The lawyers at Baker Botts understand the life sciences industry and embrace the traditional spheres of biotechnology, pharmaceuticals and medical devices. We recognize that these spheres do not represent discrete subspecialties: drug discovery often involves biotechnological tools; diagnostics combine materials with assay systems; medical devices often carry drug or biological actives.
Known as "a strong bench of experienced practitioners providing intellectual property, litigation and corporate services."
Chambers USA 2014 - Life Sciences
With over 40 lawyers and scientific advisors in the Life Sciences group and over 145 IP lawyers and scientific advisors firmwide, our Life Sciences Practice has the aptitude to manage the complexity of diverse technological projects. In 2014, Chambers acknowledged the firm for having a “strong presence” in the Life Sciences sector.
Our current clients include:
- Branded pharmaceutical companies
- Established and emerging biotechnology and medical device companies
- Universities and research institutions
- Start-up and early stage companies and inspired individuals
Our life sciences trial lawyers have experience in a full-range of product, intellectual property and commercial litigation. As national coordinating counsel, we provide the comprehensive strategic direction essential to the defense of product-related multidistrict and related state court litigation. We regularly handle product liability claims in conjunction with ongoing governmental, criminal and administrative proceedings, and have advised Life Sciences clients in connection with both voluntary and involuntary product recalls. Our life sciences IP lawyers provide a high level of experience in:
- Organic and medicinal chemistry
- Molecular and cell biology
- Virology and microbiology
- Chemical engineering
- Biomedical engineering
- Mechanical engineering
Our clients are involved in all areas of medicine, including:
- Neurology and psychiatry
- Allergy and immunology
- Cardiovascular disease
- Genetic disease
- Orthopedics and dentistry
- Infectious disease
- Pain management
We have procured patents, undertaken due diligence reviews of an IP portfolio, evaluated freedom to operate for new technologies, rendered opinions, or counseled clients on their IP strategies. We have litigated biotech, pharmaceutical and medical device patents for plaintiffs and defendants.
Life sciences matters often require cross-legal collaborations, and Baker Botts has the breadth and depth of resources to match our patent and technology knowledge with transactional experience for technology ventures; seasoned patent practitioners with seasoned trial lawyers for product, commercial and patent litigation; and IP counselors with corporate transactional lawyers for due diligence projects.
Many of the lawyers in our global IP and Corporate Practices are former in-house counsel at technology companies experienced not only with traditional contractual arrangements but also with new and emerging models for structuring relationships. We regularly assist clients in negotiating and executing strategic alliances, outsourcing arrangements, distribution agreements and other mechanisms for business development partnering, such as technology swaps and control-share transactions. Similarly, our Life Sciences IP lawyers work with our Trial Practice colleagues on patent and trademark litigation, products liability and business litigation involving life sciences clients and issues. With over 40 lawyers and scientific advisors in the life sciences group, our team is equipped to recognize issues outside of their technical and legal experience, while also establishing links within our firm that regularly prove beneficial to our clients.
Client Business Orientation:
Over the years, Baker Botts lawyers have put their skills to work for a wide range of clients in almost every field that touches upon life sciences. We are sensitive to the different needs and concerns of our different clients. In life sciences in particular, we recognize that the prevalence of research collaborations and technology licenses requires sensitivity to overlapping and sometimes competing concerns. And while every strategy is certainly not appropriate for every client, all clients share common concerns: quality and cost. We balance those two to provide value to our clients.
Our lawyers commonly cite our varied client base as one of the best aspects of being a Baker Botts lawyer. This broad technical, legal and client experience equips us to address the complex scientific concepts of today’s life sciences revolution and its equally complicated legal issues. While our experience and technical and legal acumen are required to perform well for our clients, it is our outstanding enthusiasm for our clients and their innovations that drives the Baker Botts Life Sciences lawyers to provide the quality service our clients deserve.
ANDA Litigation & Hatch-Waxman Counseling:
Our lawyers are experienced in matters relating to the Drug Price Competition and Patent Term Restoration Act, informally known as the “Hatch-Waxman Act.” Our matters have included representation of proprietary pharmaceutical companies over a range of Hatch-Waxman issues, including patent portfolio review, product design and clearance, Orange Book inquiries, 505(b)(2) applications, paragraph IV certifications and notice letters, exclusivity inquiries, pre-litigation assessments, Abbreviated New Drug Application (ANDA) litigation, settlements, and trial. We have litigated patent cases pertaining to a wide range of therapeutics and pharmaceutical formulations, including monoclonal antibodies, receptor decoys, oncology agents, anti-diabetics, anti-hypertensives, cholesterol-lowering medications, viral protease inhibitors, antibiotics and animal vaccines.
Publications, Speeches & Presentations
New York Law Journal
The "Substantial New Question" Standard Lives: The Increasing Importance of Relying on New Art and ArgumentExternal Articles
Presentation at HYLA 2014