Life Sciences and Medical Technology
The goal of Snell & Wilmer's life science and medical technology industry group is to help our life science and medical technology clients improve health and quality of life by identifying and implementing workable solutions to these legal and business challenges. We understand the importance of having experienced legal counsel equipped to integrate rigorous scientific analysis with efficient advocacy where possible for our clients. Whatever stage a life science or medical technology company is in, or whatever legal issue it may have, Snell & Wilmer's team of 500 plus attorneys has the experience and the resources to provide you with effective and cost-efficient legal counsel.
Our Areas of Service
Strategic Partnerships, Joint Ventures, and Venture Capital Financings
Collaborative arrangements can be critical to the success and survival of life science and medical technology companies. We have structured numerous major pharmaceutical, medical device, cosmetic, and agricultural life science deals. Our services range from technology transfer, material transfer, research and development, clinical trial, acquisition, joint venture, and other collaborative agreements. In addition, marketing, supply, and distribution deals have also been serviced for clients across these industries.
Universities, Incubators, Start-Ups, and Fortune 500
We frequently represent our clients in licensing patents from leading universities, hospitals, and other academic institutions across the United States. In connection with such licensing activity, we provide advice and assist such clients on new entity formation, founder equity and vesting, limitations on founder participation based upon university policies, shareholder agreements, intellectual property assignment and licensing agreements, employee incentive compensation arrangements, website terms and conditions, and other issues that new enterprises face in their start-up phase.
We assist clients in procuring, protecting, commercializing, and enforcing intellectual property rights worldwide using our technical training and experience in a wide variety of scientific disciplines. Many of our patent lawyers have substantial experience working in academic laboratories and within the industry. This real-world experience fosters appreciation and familiarity in establishing close-working relationships with our client's management and scientific teams at all stages of research, development, licensing, and marketing of these technologies.
Advance degrees are particularly important in supporting the technological demands of life science and medical technologies. Many on our team have advanced degrees in these disciplines, including organic chemistry, biochemistry, molecular biology, and plant biology.
IP services include:
- Patent Drafting and Prosecution: Our services include patent drafting and prosecution through the U.S. and international patent offices. In support of these applications, we often assist clients with experimental design – assisting with the creation of experimental and analytical approaches that best support the intended scope of the patent. Our highly experienced attorneys can provide realistic and achievable experimental and prototype solutions, bridging established law and current legal trends with leading scientific developments. In this way, our group particularly excels at developing patent strategy to protect not only existing products, but also natural areas of product expansion.
- Portfolio and Life-Cycle Management: We assist clients in developing an entire portfolio of patents designed to respond to offensive and defensive strategic needs. A crowded field may require different solutions than one with pioneering technology. Strategic partnerships and joint venture opportunities will differ from a siloed development effort. Out-licensing, in-licensing and cross-licensing potentials also will drive different considerations. And in this highly regulated environment in which life science and medical technology must operate, our strategic counseling regularly considers the intersect between regulation and patent law, such as federal Orange Book listings, Hatch-Waxman / ANDA litigation potential, strategizing on patentable aspects related to clinical trials, and maximizing patent term extensions due to clinical trial and other regulatory delay. The ability to plan for and manage these various strategic considerations can be critical to a successful patent strategy and our attorneys are well-positioned and experienced to assist clients and laying the proper groundwork.
- Patent Opinion and Analytical Services: We offer a range of patent opinion and analytical services. Our white space analyses, including start-of-the-art and landscape opinions, are utilized by clients seeking to explore new commercial opportunities but are unsure of potential infringement risks or the likelihood of securing patent protection. Patentability, Freedom-To-Operate and Non-Infringement opinions are also rendered on a regular basis according to our clients' needs with a view towards current legal trends in this area, which often dictates something less than a "full and formal" opinion that was common just a few years ago.
- Due Diligence: We frequently provide due diligence investigations to clients considering a major transaction or collaboration, such as a major asset purchase, license and development, merger or acquisition, or securities offering. Our team is well-trained and experienced to respond to the comprehensive intellectual property needs associated with these investigations. Often, they include both defensive and offensive patent assessments, as well as contractual review spanning a range from basic confidentiality agreements and employment or consulting agreements, to complex collaboration agreements, manufacturing, supply, and clinical trial agreements, to understanding government and university chain-of-title complexities. These are among just a few of the nuances that can be missed by less experienced practitioners. Our due diligence expertise experience extends also to supporting investment firms having similar needs for intellectual property evaluation of potential portfolio companies.
Corporate and Securities
- Private Equity/Venture Capital: For companies at early stages and growth stages, raising capital is of primary concern. We are regularly called upon to help identify sources of capital and to structure appropriate financing arrangements. We structure, negotiate, and document private equity, venture capital and angel investments to align the interest of both the business and its investors. We have also formed private equity/venture capital funds with an investment focus in this industry.
- Mergers and Acquisitions: Companies sometimes grow through mergers and acquisitions, particularly in the biotech industry. We have represented both publicly traded and privately held biotechnology companies in a wide variety of M&A transactions, including stock and asset acquisitions, mergers, tender offers, leveraged buyouts and spin-offs.
- Securities: We assist our clients in accessing the public securities markets, guiding the public offering process from preparation of registration statements and prospectuses, and negotiation of underwriting and placement terms, to preparation of listing applications with respect to the major exchanges. We also regularly advise our publicly traded clients on continuing disclosure and compliance issues under U.S. federal and state securities laws.
