Biopharmaceutical Practice
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Maalouf Ashford & Talbot represents many of the world's leading biopharmaceutical companies, offering advice throughout a broad range of areas including:
Technology Transactions. With extensive experience negotiating successful business and strategic collaborations, our attorneys have placed the firm's life sciences clients in optimal positions to succeed in today's complex global marketplace. These collaborations include license agreements, joint ventures, co-branding and promotional agreements, R&D agreements, strategic alliances, joint development agreements, co-investment agreements, joint marketing agreements, and manufacturing, supply, and distribution agreements.
Regulatory. The firm's Regulatory attorneys help clients successfully navigate complex regulatory mazes, comply with strictly enforced regulatory and healthcare laws and regulations in numerous jurisdictions around the world, and secure timely approvals and clearances. Our services in this area include representation in negotiations and administrative proceedings, crisis and compliance management, compliance counseling on broadly enforced anti-kickback laws and new patient privacy protection laws, assessment of product development and regulatory approval options, and counseling on advertising and promotional strategies.
Trade Secret. We have one of the world's leading trade secret practices, having provided representation in dozens of cases in the past several years alone. Our attorneys handle complex trade secret and related disputes - whether between business partners or employees - regarding restrictive covenants, invention assignments, employee mobility, work for hire, UTSA preemption, inevitable disclosure, threatened misappropriation, bad faith, choice of law, and licensing transactions. We possess unique trade secret expertise in both defense and plaintiff side cases, and pride ourselves on having raised creative, cutting-edge legal theories that have been subsequently followed by other law firms. We also assist both new and established businesses in developing in-depth protective and preventative strategies.
International Business Opportunities. We have a long and successful history of advising both US and Non-US based clients in connection with a variety of international matters, including intellectual property counseling, mergers and acquisitions, joint ventures, foreign investment, branch operations, information technology outsourcing, spin-offs, public and private equity transactions, and capital markets. Of particular relevance to generic pharmaceutical companies, our attorneys are well equipped to provide expert counsel regarding offshore structures, especially those involving the establishment of international R&D and manufacturing facilities.
Employment Law. Working closely with the firm's trade secret practice, our employment law attorneys are known for their ability to obtain favorable outcomes in complex, high-exposure cases, as well as to successfully handle regulatory investigations. We have experience with every critical aspect of the employer/employee relationship, including employee mobility and non-compete disputes; recruiting, hiring, and promotion practices; compensation, leave, and wage-and-hour issues; sexual harassment and other forms of discrimination; executive misconduct and performance management; layoffs, restructurings, and terminations; internal and governmental investigations; and union organizing and NLRB proceedings.
Patent Litigation. Our team has significant experience with all types of complex litigation matters - including simultaneous litigation and interference proceedings, and litigation involving simultaneous patent, antitrust, and FDA cases - and complex settlements, licenses, product acquisitions, joint ventures, stock purchase agreements, and a variety of operational agreements (e.g., manufacturing, supply, distribution, marketing, and promotion). We also engage in litigation against or in support of the FDA, manage product development pipelines, file citizen petitions and responses, and conduct strategic due diligence. In addition, our patent litigators provide counseling with respect to patent and FDA issues surrounding new product regulatory filings and product acquisitions.
Patents and Innovation. Our patents and innovation attorneys have an impressive track record of IP value creation, having assisted in developing the IP portfolios covering such inventions as the DNA chip, cancer therapies, nanotechnology, and stem cell technologies. Our experience includes obtaining U.S. and foreign patent clearance for APIs, formulations, and manufacturing processes; integrating IP, regulatory, and commercial strategy for ANDA and 505(b)(2) filings; completing non-infringement and invalidity opinions; integrating citizen-petition filings; preparing pre-litigation strategy and ANDA notice letters; and devising comprehensive, worldwide strategies on reexam, reissue, and oppositions.
Trademark and Copyright. Our trademark and copyright attorneys provide clients with sophisticated and aggressive strategic counseling, transactional, and litigation expertise on matters involving trademark, copyright, advertising, internet, retail, media, and consumer law. We counsel clients on the selection, protection, and enforcement of company names, brand names, slogans, and trade dress for U.S. and worldwide markets, including registration and licensing, and have engaged in cutting-edge litigation in U.S. courts on trademark, trade name, trade dress, domain name, copyright, right of publicity/privacy, and unfair competition issues. We also represent clients in connection with trademark opposition and cancellation proceedings in both the U.S. and abroad.
