Life Sciences

Overview

Life sciences companies are in the business of helping people. The drugs and devices they develop are designed to alleviate pain, cure disease, treat illness, and much more. However, the life science industry continues to face the challenges of increased competition, demographic changes, technological innovation, and regulatory upheaval. 

Blank Rome’s life sciences team works with clients to mitigate those challenges by looking at the issues from all angles. How will the changing regulatory and risk environment impact your business? What security and privacy adjustments are necessary to cope with increasing digitization? How do you preserve or build shareholder value with continued pricing pressures and rising R&D expenses? We take a pragmatic, business-focused approach to create comprehensive strategies to help you succeed at every stage of your business. 

We have deep experience in corporate transactions and M&A, intellectual property matters, commercial and product liability litigation, regulatory compliance, and anti-corruption. We address numerous government relations matters through our government affairs team of top lobbying and strategic communications professionals. Many of our attorneys and advisers have significant government experience related to compliance, enforcement, and reimbursement issues,  before federal agencies such as the National Institutes of Health (“NIH”), the Food and Drug Administration (“FDA”), the Centers for Medicare and Medicaid Services (“CMS”), the Department of Justice (“DOJ”), and the Office of the Inspector General (“OIG”). 

Our industry team can also bring in attorneys focused on specific legal issues such as labor and employment, tax, business restructuring, real estate, and others, to address any issue that arises.

How We Can Help

We represent a wide range of life sciences companies and industry professionals, including:  

  • drug and device developers, manufacturers, and distributors
  • active pharmaceutical ingredient producers and importers
  • biotechnology innovators
  • academic medical centers
  • research institutions, laboratories, and investigators
  • contract research organizations
  • physician inventors
  • pharmaceutical consortia
  • financing companies

What Sets Us Apart

  • We add value for our clients by leveraging relationships within the life sciences and financial industries, as well as the government, to facilitate key introductions that create business opportunities and solve problems. 
  • Our life sciences industry team is bolstered by a deep bench of recognized intellectual property leaders with significant experience in acquiring, defending, enforcing, and invalidating medical device and pharmaceutical patents. 
  • We have achieved numerous wins in high-profile life science disputes and have extensive trial and appellate experience in federal and state courts across the country.
  • We advise on compliance strategies with respect to global data protection laws and the processing of human biological samples, including transparency initiatives in clinical research.

Experience

  • Apotex, Inc. in several transactions, including:
    • The acquisition of Aveva Drug Delivery Systems, Inc., a global developer and manufacturer of transdermal patches, from Nitto Denko Corporation.
    • The acquisition of assets from Barr Laboratories related to several products.
    • $500 million acquisition of rights to a blockbuster branded generic product suite, including the transfer of trademarks and product registrations, product licensing transactions, and an “authorized generic” licensing transaction.
  • Aegis Capital Corp. in several transactions, including:
    • A $26.4 million public offering of common stock and warrants and “uplisting” of the common stock of Advaxis, Inc., a clinical-stage biotechnology company developing multiple cancer immunotherapies.
    • A $16.1 million public offering of common stock and warrants of InVivo Therapeutics Holdings Corporation, a medical device company founded to develop and commercialize groundbreaking technologies for the treatment of spinal cord injuries.
    • A $15 million IPO of Akers Biosciences, Inc., a company that develops, manufactures, and supplies rapid, point-of-care screening and testing products designed to bring health-related information directly to the patient or clinician.
    • An $8.5 million IPO of Signal Genetics, Inc., an emerging commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make decisions concerning the care of their patients suffering from cancer.
  • Glenmark Generics in a patent interference with another generic pharmaceutical company; successfully invalidated all of the other generic pharmaceutical company’s patent claims in the interference. 
  • DJO Global acting as National Litigation Counsel for all cases related to artificial knee devices, including:
    • Successfully resolved a series of five cases consolidated for arbitration.
    • Obtained dismissal orders at the preliminary stage in cases pending in Georgia and California.
    • Currently serving as lead counsel in eight cases consolidated in federal court in Florida.

Team

Jonathan P. Mitchell Ph.D.

Jonathan P. Mitchell Ph.D.

Registered Patent Agent and Technical Specialist