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In the ultra-competitive life sciences industry, managing litigation is just a part of doing business. From complex governmental regulation to the battles between brand and generics drug companies, life sciences companies require a team with a deep understanding of all legal, regulatory, industry and scientific issues that are part of resolving litigation before or during trial.

Defending Across the Life Sciences Spectrum

The very best life science litigators don’t just have experience in the courthouse. That’s a given. To successfully eliminate claims, negotiate before trial or win in court, it demands litigators who live and breathe life sciences. Buchanan’s Life Sciences Litigation Practice features litigators with decades of industry-specific experience working for both brand name and generics companies. Our team’s depth of knowledge allows us to not only solve complex legal challenges as they happen but also to prepare our life sciences clients ahead of time, before disputes even arise. From Hatch-Waxman litigation and settlements to consumer fraud litigation, product liability, antitrust litigation, trade secrets, False Claims Act litigation, and commercial and contract disputes, our attorneys have helped clients through legal challenges of all shapes and sizes.

Hatch-Waxman Litigation and Intellectual Property Protection

The Hatch-Waxman Act, also known as the Drug Price Competition and Patent Term Restoration Act, is a 1984 federal law that created the modern generic drug industry, whereby generic drug manufacturers need only show bioequivalence to brand name drugs to gain FDA approval, allowing for greater competition more quickly and removing barriers to entry.

Buchanan’s Hatch-Waxman Litigation Team brings together five complementary practice areas:

  • Life Sciences Patent Practice
  • Federal Court Litigation Practice
  • Patent Office Litigation Practice
  • Antitrust / Licensing / Settlement Practice
  • FDA Regulatory Practice

Buchanan attorneys have represented some of the world’s most respected brand and generic pharmaceutical companies, including dozens of high-profile and high-stakes Paragraph IV cases, plus many more engagements that avoided litigation altogether. Our teams are tailored to meet the specific complexities of a particular drug and/or dispute. Our lawyers have litigated complex cases with multiple defendants and jurisdictions for blockbuster drugs as well as niche drugs with smaller markets. We understand that each requires its own approach.

Reverse Payment Patent Settlement Antitrust Litigation

Reverse payment patent settlements arise when a brand name drug manufacturer agrees to compensate a generic drug manufacturer in connection with a patent litigation settlement and license between the parties. The term “reverse payment” refers to the fact that the brand manufacturer is often the one to file suit against the generic manufacturer and, unlike traditional settlements, is often the one to compensate the company it sued. Buchanan attorneys have deep experience with reverse payment litigations and the complex legal issues involved.

Product Liability, False Labeling and Deceptive Marketing Claims

Whether your company is facing a challenge to an allegedly defective product, a false or misleading labeling allegation, a class action or a coordinated series of filings throughout many jurisdictions, Buchanan has experienced attorneys who have faced and managed any number of challenges. Whether you’re a brand or generic company, we quickly develop the facts and engage with experts about the alleged product problems or claims of false or misleading advertising practices. In addition, we can work with your insurance carriers to defend product liability claims brought against you. And when an insurance carrier denies coverage for claims, we have experience litigating declaratory judgment actions to obtain coverage.

Antitrust, Consumer Protection, Market Competition and Price-Fixing Claims

With a robust and extensive team of M&A, antitrust, and trade regulation attorneys on staff, Buchanan’s Life Sciences team is uniquely suited to help you grow your business and, if necessary, eliminate any roadblocks. We have experience representing clients through all types of antitrust matters, including counseling and compliance, consumer protection cases, M&A, price-fixing allegations, complex jury trials and everything in between. We are well positioned to handle both your antitrust transactional and litigation needs, whether in the U.S. or abroad. Our clients include some of the country’s most well-known companies in the brand and generic healthcare and pharmaceutical industries, not to mention scores of other companies outside the life sciences space.

False Claims Act Allegations, Governmental and Regulatory Investigations

Regulatory compliance is one of our core services. We can guide your company through regulatory compliance requirements at every phase of your product’s lifecycle, from development and manufacturing through marketing, distribution and beyond. However, establishing compliance programs designed to reduce risk from the onset is just part of what we do. The reality is that governmental investigations do occur, and it’s critical to have a team that’s experienced enough to know how to guide life sciences companies of all types to a positive conclusion.

We frequently represent clients before the Food and Drug Administration, Department of Justice, the Federal Trade Commission, Better Business Bureau’s National Advertising Board, state attorneys general and various other federal and state regulators. We help clients proceed efficiently and effectively through investigations to reduce risk and get back to developing the lifesaving, game-changing products of tomorrow. Our clients have turned to us to help them manage and overcome investigations dealing with deceptive marketing and labeling issues, data privacy, False Claims Act accusations, as well as state-specific issues like California’s Proposition 65 requiring specific chemical exposure product warnings.

Life Sciences Litigation Services We Offer

  • Patent and IP litigation
  • Hatch-Waxman litigation
  • Federal court litigation
  • Antitrust litigation
  • Trade secrets litigation
  • Licensing litigation
  • FDA regulatory litigation
  • Consumer fraud and consumer protection litigation
  • Product liability litigation
  • Reverse payment antitrust litigation
  • False Claims Act litigation
  • False labeling, deceptive marketing litigation
  • Commercial and contract dispute litigation
  • Counseling and compliance
  • Price-fixing litigation
  • Governmental and regulatory investigations
  • Regulatory investigations
  • Opioid litigation