Womble Bond Dickinson’s life sciences and pharmaceutical attorneys are committed to providing effective and practical advice to clients at the intersection of pharmaceutical law and innovation. Our multidisciplinary team of professionals has experience working alongside a myriad of companies within this diverse industry, including pharmaceutical, biotechnology, medical device, animal health, biodefense and other life sciences sectors.
Our professionals have deep knowledge of the complex and highly specialized life sciences industry, with many having served as former in-house counsel and scientists at life sciences and pharmaceutical companies, as well as former patent examiners and FDA regulators. This experience allows us to understand the scientific foundation of life sciences businesses and to provide efficient analysis and advice tailored to the specific needs of our clients.
Led by one of the industry’s most respected litigation teams, we counsel international, innovator pharmaceutical companies and represent them in district courts across the United States, the Federal Circuit, and before the USPTO. We also have extensive experience with Abbreviated New Drug Application (ANDA) litigation and inter partes proceedings.
Pharmaceutical Law Services
With in-depth knowledge of pharmaceutical law and access to a wider transatlantic team of professionals experienced in patent law, trademarks, licensing, litigation, regulatory law and more, we are dedicated to providing sector-specific advice to clients throughout the life cycle of their business.
Our life sciences and pharmaceutical law services include:
Patent preparation and prosecution, investigations and portfolio management
Intellectual property transactions, including complex licensing and a broad range of corporate and commercial agreements
Trademarks and brand management, copyrights, and data protection
Intellectual property litigation, including ANDA litigation
Corporate transactions, including mergers and acquisitions, joint ventures, and strategic alliances
FDA regulatory advice surrounding biologics, drugs, medical devices as well as cutting-edge biosimilars and regenerative therapies
Products litigation involving pharmaceutical and life sciences products
Pharmaceutical government contracts and regulations.
We understand the challenges life sciences and pharmaceutical companies face daily, including protecting valuable innovations and adhering to ever-changing government regulations. Our team is well-positioned to help clients navigate the challenges and take advantage of the endless opportunities for growth within this important sector.
Successfully defended a European-based pharmaceutical company in a patent litigation under the Hatch-Waxman Act for patents covering a gastrointestinal product. The multi-region Life Sciences Litigation team successfully initiated this ANDA case and narrowed the issues to infringement. At bench trial our client won on all issues
Represented a client in the opioid space in the procurement of multiple Orange Book listed patents protecting its products to 2031. Successfully defended a challenge in an Inter Partes Review of one of these patents where all claims were confirmed as valid
Represented a gene-therapy company in the global licensing and commercialization of its rAAV gene therapy technology for the treatment of rare diseases including two technology spin-out transactions involving exclusive licenses to two different large, multinational pharmaceutical companies with an aggregate deal value of up to $1 billion
Secured dismissal of a federal products liability case on behalf of a large pharmaceutical company headquartered in the UK with a significant presence in the US. The plaintiff’s complaint was over a migraine drug and its alleged side effects. After voluntary disclosure of medical records, the team was able to persuade plaintiff’s counsel that continuing litigation would not be fruitful, and the case was dismissed before extensive discovery commenced.
UK
Advising a UK based network drug discovery business on pre-IPO funding rounds on its initial public offering on the AIM market and on subsequent secondary fundraisings to raise funds in excess of £100 million
Assisting through local counsel an AIM listed protein engineering company to enter the Chinese market
Sale of UK medical software business to a NYSE listed plc and market leader in complementary analytical technologies
Advising a leading UK based protein engineering business, on seed capital and subsequent fundraisings.
Overview
Overview
With years of industry experience and lawyers across all disciplines, our Life Sciences Team excels at quickly grasping complicated medical and scientific issues and turning that subject matter experience into legal strategies.
