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Patent Considerations in Drug Development Agreements: 2012 and Beyond

January 1, 2012

Intellectual properties and issues relating to their ownership and transfer have been pointed to as significant impediments to the collaborative development of drugs. With new laws changing the definition of what may be patented and what will be considered prior art, it is now more important than ever that those involved with collaborative research agreements have a clear understanding of the patent considerations. In addition, although new model agreements, such as the “express license,” are noble attempts to simplify the process, they may produce non-optimal results with respect to how collaboratively developed patents are owned and prosecuted, and how developers are compensated.

Patent Ownership and Control of Patent Prosecution

Collaborative research agreements commonly direct that resulting patents are owned by the party, who makes the invention. In other words, if the employee of a party to the agreement is listed as an inventor on a patent, that party is an owner of that patent. This arrangement may be complicates by the fact that inventorship is a legal determination, which is made on a claim by claim basis. For certain claims, there may be more than one inventors. And for certain patents, there may be different inventors for different claims. As each patent owner may make, use, offer to sell or sell the patented invention within the United States, or import the patented invention into the United States without the consent of and without accounting to the other owners, ownership by inventorship can produce uncertain results.

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