For over 40 years, Venable's life sciences patent litigators have safeguarded the most valuable pharmaceuticals, delivering decisive victories in high-stakes cases with billions of dollars at stake. Our relentless advocacy and deep patent knowledge have made us a trusted partner in protecting groundbreaking innovations.
Our clients, many of whom have been with us for decades, trust us to protect them against competitors seeking to invalidate their patents, or to enforce their patents against infringers. They come to us because Venable has one of the largest and most experienced life sciences patent litigation groups among general practice firms in the United States. Our attorneys are dedicated specifically to serving innovator life sciences companies, which is why pharmaceutical developers, biotech innovators, and medical device manufacturers value our advice for their most important matters.
We have decades of experience representing branded pharmaceutical companies to protect and defend their products against premature generic competition. In fact, we have represented branded pharmaceutical companies in defending against generic challengers since the enactment of Hatch-Waxman in 1984, handling well over 100 cases for 30+ companies. We have also secured one of the largest damages awards ever in a pharma patent infringement trial; argued some of the most prominent cases before the Patent Trial and Appeal Board (PTAB), district courts, and the Federal Circuit involving small molecules, biologics, synthetic processes, and medical devices.
Venable's team of 40+ life sciences patent litigation attorneys combine a command of the law with a solid understanding of science, technology, and business strategy. The group includes many attorneys with advanced scientific and medical degrees, and more than 10 attorneys who have first chaired cases through trial and appeal. Whether the issue relates to small-molecule drugs, biologics, cell and gene therapy, novel vaccines, or human cellular and tissue products, we have the technical know-how, experience, and industry knowledge needed to take on the most complex and high-stakes litigation.
Experience
- Represented Melinta in the Northern District of Illinois in an ANDA litigation regarding Nexus's proposed generic version of Melinta's injectable Minocin® antibiotic. The Northern District of Illinois ruled in Melinta's favor on all counts, holding that both of Melinta's patents were valid and that Nexus infringed all claims alleged in both patents, including method of treatment claims. As a result, Venable obtained a judgment permanently enjoining Nexus from manufacturing or selling its generic ANDA product in the United States until the expiration of Melinta's patents
- Secured a victory on behalf of Bausch Health Ireland Ltd., Salix Pharmaceuticals, Ltd., Salix Pharmaceuticals, Inc., and Alfasigma S.p.A. by successfully opposing a motion filed by Norwich Pharmaceuticals Inc. to undo the final judgment the court entered after Bausch prevailed at trial on the latest expiring patents covering Bausch's blockbuster Xifaxan® product. The Court of Appeals for the Federal Circuit affirmed a patent trial victory for Bausch Health. The Federal Circuit agreed that the FDA could not approve a generic competitor's copy of Bausch's Xifaxan® drug product until the expiration of Bausch's latest-to-expire patents
- Managing the patent portfolio for a medical device company specializing in adjustable gastric balloon systems, including patent counseling
- Managing a patent portfolio for a medical device company specializing in antimicrobial implant technology that is currently under review at the FDA
- Led U.S. product clearance, diligence, and patent portfolio development for European and Israeli medical device companies, including those in the areas of neurostimulation and stents. Advised on the timing of a U.S. product launch, supported the company through diligence and acquisition by U.S. entities, and managed the strategy of a U.S. patent portfolio
