Top 3 Reasons Why Regenerative Medicine Startups Should File Provisional Patent Applications

Regenerative medicine startups and growing enterprises, as well as other life sciences and technology companies, that are developing novel technologies, should know that every patent system in the world is a first-to-file system. This means that the inventor who files a patent application on a particular technology before another inventor has the first right to the grant of a patent. It is therefore important for innovative companies, such as those developing methods for regenerating tissue, bioprinting systems, and materials, stem cell-based therapies and treatments, and other state-of-the-art technologies in the field of regenerative medicine, to think about filing a patent application on the technology as early as possible, and a provisional patent application filed in the United States is often the perfect vehicle to do so.  Australia, Austria, and France also have provisional patent applications.

Patent Prosecution Overview

To understand the benefits of a provisional application, here’s a broad overview.

The first step in obtaining a patent is the conception and reduction to practice of your invention, which does not require a working model or system. Rather, demonstrating the concept can be shown to work through detailed drawings, formulas, and the like. Next, a patentability search of prior art references is highly recommended, as a search allows the patent drafter to write an application that best defines the invention over the prior art, speeds up prosecution by preempting rejections, and improves the application’s defensibility. See my previous article titled “The importance of Patent Search for Regenerative Medicine Inventions,” If the patent search results demonstrate the likelihood that the technology is patentable, a patent application will then be filed as either a provisional patent application or a non-provisional patent application. A provisional application is considered a “placeholder” that will allow a non-provisional application to claim priority if filed within one year.

Benefit No. 1: Obtaining an Earlier Filing Date

Obtaining an early filing date is pivotal in patent prosecution because it prevents a patent examiner from citing references published between the provisional filing date and the non-provisional filing date. Such references, if applicable, may alter the protectable scope of your filing or potentially prevent your application from maturing into a patent. Since the non-provisional application will have the benefit of the provisional application’s filing date, the applicant may rely on the earlier date to prevent those cited references from being used against the application.

A provisional application can be filed when there is sufficient information on the technology being developed. Additional provisional applications can be filed after the initial filing to further describe current or new inventive features, and different aspects of the invention, or provide data.

Within one year of filing, the provisional application must be converted to a non-provisional application and/or a PCT application to maintain priority rights. The non-provisional and/or PCT application will claim priority to the initially filed provisional application, along with any other provisional applications that were filed within one year. The PCT application will enable you to file the non-provisional patent application in many countries and jurisdictions, such as Europe, at a much later time.

For this reason, it is important to include as much information known at the time of preparing the provisional application to ensure that the invention is adequately described. The applicant cannot rely on the earlier filing date of the provisional application to antedate a cited reference for a particular inventive feature if that inventive feature was not described in the provisional application.

Benefit No. 2: Early Patent Pending Status for Investors

The earlier you file, the earlier your technology will be granted the status of “patent pending.” This status is highly attractive for prospective investors of startups and emerging regenerative medicine companies since it demonstrates that you believe your technology is novel and that you took the initiative to file a patent application. Additionally, the provisional application can be used to explain your technology to the investors under a confidentiality agreement.

Benefit No. 3: More Time for Critical Business Decisions

Even if you decide not to convert your provisional application to a non-provisional and/or PCT application, the former will not be published or examined. Therefore, even if you believe your technology can be kept as a trade secret, it is advisable to file a provisional application to decide at a later time if converting to a non-provisional application is the best course of protection. Moreover, if you do convert to a non-provisional application, and have no plans to seek patent protection in countries other than the United States, you can instruct the United States Patent and Trademark Office to not publish your non-provisional application until it is issued as a patent.

Additionally, filing a provisional application allows your team to have an early discussion about your developing technology with a patent attorney. The patent attorney’s understanding of the technology is critical to performing a thorough patent search to find references that may be relevant or similar to the technology you are developing. Finding damaging references prior to prosecution will save your company thousands of dollars in fees and wasted years of waiting for an avoidable rejection. Moreover, finding damaging references early will buy time to change the course of technology development if the attorney determines the reference will bar the technology from patent eligibility.

Provisional patent applications are an essential tool for protecting your startup’s technology at the early stages. Besides the top three points above, provisional applications further provide comparatively lost costs to first-time non-provisional filings, time and cost savings to avoid semantic or formal patent office rejections, and more.

A resource you can consider in conducting your patentability study preparing and filing your provisional application, and performing other intellectual property services, is the intellectual property law firm of Carter, DeLuca & Farrell.  The firm provides guidance and representation to companies as they build and expand their intellectual property portfolios.

About the Author:

George Likourezos is a patent attorney and a partner at Carter, DeLuca & Farrell LLP. He represents inventors, startups, mid-size businesses, and Fortune 100 companies in developing strategic patent portfolios to protect their innovations and technologies in the US and worldwide. He also helps companies protect their logos, trademarks, and brands. George can be reached at or at 631-501-5706 for a free IP consultation with the 3DHEALS community.

Related Links:

Importance of Patent Search for Regenerative Medicine Inventions

3D Bioprinting and Biologics: A Look at Patent and FDA Market Exclusivity Strategies

Interview with Roger Kuan, Intellectual Property Concern for Healthcare 3D Printing

Segmentation: The Real Struggles Behind Converting DICOM to Patient-specific 3D Printable Models

The Legal Landscape in Healthcare 3D Printing (On-demand recording, 2021)

Guide: 3D Printed Stents