Biotechnology—Navigating New Twists and Turns

Uncertain science and long product-development life cycles are just some of the challenges facing biotech innovators. Evolving judicial limits on patentability, interpretation of the Biologics Price Control and Innovation Act (BPCIA) rules for biosimilars, the introduction of post-grant proceedings, and other emerging issues have made it more difficult than ever to know if a new product or process will help a company meet its business goals.

Strategies for every stage of biotech development
Marshall, Gerstein & Borun LLP offers continuity and predictability along the challenging path to biotech success. We have advised startups on the road to initial public offerings (IPOs) and acquisitions, helped middle-market businesses crack the Fortune 500, and counseled multinational companies on how to protect key assets around the world.

We have vast experience helping biotech clients devise successful IP strategies that build U.S. and foreign patent portfolios, protect commercial products and processes, maximize returns, and extend patent life cycles. We focus on client goals first and foremost, while maintaining a laser focus on legal, scientific, and industry developments that could require strategic adjustments.

Exceptional experience
Marshall Gerstein lawyers have procured, enforced, and/or defended key patents for more than a dozen commercially marketed drugs, along with dozens of clinical trial candidates. We have successfully defended well-known commercial pharmaceuticals, including Cialis® and Epogen®, in court. And we have assisted clients in billion-dollar portfolio acquisitions and company sales, as well as in high-profile IPOs and licensing agreements.

Excellent client service, drawing on in-house experience
We have been repeatedly ranked as a top biotech and life sciences firm by Managing Intellectual Property—the only Midwest IP boutique to be so honored—and were recently named Lawyer Monthly’s “Biotechnology Law Firm of the Year.” More than 75 percent of our biotech group members have advanced degrees in biotech disciplines and half have in-house experience as general and patent counsel, technology transfer managers, scientists, and engineers. We know firsthand our clients’ needs and leverage this experience to help companies achieve their business goals. As a result, numerous Fortune 500 companies have chosen Marshall Gerstein as a preferred provider.

Flexible partnerships for the long run
Marshall Gerstein serves all four major biotech market segments: Fortune 500 companies, middle-market businesses, startups, and universities and medical research institutions. We are known for long-term client relationships, many of which have endured for decades. Each client benefits from our commitment to providing flexible service options at every stage of the business cycle, from launch, through growth and market leadership, to spin off or sale. In fact, Chambers USA has described Marshall Gerstein as “Excel[ling] in understanding [each client’s] unique business and tailoring … legal work to the specific needs of the client’s business.”

Our biotech practice offers a one-stop shop for sophisticated prosecution, litigation, and licensing services, delivered with the focus, depth, and personal service of a boutique law firm. We regularly counsel clients on:

  • Patent prosecution strategies
  • Global portfolio management and strategies
  • Early-stage product development initiatives
  • Patent-term extension counseling
  • Competitor IP landscape analyses
  • Freedom-to-operate analyses
  • Due diligence investigations
  • Post-grant proceeding challenges
  • IP aspects of finance transactions

    Focused on key areas
    We develop and deploy creative, forward-looking IP strategies that align with rapidly changing technology in a variety of industries:

    • Biopharmaceuticals and immunotherapy
    • Diagnostics and personalized medicine
    • Biosimilars
    • White biotech
    • Agricultural biotech
    • Bioinformatics
    • Vaccines
    • Microfluidics
    • CRISPR gene-editing technologies
    • Enzyme replacement therapeutics

    Representative clients

    • Amgen Inc.
    • Baxter Healthcare Corp.
    • BioMarin Pharmaceutical, Inc.
    • CRISPR Therapeutics AG

    • deCODE Genetics, Inc.
    • Electrochaea GmbH
    • InterMune, Inc.
    • Ludwig Institute for Cancer Research
    • Merck Serono
    • Onyx Pharmaceuticals
    • University of Michigan
    • University of Miami
    • XOMA Corp.
    • Numerous emerging companies, universities, and hospitals

    Representative matters

    • Transformative Immunoncology Approach Achieved: Marshall Gerstein Advances Patent Strategy for NEUVOGEN
      NEUVOGEN has turned to Marshall Gerstein for patent strategy as they advance a broad pipeline of therapeutic whole cell cancer vaccine candidates designed to activate the patient’s immune system to target and eliminate existing tumors and prevent future metastases.
    • From Patent Protection to IPO Due Diligence: Marshall Gerstein Delivers IP Strategy for Immune Design
      On behalf of Immune Design Corporation, whose technologies help the body’s immune system create antigen-specific T-cells that fight cancer and other chronic diseases, we obtained patents covering two key discovery platforms and played a primary role conducting due diligence for the company’s $60 million IPO.
    • No Pain, No Gain: Marshall Gerstein Secures Key Arthritis Drug Patent for Longtime Client Amgen
      We served as part of the team that argued for and won a key patent related to Amgen’s FDA-approved drug ENBREL, used to treat moderate to severe rheumatoid arthritis in adults and children.

    • Persistence Pays Off: Marshall Gerstein Fends Off 20 Years of Patent Claims for FDA-Approved Drug
      We helped our client succeed in the highly contentious prosecution of patent claims for ActimmuneTM, an FDA-approved drug used to treat serious infections related to chronic granulomatous disease and to delay the progression of severe, malignant osteopetrosis. The two-decades-long prosecution included appeals and interferences before the U.S. Patent and Trademark Office, and an appeal to the U.S. Court of Appeals for the Federal Circuit.
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