The April 16th, 2022, New York Times editorial entitled “Save America’s Patent System” recommends that the US Patent and Trademark Office (USPTO) be improved through collaboration with other agencies such as the Food and Drug Administration (FDA). The editorial identified that “[e]xisting regulations allow medical device makers to sidestep burdensome regulatory approvals if their newer products are deemed similar to ones that already exist.”
However, the editorial board of the New York Times recognized that the lack of collaboration between the FDA and the USPTO results in an inherently contradictory situation which results in companies describing “processes as common when talking to regulators and novel with regard to [the USPTO].” Reconciling this inherent contradiction between FDA regulations and the requirements for patentability before the USPTO was the genesis of the book FDA and Intellectual Property Strategies for Medical Device Technologies.
In the book, three specific challenges are identified in reconciling FDA regulations for medical devices that “sidestep burdensome regulatory approvals” under Section 510(k) of the Food, Drug, and Cosmetic Act with the requirements for patentability before the USPTO. The specifically identified challenges are:
Novelty/ Obvious & Substantial Equivalence
The FDA requirement of “substantial equivalence” for obtaining 510(k) approval for a medical device, as well as the USPTO requirements of novelty under 35 U.S.C. §102 and non-obviousness 35 U.S.C. §103, must both be satisfied in order to obtain patent protection for a medical device that is able to enter the market using the expedited 510(k) approval process.
In order to obtain 510(k) approval, a manufacturer of a medical device must demonstrate to the FDA that the device is “substantially equivalent” to a “predicate device” that is already available on the market. For the purposes of 510(k) approval, “substantial equivalence” of the “predicate device” means that a medical device:
- has the same technological characteristics as the predicate device, or
- has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary ... that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device. [21 U.S.C. § 360c(i)(1)(A)].
In contrast, in order to obtain a patent, the manufacturer of the medical device must demonstrate that the device is novel under 35 U.S.C. §102 and non-obviousness under 35 U.S.C. §103. Therefore, the manufacturer will be unable to obtain a patent if:
- The invention is described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention [35 USC 102], or
- the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains [35 USC 103].
Accordingly, the requirement for “substantial equivalence” for a 510(k) approval and the “novelty and non-obviousness" requirement for patent procurement appear inherently contradictory.
On the one hand, the sponsor needs to demonstrate to the FDA that the medical device has the same technological characteristics as a predicate device that has been commercially available prior to the 510(k). On the other hand, patent applicants need to demonstrate to the USPTO that the medical device is novel and inventive in light of the entire corpus of human knowledge that is available as prior art. Failing to show “substantial equivalence” under the 510(k) will result in the medical device requiring a full Premarket approval (PMA) which is both costly and time-consuming. Alternatively, failing to show novelty and non-obviousness results in the medical device not having the exclusivity protection of a patent.
Duty of Disclosure to the USPTO-
Patent applicants have a duty to disclose information known to them to be material to patentability, and a breach of this duty may constitute inequitable conduct. Accordingly, submitting material information to the FDA while simultaneously withholding the same information from the USPTO may rise to the level of inequitable conduct (see, for example, Belcher Pharmaceuticals, LLC v. Hospira, Inc., 11 F. 4th 1345 (Fed. Cir. 2021) and Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs., 394 F.3d 1348 (Fed. Cir. 2005).
FDA’s Application Integrity Policy (AIP)
All applicants who submit a 510(k) submission for a medical device must comply with the FDA’s Application Integrity Policy (AIP). Under the AIP, “a false statement, misstatement, or omission of a fact” is an act “that may subvert the integrity of the review process” and may trigger an FDA investigation, fine, or full product recall. (FDA Application Integrity Policy, Section 1-1-3(1), available online
Accordingly, certifying to the FDA that the new medical device has the same technological characteristics as the “predicate device” while simultaneously arguing to the USPTO that the medical device has novel and inventive technological characteristics when compared to the “predicate device” may, at a minimum, delay regulatory approval, or at worst, result in the application being denied necessitating a recall of already sold products.
Therefore, in order for the FDA and the USPTO to collaborate as suggested by the New York Times Editorial board to overcome the inherent contradictions identified in “FDA and Intellectual Property Strategies for Medical Device Technologies,” the FDA and the USPTO should:
- Require a sponsor to identify all patents and applications that cover a medical device that is being reviewed under the 510(k) expedited approval process in the 510(k) submission process.
- Require a sponsor to identify all patents that cover a referenced “predicate device” in the 510(k) submission process.
- Require a patent Applicant to include all 510(k) submissions in the list of standard databases that are searched by Examiners at the USPTO
- Require the 510(k) submission to be identified in the specification of the patent application filed with the USPTO.
If the FDA and the USPTO were to implement any or all of the above, the communication among the agencies would be improved, which would result in higher quality patents being issued and safer medical devices being approved under the expedited 510(k) review process.
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