Locke Lord's transactional, IP and regulatory lawyers have extensive experience in advising and counseling clients in the life sciences industry. These lawyers work regularly in teams with litigation and other practice groups across the firm to assist life science clients in a variety of matters ranging from giving strategic advice, structuring commercial transactions, addressing regulatory issues and engaging in dispute resolution. The following are areas in which our transactional, IP and regulatory lawyers are constantly involved with clients in the life sciences industry.
The full breadth of our corporate department is applicable to companies engaged in the life sciences arena. The following describes our broad counseling applicable to our transactional practice to life science clients.
Our corporate practice lawyers regularly represent both publicly traded and privately held entities. Our services include advice with respect to structuring the transactions, choice of entity, location of business, tax advice and exit strategies.
Mergers and Acquisitions
Locke Lord has a broad base of practitioners engaged in mergers and acquisitions, joint ventures and other business combinations. We have represented many biopharmaceutical companies and medical device companies in their acquisition strategies, as well as companies which are the targets of acquisitions. In cooperation with our regulatory, tax, patent and licensing lawyers, all of such skills are brought together to enhance the value to our clients in these types of transactions. Representative clients in this area include pharmaceutical companies, medical device companies, medical services and software development companies, mobile medical app developers, health care providers and facilities, managed care companies, accident and health insurers and pharmacy benefit management companies.
Locke Lord has a number of lawyers dedicated to practicing in the private equity arena, representing both private equity sponsors and companies that are the vehicles in which such sponsors invest. Our private equity practice in general concentrates in three principal areas: private equity/venture capital, fund formation and leveraged buyouts. We bring this practice experience to our life science clients in many transactions, including representing funds as well as clients that are the recipients of such types of investments.
Our corporate and securities lawyers represent issuers and underwriters in a full spectrum of public and private offerings of debt and equity securities in the United States and abroad. We have represented many life science companies in capital formation through private placements and public offerings. We have also represented such clients in listing publicly traded securities on U.S. and foreign stock exchanges.
Our transactional lawyers have advised life science clients in establishing joint ventures, both domestically and internationally, with strategic partners to collaboratively develop and finance biopharmaceutical and medical device projects. We counsel such clients in the development of appropriate business structures suited to meet their objectives, documenting the relationships and producing standard operating contracts and other documents to commercialize the developed products, services or technology. Our experience includes private label and co-branding relationships, distribution agreements, marketing alliances, online and traditional sponsorship agreements and business process and IT outsourcing.
Locke Lord lawyers regularly draft and negotiate domestic and international research and development agreements, licensing agreements and other agreements involving the creation or acquisition of rights in intellectual property. In the life science area, our clients include pharmaceutical companies, device companies and medical services companies, where we counsel both licensors and licensees. We strive to be the first source of advice to biotechnology companies in all stages of product development and distribution.
We have extensive experience in research and development collaboration matters involving biotechnology and pharmaceutical companies and non-profit entities such as academic medical centers and governmental agencies. Our experience includes agreement preparation and negotiation, preparation of governmental grant funding agreements and license and development options with a view to ultimate commercialization.
Patent & Trademark Acquisition, Licensing and Counseling
Locke Lord knows that intellectual property assets are the lifeblood of many of our health care clients, and our nationally recognized Patent Strategies Practice Group has years of experience – both domestic and international – in helping our clients identify, secure, exploit, and maintain their valuable IP assets. Our Patent Strategies Practice Group has a devoted core of highly skilled lawyers and professionals, across the United States, who focus on the fundamental acquisition and maintenance of IP rights. Several of our Patent Strategies team members have 30 or more years of experience in IP law, and they have been recognized by Chambers USA, The Best Lawyers in America and other peer reviewed publications. We have numerous scientific advisors and patent agents with advanced degrees across the scientific spectrum from electrical engineering to molecular biology. Our wide range of skills helps us cut to the key issues of each individual case, saving time and money for our clients. Our patent acquisition experience includes original applications, reissues, offensive and defensive reexaminations, interferences, defensive publications and appeals within the U.S. Patent and Trademark Office (PTO) to the Board of Appeals and Interferences and from the PTO to the Federal Circuit Court of Appeals. We assist in handling foreign patents and work regularly with colleagues around the world in the acquisition of these patents and assist in European and Japanese Patent Opposition proceedings.
Our IP lawyers provide sophisticated legal opinions to our clients on freedom to operate issues, validity, infringement, ownership and enforcement of patent rights. We also give legal opinions regarding trademark infringement and dilution, validity and ownership issues involving brands, logos, trademarks, service marks, trade names, and trade dress.
Our lawyers also counsel clients involving confidential business and technology information and trade secrets. We work with the Uniform Trade Secrets Act and the corresponding laws of various states. We design programs for protecting trade secrets and confidential information for businesses, including preparation of appropriate confidentiality and non-disclosure/non-use agreements.
We represent both lenders and borrowers in a variety of secured and unsecured lending transactions. Our team of commercial finance lawyers has also developed a set of skills which take into account the specific vagaries of financing companies engaged in life sciences industries and the security and collateral specifications involved.
Locke Lord represents academic medical centers, hospitals, medical device manufacturers, independent clinical research companies and physicians on clinical research matters. Our experience includes drafting clinical research agreements, structuring and advising institutional review boards (IRBs) and analyses of laws and regulations applicable to IRBs, advising regarding compliance with federal regulations governing clinical research and research grants, compliance issues, Medicare coverage of experimental devices, drafting and implementation of clinical research policies and advising regarding HIPAA and informed consent issues relating to clinical research.
Locke Lord has experience representing academic medical centers, hospitals, physicians, and medical device companies on reimbursement for medical devices and procedures or treatment utilizing such devices by Medicare, Medicaid and other third party payors including working with the Centers for Medicare and Medicaid Services on Medicare coverage as well as representing clients in coverage, contracting, and payment disputes.
FDA and Regulatory Matters
Locke Lord lawyers have experience counseling clients in the life sciences arena with respect to the applicability of and compliance with applicable FDA laws and regulations as well as state food, drug and cosmetic laws. Locke Lord has experience representing device manufacturers, drug manufacturers, compounding pharmacies, biotech companies, companies and health care providers using and dispensing FDA approved drugs and devices, and other life science companies regarding the vast array of laws, regulations and FDA guidance applicable to their industry and the regulation of specific drugs and devices. We have advised clients with regard to FDA regulations including Abbreviated New Drug Application (ANDA) filings, Citizen Petitions and Risk Evaluation and Mitigation Strategies (REMS) issues. We have represented clients in enforcement matters at the FDA and on a state level and have coordinated recalls and the destruction of recalled or impounded foods, drugs and devices. Locke Lord also has experience representing clients in regard to dietary supplements and has advised life science clients on labeling and other federal and state regulations.
Our representative corporate and securities transactions include:
Our representative IP counseling work includes:
Locke Lord assisted Zydus Cadila, an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, in the acquisition of all of the shares of stock of Sentynl Therapeutics Inc., a San Diego-based commercial-stage specialty pharma company that specializes in marketing products in the pain management segment.