Medical device innovators who bring novel diagnostics, wearables, implantables, and research tools from conception to commercial reality face immense technology, regulatory, and business risks. Intellectual Property (IP) protections shield unique creations from imitators who attempt to capitalize unfairly on breakthroughs without expending the required time or investments.

When a developer discovers an invention, sometimes he/she has a choice to protect it with patents or trade secrets. Any inventions that can be easily reverse-engineered by seeing or using the product, system, or service intended to be placed in the public are not candidates for Trade Secret Protection. However, software object code, material compositions, methods of manufacturing in private confines, etc., are eligible for Trade Secret protection. Some of these innovations may also be protected with patents. Therefore, the innovator must choose how to protect the invention. Understanding the subtle differences between patent and trade secret protection allows an Innovator to maximize commercial prospects.

Patent Protections Offer Powerful Exclusivity

A patent is an agreement between the Inventor and the federal government. It may be summarized as follows. The Inventor agrees to file a patent application and disclose his/her invention with enough specificity to enable one of ‘… ordinary skill in the art to make and use the invention’ (35 U.S.C. 112). This requirement is typically referred to as the ‘Enabling Requirement’. In return, the federal government will allow the Inventor to have a 20-year monopoly on the new aspects of the invention.

Patents are conditional 20-year monopolies granted by the government in exchange for fully disclosing the innovation. By meeting the filing and successfully prosecuting a patent application meeting the Enabling Requirement, the Applicant is granted the right to stop an entity from making, using, selling, or importing into the country any system or service covered by the claims of the Applicant’s issued patent.

Patents allow the Applicant to recoup the required research and testing costs necessary to improve current medical equipment and fill previously unmet diagnostic/treatment needs. Patents also signal technical competencies attracting investors otherwise wary about backing unproven teams or minimal viable products. However, mandatory public disclosures expose roadmaps that competitors without equal scruples may leverage ‘designing around’ aspects not covered by patent wording. Still, patents remain pivotal in recovering significant investments pioneering medical products in the modern era.

Patents are only enforceable in the countries in which they issue. No patent rights exist in countries in which there are no issued patents. However, patents applications are freely published 18 months after filing. These publications can be accessed by people globally. Therefore, in countries without patents, entities are free to make and use the inventions. It is costly to file patents in multiple countries. Even the largest corporations cannot file in every country. Therefore, by filing a patent application, you are teaching the world how to make and use your invention, but you will not have the right to stop it in countries in which you do not have issued patents.

Trade Secret Laws Protect Undisclosed Advantages

In contrast, there are no publication requirements for Trade Secrets.

Essentially, the requirements for a Trade Secret are that the information must not be publicly known, has value, and is kept confidential. As indicated above, certain types of inventions cannot be easily reverse-engineered.

These include circuitry embedded in a chip, executable object code, the chemical makeup of a substance, specifications, and secret machine or computer configurations used in the manufacture of a product or providing a service, among others.

These Trade Secrets are enforceable if they are kept secret.

In certain cases, they can be sold as products without being considered ‘published’ if the invention is not disclosed by viewing or using a product. For example, selling a silicon chip with an innovative circuit will not be considered a publication, and the Trade Secret will remain enforceable.

The federal Defend Trade Secrets Act (DTSA) upholds rights for organizations that maintain advantageous techniques that are confidential within inner circles (bound by non-disclosure agreements). By describing each trade Secret in a file, providing an identifier for each (such as a Docket Number), restricting access to them (physically or electronically), and keeping a log of who has seen each Trade Secret, medical innovators can make them protectable and preserve their Trade Secret rights.

Balancing Protections Maximizes Outcomes

Savvy medical innovators weigh the merits between public patenting to temporarily exclude free-ridership against perpetuating trade secrecy allowing longer-lasting internal edge retention absent written externally accessible confirmations relinquishing obscurity around potentially patentable processes. Hybrid approaches with segmented protections across production chains and product generations enable sustained market positions.

Often, no single legal framework proves superior. Companies combine short-duration utility patent claims around physical device embodiments and surgical approaches with enduring manufacturing practice protections guarding back-end craftsmanship and industrial expertise competencies. Integrating both protocols maximizes the potential to protect medical breakthroughs from imitation, sustaining deserved advantages despite competitive catching up over time.

For help with patent and trade secret strategy and for preserving your IP rights, feel free to contact Zale Law.

 

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