Biologics and Drug Pioneering Solutions
Helping to bring innovative life-saving products to the market effectively and efficiently.
As biotech, biopharma, and pharma companies develop new therapeutics, aligning legal strategies with development and commercialization goals throughout the extensive process of funding, R&D, clinical trials, and market entry is imperative to a company’s strategy, success and growth. We assist clients in developing and implementing strategies to protect and expand their pipeline and maximize the benefit of their products to their target patient population.
Bringing Technology to Life
Representing top medical device manufacturers working to improve and enhance medical outcomes.
Medical device manufacturers encounter a wide range of issues when bringing a product to market and keeping it on the market. From device design and development through clinical trials and regulatory approval before marketing, to post-market surveillance and product liability concerns, medical device manufacturers face a complex field of potential issues and problems. We assist medical device manufacturers at every stage of the lifecycle of a medical device—from protecting IP, negotiating supply and distribution contracts, assisting with the regulatory review process, and mitigating and defending against the threat of products liability litigation.
Providing strategies to deliver diagnostic and imaging offerings and services to the world.
Diagnostics and personalized medicine companies developing and commercializing innovative tests face an evolving patent landscape, increased regulation, and challenging data, privacy and reimbursement issues. A multifaceted strategy is key to monitoring and addressing these challenges.
Cutting-Edge Life Science Innovations
Providing creative solutions for disruptive technologies.
As artificial intelligence, additive manufacturing, robotics, and telemedicine/digital health revolutionize discovery, development, and manufacturing of biologics, drugs, diagnostics, and medical devices, legal solutions to address traditional and unprecedented IP, regulatory and data and privacy issues must be re-imagined to keep pace.
Advising leading contract organizations on providing health insights and solutions.
Contract research, manufacturing and sales organizations provide vital resources and expertise to companies developing new products and technologies, as an avenue to improve efficiencies and smooth market entry. Up-to-date advice on contracting, compliance, and regulatory developments and solutions facilitates seamless integration of contract services for translating cutting-edge concepts and discoveries to the market.
Experience in the Field
Raising understanding of the agriculture and animal health industries and how the two intersect.
Duane Morris attorneys are well-versed in and provide incisive strategies for exclusivity and market positions, including IP procurement, defense and enforcement, in this specialized area. When it comes to veterinary pharmaceuticals, vaccines and biologicals and plant and plant-related technologies (including traditional Mendelian genetics through genetically modified plants for heterologous expression of proteins useful in pharmaceuticals), Our attorneys have extensive experience in obtaining, defending and enforcing IP, as well as in clearing the underbrush of third party patent positions. Duane Morris is uniquely positioned to protect hard-earned scientific advancements and secure and preserve market and exclusivity positions in the agriculture and animal health industries.
Range of Services
Duane Morris attorneys understand the issues that innovators in the life sciences industry face from every angle: from the science and technology to business realities and from the impact of changes in the law to potential legal challenges. Many of our life science attorneys have been in-house counsel at life sciences companies and/or have worked as scientists in research laboratories. Our intellectual property attorneys represent clients with license and transfer agreements, procurement issues, IP diligence, license reviews, audits, disputes and other strategic matters in connection with other licensing and permitting of technology or products.
Duane Morris attorneys provide counsel on the most effective methods of establishing and developing IP holdings. Our attorneys understand that a thorough and accurate IP asset due diligence review to align IP strategy with business goals is essential to help companies acquire and protect their IP rights, maximize their patent term and realize the most value from their assets.
Our registered patent attorneys and agents work synergistically with health, life, medical technology and biotechnology sciences clients, from start-ups and universities to multinational corporations, in identifying potentially patentable subject matter, aligning that subject matter to business and market goals, and preparing, prosecuting, defending, maintaining and enforcing (including through licensing) global patent portfolios. Our Registered patent practitioners assist these clients in developing patentable design-arounds as to existing technologies of others. These practitioners also work with these clients in establishing portfolios that can withstand due diligence by investors and licensees, and moreover challenges by third parties. Similarly, the Duane Morris health, life, medical technology and biotechnology sciences IP strategy/prosecution registered patent attorneys and agents collaborate with litigation teams, both in the U.S. and around the world, in the enforcement of client IP rights and in the defense from allegations of infringement or misappropriation of technology. Our practitioners also help our clients manage IP risks, including conducting product clearances, and responding to audit inquiries and invitations to license.
