Animal Health and Agribusiness Law

Whether a client is developing, producing, or distributing new animal therapies, is in the business of providing consumer and nutritional products in the sector, or is providing related goods or services to the animal health or agribusiness space, our attorneys have the experience and know-how to help.

For decades Venable's animal health and agribusiness attorneys have advised and represented innovators, manufacturers, distributors, suppliers, and vendors supporting a broad range of animal health and care products. These include vaccines and therapies, animal feed, dietary supplements, shampoos, and goods and services supporting companion animals and livestock producers, as well as the veterinarians who care for them.

Our clients in the animal health space include large publicly listed entities, as well as start-ups. We regularly represent companies operating in the animal health and agribusiness sector on regulatory matters, intellectual property (IP) matters, transactions, and litigation.

Regulatory

Our attorneys are advisors who are experienced with the uniquely complex and evolving regulations related to products designed for animal use. We help clients through the drug approval process, with deep experience in interpreting and applying the regulatory landscape, to move from lab to market in an efficient and effective manner.

With a focus in veterinary medicine, our team is highly experienced in engaging with the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA). We routinely draft and negotiate clinical trial agreements for animal drugs and biologics and advise animal health companies on cGMP issues related to commercial and clinical-stage animal drugs.

We guide manufacturers and marketers in regulatory matters as well—from product development and safety to regulatory licensing and registration, manufacturing, advertising and marketing review, claim substantiation, distribution, and beyond.

We know the regulators and have experience working with them on animal health matters, including the USDA Animal and Plant Health Inspection Service's (APHIS) Veterinary Biologics Program, which regulates animal vaccines, the USDA Food Safety and Inspection Service (FSIS), the USDA Agricultural Marketing Service (AMS), and the Federal Trade Commission (FTC), among others.

Intellectual Property

To protect animal health innovators, we have a large intellectual property (IP) team focused on prosecuting patents and supporting the acquisition and maintenance of other intellectual property rights related to innovation as well, such as trade secrets, trademarks, and copyrights. In addition, we have seasoned trial lawyers with the technical knowledge required to handle intricate IP matters of all types. Our team includes more than 100 patent prosecutors and litigators, many with advanced degrees, who have decades of experience in the subject matter underlying our clients' innovations.

Commercial Transactions

Recognizing that the animal health sector is built with and around intellectual property and regulatory frameworks, we leverage those offerings while bringing to bear our extensive commercial transactional capabilities in the sector. Venable's dealmakers have represented some of the largest veterinary pharmaceutical innovators, suppliers, and distributors, as well as start-ups. We also support third parties in business to support such entities. Transactions on which we have advised include strategic ventures and licensing deals, as well as various CMO, CRO, and similar outsourced arrangements. We also support our clients in their go-to-market efforts, including distribution, reseller, and sales representative transactions.

Corporate and Finance

We routinely support companies from start-ups to large corporations with all of their needs, from formation to mergers and acquisitions, financings, and IPO. Our experienced team of corporate attorneys working in the animal health sector also counsel on the influx of private equity investments and ongoing industry consolidation.

Litigation Services

Our team regularly represents clients in commercial lawsuits and consumer class actions, including breach of contract, business torts such as fraud and negligent misrepresentation, and matters related to pet food labeling and manufacturing. Venable also has one of the most active product liability and mass torts practices in the United States. Our litigators have served as lead counsel in federal multidistrict litigations (MDLs) and statewide coordinated proceedings in more than a dozen jurisdictions. We are particularly well known for our defense of pharmaceutical, vaccine, and consumer products manufacturers. Venable also has a proven track record of defending agribusiness clients in antitrust cases.

Experience
+

Regulatory

  • Represented a major U.S. food and agricultural company in conversations with the U.S. Department of Agriculture (USDA) to produce revised guidelines on substantiating animal-raising or environment-related labeling claims
  • Served as outside general counsel to an innovative biologics company that is developing therapeutics and vaccines for livestock and companion animals
  • Advised a clinical research organization on the drafting and negotiation of clinical trial agreements for animal health therapies and vaccines
  • Supported an animal drug developer in identifying and resolving manufacturing and quality issues
  • Advised a leading pet health company in insurance regulatory and subscription marketing matters
  • Served as counsel to the National Animal Supplement Council, a trade association dedicated to the animal health supplement industry
  • Provided pro bono counsel to the Warrior Canine Connection, a charity that helps soldiers suffering from traumatic brain injury and psychological issues train service dogs for physically wounded soldiers

Intellectual Property

  • Won a defense verdict in an arbitration hearing on behalf of an international veterinary education provider. Successfully defended the client against claims of copyright infringement and breach of license agreement involving their teaching materials
  • Defended a pet products manufacturer against and resolved a patent infringement lawsuit in the Northern District of Ohio
  • Represented one of the global leaders in veterinary products in a complex two-year arbitration and multi-party mediation; the arbitration was settled after substantial work over the period