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About Us
Womble Bond Dickinson’s Life Sciences Practice
Life Sciences Patents, Trademarks, and Trade Secrets
Our attorneys, IP professionals, and technical advisors work in tandem to provide clients with a seamless experience, rooted in consistent, high-quality legal counsel. Our services and advice cover:
Patent prosecution and portfolio strategy
Patent litigation
PTAB proceedings
Trade Secret counseling and litigation
Trademark prosecution and litigation
Our IP lawyers are highly experienced in many areas of life sciences, with advanced knowledge of pharmaceuticals, small molecules, and biologics; immunology; diagnostics, medical devices, and surgical tools; imaging and testing equipment; compositions and formulations; manufacturing and synthesis processes; and methods of treatment.
Corporate Services for Life Sciences Companies
Womble Bond Dickinson represents a diverse client base, including venture capitalists, private start-ups, and large public companies. We provide transactional support for strategic deals and offer cost-effective options for routine matters. Because of Womble’s size and resources, we can quickly respond to the evolving corporate needs of life science companies at every stage of growth. Our corporate services most often involve:
Licensing, due diligence, transactions, portfolio review
Our privacy lawyers work with life sciences clients to develop and implement lawful patient data collection, sharing, and retention practices, as well as privacy compliance measures, covering HIPAA, HITECH, and state privacy laws. Our services include:
Privacy policy review and development
Data breach and incident response plans, including management and privacy class actions
Proactive legal positioning to prevent regulatory investigations and litigation
Compliance with GDPR
Data privacy and protection for clinical trials
AI and MedTech
At Womble Bond Dickinson, we advise life sciences companies at the forefront of artificial intelligence as it reshapes medical technology and drug and biologics development. From AI enabled medical devices, diagnostics, and digital health platforms to AI driven drug discovery and biologics research, we help innovators manage the legal and regulatory issues that arise as advanced technologies move from concept to commercialization.
Our attorneys counsel emerging, growth stage, and established companies across the innovation lifecycle. On the MedTech side, we advise on software enabled and connected devices, data driven clinical tools, and platform technologies. For pharma and biotech companies, we support AI enabled R&D, research collaborations, data and algorithm licensing, and strategic partnerships. Across both sectors, we help structure co development arrangements, protect intellectual property, and execute strategic transactions that support scale and investment.
Drawing on deep familiarity with the scientific, regulatory, and commercialization landscape, we help life sciences innovators safeguard core technologies, structure critical relationships, and position AI driven products, platforms, and pipelines for sustainable growth in a rapidly evolving market.
Life Sciences Litigation, Arbitration, and Other Disputes
Life sciences companies operate at the intersection of cutting edge science, significant capital investment, and intense competition, where disputes can directly affect product pipelines, strategic partners, and long term enterprise value. Disputes can arise at every stage of a pharmaceutical, biotech, medical device, or diagnostics product’s life cycle. Our attorneys have experience in handling disputes involving licensing and collaboration agreements, supply and manufacturing, distribution and pricing, trade secrets, and related business torts. Drawing on deep industry and regulatory knowledge, we help life sciences companies protect critical assets, manage risk in strategic relationships, and resolve disputes efficiently—whether through strategic and results-focused courtroom advocacy or targeted alternative dispute resolution. We also have arbitrated life sciences disputes in leading arbitral centers around the world.