Our IP lawyers also work with health, life, medical technology and biotechnology sciences clients, filing and maintaining applications to register trademarks, current trademark registrations and copyrights each year in the U.S. and jurisdictions throughout the world. We also handle an array of issues, including disputes, related to trademarks, copyrights, trade secrets and unfair competition claims.
Our experienced litigation attorneys handle all aspects of district court and Patent Trial and Appeal Board (PTAB) proceedings throughout all jurisdictions in the U.S. and many parts of the globe. The impressive breadth of experience is constantly evolving to include cutting-edge technologies such as gene editing, medical diagnostics, medical devices, precision medicines, therapeutics and pharmaceuticals. We are an industry leader in PTAB proceedings; touting the highest institution and invalidation rate in the industry. Our clients depend upon the technical and legal acumen of our IP litigators to help avoid, resolve and where necessary litigate disputes over theft and ownership of intellectual property rights, including rights to trade secrets, patent rights and strategies for protection of intellectual property. We combine our deep understanding of the complex regulatory pathways and patent strategies and work seamlessly with Duane Morris attorneys in the health and life sciences group to help our clients efficiently and effectively bring their products to market. We also offer unmatched guidance on drug approval and market entry strategies related to approval pathways, labeling, Hatch-Waxman challenges, the scope of various nonpatent exclusivity provisions, Risk Evaluation and Mitigation Strategies (REMs), and Biologics Price Competition and Innovation Act (BPCIA) guidance. We have decades of experience achieving the best possible result for our health and life sciences clients. Let us know how we may put our experience to work for you.
We regularly represent our clients’ interests before government agencies such as FDA, DEA, CMS, the FTC and similar state regulatory bodies. Depending on where a client stands in its lifecycle, we counsel on regulatory strategies, reimbursement strategies, assist with clinical study issues and advise on marketing submissions issues. Because we work in cross-specialty teams, we work with our clients to align IP, compliance, reimbursement and regulatory strategies. We provide client support to assure compliance with the myriad of laws and regulations related to the development, manufacturing, marketing, promotion, privacy, consent, fraud and abuse and other compliance issues from the initial development of SOPs, training of personnel, promotional material review, policies and procedures, and responding to agency enforcement actions including, untitled letters, FDA Form 483s, warning letters, import alerts, civil investigations and criminal prosecutions. We often provide regulatory diligence for underwriters, investors, and purchasers of companies involved in all sections of the diverse biotechnology and medical products ecosystem.
Duane Morris attorneys have been involved in the initial formation and organization of some of the most successful companies in the life sciences industry. We understand the issues faced by innovators in the life sciences, biotech, medical devices, pharmaceuticals and biologics industries: from the science and technology, to the business realities, to potential legal challenges. We counsel life science companies in all stages of their life cycle, including entity formation; business plan preparation; friends and family seed, venture capital and growth financing; intellectual property protection; employment matters; strategic partnerships; business combinations; and mergers, acquisitions and initial public offerings. Our extensive company and investor client base in the life science industry enables us to leverage relationships and deep market knowledge on behalf of our clients.
We regularly advise clients in the life sciences industry with respect to critical issues that arise in the business formation process, to create the optimal business structure to achieve the goals of the founders and establish a strong, tax-efficient foundation for future growth, operational efficiency and successful exit. Our work in the corporate formation process includes advice and assistance with respect to:
- choice of entity and entity formation;
- tax structuring, often times coupled with founder wealth preservation strategies;
- initial agreements and arrangements among founders, including equity allocation, vesting and governance/decision making;
- intellectual property ownership and protection strategies;
- employment related agreements, non-competition and other restrictive covenant agreements, benefit plans and policies;
- structuring and implementation of equity incentive plans and arrangements designed to align the interests of founders, key stakeholders and employees and attract and retain top talent;
- regulatory and compliance issues; and
- convertible debt, SAFE (simple agreement for future equity), KISS (keep it simple securities), common stock, series seed and preferred stock financing transactions with friends and family, angel, strategic, venture capital and private equity investors.
