Venable’s Life Sciences Law Group combines regulatory, IP, transactional, and litigation strengths to guide companies and nonprofit institutions through the development, commercialization, protection, and defense of life sciences products. Our integrated approach and deep industry experience position clients to succeed in an increasingly competitive and complex market.
For decades, Venable’s life sciences attorneys have helped clients—ranging from emerging innovators to established industry leaders—develop and market drugs, biologics, and medical devices that are regulated by the FDA. From early-stage research collaborations and regulatory submissions to market entry, commercialization, reimbursement, and post-approval compliance, our life sciences attorneys provide strategic counsel at every stage of the product life cycle. Whether the issue involves small-molecule drugs, biologics, cell and gene therapies, vaccines, medical devices, or human cellular and tissue products, our team is well versed in the underlying technology and has the experience necessary to help achieve our clients’ goals.
Venable’s interdisciplinary team includes transactional attorneys with comprehensive knowledge of life sciences assets, intellectual property lawyers skilled in portfolio development and prosecution, a regulatory practice anchored by former government and FDA officials, and seasoned trial lawyers, who have successfully resolved several “bet the company” product liability cases and other complex litigation. Working seamlessly across these practice areas, we help clients navigate regulatory pathways, safeguard and leverage intellectual property rights, structure strategic transactions, and resolve high-stakes disputes. We also have particular expertise helping our clients enter into partnerships with the federal government to fund the development of their technology.
With a proven record in Hatch-Waxman and BPCIA litigation—regularly achieving outcomes that meet our clients’ strategic objectives—and in regulatory advocacy before agencies such as the FDA and FTC, Venable is trusted to handle clients’ most important and complex issues. Whatever the challenge, our team’s “bench to bedside” capabilities across product categories make Venable the go-to firm for life sciences companies working to bring new innovations to market.
Life sciences innovators face a complex and evolving landscape, requiring legal counsel that understands the full product life cycle. Our team provides strategic counsel at every phase of product development, helping you protect your innovation and launch your product successfully.
Discovery and Invention
We set a strong legal foundation for innovation by:
- Helping you choose the right business structure (LLC or C-corp) to support growth and fundraising
- Drafting founder agreements to define ownership, responsibilities, and decision making
- Developing patent portfolio strategy and acquiring patents to help protect your research, development, and innovation, including protecting your ideas early with provisional patent filings or invention disclosures
- Negotiating licensing agreements to acquire or divest important assets, including when spinning out university- or hospital-based research
- Facilitating Bayh-Dole Act compliance if federally funded research is involved. (Former U.S. Senator Birch Bayh, a principal architect of the Act, was a longtime partner at Venable, giving the firm a unique historical connection to this critical area.)
- Putting nondisclosure agreements and collaboration agreements in place to ensure efficiency in operations with development partners and safeguard confidential information
- Working collaboratively with your team to identify and refine the regulatory strategy and prepare for engagements with FDA
- Identifying expedited programs and marketing incentives, including Priority Review Vouchers, that may be available to help streamline the regulatory process
- Establishing a pricing, reimbursement, and market access strategy for your product
Preclinical Development
We help you navigate research partnerships and protect your IP by:
- Filing patents strategically to protect your molecule, method, or platform globally
- Conducting a freedom-to-operate (FTO) analysis to identify potential patent roadblocks
- Drafting clear agreements with academic partners and contract research organizations
- Engaging early with FDA, including pre-IND, Q-submission, and INTERACT meetings to confirm the nonclinical plan and prepare for an IND or IDE submission
- Helping you explore potential partnerships with the U.S. government to collaborate and fund the development of your product
- Negotiating contracts, grants, and other transaction authority agreements with the government
Clinical Development
We help you chart an efficient path through clinical studies by:
- Preparing and submitting your IND or IDE to the FDA to begin human trials
- Negotiating Clinical Trial Agreements (CTAs) with hospitals and research sites
- Drafting patient informed consent forms and ensuring privacy laws like HIPAA and GDPR are followed
- Setting up safety reporting procedures and obtaining Institutional Review Board (IRB) approvals
- Managing relationships with clinical research organizations and vendors, and on behalf of such entities with companies
- Engaging with FDA through Type B and C meetings to ensure your product remains on the pathway to approval, licensure, or clearance
- Applying for expedited programs and alternative pathways as available
- Securing access for patients when necessary through expanded access, emergency use, and Right to Try mechanisms
Product Approval and Market Entry
We provide the guidance you need for a successful product launch by:
- Guiding your New Drug Application (NDA), Biologics License Application (BLA), or device submission
- Negotiating with FDA during the approval review in key areas, including product labeling and post market studies
- Reviewing promotional materials for FDA/FTC compliance
- Managing the receipt and sale or transfer of Priority Review Vouchers
- Drafting and negotiating agreements with manufacturers, logistics partners, suppliers, and distributors
- Protecting your product and brand through trademark registrations and trade secret strategies
- Advising on pricing, reimbursement, and market access with payers and government agencies
Commercialization and Scaling
We help you grow and safeguard your operation by:
- Structuring distribution and sales agreements that minimize liability and ensure compliance
- Monitoring and addressing post-market safety issues and adverse events
- Responding to Warning Letters, investigations, and other compliance actions
- Setting up licensing or co-marketing deals with commercial partners
- Supporting your team with employment agreements, stock options, and HR policies
- Planning for and managing risk with product liability insurance and internal compliance protocols
Exit, Expansion, or Renewal
We help you plan your next move strategically and securely by:
- Supporting M&A, IPOs, and strategic investment rounds
- Extending product exclusivity with additional patents, patent term extensions, or regulatory exclusivity (e.g., Orphan Drug status)
- Handling licensing-out opportunities or global partnerships
- Navigating international regulatory and IP issues during global expansion
- Representing you in disputes, litigation, or contested proceedings (including in federal and state court and before the Patent Trial and Appeal Board and the International Trade Commission), or government investigations when challenges arise
- Developing and managing overall litigation strategy for toxic tort claims and mass torts
- Leading expert witness teams in toxic tort litigation in more than 50 medical fields and dozens of other industries, working with them on drafting reports, preparing and defending depositions, deposing plaintiffs’ experts, and examining experts at trial
- Serving as lead counsel for clients in matters going to trial
