Ophthalmic Innovator

Patents in the Innovation Process

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

Many physicians have ideas for new products or improvements to existing products, but it is critical for anyone with an idea for a new product or procedure to have a fundamental understanding of patents and patent laws.

Simply put, a patent is a property right. The property right is unique in that it is a negative property right — that is, a patent does not allow a patent owner to make, use or sell the patented subject matter. Rather, the patent property right allows a patent owner to exclude others from making, using or selling the patented subject matter.

For example, a first hypothetical inventor may own the patent rights to a bicycle and a second hypothetical inventor may own the patent rights to a bicycle with a horn. In this illustration, the second inventor may be prohibited from making, using or selling the bicycle with a horn without a license to the bicycle from the first inventor. However, the first inventor may be prohibited from adding a horn to a bicycle without a license from the second inventor of the bicycle with a horn.

Who Owns the Patent Property Right?

If no agreements exist to contractually assign ownership of a patent before an invention is conceived, then each inventor owns 100% of the patent property right. Unfortunately, this allows a third-party that may have contributed a relatively small amount to the overall invention — an engineer, for example — to own as much of the property right as the primary inventor.

Accordingly, the physician inventor must ensure that agreements are in place to assign ownership appropriately. In many circumstances, patent ownership assignment may not be within a physician’s discretion to determine. This is the case if a university, hospital or even a surgical device company employs the physician. These entities often have ownership agreements in place and may be unwilling to negotiate ownership, even for revolutionary inventions. Regardless, patent ownership is an important factor for a physician inventor to consider when selecting a mechanism for developing an idea.

Exterior of the United States Patent and Trademark Office in Washington, DC, and the office seal.

How Does an Idea Get Patented?

After an invention is conceived, the process of obtaining a patent for the invention begins with the drafting and filing of a patent application. This application includes a description of the invention and claims that describe the specific aspects of an idea that an inventor believes to be the essence of the invention.

Patent attorneys or patent agents usually prepare the applications. A patent agent has an accredited technical background and is licensed to file and prosecute patent applications at a patent examining agency. A patent attorney is a patent agent who is also a licensed attorney. A database of US patent attorneys and agents is available at https://oedci.uspto.gov/OEDCI/.

The Patent Examiner’s Role

After the examining agency receives a patent application, it will assign it to a patent examiner for review. Patent examiners search technical databases to identify whether the claimed invention is novel and not obvious.

The patent examination process is slow and expensive. It can often cost more than $10,000 and can take years for an application to result in an issued patent. It is important for an inventor to actively participate in the patent examination process to ensure that the patent eventually issues with strong claims that cover the actual invention. If an inventor fails to actively participate in the process, then the agency could issue the patent with claims that cover only a portion of the invention or do not cover the invention at all.

Loss of the Property Rights

In some cases, an inventor may lose the ability to seek patent rights if a patent application is not filed before an invention is made publicly available or publicly disclosed. Thus, patent applications should be filed as quickly as possible.

What constitutes a public disclosure? Any disclosure of the invention to a party without a legal duty to keep it confidential may constitute a public disclosure. For example, describing an invention in a presentation at a trade show is probably a public disclosure.

One method of avoiding an unintentional public disclosure is the use of non-disclosure agreements — agreements between two or more parties to keep certain information confidential. For example, describing an invention in a presentation to a company under a non-disclosure agreement is not a public disclosure. An example non-disclosure agreement is available at www.katalystsurgical.com/oin/NDA_example.pdf

What Type of Patent to Pursue

Two common types of patents exist:

■ Design patents protect novel visual characteristics of a product. The subject matter of a design patent may relate to the configuration, shape, or surface ornamentation of a product. Additionally, a qualified design is inseparable from the article to which it is applied, and cannot exist alone merely as a scheme of ornamentation. For example, a novel surgical instrument handle grip design may be eligible for design patent protection.

■ Utility patents protect novel processes/methods and devices/machines. For example, a novel surgical instrument handle may be eligible for utility patent protection. Additionally, a novel method of manufacturing a surgical instrument handle may be eligible for a utility patent. Most countries do not allow a novel surgical method to be patentable. However, if a novel surgical method must be performed with a novel surgical instrument, then most countries consider the instrument itself patentable.

Coming Next

Patents and patent rights are an important issue that every physician inventor should understand and address during commercialization of new products. Subsequent installments of this series will address commercialization of inventions with different entities and in academic environments. The next installment will address issues involved with commercializing an invention in a university environment. OM

From top: 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, Tenn. He is a consultant to Bausch + Lomb, Katalyst Surgical, Notal Vision, Synergetics and Volk. His e-mail is carlawh@gmail.com. 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. His e-mail is michaelkorenfeld@hotmail.com. Kevin P. Rollins, JD, is a patent attorney who has represented clients ranging from independent physician inventors to Fortune 500 Companies.