Life Sciences and Medical Technology
Client and Industry Challenges
Few industries are evolving and changing as rapidly as that of the life sciences and few comprise as many diverse disciplines as that of the life sciences. The diversity of the industry derives not only from the varying areas of science being explored by various companies but also in the business models pursued by such companies to commercialize their scientific discoveries. Companies operating in this field require their legal counsel to possess extraordinary subject matter expertise, to adapt to changing circumstances and to understand the company’s unique goals.
Beyond its rapid evolution and diversity, the life science industry, together with the closely related medical technology industry, is subject to an immense amount of regulation and quality control that is struggling to keep pace with changes in technological capabilities and medical need. To be successful, companies operating in these industries must have a comprehensive understanding of not only their own technology and business but that of the industry landscape as a whole, including its trends, its regulatory framework, its risks and the competitive technologies that exist within it.
Companies who operate in this industry also face unique challenges relative to raising capital. Often, these ventures require a long-term investment and are believed to be riskier than investments in other industries. In addition, the nature of the business requires larger financial demands on research, development and FDA approval. Accordingly, management of life science companies must be in a position to rely on their counsel for sound advice relative to the capital raising process, for creative financing solutions, and for pragmatic and efficient legal solutions at a reasonable cost.
The goal of each attorney comprising 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 450 plus attorneys has the experience and the resources to provide you with effective and cost-efficient legal counsel.
Areas of Experience
- Strategic Partnerships and Joint Ventures
Collaborative arrangements can be critical to the success and survival of life science and medical technology companies. We have structured numerous major drug, cosmetic and agricultural life science deals. Our services range from technology transfer agreements, research and development agreements, joint ventures and other collaborative arrangements, and marketing, supply and distribution deals for clients across these industries.
- Supply and Distribution
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 offer years of experience in implementing supply chains in the life science and medical technology industry.
- Supply agreements including API supply, component supply, bulk and finished product supply and clinical supply agreements
- Material transfer
- Collaboration/joint venture agreements
- Clinical trial 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
- University Start-Ups and Licensing
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 and after such licenses are secured, we provide advice and assist such clients on new entity formation, founder equity and vesting, limitations on founder participation based upon university policy, 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.
- Intellectual Property
We assist clients in protecting 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 in 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.
Our 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–that is, assisting with the creation of experimental and analytical approaches that best support the intended scope of the patent. Our highly experienced attorneys are able to 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 takes into account the intersect between regulation and patent law, such as federal Orange Book listings, Hatch-Waxman / ANDA litigation potential, 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, as they often 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 extends also to supporting investment firms having similar needs for intellectual property evaluation of potential portfolio companies.
- Patent Drafting and Prosecution
- Corporate and Transactional
- Private Equity/Venture Capital
For companies at early stages or growth stages, raising seed capital and venture capital is of primary concern. We are regularly called upon to help identify sources of capital and to structure appropriate financing arrangements. We negotiate structure 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 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.
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.
- Private Equity/Venture Capital
- Product Liability
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 in order 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
- FDA regulatory guidance
- Environmental and bio hazards
- Legislation and government regulations
- Scope of practice
- Bio and medical ethics
Clients We Serve
Our life science and medical technology lawyers currently represent a diverse client base from the bioscience, pharmaceutical (both prescription and OTC), medical device and healthcare industries, ranging from 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
- Drug delivery and formulation chemistries
- Health information technologies and health economics
- Medical device
- Microbiology and virology
- Pharmaceutical small molecule therapeutics
Key disease conditions and technologies for which we advise include:
- Allergy & Respiratory
- Biomarkers/Precision Medicine/Bioinformatics
- Cardiovascular and metabolic disease
- Coronary artery disease
- Chronic kidney disease
- Diabetes & Diabetic retinopathy
- Endocrine Disease / Hormone Therapeutics
- Implantable Medical Devices
- Endovascular catheters
- Vascular grafts
- General surgical including PTFE sutures, vessel guards, and patches; bioabsorbable devices for tissue reinforcement and reconstruction
- Interventional cardiology endoprotheses
- Cardiovascular patches, grafts, and stents
- 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
Understanding Your Business: Our guiding principle is to know our clients' businesses and problems and to use whatever legal resources are necessary or appropriate to solve those issues in the most efficient manner possible. Each member of our team is prepared to counsel and perform those tasks necessary to secure the best result for our clients. Given the extensive experience our attorneys have in assisting life science and medical technology companies, we understand the unique commercial, operational and legal challenges faced by our clients.
Commitment: We have a breadth of experience representing the interests of the life science and medical technology industries, and we help our clients grow their businesses, provide solutions to their legal needs and help them solve complex problems by bringing business, law and science closer together. In addition, Snell & Wilmer supports local and national professional organizations that are focused on assisting and promoting the interests of the industry.
Collaboration: Snell & Wilmer is one of a small number of law firms in the southwest that has the experience and resources necessary to service life science and medical technology companies throughout their entire life cycle. Our life science and medical technology group is made up of lawyers from various disciplines, including corporate and securities, intellectual property, product liability litigation and health care. Clients operating in these industries require counsel with respect to all of these areas and often a single contract will require input from specialists in each of these areas. Snell & Wilmer lawyers regularly collaborate in order to produce the highest quality work product and to provide our clients with the most comprehensive and sound legal advice.
Specialized Knowledge: Our life sciences and medical technology lawyers include registered patent attorneys and former practicing engineers with degrees in the electrical, computer, chemical, mechanical, environmental, bioscience, systems software, civil and other engineering and scientific disciplines. Many are admitted to practice before the U.S. Patent and Trademark Office and admitted to practice before and experienced in appeals to the United States Court of Appeals for the Federal Circuit, which hears all appeals in patent litigation. Our lawyers meaningfully participate in a variety of professional organizations including various sections of the ABA, INTA, AIPLA and others, and teach at the university level as well.
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, including co-vice chair of its Founder Forum
- 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”
- Co-Chair of CCJL’s Legal Advisory Board; Board Member of CCJL – one of our attorneys was named the CCJL Lawyer of the Year for 2005
- President of the Association of Defense Counsel and registered lobbyist for the organization;
- Legislative testimony on multiple occasions on proposed legislation, including: ER Tort reform Bill SB 1351 (AZ); contingency fee reform Senate Bill 27 (CO); opposition to raising the cap on non-economic damages in Senate Bill 25 (CO); support of food consumption liability House Bill 1150 (CO); support of judicial nominations and retention procedure in Senate Joint Resolution 56 (CO); support of product liability reform Senate Bill 120 (CO); support of punitive damages procedure House Bill 1186 (CO); support of statutory offers of settlement House Bill 1121 (CO); comments to Colorado Supreme Court on proposed changes to Colo. R. Evid. 701, 702 and 703; and before the CO Senate Transportation Committee regarding vehicle event data recorder bill
- Drafting legislation on, for example, scientific testimony, elder abuse standards, ER evidence, product liability reform and punitive damages procedure; and submission of amicus curiae briefs