Pharmaceuticals
McAndrews serves as counsel for small and large molecule pharmaceutical companies ranging from Fortune 100 companies to small, privately held enterprises, and major research universities. Focus areas include small-molecule therapeutics, large-molecule therapeutics, cell-based therapeutics, combinatorial products, drug conjugate technologies, dosage forms, drug delivery systems, and diagnostic products, among others.
Pharmaceutical companies face unique business and strategic challenges unlike other industries due to the complex intertwining of regulatory and intellectual property business needs impacting commercial products that take decades to develop and launch on a global basis. Typically, pharmaceutical products are protected by a suite of core patents and require millions and sometimes even billions of dollars of investment from the drug discovery phase through regulatory approval and then commercial launch. Accordingly, strategic intellectual property development and positioning that takes into account the technical as well as the business needs of a pharmaceutical product is the cornerstone of the McAndrews IP approach.
At McAndrews, we understand those needs and work to secure rights that are robust, durable, and strategic. IP protection in the pharmaceutical space must also be global in scope due to the constant threat posed by competitors located in many jurisdictions. The McAndrews pharmaceutical team provides that level of trusted performance to our clients. Additionally, for startups and growth companies, strong, strategic IP protection is the key to funding.
The McAndrews team features highly diverse backgrounds and credentials. Most team members have either advanced degrees or hands-on professional experience, or both. Many of our attorneys and patent agents hold Ph.D.s in fields such as chemistry, biochemistry, medicinal chemistry, pharmacy, cell and molecular biology, and biomaterials, among others. Our clients benefit from these viewpoints and the varying perspectives they provide.
We offer our clients in the pharmaceutical industry a complete range (i.e., one-stop shop) of IP services, including patent litigation, global patent prosecution and portfolio management, strategic IP management, post-grant proceedings (e.g., inter partes reviews), derivation proceedings, freedom-to-operate and patent validity opinions, due diligence, competitive landscaping, client-centric in-and-out licensing programs, and support for other complex IP transactions. We also have extensive experience in ANDA litigation, BPCIA counseling, and FDA regulatory matters.
Our pharmaceutical team is also notable for their in-the-trenches approach and their client-focused/business partner perspective. We know that our clients’ success and our success are closely linked. Our firm focuses upon long-term, mutually beneficial working relationships, not transactions. When what is at stake represents years of work and enormous investments of funds, effort, time, and innovative thinking, you need a legal team that is as committed to your success as you are, and one that has the experience, judgment, and expertise to help make it happen. You need a trusted business partner. You need the McAndrews pharmaceutical team.
"I've tried hundreds, maybe thousands, of cases in my life and can honestly say I've never tried a case better prepared or better presented than this (one). Each of you should be commended for your professionalism, for your preparation, for your knowledge, and for your grasp of the issues — factually as well as legally. It has been a pleasure having you in my court."
U.S. District Court Judge