In a series of upcoming articles, I’d like to recall and share some of my experiences as a dental product developer since 1987 and some basics about how our own product development process works at Practicon, Inc. Free advice is worth the cost, but maybe something herein will help someone who is equally excited about an idea for a better “mouth” trap.

In previous Practivations articles, we have explored Intellectual Property (IP) in some detail, including Non-Disclosure Agreements (NDAs), the IP “filter,” and how Practicon approaches patent justification. The decision to patent something is an expensive, multi-year commitment requiring knowledge and communication skills bordering on a second language, as anyone who has ever read a utility patent would agree. I have recommended seeking the guidance and advice of a competent patent attorney along the way to make sure all Ts are crossed. Then, there is the benefit of having experienced legal support if one ever faces a case of infringement. All this to say that worthwhile IP, and its procurement, is best left to professionals.

A good example of the value of a patent attorney is in trying to understand the difference between First-to-File and First-to-Invent when it comes to establishing a US patent priority date. If you have never heard of this, I kindly rest my case. This shift in patent law came about over a decade ago, but still leaves many of us inventors scratching our heads. Is it really as simple as “first come, first served”? I have asked our patent attorney, Ryan Simmons with Ward & Smith, P.A., to help us all understand this distinction a little better since it affects everyone seeking to legally protect an idea. Here is Ryan:

First-to-File: A Game-Changer in US Patent Law

The United States patent system underwent a significant change with the enactment of the First-Inventor-to-File (FITF) provision of the America Invents Act, which became effective on March 16, 2013. The FITF provision transitioned the US from a First-to-Invent system to a First-Inventor-to-File system (aka First-to-File), and has had a profound impact on inventors, determination of patent ownership, and the patent process.

First-to-Invent
Prior to implementation of the FITF provision, First-to-Invent was the standard in the United States. Under First-to-Invent, the patent (assuming a device was patentable) was awarded to the inventor who could prove he/she was the first to conceive and develop the invention, regardless of who filed the patent application first. For example, if two inventors independently conceived the same invention, the one who could prove prior inventorship would be awarded the patent, even if he/she filed later. The second inventor to file would have to prove that he/she was the first to invent and did not unduly delay filing. Thus, the First-to-Invent system required inventors to maintain records of their invention process, including dates, sketches, and witness testimonies, in order to establish their priority in case of a dispute.

First-to-File
The First-to-File system which is now used in the United States and most other countries, awards the patent to the first inventor who files a patent application, regardless of who actually invented a device first. In the example above, the inventor who filed his/her patent application first would have priority, regardless of who invented it first chronologically. Since there is no burden on the first filer to prove the date of his/her idea conception, this First-to-File system improves speed and efficiency in the patent process. The USPTO (US Patent and Trademark Office) can process applications with fewer complications. Plus, the FITF provision better aligns with international patent practices, making it easier for US inventors to obtain patent protection in foreign jurisdictions.

Advantages and Disadvantages
Both systems have their advantages and disadvantages.

The First-to-Invent system was seen as more equitable to individual inventors and small businesses who may not have had the resources to file a patent application as quickly as larger companies. Larger entities might have the funds to file a patent before an individual inventor or small business could justify or afford the expense. Under First-to-Invent, the actual filing date was irrelevant, giving the smaller entity a better chance at controlling the IP. However, First-to-Invent often led to complex and costly legal battles to determine inventorship, possibly negating the fairness factor.

The First-to-File system is simpler and more predictable, reducing legal disputes and promoting faster dissemination of knowledge and ideas. However, it can disadvantage individual inventors and small businesses who may need more time and resources to develop their invention and/or file a patent application. A better-financed party, who honestly conceived of the invention independently but later than the original inventor, could file a patent application earlier than the first inventor and control the IP.

The FITF provision does provide for some exceptions. For example, if a later filer can prove that an earlier filer derived the claimed invention from him/her without authorization, the later filer can establish priority through a “derivation” proceeding. This is basically a trial or appeal to determine whether an invention was improperly derived from another, but the evidence must be substantial with a high burden of proof. Due to the difficulty of proving derivation, these proceedings are rare and considered to be a last resort compared to regular patent challenges such as interferences or post-grant reviews.

Implications of the Change
The shift to First-to-File has had several implications for inventors and the patent system. FITF has placed much greater emphasis on patent filing strategies. Inventors must now act quickly to file a patent application as soon as they have a viable invention. Consequently, this has led to an influx of application filings, especially initially, which caused increased patent backlogs and delays in the examination process. Beneficially, the change has encouraged greater international harmonization of patent law as most other countries already used the First-to-File system.

Conclusion
The shift from First-to-Invent to First-to-File was a significant change in the United States patent system. While the new system offers greater clarity and efficiency, it also places a greater emphasis on speed and strategic patent filing. To adapt to this system, inventors need to be more proactive in protecting their intellectual property; they will want to consider filing on key inventions as soon as possible. Inventors may want to consider utilizing provisional patent applications, which offer a quicker, less expensive, and less formal way to establish an early filing date (i.e., priority date) and give inventors an additional 12 months to file a full formal, non-provisional patent application.

Thanks again to our attorney, Ryan Simmons, for his clarification on the First-to-File provision. Under FITF, it sounds like procrastination on patent matters could lead to lost opportunity, if an idea is patent-worthy AND happens to be under development by two inventors at the same time. I have never run into this exact situation within my dental experience, but out of an abundance of caution, with your best ideas, it is probably wise to go ahead and “take a number.”

See our Practivations Dental Product Development Blog at www.practicon.com/blog.

Next up: Practivations Article 10: Practicon Product Development Case Studies—Part 1

Practicon was founded in 1982 with a vision of advancing dental health and increasing practice success through improving patient education. Building on a mission to Make Dentistry Better, we have grown to become a trusted developer and marketer of “Practical Innovations” that provide effective solutions for common problems, sold alongside a growing line of brand-name supplies. Customers describe Practicon’s products as creative, unique, and hard-to-find, many inspired or designed by dental professionals looking to Make Dentistry Better. Our product development mission is to develop exciting products that are relevant and useful in everyday practice—or in short, practical innovations.