Life sciences turns scientific discovery into approved therapies, and the legal work has to span that entire distance. MC Law advises pharmaceutical companies, biotechnology firms, and life sciences investors on intellectual property, FDA regulatory strategy, and the deals that carry a product from the lab to the market. Our attorneys have technical training, so we can engage with the science behind your patents and submissions rather than relying on someone else to translate it.
Patent Strategy and IP
In life sciences, the patent estate often is the company. We develop patent strategies for therapeutics and biologics, protect both small-molecule and biologic inventions, and advise on patent term extensions that preserve exclusivity. We conduct IP due diligence for financings and partnerships and handle patent disputes when competitors push into your space. The objective is an IP position strong enough to support the years of investment a therapy demands before it reaches patients.
FDA Regulatory Pathways
Nothing reaches the market without clearing the FDA, and the path is rarely simple. We advise on regulatory strategy, draft clinical trial agreements, and help prepare for FDA interactions and submissions across development. We work through post-approval obligations and map international regulatory pathways for companies commercializing beyond the United States. The aim is a regulatory plan that anticipates the agency's questions instead of reacting to them after a hold or a complete response letter.
Licensing and Commercialization
Few life sciences companies go it alone, and the deals can define a product's future. We negotiate licensing, collaboration, and co-development agreements, structure manufacturing and supply arrangements, and handle the commercial contracts that bring a therapy to market. We pay close attention to milestone payments, royalty terms, and rights reversions, so your agreements reward success without surrendering control of an asset you spent years building.