IP litigation, ITC Section 337, and post-grant proceedings
Integrated Practices
Complementary Legal Practices, Same Level of Service
Real Estate
With years of experience in life sciences, our team understands the industry’s distinct real estate challenges. We work with the firm’s corporate and regulatory attorneys to advise clients on acquiring, developing, and managing laboratories, manufacturing sites, R&D facilities, and other real estate. Our real estate services for life sciences companies include:
Acquisition, leasing, and development of laboratory and manufacturing space
Zoning, land use, and permitting for regulated operations
Real estate aspects of venture financings and M&As
Facility expansions and compliance-driven modifications
Tax
Tax strategy is central to structuring investments, transactions, and IP driven growth. Womble’s tax group delivers strategic tax advice tailored to the life sciences business cycle, from formation through exit. Our tax attorneys have experience in all 50 states and 50 countries internationally, with services that include:
Tax structuring for venture capital, M&A, and collaborations
Managing talent is critical in a highly competitive, highly regulated industry like life sciences. Our employment lawyers advise life sciences companies on everything from hiring and retaining employees to addressing high-risk workplace issues. Our counsel covers the following:
Executive hiring, employment agreements, and equity compensation
Workforce policies and regulatory compliance
Employee mobility, restrictive covenants, and trade secrets
Employment litigation and government investigations
Ancillary Services
WBD Advance
Medical and Scientific Solutions (MedSci)
Our MedSci group provides an additional layer of insight into medical and scientific issues in complex litigation and regulatory matters. The team, which includes attorneys, paralegals, nurses, PhDs, and research analysts, typically assists life sciences clients with the following:
Life science-specific consulting and scientific documentation services
Expert witness identification and preparation
Scientific and medical research, medical writing, and case analyses
Clinical trial support and documentation
FDA Regulatory Affairs
The firm’s FDA Regulatory Affairs group combines the experience of FDA-focused attorneys and regulatory scientists to support life sciences companies across the product lifecycle. The team delivers practical regulatory guidance designed to keep development, approval, and commercialization on track in highly regulated markets. Our integrated legal and scientific FDA support model includes:
FDA submission strategy for drugs, biologics, and medical devices
Regulatory and scientific support for pre-market and post-market requirements
Compliance and regulatory diligence aligned with business objectives
GCSolutions Cost-Effective Legal Support
GCSolutions is an agile, cost-friendly option for growing life sciences companies. The team offers lower hourly rates, predictable fixed fees, and other alternative fee arrangements for routine and high-volume legal work. GCSolutions attorneys regularly provide in-house teams with:
Day to day commercial contracting support
Scalable assistance during growth and transactions
High volume contract review and due diligence
BullDox Technology-Enabled Discovery for High-Stakes Matters
Womble’s BullDox Team offers end-to-end eDiscovery and information management services for complex, data-driven disputes and investigations. Ideal for high-stakes, large-scale litigation, BullDox helps life sciences companies manage discovery efficiently while controlling cost and risk. Services include:
eDiscovery support for patent litigation, product liability, and regulatory matters
Early case assessment and defensible discovery strategies
Advanced workflows for large scientific and technical datasets
In need of an life sciences and pharmaceuticals lawyer? Look no further.
At Womble Bond Dickinson we have an exceptional team of talented lawyers and business professionals who can offer guidance and find the solutions right for your business. We have both broad and niche expertise across all our UK and US offices.
Examples of our work and how we’ve helped companies of all sizes with a wide range of challenges.
UK
Advising a UK based network drug discovery business on pre-IPO funding rounds on its initial public offering on the AIM market and on subsequent secondary fundraisings to raise funds in excess of £100 million
Assisting through local counsel an AIM listed protein engineering company to enter the Chinese market
Sale of UK medical software business to a NYSE listed plc and market leader in complementary analytical technologies
Advising a leading UK based protein engineering business, on seed capital and subsequent fundraisings.
US
Successfully defended a European-based pharmaceutical company in a patent litigation under the Hatch-Waxman Act for patents covering a gastrointestinal product. The multi-region Life Sciences Litigation team successfully initiated this ANDA case and narrowed the issues to infringement. At bench trial our client won on all issues
Represented a client in the opioid space in the procurement of multiple Orange Book listed patents protecting its products to 2031. Successfully defended a challenge in an Inter Partes Review of one of these patents where all claims were confirmed as valid
Represented a gene-therapy company in the global licensing and commercialisation of its rAAV gene therapy technology for the treatment of rare diseases including two technology spin-out transactions involving exclusive licenses to two different large, multinational pharmaceutical companies with an aggregate deal value of up to $1 billion
Secured dismissal of a federal products liability case on behalf of a large pharmaceutical company headquartered in the UK with a significant presence in the US. The plaintiff’s complaint was over a migraine drug and its alleged side effects. After voluntary disclosure of medical records, the team was able to persuade plaintiff’s counsel that continuing litigation would not be fruitful, and the case was dismissed before extensive discovery commenced.
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