when litigating against a brand company. We’re efficient at the discovery level, sophisticated when dealing with experts, and relentless at trial. We’ve even been known to change the law when appropriate, such as with the landmark Knorr-Bremse v. Dana case.
At SSJR, our attorneys specialize in ANDA litigation, possessing an expertise in intellectual property law, science, and pharmaceutical regulation. The breadth and depth of our practice enable us to work smarter and faster, strategically facilitating speed to market for your product. We prepare opinion and notice letters, prosecute patent applications on new drugs, and guide you through the associated regulatory processes. By fostering partnerships that surpass the typical client/attorney relationship, SSJR creates new opportunities that further your business goals.