Gibbons brings to bear experience and skill in various practice areas to address the many unique issues faced by the biotechnology and pharmaceutical industries, with attorneys in the intellectual property, litigation, corporate, tax, and antitrust areas available to handle the full range of legal issues companies in these industries face.
Antitrust & Trade Regulation
Gibbons provides for the complete protection of compounds, technologies, formulas, designs, programs, and intellectual endeavors of all kinds. The patent prosecution and licensing of rapidly developing technologies and innovative products are all within our scope, and we have been involved in every type of intellectual property litigation, including representation of clients in the defense and prosecution of their pharmaceutical and biopharmaceutical patent and license rights, breach of confidentiality agreements, and various infringements on copyrighted materials. The firm is also highly experienced in trademark registration, copyright registration, and protection of trade secrets through appropriate documentation. We advise clients on the use and licensing of trademarks, importance of trademark searches, and value of trademark registration, and we obtain trademark registration for clients in other countries. We also counsel clients on the use and licensing of copyrighted materials and on the importance of seeking copyright protection for a variety of works. The firm prepares copyright applications for works ranging from graphic designs to computer software. Clients also consult the firm in evaluating potential infringement claims. For additional information, visit the Intellectual Property section of this website.
We represent and counseled corporations and individuals in the law applicable to antitrust issues. We handle civil and criminal antitrust cases, business torts, and competition matters involving issues such as price fixing, market and customer allocation, termination of distributors, boycotts, monopolization and attempted price discrimination, unfair competition, and state antitrust law claims. Gibbons has prosecuted and defended clients in matters involving a range of antitrust and competition claims and is experienced in handling multidistrict and multi-party litigation.
The firm is experienced in all types of business transactions, such as initial public offerings; mergers; stock and asset acquisitions and divestitures; corporate organizations and reorganizations; issuance and exchange of securities, including private placement and debt offerings; partnering agreements; and many types of business agreements, including technology and intellectual property licensing and sale agreements, employment and consulting agreements, manufacturing and supply agreements, and distribution agreements, among others. Gibbons also has considerable experience in financial services, such as negotiation and documentation of financial transactions; secured and unsecured commercial loans; asset-based financings; factoring; project financings; direct and indirect and leveraged lease financings; syndications and participations in multi-lender financings and LBO financings; bond indenture financings; trust structure financings; recourse and non-recourse real estate financings of all types; letters of credit; and guarantees and other credit enhancement transactions. For additional information, visit the Corporate section of this website.
The firm handles a broad range of federal, state, and local tax matters. We have extensive experience with tax issues that arise in merger and acquisition transactions, as well as divestitures, recapitalizations, and spinoffs. Gibbons is actively involved on a continuous basis in rendering advice to start-up ventures, corporations, and partnerships as well as multifaceted mature businesses, including the structuring of business enterprises through the utilization of C corporations, S corporations, and partnerships.
We are also experienced in the handling of international transactions, including problems faced by U.S.-based companies doing business outside the U.S. and foreign-based companies doing business in the U.S. We have worked extensively with clients involved in joint ventures with U.S. and foreign participants. In addressing clients’ needs in these areas, our attorneys have given in-depth consideration to issues raised by the allocation of income among related entities under Section 482 of the Code, including the Treasury Department White Paper analyzing the treatment of income from intangible property under Section 482.
Criminal & Government Investigations
Gibbons is actively engaged in the defense of manufacturers of ethical pharmaceutical and medical/surgical devices and diagnostic laboratories, as a focus area within its comprehensive general litigation practice. In this targeted area, the firm has defended a number of major pharmaceutical companies, medical device manufacturers, and laboratories in complex actions related to adverse effects, warning, manufacture, and use of products, devices, and implants, as well as the results of laboratory analyses. For additional information, visit the Pharmaceutical & Medical Device section of our Products Liability practice description.
Gibbons has a skilled and experienced team of lawyers who can effectively navigate the complex legal and financial issues that arise in connection with government and regulatory investigations addressed to the pharmaceutical industry, including in such areas as off-label promotion, anti-kickback and other marketing issues, pricing, clinical trial fraud or other irregularities related to FDA approval and product safety, and issues regarding potential violations of internal corporate guidelines and contractual requirements. We also have a wide range of experience representing public and privately held companies, including pharmaceutical companies, in securities fraud, financial reporting and accounting irregularity (including internal controls), government procurement, bribery and corruption (under the Foreign Corrupt Practices Act and otherwise), environmental, antitrust, and tax matters, in proceedings before federal and state trial and appellate courts and in arbitrations, as well as before Congress, the Securities and Exchange Commission, Food and Drug Administration, Federal Election Commission, Federal Trade Commission, Financial Industry Regulatory Authority, and other self-regulatory organizations, various United States Attorneys offices, regional stock exchanges, and state attorney general offices.
Gibbons has successfully advocated with two state attorney generals’ offices against taking action against a major pharmaceutical manufacturer for allegations regarding improper marketing of an important psoriasis drug, including allegations of systematic violations of HIPAA; we have succeeded in avoiding government intervention in a series of qui tam (False Claims Act) cases alleging off-label promotion and other marketing improprieties; and we have prevented action being taken against the American subsidiary of a European pharmaceutical manufacturer for significant cartel-type antitrust activities. We have represented pharmaceutical companies or their highest level employees in complex, high-stakes antitrust matters, both criminal and civil, and we have assisted in shepherding our pharmaceutical company clients through Congressional investigations. The firm has prevented the prosecution of high-level corporate officers in a series of criminal healthcare investigations involving the off-label marketing of drug products and clinical testing fraud. We have also successfully represented the CEO of a drug manufacturer in connection with an FDA investigation and subsequent civil litigation regarding the marketing of tainted blood thinner, as well as a high-level sales manager of a medical device manufacturer alleged to have committed billing fraud.
Gibbons has represented the two largest private clinical laboratories in the world in hundreds of matters throughout numerous jurisdictions across the country, and we also represent smaller clinical laboratories and laboratory-related companies. The Laboratory Defense Team has advised clients on risk management strategies, litigation defense, regulatory compliance, privacy matters, reference lab arrangements, and reporting and provides crisis management counsel involving retesting and recall programs. We also negotiate and draft a wide variety of agreements, including clinical trial agreements, confidentiality agreements, consulting agreements, and laboratory and other services agreements. Our attorneys interface with multiple state boards of health and other officials regarding the establishment of specimen collection facilities and transportation of specimens across state lines for testing. In addition, Gibbons regularly presents on-site risk management seminars to doctors, nurses, laboratory professionals, insurance companies, and risk management associations nationwide, which cover such topics as, for example, emerging standards of care in cervical cancer screening; laboratory testing; and best laboratory practices.