Export Controls and FCPA. The firm's export controls and Foreign Corrupt Practices Act (FCPA) practices advise organizations with respect to a broad array of regulatory and compliance issues, including determining how regulations apply to their products and services, preparing for and conducting civil and criminal government investigations and enforcement actions, and developing compliance policies and procedures. Our attorneys regularly work with companies to resolve complex jurisdiction and classification issues, devise licensing strategies, design compliance programs, provide employee compliance training, prepare voluntary disclosures, assist with transactional due diligence, and conduct internal audits and investigations.
We also advise clients on compliance with the Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), and trade and economic sanctions administered by the Office of Foreign Assets Control (OFAC). Further, we regularly provide representation in enforcement-related matters before the Justice Department, the Commerce Department's Bureau of Industry and Security, the State Department's Directorate of Defense Trade Controls, and the Treasury Department's OFAC.
Antitrust & Settlement Strategies. Our internationally recognized antitrust practice advises clients on the full spectrum of pharmaceutical antitrust issues, including patent settlement counseling and related FTC investigations, private antitrust litigation, Hart-Scott-Rodino merger filings and compliance, and matters involving the intersection of antitrust and intellectual property law.
In addition, we have years of experience representing generic pharmaceutical companies in litigation settlements with brand pharmaceutical companies. As a result, we are highly skilled at crafting and negotiating favorable settlements and related licensing arrangements.
Representative Pharmaceutical and Biotechnology Areas Served:
Agricultural Biotechnology
Medicinal Chemistry
Animal Health
Organometallic Compounds
Antibody-Drug Companies
Pharmaceutical Dosage Forms
Antivirals
Plant Biotechnology
Bioinformatics
Recombinant Proteins and Viruses
Biosimiliars
siRNA
Blood Products
Process Chemistry
DNA Probes
Immunodiagnostics
Drug Delivery Systems
Industrial Biotechnology
Drug Device Combinations
Toxicology
Gene Therapy
Stem Cells
Gene Testing
Vaccines
Imaging Agents
Personalized Medicine
________________________________________________________________________________________________________________
Maalouf Ashford & Talbot represents many of the world's leading biopharmaceutical companies, offering advice throughout a broad range of areas including:
Technology Transactions. With extensive experience negotiating successful business and strategic collaborations, our attorneys have placed the firm's life sciences clients in optimal positions to succeed in today's complex global marketplace. These collaborations include license agreements, joint ventures, co-branding and promotional agreements, R&D agreements, strategic alliances, joint development agreements, co-investment agreements, joint marketing agreements, and manufacturing, supply, and distribution agreements.
Regulatory. The firm's Regulatory attorneys help clients successfully navigate complex regulatory mazes, comply with strictly enforced regulatory and healthcare laws and regulations in numerous jurisdictions around the world, and secure timely approvals and clearances. Our services in this area include representation in negotiations and administrative proceedings, crisis and compliance management, compliance counseling on broadly enforced anti-kickback laws and new patient privacy protection laws, assessment of product development and regulatory approval options, and counseling on advertising and promotional strategies.
Trade Secret. We have one of the world's leading trade secret practices, having provided representation in dozens of cases in the past several years alone. Our attorneys handle complex trade secret and related disputes - whether between business partners or employees - regarding restrictive covenants, invention assignments, employee mobility, work for hire, UTSA preemption, inevitable disclosure, threatened misappropriation, bad faith, choice of law, and licensing transactions. We possess unique trade secret expertise in both defense and plaintiff side cases, and pride ourselves on having raised creative, cutting-edge legal theories that have been subsequently followed by other law firms. We also assist both new and established businesses in developing in-depth protective and preventative strategies.
International Business Opportunities. We have a long and successful history of advising both US and Non-US based clients in connection with a variety of international matters, including intellectual property counseling, mergers and acquisitions, joint ventures, foreign investment, branch operations, information technology outsourcing, spin-offs, public and private equity transactions, and capital markets. Of particular relevance to generic pharmaceutical companies, our attorneys are well equipped to provide expert counsel regarding offshore structures, especially those involving the establishment of international R&D and manufacturing facilities.
