By Howard Dittmer Executive Vice President HLB

Those involved in the design and development of tomorrow's medical devices must take into account the intellectual property associated with their innovations. This may or may not lead to pursuit of a patent. Even though a design process won't always result in the need for or the justification of a patent, intellectual property is an important consideration for those developing tomorrow's solutions to today's needs.

There are two patents to consider: the utility patent, which recognizes and protects the mechanism, or the way something works. The other is the design patent, which recognizes and protects the appearance of the solution. If the appearance of the product is important to the accomplishment of the result, the design patent may be valuable.

Patents vs. trade secrets

During the early 1990s, the U.S. patent process came into harmony with practices around the world. Patent protection changed from 17 years from the date the patent issues to 20 years from the date of patent application. The change, coupled with a review period that can span years, has affected decisions by companies about their intellectual property. Companies need to decide if they will file for patent protection or if they will treat the intellectual property as a trade secret.

Patents, which first came into being as a teaching mechanism, a way of spreading technology developments for the benefit of a whole community of enterprises, also serve as references. In return for providing that service, the inventor enjoys a protection from imitation for a period of time. Today, the patent databases remain excellent sources of information.

When a project begins, discussion of patents can be explicit. The origin of the design effort can be a company's recognition of the benefit a competitor gains from its own intellectual property. The client needs to offer the same solution. But can the solution be accomplished in another novel way?

With that in mind, the design process often begins with existing patents. The review considers the patent protections, the features of the invention, and any apparent problems with the solution. In addition to the database of patents issued, the review includes the database of patent applications.

When a project is meant to counter and surpass the specific offering of a competitor, the design solution needs to be totally different from the competitor's patent. The creative process follows its own path, concerning itself with the solution more than avoidance of a protected idea. Ideas may be encumbered, but as they develop, the design process may begin yielding new and distinct solutions.

Details count

The design process should include recordkeeping by engineers and designers keeping notebooks with dates of activities, dates on drawings, and signatures attesting to presentation and discussion of ideas. The records provide a reference in case there is a dispute about the original inventor, resulting in a need to go to the U.S. Patent Office for a ruling. Even then, the governing matter in some jurisdictions will be “first to file.”

If the client intends to file for patent protection outside the United States, the design process has to protect absolute novelty. This evidence can be important when it comes to support of a client's patent application or to show that our invention predates a competitor's design.

Prior to filing a patent application, it is important to maintain secrecy around a potentially patentable idea. In the U.S., you have one year to file for a patent following disclosure of an idea in the absence of a non-disclosure agreement. However, in most of the world, a patent application requires “absolute novelty,” and an idea covered by a patent application may never have been previously disclosed.

Pros and cons

Most clients take on the responsibility of reviewing the patent databases and applying for protection of any important intellectual property. If a competitor's patent has come to light during a final stage of the design process, there may be a need for backpedaling and replacing the intended solution with another idea. If the new patent is one held by an owner in a tangential business, there may be value in proposing a joint leasing agreement.

When the patent application is made, the list of inventors is a critical part. Even though our contracts require the invention to be the property of the client, our names appear on the patent as inventors. The U.S. Patent Office insists on this. If a company applies for a patent and lists the inventors falsely, the company may lose all rights to its intellectual property. Putting the correct names on the application costs nothing; but listing the wrong names may cost a company everything.

The ability to patent something doesn't always justify the time, trouble, and cost. In some cases, patents don't hinder rivals as they find other ways to achieve the same solution. Or, the patent may have value for only a brief time as technology advances and new products are developed. And there are companies that simply launch a patent-infringing product after weighing the risks.

Nonetheless, when it comes to good ideas gelling into great solutions, managing intellectual property and weighing the merits of patents need to be incorporated into the design process.