Medical Devices

Sterne Kessler’s medical device industry team has broad and deep experience providing integrated IP services to leading medical device innovators.

Sterne Kessler’s medical device team is highly experienced and is tuned into new developments in the industry. As a result, we work efficiently with clients’ teams — executives, in-house counsel and inventors — to provide effective counsel on IP strategy and deal negotiation focused on achieving strategic corporate goals.

Innovation is accelerating and revolutionizing medical treatments. Smart technologies that integrate engineering and biology are emerging and fields such as nanotechnology are being integrated in medical device product development. With so much change on the horizon, a comprehensive IP strategy is critical for companies innovating in this sector.

We help medical device clients manage the interplay between the patent process and the FDA approval process. Our team helps clients manage astute product development strategy, coordinating assertions made in FDA filings with claims (and the timing of filings) made in patent applications. Further, we understand the importance of product lifecycle management in developing an appropriate IP strategy and work with clients to obtain patents optimized to product lifecycles.

With more than 60 Ph.D.s on staff, we have the technical experience medical device clients need in scientific and technological disciplines, including biomedical engineering; mechanical and materials science engineering; and polymer and organic chemistry. We represent companies, including three of the Global Top Twenty, working in a variety of areas including:

  • Cardiovascular devices (including catheters and stents)
  • Cardiac rhythm treatment methods
  • Pacemakers and defibrillators
  • Peripheral vascular devices
  • Neurovascular treatment methods
  • Devices for preserving neural pathways
  • Syringes and needle assemblies
  • Auto-injection devices
  • Surgical gloves
  • Inhalers
  • Insulin delivery devices
  • Tracheotomy tubes
  • Cervical caps
  • Incontinence and impotence treatments
  • Circadian phase modification
  • Surgical supports
  • Diagnostic systems
  • Diagnostic kits and reagents
  • Hematology instruments
  • Sleep quality testing instruments

Our experience on behalf of medical device clients includes:

  • Drafting and prosecuting patent applications
  • Conducting interviews with patent examiners
  • Negotiating licenses
  • Enforcing patent rights in district court and ITC litigation
  • Leading contested post-grant proceedings at the PTAB
  • Providing opinions on infringement, validity and patentability
  • Creating company-wide IP guidelines
  • Conducting IP audits
  • Conducting IP due diligence investigations
  • Assessing IP valuation
  • Providing international protection strategy

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2023 PTAB Year in Review: Analysis & Trends