Employment Law. Working closely with the firm's trade secret practice, our employment law attorneys are known for their ability to obtain favorable outcomes in complex, high-exposure cases, as well as to successfully handle regulatory investigations. We have experience with every critical aspect of the employer/employee relationship, including employee mobility and non-compete disputes; recruiting, hiring, and promotion practices; compensation, leave, and wage-and-hour issues; sexual harassment and other forms of discrimination; executive misconduct and performance management; layoffs, restructurings, and terminations; internal and governmental investigations; and union organizing and NLRB proceedings.
Patent Litigation. Our team has significant experience with all types of complex litigation matters - including simultaneous litigation and interference proceedings, and litigation involving simultaneous patent, antitrust, and FDA cases - and complex settlements, licenses, product acquisitions, joint ventures, stock purchase agreements, and a variety of operational agreements (e.g., manufacturing, supply, distribution, marketing, and promotion). We also engage in litigation against or in support of the FDA, manage product development pipelines, file citizen petitions and responses, and conduct strategic due diligence. In addition, our patent litigators provide counseling with respect to patent and FDA issues surrounding new product regulatory filings and product acquisitions.
Patents and Innovation. Our patents and innovation attorneys have an impressive track record of IP value creation, having assisted in developing the IP portfolios covering such inventions as the DNA chip, cancer therapies, nanotechnology, and stem cell technologies. Our experience includes obtaining U.S. and foreign patent clearance for APIs, formulations, and manufacturing processes; integrating IP, regulatory, and commercial strategy for ANDA and 505(b)(2) filings; completing non-infringement and invalidity opinions; integrating citizen-petition filings; preparing pre-litigation strategy and ANDA notice letters; and devising comprehensive, worldwide strategies on reexam, reissue, and oppositions.
Trademark and Copyright. Our trademark and copyright attorneys provide clients with sophisticated and aggressive strategic counseling, transactional, and litigation expertise on matters involving trademark, copyright, advertising, internet, retail, media, and consumer law. We counsel clients on the selection, protection, and enforcement of company names, brand names, slogans, and trade dress for U.S. and worldwide markets, including registration and licensing, and have engaged in cutting-edge litigation in U.S. courts on trademark, trade name, trade dress, domain name, copyright, right of publicity/privacy, and unfair competition issues. We also represent clients in connection with trademark opposition and cancellation proceedings in both the U.S. and abroad.
Export Controls and FCPA. The firm's export controls and Foreign Corrupt Practices Act (FCPA) practices advise organizations with respect to a broad array of regulatory and compliance issues, including determining how regulations apply to their products and services, preparing for and conducting civil and criminal government investigations and enforcement actions, and developing compliance policies and procedures. Our attorneys regularly work with companies to resolve complex jurisdiction and classification issues, devise licensing strategies, design compliance programs, provide employee compliance training, prepare voluntary disclosures, assist with transactional due diligence, and conduct internal audits and investigations.
We also advise clients on compliance with the Export Administration Regulations (EAR), International Traffic in Arms Regulations (ITAR), and trade and economic sanctions administered by the Office of Foreign Assets Control (OFAC). Further, we regularly provide representation in enforcement-related matters before the Justice Department, the Commerce Department's Bureau of Industry and Security, the State Department's Directorate of Defense Trade Controls, and the Treasury Department's OFAC.
Antitrust & Settlement Strategies. Our internationally recognized antitrust practice advises clients on the full spectrum of pharmaceutical antitrust issues, including patent settlement counseling and related FTC investigations, private antitrust litigation, Hart-Scott-Rodino merger filings and compliance, and matters involving the intersection of antitrust and intellectual property law.
In addition, we have years of experience representing generic pharmaceutical companies in litigation settlements with brand pharmaceutical companies. As a result, we are highly skilled at crafting and negotiating favorable settlements and related licensing arrangements.
Representative Pharmaceutical and Biotechnology Areas Served:
Agricultural Biotechnology
Medicinal Chemistry
Animal Health
Organometallic Compounds
Antibody-Drug Companies
Pharmaceutical Dosage Forms
Antivirals
Plant Biotechnology
Bioinformatics
Recombinant Proteins and Viruses
Biosimiliars
siRNA
Blood Products
Process Chemistry
DNA Probes
Immunodiagnostics
Drug Delivery Systems
Industrial Biotechnology
Drug Device Combinations
Toxicology
Gene Therapy
Stem Cells
Gene Testing
Vaccines
Imaging Agents
Personalized Medicine