We also introduce clients and entrepreneurs to prospective investors, strategic partners and key industry leaders and advisors through our vast network of connections and a variety of programs and events.
Duane Morris attorneys have decades of experience guiding life sciences clients from startups to publicly traded companies, as well as academic and research institutions, working with a broad range of technologies, including biologic drugs, pharmaceuticals, biotechnology, immuno-oncology, regenerative medicine, gene editing, precision medicine and diagnostics, medical devices and veterinary medicine at all stages of the product life cycle. We regularly advise clients in the life sciences industry with respect to convertible debt, SAFE (simple agreement for future equity), KISS (keep it simple securities), common stock, series seed and preferred stock financing transactions with friends and family, angel, strategic, venture capital and private equity investors. We also have substantial experience guiding companies through initial public offerings and follow-on offerings, including conventional private placements, private placements with trailing registration rights, traditional PIPEs, structured PIPEs, private equity lines, underwritten offerings, bought deals, at-the-market offerings and equity shelf programs.
As a result of our work, we have been named one of the top 25 PIPEs placement agent legal counsel for several years in The Deal Power Rankings. We have also been recognized by publications, such as Bloomberg Law, for helping companies position themselves to raise billions of dollars through at-the-marketing offerings. Our attorneys have guided numerous companies raise an aggregate of over $500 million in private transactions. Additionally, we counsel underwriters assisting life sciences and medical technologies companies to raise capital in the private and public markets.
We advise companies on exit strategies and considerations and ensuring competitive markets. This includes counseling on mergers and acquisitions and related aspects of M&A, IPOs and licensing and alliances. Corporate attorneys throughout Duane Morris are experienced in developing and implementing creative strategies to help maximize value and position emerging companies as advantageously as possible to meet their immediate needs and long-term business goals. We are also adept at shaping the dissolution of joint ventures for our clients, formulating exit strategies that address issues such as ownership and licensing of intellectual property, division of territories and customers, and noncompete agreements. Our reach is global as well as cross-border and national.
Stakeholder relationships have evolved, as a result of technological advances, but it is still imperative to maintain a cohesive working relationship from all sides. Duane Morris attorneys represent high-growth companies to develop stakeholder engagement strategies, including organization matters, founder relationships, collaborations, licensing and partnering transactions, clinical trial and other research agreements, and other important commercial and operational arrangements. First and foremost, we work with clients to establish sound relationships and clearly-written and complete agreements with and among stakeholders to avoid, as much as possible, disputes before they arise. In the event disputes arise, we work with clients to navigate such disputes and establish a plan to minimize possible backlash or problems, as a result of stakeholder challenges.
Duane Morris attorneys have extensive experience resolving matters prior to litigation and litigating a broad range of commercial disputes for life sciences clients covering all aspects of their business. We regularly handle “bet the company” litigation involving antitrust, intellectual property, unfair competition, and product liability issues. We also represent clients in high stakes contract disputes involving partner and shareholder issues; licensing, marketing and collaboration agreements; and distribution and other commercial agreements.
Our group has extensive experience representing health and life sciences companies and academic institutions with critical partnering, licensing, joint venture and other collaboration transactions. Duane Morris attorneys have significant experience in drafting, negotiating and advising clients in connection with a variety of agreements and other documentation relating to U.S. and pre-clinical and sponsored research, global clinical trials, manufacturing activities, distribution arrangements and various other matters unique to the health and life sciences industry. Our attorneys also have extensive experience in assisting clients with corporate and IP due diligence in connection with collaborative transactions.
Duane Morris attorneys have significant experience in drafting, negotiating and advising clients in connection with a variety of agreements and other documentation relating to all aspects of operations, including U.S. and global pre-clinical and sponsored research, clinical trials, development, licensing, manufacturing, distribution and various other matters unique to the health and life sciences industry. Our attorneys have advised clients on a variety of contracts, including service agreements and commercial arrangements in the U.S., EU, Latin America and Asia. We also counsel clients on breach of contract actions, contract reviews and negotiations for distribution and other related issues, and contract disputes.
