Overview
From pricing to patents, pharma and biotech companies face a myriad of legal and business issues. Katten's multidisciplinary team brings a deep understanding of those complexities with a proven track record of results.
Strategy based in science, validated by experience
In the high-stakes business of pharmaceutical products, your legal counsel needs to be agile and speak your language. Our team includes several members with advanced degrees, providing us with the insight necessary to handle complex scientific and medical issues.
Our litigators have handled several multi-million dollar "at-risk" launch cases and have worked on matters involving more than 45 different drugs. Katten also was selected as the monitor of a multinational pharmaceutical company’s implementation of a compliance program subject to a deferred prosecution agreement and parallel civil settlement. This case includes one of the largest penalties imposed on a company of its kind in a Foreign Corrupt Practices Act (FCPA) enforcement.
Some of our key services include:
Intellectual property litigation
- Defends allegations of patent infringement as well as those asserting patents
- Litigates pharmaceutical patent damages cases
- Counsels companies regarding Hatch-Waxman Act-related patent litigation, as well as USPTO trial proceedings, such as inter partes reviews
- Argues related appeals to the Federal Circuit
- Leverages knowledge of FDA's policies and procedures to assist with regulatory issues and provide counsel on FDA exclusivities that can affect launch decisions
- Maximizes the value of intellectual property assets and supports business development efforts through beneficial settlement terms or trial, and appellate-level advocacy in court or the USPTO
Antitrust
- Advises on antitrust investigations, which often result from Hart-Scott-Rodino Act-related filings, by the Federal Trade Commission (FTC) and complaints filed by the plaintiffs’ bar in relation to pharma mergers and acquisitions
- Negotiates settlements with the FTC and manages drug divestitures when necessary
- Litigates "pay for delay" matters between brands, generics and pharmacies
- Handles reimbursement-related disputes involving pharmacy benefit managers (PBMs)
- Provides guidance on violations regarding "reverse payments," fraud on the USPTO and price-fixing allegations
Federal and state investigations
- Provides comprehensive support for the broad range of investigative issues, including:
- Foreign Corrupt Practices Act (FCPA) matters
- False Claims Act litigation
- Shareholder demand letters
- Securities class action lawsuits
- Off-label promotion allegations
- Disclosure-related complaints
- Average wholesale price (AWP) issues
- Stark Law and federal Anti-Kickback Statute investigations
- Accounting-related matters
- Represents corporations or serves as pool counsel for government investigations
Commercial litigation
- Handles breach of contract cases resulting from pharma patent infringement cases, as well as matters involving vendor and supplier contracts
- Strategizes the how to achieve the best outcome, whether it is a "bet the company" case or opting out of a class action case
Corporate and transactional
- Advises on a variety of corporate transactions for pharma companies, including mergers, acquisitions, joint ventures, divestitures and the issuance of stock
- Drafts development and licensing agreements, which include setting benchmarks throughout the trial and approval phases
- Coordinates the acquisition of rights to market and sell individual drugs on behalf of developers and distributors
- Represented investment management companies and hedge funds in transactions involving pharma-related entities
- Handles senior secured credit facilities, acquisition of securities (e.g., common stock, convertible preferred stock, common stock warrants), and private investment in public equities (PIPEs)
Experience
Insights
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Publication | September 2024
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Publication | September 9, 2024
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Publication | July 2024
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Publication | July 22, 2024
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News | March 25, 2024