Marshall, Gerstein & Borun LLP

Medical Devices

Building a Solid IP Foundation for Highly Regulated Products

New medical device designs face numerous intellectual property and regulatory hurdles.  Few law firms surpass Marshall, Gerstein & Borun’s ability to help corporations, medical research organizations and individual inventors navigate the medical device patent, approval and marketing process.  For pre-market approval, medical device producers must often submit to the FDA an enormous amount of information on product safety and efficacy, product specifications and manufacturing methods, and clinical and non-clinical test results. 

Medical device manufacturers look to Marshall, Gerstein & Borun as an ally in securing the patent protection desired to complement their regulatory approval.  You can rely on our lawyers, who are skilled and experienced in mechanical, materials science, chemical, biotech, and electrical/electronic technologies, to successfully prosecute patents for even the most complex medical technology applications.  Medical device manufacturers based in the United States, Denmark, Germany, and other countries have relied on us to handle patent-related matters for:

• Blood homeostasis analysis and testing equipment.
• Hearing screening and hearing disability diagnostic and testing equipment.
• Implantable vascular filter devices.
• Dental, orthodontic and periodontal equipment.
• Surgical instruments.
• Urinary incontinence products such as external catheters.

We help these and other clients with patent procurement and licensing, and have extensive experience in U.S. and foreign prosecution and opposition practice for medical devices.

Our approach also provides strong support in the event of subsequent infringement controversies.  Our patent attorneys have litigated numerous cases for clients involving such medical devices as ventilators, tissue expanders, pacemakers, and surgical and x-ray equipment in patent infringement cases before federal courts nationwide as well as the U.S. International Trade Commission.  We also have experience with patent interferences before the U.S. Patent & Trademark Office Board of Patent Appeals and Interferences; for those instances where proving the earliest to conceive of an invention and diligently reduce it to practice, becomes a contest with high-stakes patent rights that are "in-the-balance." 

From patentability investigations to freedom-to-operate considerations; to obtaining patent protection in the U.S. and abroad, our comprehensive approach is assurance that your medical devices have solid intellectual property footing.