Collaborative Work: Identifying Each Party's Inventive Contributions
As medical technology is multidisciplinary, medical technology companies frequently collaborate with outside entities such as research institutions or other technology companies. For example, researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University teamed up with ReWalk Robotics Ltd. to design and market soft robotic exosuits having compact actuators for individuals with mildly or moderately impaired movement ability. (10) Such collaborative arrangements typically include intellectual property licenses, funding agreements, and joint development agreements. These agreements (or contracts) serve to define each party's role in the collaborative project and to identify the relevant pre-collaboration intellectual property owned by each party. In this context, three intellectual property considerations should be addressed: inventorship, ownership, and sharing of information.
Inventorship is determined by the “claims” of a patent application, so that any individual who has contributed to the complete mental conception of the subject matter of any claim needs to be named as an inventor. Simply taking part in the reduction to practice of the invention does not make an individual an inventor. However, the conception must be complete so that any person skilled in the art would be able to reduce the invention to practice using no more than routine experimentation. Joint inventorship occurs when the ideas of two or more individuals are combined to form the invention. Per statute, inventors may apply for a patent jointly even though (1) they did not physically work together or at the same time, (2) each did not make the same type or amount of contribution, or (3) each did not make a contribution to the subject matter of every claim of the patent.
An assessment of inventorship should be completed before any patent application is filed to mitigate issues over patent rights. In addition, if, during the course of developing a product for commercial release, there is an improvement that is not described in a previously filed patent application or patent, a new patent application can be filed on the improvement. This can be critical because, often, it may be the improvement that is the most important or only intellectual property that ultimately can be protected.
Understanding Who Owns the Intellectual Property
Under U.S. law, an inventor owns the rights in a patentable invention until the inventor transfers ownership to another party. Although employment circumstances may result in ownership by an employer, it is best that a company have employees assign their rights in future inventions to the company when they become employees. Otherwise, if a patent is found to be owned by an inventor, the inventor can independently license or assign her rights and collect proceeds from any license or assignment without accounting to the company or other inventors named on the patent. Even if the inventor had agreed to assign the rights under an employment agreement with the company, failure to actually assign those rights and have the assignment recorded in the U.S. Patent and Trademark Office may enable the inventor to assign the rights to a third party. This may result in a breach of the employment contract but leave intact an inventor's actual assignment of rights to a third party. Preferably, the language of an employment agreement will make present assignments of future inventions, e.g., by specifying that the employee “hereby assigns his or her rights” in any invention conceived while employed.
In collaborative work, patent applications and patents may be jointly owned among multiple parties. Assignments of rights by inventors having obligations to assign their rights to two different companies will cause the resulting patent application or patent to be jointly owned by both companies. Certain consequences of joint ownership should be understood when entering into collaboration agreements. Absent agreement to the contrary, a joint owner of a patent may make, use, sell, or license the patented invention without consent of and without accounting to any other joint owner. In addition, under U.S. law, all joint owners of a patent must be joined as parties to a suit for infringement. Agreements underpinning collaborative work arrangements can be drafted, or amended, to address the issues.
Identifying Intellectual Property and Sharing of Information
Several different types of agreements are often associated with intellectual property of medical technology companies. A nondisclosure agreement (NDA) can be an important tool in protecting confidential information from being disclosed to the public before any inventions have been filed as patent applications. An NDA is a written agreement to keep confidential the information to be shared. Often, parties enter into an NDA before negotiating the collaboration agreement, to allow confidential sharing of know-how and technology while working out the agreement. Regardless of any confidentiality agreement, it is recommended that a patent application be filed before disclosing a pre-collaboration invention to another party. In this way, the intellectual property can be identified in a listing of patents and patent applications at the outset of the collaboration, and the filing date of the listed patent or patent application will help prove prior possession of the subject matter disclosed therein.
Patents and patent applications can be licensed on an exclusive or nonexclusive basis. An “exclusive” license generally means that there is only a single licensee. A “nonexclusive” license implies multiple, or an open-ended number of, possible licensees. Both types of licenses are useful for medical technology companies, and further explanation of licenses is beyond the scope of this article.
The coming years promise to deliver many exciting developments in the field of medical robotics, particularly as the level of sophistication of human-robotic interfaces continues to grow and as the availability of new sensors, actuators, and control systems for rehabilitative and prosthetic robotics continues to expand. As researchers and institutions continue to develop in this space, they should be mindful of seeking protection for their intellectual property throughout the course of development of new products and throughout collaborative efforts.
This article was written by Kristen K. Salvaggio, Associate, and Alexander Adam, Associate, at Hamilton Brook Smith Reynolds. Boston, MA. For more information, Click Here.