“Patenting Considerations for 3D-Printed Medical Devices”

July 13, 2020
24x7 Magazine

There has been no shortage of innovation during the COVID-19 pandemic, particularly in the product design and development of medical devices. For example, companies have developed new 3D-printed respirators, sterilizable and reusable face masks and shields, and 3D-printed ear savers (meant to reduce chafing caused by face masks).

This is expected to continue, as time restrictions and supply shortages persist and a resurgence in coronavirus cases may occur this fall. Companies may want to consider protecting their innovations with a U.S. utility patent, filing a request for prioritized examination when filing a U.S. utility patent application, and/or conducting a freedom-to-operate search and review.

Protecting Innovations with a U.S. Utility Patent

A U.S. utility patent is “a grant to the patentee…of the right to exclude others from making, using, offering for sale, or selling throughout the United States, or importing the invention into the United States.” Provided periodic maintenance fees are paid, this right to exclude extends from the date the patent was issued to the date the patent expires, but not to exceed a period of 20 years from the applicable filing date for the application in question.

To obtain a U.S. utility patent, each patent claimin a U.S. utility application must include patent eligible subject matter. Patent eligible subject matter includes a process, machine, manufacture, or a composition of matter. For innovations in medical devices using 3D-printing technologies, for example, such subject matter may include improvements to methods of operating the 3D printer and systems within the 3D printer, as well as materials used within the 3D printer to make the new medical device. Other subject matter may include the software used to direct the 3D printer to print the medical device and the 3D-printed medical devices themselves.

In addition, each patent claim must also be useful, novel, and not obvious. For example, a third-party patent disclosing the same improved 3D-printed medical device and invented before the device covered by a claim in the patent application may prevent the claim from being novel.Also, the differences between the claimed invention and one or more prior art patents or publications, for example, must not be obvious to a person having ordinary skill in the art, i.e., the technical area, to which the claimed invention pertains.

One strategy includes having claims in a single utility patent application directed to at least one of an improved 3D-printing process for the new medical device, software used to direct the 3D printer to print the medical device, and the 3D-printed new medical device, as relevant. In some circumstances, it may be helpful to conduct a patentability search to understand any third-party patents and publications related to the proposed invention before filing. The patentability search results may help both the inventor understand the potential scope of the patent protection available before proceeding and the patent drafter craft a claim strategy tailored to the same.

The subject matter of some more recently issued U.S. utility patents relating to improvements in medical devices using 3D-printing technology include methods of producing orthopedic implants, 3D-printed splints, and 3D-printed expandable spinal fusion cages, to name a few.

COVID-19 Prioritized Examination Pilot Program

Companies looking to protect a COVID-19 related innovation with a U.S. utility patent may also want to consider filing a request for prioritized examination under the new COVID-19 Prioritized Examination Pilot Program announced by the U.S. Patent and Trademark Office (USPTO) on May 8, 2020.

Under the COVID-19 Pilot Program, qualifying applications will be “advanced out of turn” in which U.S. utility patent applications typically await review. If the request is granted, the USPTO plans to issue a final disposition within 12 months of the filing date. This includes the mailing of a final office action, the mailing of a notice of allowance, or the filing of a notice of appeal.For non-prioritized applications, the first office action is not even received until about 16 months after the filing date.

However, before requesting prioritized examination under the COVID-19 Pilot Program, several requirements must be satisfied. First, the COVID-19 Pilot Program is only available to small or micro entities (e.g., companies with fewer than 500 employees or a university[1]). Second, the patent application must cover technology that is subject to an applicable FDA approval for COVID-19 use. This includes an Investigational New Drug application, an Investigational Device Exemption, a New Drug Application, a Biologics License Application, a Premarket Approval, or an Emergency Use Authorization. Third, the application cannot include more than four independent claims and 30 total claims, with no multiple dependent claims.

In addition, the USPTO will only accept 500 requests under the COVID-19 Prioritized Examination Pilot Program beginning May 14, 2020. As of June 4, there were 83 requests received by the USPTO, of which, 11 were granted. Thus, if there is an interest in filing a request under this prioritized examination program, it is best to file the request as soon as possible. The USPTO often extends other pilot programs, so it is possible that more than 500 requests will be accepted, but that is not known at this time.

Other Considerations

Even if companies do not wish to obtain U.S. utility patent protection for their innovations, it may be prudent to search and review unexpired patents relating to their innovations to reduce any risks of infringing such patents before proceeding. This search is typically referred to as a freedom-to-operate search. When conducting a freedom-to-operate search, the claims of issued, unexpired patents are analyzed to determine whether one’s product may infringe such claims. By performing a freedom-to-operate search, companies can often identify potential infringement issues before the product is released and implement any design arounds to mitigate such issues.

One consideration when conducting a freedom-to-operate search for COVID-19 related technology is that COVID-19 is not the first widespread coronavirus outbreak. The severe acute respiratory syndrome (SARS) outbreak in 2002-2003 and the Middle East respiratory syndrome (MERS) outbreak in 2012 previously led to an increase in coronavirus-related patent applications.

To this end, 145 U.S. utility patent applications filed between 2002 and 2004 have claims that recite “coronavirus” and 197 U.S. utility patent applications filed between 2012 and 2014 have claims that recite “coronavirus.” Many of these patent applications relate to methods of treating respiratory diseases and/or diagnosing respiratory diseases, including diseases associated with coronaviruses generally, and may be relevant to COVID-19 related products.

Another consideration is the 18-month delay between when an original U.S. utility patent application is filed and when the U.S. utility patent application is published by the USPTO. Accordingly, recently filed COVID-19 related U.S. utility patent applications will not yet be publicly available for review. However, there are a variety of patent tracking tools available to identify any potential concerns as new patent applications are published. For example, some monitoring services include tools that enable one to set up keyword and/or assignee-based alerts when new patent applications are published.

Companies may also want to consider protecting their innovations with a U.S. design patent. To obtain U.S. design patent protection, the design for the article must be “new, original and ornamental.” The design for an article consists of the visual characteristics embodied in or applied to an article, and the subject matter of a design patent application may relate to the configuration or shape of an article, the surface ornamentation applied to an article, or a combination of both. Thus, the U.S. design patent application may be directed to a new, ornamental design configuration, shape, or surface ornamentation of a 3D-printed medical device, for example. The term of a U.S. design patent is 15 years from the date of grant, and no maintenance fees are required for U.S. design patents.

In addition to innovations in medical devices and supplies, the current pandemic has also brought to light the need to improve our remote healthcare systems. While some types of medical care can effectively be provided via teleconferences, remote testing and treatment capabilities are expected to expand as we preserve hospital space for responding to pandemics. This includes an expansion of medical diagnostic tools that can be administered under the guidance of a remote physician and allow results to be securely sent to the diagnostic labs from the patient’s home, for example.

Another area that may see an expansion of investment and innovation is in automating and customizing the pharmacy experience via 3D drug printers. In addition to being able to customize dosages based on a patient’s attributes, printing medications may reduce the risk of exposure to pharmacists and those queueing in line.

As the world navigates the challenges and unmet needs of the COVID-19 pandemic and innovation continues, it may be worthwhile to keep the foregoing patenting considerations in mind as part of your company’s business strategy.

DISCLAIMER: The information contained in this article is for informational purposes only and is not legal advice or a substitute for obtaining legal advice from an attorney. Views expressed are those of the authors and are not to be attributed to Marshall, Gerstein & Borun LLP or any of its former, present or future clients.