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Life Sciences

LeClairRyan’s Life Sciences Industry team is comprised of a deep bench of attorneys with experience in the many disciplines that affect pharmaceutical and life sciences companies. Our team represents clients in all aspects of their businesses—from product development to regulatory compliance—and everything in between.

The types of pharmaceutical and life sciences companies we serve are equally diverse, ranging in size from start-up entities with emerging technologies to large branded companies that are traded in domestic and foreign markets. Our list of clients includes developers and manufacturers of active pharmaceutical ingredients and finished dose pharmaceuticals, as well as innovator and generic pharmaceutical companies. We also serve as outside general counsel for many of our clients.

Regardless of the issue at hand, our team consistently provides pharmaceutical and life sciences companies with an invaluable legal perspective on the issues they face on a daily basis. Following is a list of the skill sets we offer our clients.

Intellectual Property
  • Patent application preparation and prosecution
  • Post-issuance patent practice, including patent interferences, reexaminations, reissues and oppositions
  • Inventorship evaluations, opinions and litigation
  • Intellectual property counseling, opinions and strategy services
  • Trademark clearance, prosecution and licensing
  • Copyright registration and counseling
  • Litigation of patent, copyright, trademark, trade secret, and licensing and technology contract disputes nationally and internationally, including Abbreviated
  • New Drug Application (ANDA) litigations
  • Hatch-Waxman (Section IV) litigation

Product Development and Commercialization 

  • Joint development
  • Joint venture
  • Licensing
  • Collaboration agreements
  • Clinical research outsourcing
  • Clinical trial strategies and agreements
  • Strategic partnering
  • Distribution and supply agreements
  • Durable medical equipment service agreements
  • Technology transfers

Financing 

  • Venture capital funding
  • Public offerings (primary and secondary)
  • Mergers and acquisitions
  • PIPE offerings

Regulatory Compliance and Investigations 

  • Clinical trial issues
  • Off-label use of drugs and devices
  • Tax controversies
  • Regulatory due diligence
  • Site audit assistance
  • Federal Drug Administration 501(k) applications and approval process
  • False claims / qui tam matters
  • Foreign Corrupt Practices Act violations
  • Stark Law and Anti-Kickback Statute compliance
  • State and federal criminal and quasi-criminal investigations
  • White collar criminal defense

Compounds and Medical Device Liability Litigation 

  • Drug and medical device product liability cases
  • Defense of mass tort cases
  • National coordinating counsel for medical device companies
  • Large-scale electronic discovery related to litigation

Labor and Employment

  • Employee policies and manuals
  • State and federal layoff statute compliance
  • Regulatory requirements specific to employees in the pharmaceutical industry
  • Compensation and benefits
  • Non-compete agreements
  • Separation agreements
  • Representation of employers in wrongful discharge claims
  • Union elections resulting from attempts to organize nonunion facilities
  • Immigration issues
  • Advice on day-to-day employment issues

Contact

  • Industry Team Leader
    703.647.5911