Medical Devices — Protecting Innovation in a Competitive Industry

Without a doubt, advances in medical-device technologies have improved patients’ quality of life by leaps and bounds. Equally impressive is the rate of expansion in the medical devices industry. These positive statistics are offset by a number of challenges, however, including increased regulation, an aggressive plaintiffs’ bar, and major reforms at the U.S. Patent and Trademark Office (USPTO). Marshall, Gerstein & Borun LLP helps clients protect their pioneering ideas, maximize the value of their innovations, and resolve disputes with competitors at home and abroad.

Three points of strength: experience, knowledge, and breadth

Industry experience, in-depth legal knowledge, and full-spectrum capabilities: these are what clients need and what Marshall Gerstein delivers. We draw on our deep understanding of the law, our scientific training, varied work experience in the medical fields, extensive Firm resources, and global network of foreign agents to develop, implement, and manage comprehensive IP and business strategies for the medical devices industry. We know our clients’ technologies, the competitive markets in which they operate, and the IP challenges they face.

End-to-end counsel

We strive to understand the value and role of our clients’ IP as an integral part of their overall business strategies. We advise Fortune 500 corporations, emerging growth companies, universities and research institutions, and startups at every step of the lifecycle, including:  

  • Capital formation
  • Copyright
  • Due diligence
  • Freedom to operate
  • Intellectual property audits
  • Licensing and other IP agreements
  • Litigation
  • Patent landscape evaluations
  • Patent prosecution
  • Trademark
  • Trade secrets

Deep industry knowledge

Medical device representation has been a pillar of our Firm for nearly 70 years. We have cultivated long-term relationships with multinational enterprises and successful entrepreneurs who have developed and marketed many of the world’s best-known and best-selling technologies. Our long history in the industry enables us to handle the most complex matters efficiently and with minimal ramp-up time. We regularly advise clients with inventions in the following medical fields:

  • Anesthesiology and pain management
  • Cardiology and cardiothoracic surgery
  • Colorectal surgery
  • Continence care products
  • Drug delivery
  • Dental equipment
  • Emergency medicine
  • Gastroenterology
  • General surgery
  • Hematology and oncology
  • Medical diagnostics and imaging
  • Medical records management and management information systems (MIS)
  • Neurosurgery
  • Ophthalmology and optometry
  • Obstetrics and gynecology
  • Orthopedic equipment and implants
  • Plastic surgery
  • Pulmonology
  • Radiology
  • Urology
  • Vascular surgery

Interdisciplinary resources

Interdisciplinary collaboration is more important than ever in today’s complex scientific, business, and legal environments. We draw on our deep, diverse bench to create customized legal solutions for each client and project. Our professionals collaborate seamlessly and efficiently to address the complex issues involved in protecting devices that cross technology categories. While we draw from a variety of disciplines, we also keep client teams lean to optimize and cater our services to each client’s individual needs and preferences.

Global vision and reach

We advise clients across the country and abroad with equal facility. Foreign law and legal developments are on our radar at all times. We have a keen understanding of international legal systems and have developed close working relationships with a network of trusted foreign agents.

Representative clients

  • Amgen, Inc.
  • Baxter Healthcare Corp.
  • Medela
  • University of Michigan
  • XOMA Corp.

Representative matters

  • Accelerating Patent Prosecution and Negotiating Biomanufacturing Agreements
    We helped XOMA negotiate and finalize a license with the Texas A&M University System for its patented flexible manufacturing design using mobile clean rooms. The innovative technology, which has the potential to transform the industry with its plug-and-play design, will be used at the pioneering Texas A&M Center for Innovation biomanufacturing facilities, sponsored by the U.S. Department of Health and Human Services. Our team prepared the patent applications for this technology, pursuing a strategy of accelerated examination in the United States to expedite issuance of a fundamental patent included in the license. We continue to advise XOMA on worldwide patent strategy and transactions.
  • Home-Based Drug Delivery System Provides Timesaving Benefits to Cancer Patients
    Our attorneys helped Amgen, a multinational biopharmaceutical company, bring revolutionary new technology to the marketplace. The Neulasta® (pegfilgrastim) OnPro™ Kit allows patients to inject the proper dosage of a post-chemotherapy, infection-fighting drug without returning to a clinic. We secured broad protection for the product in the United States by leveraging nuances in USPTO procedure in conjunction with examiner interviews.
  • Protecting Cancer-Detection Innovation
    On behalf of the University of Michigan, the Firm secured a patent covering software that greatly reduces the rate of false positives that occur in cancer screenings. The patent provides IP protection for a healthcare innovation that eliminates heartache for vulnerable patients, as well as their families and doctors.
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