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Life Sciences

Every life sciences company is under the microscope.
Not only do life sciences companies face competition from business rivals, they draw intense scrutiny from government regulators, Congressional oversight, State Attorneys General and litigators. Plus, there are new areas of competition like formulary placement, and new adversarial forces like PBMs and P&T committees.

We protect, defend and optimize the lifecycle of your product.

Buchanan’s Life Sciences Industry Group offers a rare and comprehensive mix of FDA Regulatory, Intellectual Property, Litigation and Government Relations services delivered through one seamless team. We counsel clients on the full range of issues that arise during the product lifecycle, from idea conception to commercialization. Our clients, which include leading pharmaceutical companies, biotechnology companies, wholesalers and distributors, retailers, industry trade associations and leading research institutions, trust Buchanan Life Sciences with their most challenging business and legal problems. 

Comprised of more than 50 attorneys and government relations professionals throughout the United States, our unique team has decades of experience working with Congress, FDA, DOJ, FTC and the USPTO. Our deep understanding of the legal and technical issues impacting the life sciences industry allows us to develop novel and effective approaches to addressing our clients’ legal and business objectives.

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We also help clients navigate emergent issues by sharing proactive intelligence on:

  • FDA regulatory trends
  • Intellectual Property strategies and services
  • Federal and state regulation of drug pricing
  • FTC regulation of consumer privacy and advertising
  • False Claims Act litigation trends
  • Pharmaceutical antitrust
  • 505 (b)(2) products
  • Opioid regulation/legislation and litigation
  • Market access obstacles

We Offer Life Sciences Clients

  • A full range of FDA services covering the entire product lifecycle including regulatory approval, pre- and post-approval of marketing, compliance and enforcement, clinical trials, drug and device safety, crisis management, due diligence, and drug pricing optimization.
  • Highly regarded patent procurement and prosecution with a focus on biotechnology and pharmaceuticals. Our 45+ USPTO-registered practitioners prepare and prosecute patent applications worldwide for U.S. and international clients. We also have an extensive network of foreign counterparts for obtaining global rights. Our team regularly works with USPTO personnel in examiner interviews and oral hearings to pursue and obtain patent protection. In addition, our IP Litigation team handles all manners of litigation including, Hatch-Waxman (Paragraph IV), trade secrets, International Trade Commission (ITC), PTAB, IPR and trademark and copyright.
  • Skilled corporate lawyers who can help life sciences companies form strategic alliances to spread financial risk. We have experience in securities offerings, mergers and acquisitions, IPOs, and SEC compliance as well as in constructing and negotiating the contractual agreements required during a product’s lifecycle. We provide access to our long-standing relationships with financial institutions, established corporations, emerging companies, venture capitalists, healthcare organizations and universities. 
  • Highly recognized litigators with industry-specific experience with Hatch-Waxman litigation, consumer fraud litigation, and commercial and contract disputes. We currently represent a number of life sciences clients in the Average Wholesale Price litigation, opioid litigation, and generic drug pricing antitrust litigation.
  • Specialized antitrust and trade regulation attorneys who represent clients in nearly all types of antitrust matters and include some of the most well-respected and significant pharmaceutical and biotechnology companies both domestically and abroad. We have assisted clients with matters regarding price-fixing, monopolization, boycotts, mergers and acquisitions, distribution, exclusive dealings, and other antitrust and trade regulation issues. We have also helped foreign companies navigate U.S. federal and state antitrust laws, including both civil litigation and parallel government investigations.
  • Seasoned government relations professionals entrenched in drug pricing, bill reauthorizations, legislative issue development and relationship building, as well as regulatory matters before FDA, CMS, the Medicare Payment Advisory Commission (MedPAC) and others.
  • Labor & Employment attorneys that provide full guidance and counseling concerning compliance with all federal, state and local statutes and regulations affecting employee rights, benefits and workplace safety. We also know that attracting and keeping talent can be a very competitive proposition. Our Immigration team can provide strategies around both foreign and domestic talent acquisition and retention that will highly benefit your overall business goals.

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