It is common for medical device makers to partner with doctors, universities, designers, manufacturers, R&D labs, or salespeople in the development of medical devices. To reap the intended benefits of such efforts, collaborators should consider at least three aspects of intellectual property (IP) law: disclosure, inventorship, and ownership.
Disclosure – Identify Each Party’s Pre-Collaboration IP
It is important to identify the know-how of each party before collaboration begins. This pre-collaboration IP can be identified in a collaborative agreement or contract, which may be a Joint Development, Consulting, License, or Manufacturing Agreement. How pre-collaborative IP is identified depends on the nature of the know-how. For example, medical devices may be identified with engineering drawings, whereas software could be identified using functional descriptions, flowcharts, or code.
One approach for identifying pre-collaborative IP is using patents and patent applications. A utility patent application should clearly identify the subject matter possessed, and a pre-collaboration filing date of the application can help prove prior possession.
Inventorship – Identify Each Party’s Contribution to the Developed IP
To be an inventor under U.S. patent law, conception of the invention is key. The inventor must contribute a “definite and permanent idea of the complete and operative invention” such that one of ordinary skill in the field could practice the invention. Thus, a technician or manufacturer merely reducing an idea to practice is generally not an “inventor.”
Combining ideas from multiple people results in “joint inventorship.” To qualify as a joint inventor, a person need not have contributed to every “claim” at the end of a patent. Rather, contribution to one claim is all that is required. Even when partnering with seemingly non-inventive collaborators, joint inventorship may still occur. For instance, if a manufacturer or technician alters an idea to make it work, he or she may be an inventor. However, such alterations must help distinguish the invention from the existing state of the art (i.e., more than just an existing idea or an obvious modification). The analysis is contextual. For instance, conceiving of screws to fasten parts together does not typically help make an idea patentable. But, in the context of regenerative scaffolds secured to tissue or bone, the use of a screw may qualify as an inventive contribution.
Ownership – Identify Each Party’s Ownership of the Developed IP
In the U.S., inventors are the default owners of their patentable inventions. However, employers typically require employees to assign ownership to the employer. In collaborations, assignment to another party across the table may be required. Therefore, collaborators should be alert for conflicting agreements, such as where an inventor has assigned one invention to multiple parties.
Further, inventions can be assigned before they are conceived. In collaborations, this can be good, for example, to proactively address allocation of ownership. But it can also cause problems, for example, where the scope of the assignment is not appreciated. Ownership of expected innovations may be straightforward, but ownership of unexpected spinoffs may be less obvious. Where capturing ownership is desired, assignment clauses should be broadly drafted.
If joint inventors exist on multiple sides of a collaboration, the default result is joint ownership. Any joint owner of a patent may make, use, sell, or license the patented invention without permission from or sharing profits with the other joint owner(s). Further, all joint owners of a patent must agree to sue for infringement. Additionally, an accused infringer may protect itself by securing a license from a single co-owner.
These are just some considerations to keep in mind when collaborating to develop medical devices. The assistance of legal counsel is highly recommended to address these and other important issues.