Understanding the Patents and Licensing Process at the Medical College of Wisconsin

A patent is a grant of intellectual property rights related to an invention or owner by assignment of those intellectual property rights. Patents are granted by the United States Patent and Trademark Office (USPTO) or its counterpart in other countries/jurisdictions. Patents have a term of approximately 20 years. The right conferred by the USPTO is “the right to exclude others from making, using, offering for sale, or selling” the Invention (and products that are claimed in the published patent document) in the United States or “importing” the Invention into the United States. What is not granted are rights to make, use, offer for sale, sell or import the Invention or products. For example, consider the situation where a patent is granted on the use of an existing drug to treat a disease. The owner of the use patent could prevent others from offering for sale or selling the drug for that use. However, if someone else has a patent on the drug itself, including chemical structure, etc., the owner of this “composition of matter” patent could prevent the owner of the use patent from making the drug, hence blocking the use patent. So having a patent does not necessarily provide all the rights needed to commercialize the invention.

Not all inventions are patentable. A patentable invention must be:

NOVEL: The novelty requirement means that the invention must be new and cannot have been publicly known. Public disclosure of the invention has a negative effect on the patentability of an invention. You are advised to contact the Office of Technology Development to avoid inadvertent loss of patent rights due to public disclosure.

USEFUL: The invention must have at least one specific use.

NON-OBVIOUS: The U.S. Patent and Trademark Office says: “The subject matter sought to be patented must be sufficiently different from what has been used or described before that it may be said to be non-obvious to a person having ordinary skill in the area of technology related to the invention.

Naturally-occurring, unmodified molecules, such as:

• Proteins
• Genes
• RNA structures
• Drug targets
• Metabolic intermediates
• Drug metabolites

Following disclosure, inventions undergo an evaluation process that is designed to be a surrogate for industry, leveraging both internal and external expertise early in the development process. The OTD objectively and transparently reviews technologies, makes informed and timely decisions, and provides multiple opportunities for communication with inventors during the entire process.

First, inventions are evaluated internally by the OTD through consultation, disclosure, and review. This preliminary evaluation helps outline the invention in terms of what the product is, commercialization strategy, proof of concept and needed patent(s), as well as identifying potential barriers.

The OTD works in consult with industry leaders, scientists, technology sector experts, clinicians, investors, and business professionals to consider whether an invention has an addressable market, whether additional research and development is needed, what the IP landscape looks like, the quality of the science behind the concept, available funding and resources, and inventor commitment.

Inventions are also reviewed by MCW senior leadership to ensure proper budgets and resources are in place, and that the invention will provide an appropriate return on investment.

The OTD will be present to answer questions, make recommendations, and help inventors navigate every stage of the patent process.