Not everyone is thrilled when a generic version of a medicine hits the market. Sometimes the company that made the brand-name drug sees a generic version as an infringement on intellectual property. And things get litigious in a hurry.
There’s no such thing as too early to start planning your case when you get sued by a major drug maker. There are deadlines to meet, a process to follow, and no time to be haphazard. In short, when a suit is filed against you, you need experience and support, fast.
Christina Saveriano, an attorney at Hill Wallack’s Princeton office, specializes in commercial litigation, complex civil litigation, and regulatory law with a focus on corporate compliance issues in state and federal court. Since 2004 Saveriano has helped Hill Wallack clients get their fair say in the highly complex world of commercial litigation, and when it comes to the Princeton region’s pharma and biotech industry, she is a major asset to have.
Keeping up with the changes in laws and regulations, after all, is no amateur task. Like many states New Jersey has enacted local patent rules and local rules about the process a complex commercial litigation process can take. These rules are, in part, designed to protect generic drug makers while they seek approval for their products ‒‒ and seek to avoid potentially costly fights with brand-name drug makers.
These rules also outline a specific and highly structured set of deadlines and procedures to follow in patent litigation. It’s these deadlines that must be prepared for as early as possible. They come up fast and frequently, and missing one is not an option for a winning argument.
And when a generic drug maker is sued, the most pressing thing, Saveriano says, is to preserve all documents that support the company’s right to make and sell a medicine and prepare its positions early. “Generic drug makers make one of two contentions,” she says. “Either that the generic product does not infringe on the branded product, or that the branded product’s claims are invalid.”
With no sign of generic medicines slowing down and, consequently, no sign of infringement suits slowing down with it, Princeton’s smaller pharma companies and generic product makers will remain in need of experienced attorneys like Saveriano, who has built her reputation through more than a decade of defending and representing companies in Hatch-Waxman litigation, employers, management, businesses, and individuals against wrongful discharge, discrimination, harassment, breach of contract, and violations of both state and federal civil rights and laws.
Ms. Saveriano can be reached at 609-734-6395.
Hill Wallack, 21 Roszel Road, Princeton. www.hillwallack.com.