- Commercial Agreements and Licensing: Our transactional attorneys have significant experience with assisting life science and medical technology companies with commercial contracts including asset purchase agreements, supply and procurement agreements, buy/sell agreements, option and right of first refusal agreements, sales and distribution agreements, sourcing and procurement agreements, transportation and logistical services agreements, consulting and other contract services agreements, joint venture agreements, equipment purchase and equipment leasing agreements, sponsorship agreements and franchise agreements. Our team is equipped to assist with a variety of other contracts including, but not limited to those related to entity formation, employment, intellectual property, and real estate.
Once faced with litigation, pharmaceutical and medical device manufacturers rely on our attorneys to assist them through the process, handling all types of product liability and tort actions including individual lawsuits, class actions, mass tort litigation and multi-district litigation cases. We understand the importance of having experienced legal counsel equipped to integrate rigorous scientific analysis with efficient advocacy to limit liability wherever possible for our clients.
Regulatory and Compliance
Our services include:
- Stark Law and Anti-Kickback Law
- Corporate compliance plans
- Medicare and Medicaid compliance
- Medicare and Medicaid reimbursement
- Health facilities licensure
- CLIA certification and compliance
- Risk management and quality
- Peer and utilization review
- HIPAA and HITECH
- State privacy laws, including CCPA, CPRA, UCPA, CPA, VCDPA, and FTC
- FDA regulatory guidance
- Environmental and biohazards
- Legislation and government regulations
- Scope of practice
- Bio and medical ethics
Research, Manufacturing, Supply, Distribution, and Other Service Agreements
A key asset of any life science or medical technology company is its supply and distribution chain. Bad supply chain decisions can haunt a company for years and have a significant effect on its bottom line. We have years of experience in supporting supply chain implementations in the life science and medical technology industry.
Our experience includes:
- Supply agreements including API supply, component supply, bulk and finished product supply and clinical supply agreements
- Material transfer agreements
- Distribution agreements
- Providing advice on recalls, out of spec situations, and plant inspections
- Providing advice on other legal and regulatory concerns relating to supply and distribution
Clients We Serve
Our life science and medical technology lawyers currently represent a diverse client base from the bioscience, pharmaceutical, medical device, and healthcare industries, ranging from universities and large, publicly traded organizations to early and mid-stage start-up companies.
We have a proven track record representing manufacturers, distributors, inventors, researchers, venture capitalists, angel investors, engineers, product designers and vendors, in their intellectual property, transactional, litigation and various other legal matters.
Our clients' products and services span the fields of:
- Bioengineering and medical device development
- Biologics including genomics and proteomics-based therapies
- Blood glucose monitoring
- Drug delivery and formulation chemistries
- Genetic sequencing
- Health information technologies and health economics
- Medical devices
- Microbiology and virology
- Regenerative medicine
- Small molecule therapeutics
Key disease conditions and technologies for which we advise include:
- Allergy & Respiratory
- Precision Medicine
- Cardiovascular and metabolic disease
- Coronary artery disease
- Chronic kidney disease
- Diabetes & Diabetic retinopathy
- Endocrine Disease / Hormone Therapeutics
- Implantable Medical Devices
- General surgical including PTFE sutures, vessel guards, and patches; bioabsorbable devices for tissue reinforcement and reconstruction
- Vascular and cardiovascular patches, grafts, stents, catheters, endoprostheses, and ablation devices
- Non-small cell lung cancer
- Ovarian cancer
- Pancreatic cancer
- Renal cell carcinoma
- Alzheimer’s Disease
- Amyotrophic lateral sclerosis (ALS)
- Anxiety and Depressive Disorders
- Multiple sclerosis
- Parkinson’s disease
- Inflammatory Disease
- Osteo arthritis
- Rheumatoid arthritis
- Infectious Disease
- Antimicrobial susceptibility testing
- Imaging sciences
- Research tools, assays, kits and reagents
Why Clients Select Us
Collaboration: Snell & Wilmer has the resources to service life science and medical technology companies throughout their entire life cycle. Our life science and medical technology group is highly collaborative, and includes lawyers with experience in intellectual property, corporate and securities, product liability litigation and health care. Snell & Wilmer lawyers regularly work with one another to provide our clients with comprehensive and sound legal advice.
Technical Knowledge: Many of the registered patent attorneys on our team were practicing scientists or engineers in their previous roles before joining the firm, and have degrees in fields such as cell biology, biochemistry, molecular biology, molecular and integrative physiology, organic chemistry, physical chemistry, chemical engineering, mechanical engineering, or electrical engineering.
Service to the Industry: Snell & Wilmer attorneys are dedicated to promoting the interests of their life science and medical technology clients, as shown by the following examples of involvement in the industry:
- Membership and active involvement with Biocom California
- Membership and active involvement with Athena, Women in STEM
- Membership and active involvement with Women in Bio
- Membership and active involvement in the AZ Medical Association liability reform committee, EMTLA committee and tort reform committees, CO Civil Justice League (CCJL), Defense Research Institute, CO Defense Lawyers Association, PLAC, AZ Association of Defense Counsel, American Academy of Healthcare Attorneys, International Association of Defense Counsel, and CO Bioscience Association - Public Policy Committee
- Board of Directors, Colorado BioScience Political Action Committee
- Board of Directors, Arizona BioIndustry Association (AzBio)
- Advisory Board, University of Arizona's "TechLaunch Arizona"