OPHTHALMIC INNOVATOR

Protecting inventions in the new first-to-file system

New patent law can influence how inventors protect their intellectual property.

By Carl Awh, MD, Michael Korenfeld, MD, Kevin Rollins, JD, Gregg Scheller

	Gregg Scheller is an engineer/inventor with 90 patentable inventions. He has been in ophthalmology for 30 years and started four medical-device companies. He holds significant financial interest in Katalyst Surgical. His e-mail is gs@katalystsurgical.com.
	Carl C. Awh, MD, is a retina specialist with Tennessee Retina PC in Nashville. He is a consultant to Bausch + Lomb, Katalyst Surgical, Notal Vision, Synergetics and Volk.
	Michael Korenfeld, MD, is in private practice with Comprehensive Eye Care Ltd., of Washington, Mo. He is a consultant to Bausch + Lomb, Katalyst Surgical, and Volk.
	Kevin P. Rollins, JD, is a patent attorney whose clients range from independent physician inventors to Fortune 500 Companies.

The America Invents Act (AIA) went into effect last March and changed the way the United States awards patents, from a first-to-invent system that awarded patent rights to the earliest inventor of a new technology to a first-inventor-to-file system that grants rights to the first inventor to file an application. Although the change may seem subtle, it has several implications for inventors, and one should factor the AIA into a product commercialization strategy.

This installment of our series aims to inform inventors of the differences in US patent law resulting from the AIA.

WHAT IS DIFFERENT?

The biggest difference between the old and the new systems is the legal significance of the date of the invention. Prior to the AIA, the date an invention was conceived played a critical role in resolving disputes over whom among a multitude of independent inventors was entitled to patent rights. For example, in the rare case that separate inventors filed patent applications for the same invention, the rights to the invention were generally awarded to the first inventor to conceive the invention even if that inventor filed an application after others did so.

In the old system, the date of invention was also used to determine whether particular publications and disclosures could prevent a patent application from issuing as a patent. Specifically, an inventor could overcome patent examination rejections based on prior art made available publicly before the application filing date — that is, by establishing the invention date occurred before the prior art was publicly available.

The AIA also changed patent laws in other ways relevant to an ophthalmic innovator. These include a general increase in USPTO patent fees, creating a new entity that determines those fees, and eliminating secret pre-filing sales of the invention as an event that starts the one-year deadline to file an application or forfeit the ability to seek patent protection.

The new entity for patent fee setting is called a “micro-entity” and it entitles independent inventors to a 75% reduction in fees. More information about the new micro entity status is available at: http://www.uspto.gov/inventors/independent/eye/201302/Advice.jsp.

WINNING THE FILING RACE

The first-inventor-to-file system encourages inventors to file patent applications as quickly as possible after an invention is conceived. This incentive is particularly strong when the invention is in an area that others are developing concurrently.

Inventors and entrepreneurs should consider this new reality in the early stages of product development. New issues to address may include determining the likelihood that a third party has already filed for a patent on a similar new product and how to minimize the time period between the date of invention and the application file date. For example, it might make sense to allocate resources to file a provisional patent application before using them to develop a prototype.

Good communication with your patent counsel is essential to winning the first-inventor-to-file race. Communicate new ideas and inventions to your counsel as quickly and completely as possible and agree on a filing deadline with counsel. It is now a good idea to ask the patent attorney what you can do as an inventor to file your application quickly.

CONSIDER TRADE SECRETS

The AIA provides several incentives for an inventor to consider protecting an invention as a trade secret. For example, there was some risk for an inventor to elect to protect an invention as a trade secret; a third party could patent that trade secret and prevent the inventor from making and using the invention. The AIA reduces this risk by creating a prior user rights defense to patent infringement. Inventors may protect their intellectual property as a trade secret under three conditions:

• It is not generally known or available publicly.
• It has some economic or commercial value
• It is subject to reasonable measures to prevent the invention from becoming publicly known or available.

Protecting an invention as a trade secret is usually less expensive than protecting an invention with patents, and trade secret protection is potentially indefinite in duration, whereas patent protection is limited to 20 years.

OTHER CONSIDERATIONS

If you have a pending patent application from before AIA implementation, then it may be possible to convert it to post-AIA application by filing a continuation-in-part application. For example, if a pending application was subject to secret pre-filing sales or uses, then converting to an AIA application might eliminate the pre-filing activities as prior art. Consult patent counsel to help determine the benefits of examining a pending application under the AIA.

Many provisions of the AIA will not become entirely clear until federal courts issue rulings on litigation, a lengthy process that may take years. Additionally, other proposed legislation may further change the US patent system. Inventors and entrepreneurs should watch these developments to effectively protect their intellectual property. OM