Commercial Transactions

  • Advised Dechra Veterinary Products on international tax issues in an exclusive licensing deal with Kane Biotech Inc.
  • Represented a veterinary pharmaceuticals products company based in the UK in its pending acquisition of the worldwide rights to a weight management drug for weight loss in cats from a biopharmaceutical company; it is the first and only FDA- and EMA-approved transdermal medication for the management of weight loss in cats
  • Represented Dechra Pharmaceuticals PLC, a global specialist in veterinary pharmaceuticals and related products, in the acquisition of the worldwide rights to the Mirataz® product portfolio from Kindred Biosciences, Inc. for a total consideration of $43 million and a royalty on future sales
  • Represented Dechra Pharmaceuticals PLC in the acquisition of the worldwide rights to the Osurnia product portfolio from Elanco Animal Health Incorporated for $135 million
  • Represent an animal health pharmaceutical company in the negotiation of option agreements for the development of new therapies focused on clear criteria for invoking the option while balancing the risk and reward for both parties
  • Support companies' distribution arrangements focused on allocating sales opportunities by territories or targeted animal
  • Represented a global animal health pharmaceutical company in numerous sales representative and distribution agreements to optimize the companies go-to-market and sales efforts

Corporate and Finance

  • Represented an international veterinary pharmaceuticals and related products business in the acquisition of the worldwide rights to a long-acting treatment for otitis externa (inflammation of the outer ear) in dogs and the product portfolio for an American pharmaceutical company that produces medicines and vaccinations for pets and livestock, completing the client's otitis service offering to veterinarians
  • 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 its equity interests in a strategic acquisition by a publicly traded pharmaceutical company based in the United Kingdom
  • 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 veterinary pharmaceuticals and related products company regarding the acquisition of the entire capital share of an international veterinary pharmaceutical company, which sells its large portfolio of vaccines and other food-producing animal products throughout South America; the acquisition provides the client with a strategically significant presence within the rapidly growing South American markets
  • Represented a veterinary pharmaceuticals and related products company in its acquisition of 100% of the membership interests of a pharmaceutical company serving customers as a manufacturer of companion animal products approved by the FDA; the deal also included the acquisition of a related products company, a limited liability company, a domestic limited liability company (LLC), and the production facility; the acquisition involves the client's first FDA-registered manufacturing facility in the United States
  • Represented Dechra Pharmaceuticals PLC in all stages of its $200 million acquisition of Putney Inc., a U.S. veterinary pharmaceutical company, including pre-acquisition tax planning, tax due diligence, merger agreement negotiation, and post-acquisition integration
  • Advised R2P Pet, a leading manufacturer of quality pet products for cats and dogs, in connection with its sale to Hyper Pet LLC, an industry-leading brand in dog collars, leashes, and innovative dog toys
  • Represented R2P Pet in a multijurisdictional management buyout transaction involving Hong Kong, the United States, Canada, and the Cayman Islands

Litigation: Class Actions

  • Served as lead counsel for a large pet food manufacturer in a first-of-its-kind "natural" pet food labeling class action. Succeeded in a motion to dismiss in part an industry effort to petition the California Department of Public Health (CDPH) to formally adopt the industry definition of "natural" and guidelines for when it can be used on a pet food label in a non-misleading manner as a regulation in California
  • Won a motion to dismiss, in part, limiting claims and obtained a favorable settlement for a pet food manufacturer in a putative California consumer class action relating to alleged levels of certain heavy metals present in cat food
  • Defending a seafood company against a consumer fraud class action based on an allegation that its fishing practices are harmful to marine life
  • Representing a food manufacturer in a putative false advertising class action alleging that the use of antibiotics in the supply chain is misleading to consumers

Litigation: Antitrust

  • Representing Perdue Farms Inc. (Perdue) against claims brought by multiple putative classes and over 150 direct action plaintiffs alleging that broiler producers conspired to fix the price of broilers by coordinating and restricting production in violation of Section 1 of the Sherman Act
  • Representing Perdue in an antitrust class action complaint filed on behalf of poultry growers in the United States against allegations that the five largest poultry producers conspired to fix the price of grower pay in violation of Section 1 of the Sherman Act
  • Representing Perdue against claims brought on behalf of chicken and turkey plant workers alleging that certain poultry companies, along with two benchmarking services, conspired to fix wages for processing plant workers
  • Representing Perdue against claims by putative direct and indirect purchasers of turkey, alleging that 10 turkey producers, plus a benchmarking service, conspired to exchange competitively sensitive information regarding their production and sales of turkey

Government Investigations

  • Represented a company in a U.S. Fish and Wildlife Service (FWS) and Department of Justice (DOJ) investigation into allegations of illegal importation of CITES-protected materials for the manufacture of high-end consumer goods, resulting in closing the investigation with no action taken
  • Represented Dechra, a global top-ten animal health company, in a six-month Federal Trade Commission (FTC) investigation of its proposed acquisition of Osurnia, a canine prescription drug being divested by Elanco Animal Health, Inc. as part of its $7.6 billion acquisition of Bayer Animal Health GmbH. The FTC ended up unanimously approving Dechra as the purchaser
  • Represented Nestlé in a government antitrust investigation of its acquisition of Ralston Purina