Animal Health

Our global animal health team distinguishes itself in multiple ways:

• Comprehensive Counseling: We assist clients with managing the entire life cycle of veterinary medicines from pre-authorization to commercialization. Our services cover development, licensing, co-marketing, and commercial agreements; clinical trials; manufacturing; regulatory approval and market access; novel therapies; regulatory exclusivities and data protection; advertising and promotional campaigns; product recalls; responding to Warning Letters and state inquiries regarding product claims; advising on GRAS notifications for pet food ingredients; addressing the suspension of marketing authorizations by regulators; off-label prescribing issues; imports and exports; and antitrust and competition law. We are also well versed in managing these issues in a digital world that is increasingly leveraging artificial intelligence (AI) and AI-based solutions.
• Diverse Client Base: We handle regulatory, compliance, and enforcement matters for clients across the animal health industry, including leading veterinary pharmaceutical companies, mid-sized animal health product manufacturers, and innovative development-stage companies. Our experience spans a broad spectrum of products, including veterinary pharmaceuticals, biologicals, vaccines, over-the-counter animal medications, active pharmaceutical ingredients, pet foods, supplements for pets, diagnostic devices, controlled substances, and adjacent products.
• Global Thought Leadership: Our lawyers lead in animal health policy and legislation, identifying innovative solutions to the most complex issues. Sidley’s Animal Health Legal Forum (AHLF), led by life sciences partner and qualified veterinarian Dr. Chris Boyle, is a distinctive network that brings together in-house animal health lawyers, regulatory and compliance professionals, and investors. The AHLF provides a platform for discussing the latest industry developments, exchanging best practices, and nurturing connections within the animal health sector and convenes annually (click here to join).

Representative Matters

U.S.

• Advised animal drug companies on FDA requirements pertaining to drug development, product classification, and marketing.
• Advised a global pharmaceutical company on FDA regulatory matters related to the recent launch of a novel therapy.
• Advised animal health and nutrition companies on FDA regulatory issues pertaining to the development and use of “direct-fed microbials” and “guided biotics” in animal feed.
• Advised a pioneer in the field of biotechnology on a range of complex and precedent-setting matters involving FDA oversight under the agency’s “new animal drug” authorities, post-market compliance, product labeling, and congressional strategy.
• Advised an American online retailer of pet food and other pet-related products on an assessment of federal and state regulation issues relating to the dispensing of controlled substances, including identification and signature requirements, Prescription Drug Monitoring Program (PDMP) compliance, and autoship questions.
• Assisted pet food companies in responding to CVM Warning Letters and engaging with FDA on remediation efforts.
• Provided comments to FDA on FDA’s claims paradigm for pet food products.
• Advised on one of the first Generally Recognized as Safe (GRAS) filings with CVM as they began to accept such filings modeled after the human food GRAS process.
• Advised a client on prescription platform product biologic (RxPP) products, providing them with additional regulatory support on USDA’s animal biologic regulatory authority and federal and state animal biologics licenses.
• Advised a global animal health company on the extent and availability of regulatory exclusivities for animal health products.
• Represented a top-five veterinary medicines company in a sharply contested litigation in the U.S. after a competitor purchased the assets required to manufacture a core product. Sidley sought an immediate emergency injunction ordering the supplier to resume production and the competitor to refrain from interfering with supply.

EU/UK

• Advised a top-five veterinary medicines company on advertising campaigns for veterinary medicines in the EU and the UK.
• Advised a top-five veterinary medicines company on discounts and rebate schemes in the EU and UK.
• Advised a top-five veterinary medicines company on compliance with the industry codes of practice in the EU and UK.
• Performed a market dominance analysis for a top-five veterinary medicines company in the EU and UK.
• Performed a compliance risk assessment analysis for a top-five veterinary medicines company product portfolio in the UK.
• Advised an animal health company on borderline issues between veterinary medicines and pesticides in the EU.
• Advised a top-five veterinary medicines company on the withdrawal of a marketing authorization in the EU.
• Advised a global animal health company on the defense of its supplementary protection certificate (SPC) in the EU.
• Advised an animal health company on product recalls in the EU.
• Advised a top-five veterinary medicines company on a global licensing dispute.      

China

• Advised a global animal health company on regulatory matters for registration of veterinary drugs and vaccines in China.
• Advised a global animal health company in establishing and acquiring animal vaccine facilities in China.
• Advised a global animal health company on data exclusivity and other IP issues for registration of veterinary drugs in China.
• Advised a leading animal protein genetics company in a licensing transaction with a global animal genetics company for research, development, manufacturing, and commercializing genetically edited anti-PRRSv pigs in China.
• Advised a leading animal protein genetics company in a genetic production and distribution agreement with a global porcine genetics company to introduce elite porcine genetics and associated breeding services in China.
• Advised a number of medical device companies on potential sales of human devices to the animal health field in China.