Concerns about corporate governance are always on the minds of board members, executive officers, shareholders and investors. Our clients in the life sciences and medical technologies industries are able to draw upon our global platform, which includes many attorneys with years of practical experience as general counsel, board members, officers and advisors of life sciences and medical technologies companies, as well as experience as SEC staff members, for sound legal advice on the regulations and practices affecting their businesses.
Our attorneys regularly advise public, private and non-profit businesses, boards of directors, board committees and executive officers of companies in the life sciences and medical technologies industries to formulate and implement practices and procedures to help prevent governance crises, and also advise clients when crises must be managed.
We counsel such clients on the full spectrum of governance issues, including fiduciary responsibility of directors and officers, disclosure issues, best practices, management succession and compensation, indemnification, insurance, conflicts of interests, internal investigations, defensive mandates and crisis management. Our experience also includes advising on board and committee composition including board diversity, leadership structures and oversight of risk management; as well as board functions and duties including reviewing bylaws, committee charters, codes of ethics and other governance-related materials and policies designed to comply with legal and regulatory requirements and best practices.
When crises must be managed, our clients draw on the depth of the knowledge and experience of our attorneys practicing in the areas of securities enforcement, complex civil and administrative litigation, internal corporate investigations, white-collar criminal law and Foreign Corrupt Practices Act investigations and defense. The close collaboration between our lawyers resulting from our multi-disciplinary approach and our deep knowledge of the life sciences industry enables us to provide our clients unparalleled counsel with respect to corporate governance issues.
Health and life sciences clients draw on Duane Morris litigation attorneys to represent them in a wide variety of commercial matters, including disputes involving antitrust law, securities law, fiduciary duties, commercial contracts, and mergers and acquisitions. Our health and life sciences team effectively represents clients in high-stakes commercial class actions, multidistrict litigation, and bet-the-company disputes between businesses and partners. We combine substantial health and life sciences industry knowledge with smart litigation and trial strategy to offer clients early assessments of litigation risk and avoidance, a clear path toward reasonable dispute resolution opportunities, and when unavoidable, a strong record of success at trial.
Duane Morris helps clients in the life sciences industry strategically navigate mass tort and individual high stakes products liability litigation. Our experience spans the wide range of cases involving various generic and brand drugs, surgical instruments, orthopedic implants, tissue matrices and patches, bone cement products and other medical devices, including biologics. Duane Morris has handled all aspects of numerous, complex multiparty and multidistrict litigation at both the federal and state level—earning a top-tier ranking by U.S. News-Best Lawyers Best Law Firms for its mass tort litigation practice. Duane Morris guides clients through all aspects of complex products liability litigation, including general and expert discovery, strategic motion practice, selecting and conducting bellwether trials and structuring settlement programs. Given this vast experience, Duane Morris’ products liability team is also well equipped to consult and advise clients on practices and procedures during the product development and pre-market phases to mitigate future litigation risks.
The Duane Morris White Collar and Government Regulatory Group routinely advises clients, including corporations, partnerships, sole proprietorships, and individuals responses to government investigations, grand jury and administrative subpoenas, civil enforcement actions and criminal prosecutions. Our attorneys have done so in actions and investigations involving the spectrum of violations of federal and state law, including allegations of wire and mail fraud, off-label promotion, false claims and Qui Tam actions, antitrust claims of price fixing and other anti-competitive conduct, fraud and abuse, and the misuse of federal funds in research and product development.
We counsel our clients on developing internal procedures and corporate compliance plans to ensure that all employees conduct themselves in a lawful manner. We work with our clients to devise guidelines for the internal monitoring of employee conduct and the enforcement of compliance plans. Active and effective compliance programs, including internal investigations or audits, can shield your company from liability. Our attorneys have a depth of knowledge and experience in assisting life sciences and medical technology companies develop this programs from scratch as well as conducting gap analysis to assure compliance with DOJ guidelines on effective corporate compliance programs. On numerous occasions, compliance programs developed by our attorneys and implemented by our clients have been credited with persuading government authorities not to bring a prosecution or enforcement action.
