Practice/Industry Group Overview
Duane Morris attorneys understand the issues that innovators in the life sciences industry face from every angle: from the science and technology, to the business realities, to potential legal challenges. We know because we have been there. 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 lawyers have decades of experience guiding life sciences clients from startups to publicly traded companies, as well as academic and research institutions, working in a broad range of technologies, including pharmaceuticals, biotechnology, medical devices and diagnostics at all stages of the product life cycle, from discovery through clinical development and commercialization.
The Duane Morris Life Sciences practice group and its individual attorneys have received numerous accolades, including being named one of the top global legal advisors for biotechnology and pharmaceutical licensing transactions, being recognized as one of the most prominent Intellectual Property practices in the United States and winning statewide and international client service awards.
Corporate Startups and Financing Transactions
Attorneys in Duane Morris' Life Sciences practice group have been involved in the initial formation of some of the most successful companies in the life sciences industry and have assisted dozens of companies raise an aggregate of over $500 million in private transactions, including from angel investors, venture capital funds, corporate venture arms, and public offerings. Duane Morris welcomes representation of early-stage companies and frequently partners with them by extending substantial fee-deferral arrangements to foster innovation and support promising entrepreneurs. Duane Morris also works tirelessly to introduce our early-stage clients and entrepreneurs to prospective investors and strategic partners through our vast network of connections and a variety of programs and events.
- Represented Aclaris Therapeutics, Inc., a specialty pharmaceutical company with a focus on the development of novel topical dermatological therapies, in connection with the sale of $21.3 million of Series B Preferred Stock. Investors included Vivo Ventures, Beacon Bioventures and Sofinnova Venture.
- Represented Marinus Pharmaceuticals, Inc., a biopharmaceutical company developing neuropsychiatric therapeutics, in its $46 million initial public offering of common stock, and transitioning from a venture-financed company to a public company.
- Represented Enumeral Biomedical Corp. in closing an alternative public offering, allowing the company to raise $21.5 million in a private placement financing in connection with a reverse merger into a publicly held company.
Collaborations and Licensing
Our Life Sciences practice group has extensive experience in representing life science companies and academic institutions with critical partnering, licensing, joint venture and other collaboration transactions. For example, Duane Morris has been recognized as one of the top legal advisors worldwide in biotechnology and pharmaceutical licensing deals.
- Represented Allele Biotechnology & Pharmaceuticals, Inc. in its license agreement with Ocata Therapeutics, Inc. for Allele's proprietary technology for generating human induced pluripotent stem cells (iPSCs).
- Represented Aurigene Discovery Technologies Limited in its collaboration, license and option agreement with Curis, Inc. for immuno-oncology and selected precision oncology targets.
- Represented Annellotech, Inc. in negotiations with IFP Energies nouvelles (IFPEN) and its subsidiary Axens on a strategic alliance to develop and commercialize a new technology for the low cost production of bio-based benzene, toluene and paraxylene using Anellotech's process of Catalytic Fast Pyrolysis (CFP) of non-food biomass.
Mergers and Acquisitions
Duane Morris has represented life sciences industry companies in mergers and acquisitions and related aspects of M&A. Corporate attorneys throughout Duane Morris are experienced in developing and implementing creative strategies to help maximize value and position emerging and mid-market life sciences companies as advantageously as possible to meet their immediate needs and long-term business goals.
- Represented biopharmaceutical company Ception Therapeutics, Inc. in its acquisition by Cephalon, Inc. for $250 million and up to $500 million in milestone payments.
- Represented Quest Diagnostics in the sale to Royalty Pharma of royalty rights from commercialization of the drug candidate Ibrutinib for $485 million.
- Represented Orthovita, Inc. in its agreement to be acquired by Stryker Corp. for $316 million.
Patent Prosecution and Maintenance and IP Due Diligence
The Intellectual Property practice at Duane Morris is recognized as one of the most prominent IP practices in the United States by national publications such as U.S. News & World Report, Intellectual Property Today and IP Law360. Duane Morris' IP 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 is essential to help companies protect their IP rights and realize the most value from their assets. Duane Morris' due diligence can help reduce risk and identify opportunities for our life sciences clients.
- Advised Quest Diagnostics on patent, licensing and IP litigation due diligence issues in connection with Quest's acquisition of Athena Diagnostics from Thermo Fisher Scientific for $740 million.
- Advised Quest Diagnostics on IP litigation due diligence issues in connection with Quest's definitive merger agreement with Celera Corporation.
- Prosecuted U.S. Patent No. 8,523,870, pertaining to an adjustable femoral resection guide, on behalf of Wright Medical Technology, Inc.
Regulatory and Compliance
We regularly represent our clients' interests before government agencies such as FDA, DEA, CMS and the FTC. Depending on where a client stands in its lifecycle, we counsel on regulatory strategies, assist with clinical study issues and advise on marketing submissions issues. For firms with marketed products, we help ensure compliance with the myriad of regulatory requirements impacting operations and marketing, including review of marketing materials (real and virtual) and responding to agency enforcement actions ranging from Warning Letters to criminal prosecutions. For all clients, we also engage in training and procedures development to enhance regulatory compliance and reduce the potential for adverse agency actions.
- Counsel to executives at a biotechnology company in investigation of Food & Drug Act violations by the Department of Justice and Veterans Administration.
- Represented a healthcare technology company in providing FDA, privacy and security compliance support for a mobile health application targeted at cardiac conditions.
- Represented dietary supplement manufacturer in negotiation of consent decree with FDA following alleged repeated violations of good manufacturing practices.
Life sciences clients draw on Duane Morris' trial teams to defend them against patent infringement and products liability claims. Our lawyers provide clients with counsel experienced in patent infringement, products liability and toxic tort law, including the use of class actions in mass tort litigation, and problems arising from the acquisition of another company.
- Representing Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC in a request to the U.S. Supreme Court to review a Pennsylvania appellate court ruling that the product liability claims of thousands of generic Reglan users weren't necessarily preempted by federal law.
- Stillman v. Novartis Consumer Health Inc. - Represented defendants CVS Pharmacy Inc. and Walgreen Company in a patent infringement suit related to a generic product.
- Obtained a $65 million plus settlement on behalf of Tekmira Pharmaceuticals Corp. from Alnylam Pharmaceuticals Inc. and AlCana Technologies, Inc. in connection with alleged misappropriation of Tekmira's trade secrets related to gene-silencing therapeutics.
Clinical Trials, Manufacturing, Distribution and Other Life Sciences Agreements
Duane Morris' Life Sciences practice group has 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 life sciences industry.
Trademarks, Copyrights, Trade Secrets and Unfair Competition
Duane Morris has been repeatedly ranked among the top trademark filing law firms by Intellectual Property Today and Managing IP. Our IP lawyers work with life sciences clients, filing and maintaining applications to register trademarks, current trademark registrations and copyrights each year in the U.S. and throughout the world. We also handle an array of disputes related to trademarks, copyrights, trade secrets and unfair competition claims.
International Trade, Customs and Taxation
Life sciences companies engaged in the import or export of goods face numerous regulatory issues and Duane Morris routinely assist clients regarding presentations to U.S. Customs relating to royalty and license agreements and dutiable value of goods; transfer pricing; tariff classification of products; country of origin issues; and interdiction of unauthorized shipments of products produced in non-FDA-certified foreign facilities.