Even if you have already been granted a patent, FDA approval is still required before you are allowed to market and sell your device. That’s why it is critical to properly plan out your Medical Device’s Patent Prosecution and FDA approval Process.

The FDA classifies medical devices into three distinct categories, Class I, Class II, and Class III. The regulatory control increases as the medical device moves from Class I to Class III.

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FDA Classifications

Class I – Exemption

  • Any medical device that presents minimal potential for harm to a user (e.g., stethoscopes or thermometers).
  • 510(k) Notification and FDA clearance are not required before marketing device in United States.
  • Manufacturer is still required to register their establishment with the FDA through the payment of a fee.
  • Establishment Registration Fee in 2022: $5,672.

Class II – 501(k) Notification

  • Any medical device that presents an intermediate risk to a user (e.g., Powered Wheelchairs or Pregnancy Test Kits).
  • Most medical devices fall under this category.
  • FDA requires medical device manufacturers to demonstrate to the FDA’s satisfaction that the new device is “substantially equivalent” (i.e., safe and effective) to a device already on the market.
  • Applicants can expect 510(k) Notification submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Additionally, applicants with outstanding review issues will be notified within 100 days.
  • 501(k) Filing Fee in 2022: $12,745.

Class III – Premarket Approval

  • Any medical device that is used to sustain or support the life of a user, is implanted within the user, or presents a potential unreasonable risk of illness or injury to a user (e.g., Implantable Pacemakers; Ventilators).
  • A Premarket Approval (“PMA”) application is required before you are allowed to market a Class III medical device.
  • In addition to the PMA application, you must also submit valid scientific evidence collected from clinical tests and trials
  • These tests must show to the FDA’s satisfaction that the device is “safe and effective” for its intended use.
  • The PMA submission can be an extremely expensive and time-consuming process for the medical device manufacturer or developer.
  • PMA Application Fee in 2022: $374,858. However, total cost, including all stages of clinical trials, can be upwards of $9 million.

Class III – Patent Term Extension (“PTE“)

  • The PMA process can take several years and should be started as soon as possible for Class III medical devices.
  • USPTO can extend the life of your patent rights related to the FDA- approved use of the product through PTE.
  • Maximum extensions that can be obtained for a patent is limited to five years.
  • The total remaining patent term (with PTE) is limited to fourteen years from the date of product approval by the FDA.

Key Litigation – Medical Device Patents and FDA Approval

FDA Approval and USPTO Patent Prosecution usually occur during the same timeframe. Because of this, it has been debated in courts (e.g., Federal Circuit) whether the information disclosed to the FDA should weigh on the examination of a patent application.

Arthorcare Corp v. Smith & Nephew, Inc., 406 F.3d 1365 (Fed. Cir. 2005)

  • Federal Circuit Court held that a 510(k) submission was irrelevant in 25 U.S.C. §102 (“novelty”) analysis because novelty is determined by comparing the limitations of the asserted claims, not the commercial embodiments as described in the 510(k) submission.
  • However, the Factual Summary of technological characters found in the 510(k) submission could help/hurt patent analysis.
  • The Factual Summary could be used as prior art if relevant aspects of the claimed invention exist in the patent claim elements.
  • The Factual Summary could also help show the distinction of the patent claim from the predicate device, which in turn might support an argument of patentability or validity of the patent claim.

Innovative Therapies, Inc. v. Kinetic Concepts, Inc., 599 F.3d 1377, 1382 (Fed. Cir. 2010)

  • The Federal Circuit Court has repeatedly refused to allow the FDA 510(k) – Notification of Substantial Equivalence as admission of infringement in patent cases.
    1. Substantial equivalence in a 510(k) Notification pertains to a comparison of two products’ safety and efficiency while substantial equivalence has a different meaning in the patent context.
    2. Substantial equivalence in USPTO’s Patent Prosecution is an element-by-element comparison of a patent’s claims to an accused product.

Halo Electronics, Inc. v. Pulse Electronics, Inc., 136 S. Ct. 1923, 1933 (2016)

  • Willful infringement is determined based on the “subjective willfulness of a patent infringer, intentional or knowing.”
  • A competitor owning a patent covering the predicate may use statements made in the 510(k) submission as an admission to establish knowledge of the predicate device and any relative patent.

TC Heartland LLC v. Kraft Foods Group Brands LLC, 137 S. Ct. 1514 (2017)

  • The Supreme Court held that patent infringement cases must be heard in the district within which the defendant is incorporated.

Ethicon LLC v. Intuitive Surgical, Inc., No. 20-1528 (Fed. Cir. 2021)

  • The Federal Circuit held that PTAB “went too far” holding Ethicon’s patent as “non-obviousness” by requiring Intuitive Surgical to specifically identify a preexisting surgical device performing as many functions as required by the Ethicon patent.
  • It was enough that the prior art established a surgical device was “at least possible” to show obviousness
  • Obviousness may result from combination of prior art showing technology to be “at least possible.”

With a team of highly-skilled patent attorneys, we are always in a position to achieve optimal results for our clients. Get in touch with us today to secure your rights and help answer any questions you may have with your Medical Device’s Patent Prosecution and FDA Approval Process.

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