Duane Morris employment lawyers regularly counsel health and life sciences industry clients on compliance with federal, state and local employment laws with the goals of reducing the risk of potentially expensive and disruptive litigation and facilitating a safe and quality-conscious workplace. When disputes cannot be avoided, we represent clients in litigation, arbitration, and administrative proceedings. We regularly assist clients with:
- Equal Employment Opportunity compliance
- Wage and Hour Compliance, including specific requirements for home health care workers
- Preparing employee handbooks and personnel policies
- Responding to requests for reasonable accommodation and FMLA compliance
- Occupational Safety and Health Act (OSHA) compliance
- Drafting and negotiating executive employment agreements, severance agreements, non-compete agreements and other restrictive covenants critical to protecting the interests of companies in the rapidly-evolving health and life sciences industry
- Representing management interests in minimizing potential labor problems including maintaining a union-free workplace, negotiating collective bargaining agreements, handling unfair labor practices at the NLRB, and advising management in work stoppage situations
Duane Morris' benefits attorneys recognize that creative thinking, planning and a thorough understanding of the client's unique needs are an essential prerequisite to offering legal services that are in-line with each client's expectations. We provide clients with the full range of employee benefits legal services. From qualified retirement plans to sophisticated equity compensation arrangements and from executive employment agreements to broad-based health and welfare plans, our attorneys combine practical experience with high-quality and efficient service that leads to practical solutions.
Duane Morris attorneys provide clients with a full range of U.S. and global immigration services. We provide advice during the pre-hiring screening process for our corporate clients, as well as legal representation regarding a wide variety of non-immigrant, immigrant, global and related services, including, advice during corporate changes, I-9 and E-Verify compliance. Through our comprehensive knowledge of the legal, political and business contexts in which immigration and citizenship concerns arise, we assist our clients to operate successfully in a world where capital and business opportunities have no borders.
Our experienced immigration attorneys work with biotechnology, life science, pharmaceutical, medical device companies and research organizations and assist them with obtaining the proper temporary or permanent work authorization to ensure the hire and retain highly skilled talent and innovators from around the globe. From start up to large entities, including nonprofit institutions, we provide strategies to medical technologies and life science companies to ensure their immigration compliance and that they can rely on the best and the brightest. We successfully handle complex O-1 extraordinary ability visas, L-1 intra company transfer visas, J-1 visas for research scholars or J-1 waivers, immigrant petitions in the national interest, extraordinary ability or outstanding researchers categories, to name a few.
We also provide strategic advice regarding practical training for foreign students and H-1B visa petitions, changing visa procedures at U.S. embassies worldwide, corporate restructurings, layoffs and terminations of foreign employees, as well as regarding individual immigration options and citizenship matters. Duane Morris attorneys work with post-doctoral fellows, scientists, researchers, entrepreneurs in the industry and design strategies and creative solutions for securing non-immigrant or immigrant status or work authorization in the United States.
Our immigration attorneys further provide corporate clients with internal audits and compliance reviews, as well as representation in enforcement actions by the U.S. Department of Homeland Security or U.S. Department of Labor.
Duane Morris immigration practice includes representation of multinational clients in global visa, work and residence permit applications, in addition to compliance audits in countries throughout the world. This is a rapidly expanding and changing area of law, as countries struggle to protect domestic work forces while addressing the needs of international business. Our global immigration practice provides a seamless home-host model that involves an in-house team working in conjunction with local counsel.
The immigration landscape in the U.S. and globally is subject to ever evolving changes and complexities. Duane Morris immigration attorneys stay abreast of the latest immigration developments and helping our clients resolve these changes quickly and effectively is the hallmark of our practice.
- BIO International
- Food and Drug Law Institute (FDLI)
- Life Sciences PA (LSPA)
- Philly BioBreak
- San Diego Entrepreneurs Exchange (SDEE)
- University City Science Center
- Ranked by Legal 500: United States as a leading law firm in Life Sciences
- Ranked by LMG Life Sciences 2022 among leaders in Patent Prosecution
Duane Morris Life Sciences and Medical Technologies Industry Group at a Glance
Duane Morris Life Sciences: Biologics and Drugs at a Glance
For More Information
For additional information, please contact Dana J. Ash, Frederick R. Ball, Patrick C. Gallagher, Ph.D., Jonathan Lourie, Vicki G. Norton, Ph.D., Shannon Hampton Sutherland, Driscoll R. Ugarte or any of the group members referenced in the Attorney Listing.