Constant technical advances, unprecedented global turmoil and an increasing regulatory burden pose opportunities and challenges for the life sciences industry. To help clients succeed in this changing environment, Venable’s experienced legal counsel combine a firm grasp of legal precedent and procedure with a solid understanding of technology and business strategy.
We work with life sciences companies at every stage—from research institutions spinning out start-up companies to emerging businesses to established publicly traded companies. Our Life Sciences attorneys span all relevant disciplines—including intellectual property (IP), corporate finance, government relations, litigation and regulatory.
CLIENT-CENTERED MULTI-DISCIPLINARY APPROACH
Our view of industry dynamics.
Life sciences companies face technical, commercial and legal concerns that distinguish them from other industries. Venable attorneys take these factors into account in creating and implementing successful client strategies.
- Advanced research requires a significant financial investment over a long period of time to develop a new commercial product.
- Intellectual property is crucial to protect the investment in research and to gain competitive advantage.
- Collaboration is common between companies and research institutions to solve complex scientific challenges.
- Commercial products are subject to extensive regulatory oversight from federal agencies, notably the Food and Drug Administration, Department of Health and Human Services, Environmental Protection Agency, Department of Agriculture and Department of Defense.
- Commercial products can be high profit blockbusters, and require special marketing to end users and Life Sciences professionals.
A sampling of our experience representing life sciences companies follows.
- Built and managed worldwide intellectual property portfolios of hundreds of patents and trademarks for various pharmaceutical, biotechnology and medical device companies.
- Submitted a joint amicus brief to the Federal Circuit on behalf of the Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) in Marine Polymer Technologies, Inc. v. Hemcon, Inc., a case involving intervening rights in re-examination proceedings.
- Defended a subsidiary of the world’s largest research-based pharmaceutical company regarding an alleged infringement of patents concerning Hepatitis C virus (HCV) technology, brought by a multinational biotechnology firm.
- Represented a biotechnology company, in an International Trade Commission lawsuit involving two patents related to smallpox vaccines, and reached a favorable federal court decision rejecting a claim of theft of trade secrets and misappropriation, leading to a global resolution of the dispute.
- Handle all global patent and trademark prosecution and counseling for a multinational pharmaceutical company, along with regulatory advice. We obtained several U.S. and foreign patents for an improved topical pharmaceutical formulation, managed a diverse global portfolio of patents and trademarks for spill-resistant oral formulations, and handled several patent litigations for the company.
- Successfully negotiated the reconditioning and release of FDA regulated products detained upon import into the United States.
- Represented leading life-science researchers in their approved outside activities, before Congress, in their departure from government employment and affiliation with a university, and in the development, financing and growth of their private sector business.
- Represented a French pharmaceutical company against numerous generic drug manufacturers in a Hatch-Waxman Act case involving anti-cholesterol therapeutics.
- Provide FDA regulatory advice and are prosecuting the worldwide patent rights for Thermotex.
- Venable’s antitrust attorneys successfully defended a multinational pharmaceutical company in a complex FTC investigation of alleged antitrust violations related to settlement of patent litigation involving branded and generic pharmaceuticals.
- Represented Universal Biosensors, an Australian-headquartered medical diagnostic device company, in connection with registration of its U.S. parent under the Securities Exchange Act of 1934 and related periodic filings. Venable also represented Universal Biosensors in connection with Regulation S matters.
- Represented Pharmaxis, Ltd., an Australian-headquartered specialty pharmaceutical company (ASX:PXS), in establishing a Level One ADR program in listing its American Depositary Shares on NASDAQ Global Market (NASDAQ:PXSL) and in connection with the U.S. portion of a registered global initial public offering of ordinary shares and American Depositary Shares. We also represented Pharmaxis, Ltd. in the U.S. portion of global placement of ordinary shares under Regulations D and S. The total amount raised in these offerings exceeded $75 million.
- Represented one of the world’s largest pharmaceutical companies in evaluating a potential multibillion-dollar acquisition of a European biotechnology company.
- Represented a family-owned and -managed veterinary dermatological products company that maintained distribution channels throughout the United States, Europe and Asia in connection with the sale of their equity interests in a strategic acquisition by a publicly-traded pharmaceutical company based in the United Kingdom.
- Served as outside counsel to a medical device company in connection with the structuring and implementation of three rounds of equity financing, corporate governance matters, and equity-based compensation plans, as well as overseeing government contract and regulatory matters.
- Represented the world's largest biopharmaceutical company in its divesture of various animal health products, including the negotiation of manufacturing agreements for the cross-supply of pharmaceutical and biological products.
- Represented a large, publicly-held pharmaceutical product wholesaler in connection with the intellectual property aspects of its joint venture with another public company to form an independent health informatics business.
- Represented the world's leading provider of transformational medical technologies in its acquisition, commercialization and global distribution of state-of-the art medical imaging, diagnostics and patient monitoring products, including a strategic alliance to develop and distribute next generation home healthcare products.
- Venable negotiated a development agreement between Celsion Corporation (NASDAQ:CLSN) and Philips Electronics, a large Dutch conglomerate, to combine Philips’ heat drug delivery device with Celsion’s liposomal-based oncology drug. We also negotiated a complex license, clinical research, product development, distribution and commercialization agreement between Celsion and Yakult, a large Japanese consumer products company, involving potential royalty payment streams in excess of $75 million.
- Designed and implemented legal structures for manufacturers and academic teaching hospital systems in areas of (i) global affiliations, (ii) development of new institutes and research centers, and (iii) research and transactional alliances with multiple organizations.
- Currently representing a multi-national generic pharmaceutical company in 16 separate antitrust cases, many of which are class actions.
- Represented an organ and tissue transplant provider in a patent infringement suit involving bone graft cleaning and bone demineralizing technologies that resulted in a $23 million jury verdict in client’s favor.
- Served as lead trial counsel for Boehringer Ingelheim in the Mirapex litigation, as well as lead counsel in two bellwether cases tried in the MDL.
- Served as a member of the national trial team for Cardinal Healthcare Corporation in the latex glove litigation.
- Coordinated the national defense of a recalled surgical product for Pharmacia.
- Successfully represented a manufacturer of smallpox vaccines in an International Trade Commission proceeding that invalidated patent claims, and in a District Court proceeding finding no misappropriation of trade secrets or biological materials.
- Defended a pharmaceutical company in a lawsuit seeking a preliminary injunction brought in the U.S. District Court for Delaware involving accusations that the company violated the Lanham Act by using an FDA labeler code in connection with pharmaceutical products that the company purchased from a former competitor in the generic pharmaceuticals industry. Case settled after a successful mediation.
- Serve as lead counsel for prescription drug manufacturers in federal MDLs in the District of New Jersey and Southern District of New York, as well as in state-wide coordinated proceedings in Philadelphia, Pennsylvania; Orange County, California; and San Francisco County, California.
- Serve as lead counsel for hormone replacement therapy manufacturer in federal MDL in the Eastern District of Arkansas.
One of the nation’s leading law firms, Venable provides comprehensive legal services to fast-growing and emerging life science companies—including advising corporate management, protecting intellectual property, working with the government and resolving disputes.
Our Life Sciences attorneys, many with advanced scientific degrees, offer a combination of technical, business and transactional experience that enable us to complete projects efficiently in today's competitive environment.