Given its alluring profitability, the medical device industry is highly competitive. A patent, consequently, is of high value to medical device companies; it protects their market share and helps attract investors. When bringing a medical device to the market, however, compliance with federal regulations can present a unique risk regarding the patentability of a medical device. This article will briefly discuss that risk and strategies to minimize it.
Medical devices marketed in the United States are subject to the regulatory controls of the Federal Food, Drug, and Cosmetic Act (“FDCA”). Under the FDCA, unless exempt or otherwise subject to premarket approval, medical devices can only enter the market after being “cleared” in accordance with FDCA 510(k). The 510(k) clearance process is the most common avenue for acquiring the FDA’s authorization to introduce a medical device to the market, and so it will be the focus of this article. Briefly stated, during the 510(k) clearance process, information about the medical device sought to be cleared must be submitted in a Premarket Notification 510(k) (or “510(k) submission”) to the FDA for an evaluation of the device’s safety and efficacy. For the device to be cleared by the FDA, the 510(k) submission must contain sufficient information to demonstrate that the device is “substantially equivalent . . . to a legally marketed device” (or a “predicate device”). The information required to be submitted includes, among other things, an identification of the predicate device and a comparison of the predicate device’s technological characteristics with those of the device sought to be cleared. After the FDA clears the device, some of this information, such as a 510(k) summary and parts of the 510(k) submission, will be made publicly available. This can be problematic with respect to the patentability of the medical device, especially if care was not exercised in selecting and preparing the information for submission.
Under United States patent law, when examining a patent application directed to a medical device, the examiner can reject the claimed device if it is anticipated by, or obvious over, the prior art. Except as otherwise provided in 35 U.S.C. 102(b), the “prior art” includes descriptions of the device in “printed publications . . . or otherwise available to the public” before the effective filing date of the claimed device. Section 102(b), however, provides that a disclosure made one year or less before the effective filing date of the claimed device will not be prior art if the disclosure was made by the inventor, a joint inventor, or a person who obtained the subject matter disclosed from the inventor or a joint inventor. Hence, assuming 102(b) applies, publicly available information about a medical device, as described in a 510(k) summary or 510(k) submission, will be prior art in examining a patent application directed to the device if the patent application was effectively filed more than one year after the date that the information became publicly available. If 102(b) does not apply, such information would be prior art in examining any patent application directed to the device effectively filed after the date that the information became publicly available.
Given that the purpose of the information in a 510(k) submission is to demonstrate that the medical device is “substantially equivalent” to the predicate device, it is easy to understand the reason this information could compromise patentability if it comes within the scope of the prior art. Indeed, commonalities among the devices’ respective elements can support a rejection on the basis of anticipation or obviousness. Additionally, certain statements in the 510(k) submission might be construed as a motivation to modify the predicate device, or an expectation that such a modification would be successful, either of which may be used in a rejection on the basis of obviousness.
To avoid the risk of such information becoming prior art, ideally, a patent application directed to a medical device should be filed before publication of the 510(k) summary. But if a medical device company finds itself in a position where it must file a patent application after the 510(k) summary is published, careful selection and preparation of the information submitted in the § 510(k) submission can help minimize the risk of the information compromising the patentability of the device after becoming publicly available.
First, when preparing a 510(k) submission, consider limiting the information in the submission to only that which is necessary to demonstrate that the device is “substantially equivalent” to the predicate device.
Second, consider selecting a predicate device with different technological characteristics than the medical device sought to be cleared. In demonstrating substantial equivalence, the predicate device can have the same or different technological characteristics. While other accompanying factors might dictate an applicant’s choice of predicate device, if possible, the predicate device should have different technological characteristics than the medical device sought to be cleared. Indeed, a showing that the medical device has the same technological characteristics as the predicate device can strengthen the argument that the device is obvious or not novel, whereas a showing that the medical device has different technological characteristics than the predicate device tends to support the argument that the medical device is novel and nonobvious.
In conclusion, when bringing medical devices to the market, inattentive compliance with the regulatory controls of the FDCA can pose risks to their patentability. Given the vital importance of patent protection and FDA authorization in the medical device industry, it is imperative for medical device companies to exercise due care in submitting information about their medical devices to the FDA, as such information may become prior art in examining a subsequently-filed patent application directed to the device. To avoid risking the patentability of a medical device by such submissions, the best practice is to file a patent application directed to the device before such submissions are made available to the public, but careful selection and preparation of the information submitted can nevertheless reduce the risk of it compromising patentability if it falls within the scope of the prior art.
This information is provided by Bailey & Company, Attorneys & Counselors, P.A. (“Bailey & Company”), solely for informational purposes. This information does not form, nor should it be construed to form, an attorney-client relationship, or any other fiduciary relationship, with Bailey & Company or any attorney, agent, or employee of Bailey & Company. For additional information about the topic of this article, contact Drew Bailey.