Rob Lindberg, Ph.D., R.A.C., is the Center's BATON Director. He holds a Ph.D. in Physiology and Biophysics. His specialty is microvascular physiology, with emphasis in endothelial function in inflammation, thrombosis and cancer.
Full Biography.
By Rob Lindberg, Ph.D., North Carolina Biotechnology Center
Editor's Note: The following is one of a series of columns by Rob Lindberg, Ph.D. Rob directs the Center's Business Acceleration and Technology Out-licensing Network (BATON) program, designed to link university technologies with necessary commercialization resources in the community.
Intellectual property (IP) refers to ideas, creations, inventions and the legal protection of ownership on the part of the creator. Federal legal protection for inventions dates back to the U.S. Constitution — it was intended to provide incentive for the generation of novel creations by establishing, for the creator, sole ownership and rights to practice the invention.
IP exists in the form of patents, trademarks, copyrights and trade secrets. In the biotechnology world, patents and trade secrets are the dominant forms of IP. The protection of trade secrets is the responsibility of the inventor (for example , the recipes for Coca-Cola or “the Colonel’s secret eleven herbs and spices”). Patents, on the other hand, are protected under federal law upon issuance. Technically, patents do not grant permission to the inventor to pursue the commercialization of the invention, but rather, exclude others from practicing the invention for the life of the patent.
Claims of invention made in biotechnology-related patents are typically associated with: 1.) Composition of Matter (COM), 2.) field of use or 3.) method of production. Generally, COM patents represent the strongest business asset associated with an invention, because (a) infringements are easier to monitor (“police”), and (b) holders of subsequent use or methods patents often must first gain license to the related COM patents. However, patents pertaining to COM are not always possible, particularly for naturally occurring biological molecules or commonly known natural products with historical anecdotal benefits.
The keys to determine patentability of an invention are the concepts of novelty, usefulness and non-obviousness. A primary task of a U.S. Patent and Trademark Office (USPTO) patent examiner is to determine that the key elements of an invention are not already commonly known, claimed by an existing patent (“prior art”) or easily deduced by anyone “reasonably skilled in the art.”
The priority date is the date of the earliest patent filing for an invention. In Europe, priority date is used to resolve disputes in the event that several inventors claim ownership to an invention. In the U.S., patent holder preference is given to the inventor claiming the earlier date of conception of the invention. Therefore, documentation of studies leading to the invention (e.g., lab notebooks) is critical for filings with the USPTO. For this reason, university technology transfer offices (TTOs – see Technology Transfer Primer) and corporate intellectual property review committees are adamant the inventors disclose their inventions immediately so that proper documentation procedures can be invoked to substantiate the date of invention.
U.S. patents typically require significant iterative dialog with the USPTO over the course of months or years before issuance - a regular U.S. patent often takes 3-5 years to issue - at a cost of $25,000 – $30,000 in filing costs and legal fees. These costs may skyrocket to $100,000 – $200,000 for international coverage that provides protection in the most commercially dominant markets (United States, Europe, Japan, Canada, and others). Regular U.S. patents provide protection for a period of 20 years from the filing date.
In the United States, universities and resource-constrained companies often file inexpensive preliminary patents (provisional patents) in advance of more detailed, rigorous (and expensive) regular U.S. or international Patent Cooperation Treaty (PCT) patents. Unlike a full patent, a provisional patent can be rapidly filed with minimal supporting data or exploration of the prior art, and provides a priority date from which a subsequent full patent may “claim the benefit.” Note that the provisional application is itself never examined by the U.S. patent office, and no patent will ever issue directly from a provisional application. Further, the provisional patent is only in effect for 12 months and is disallowed if not followed by a more thorough and substantiated full patent filing within the life of the provisional patent. In the event that the provisional expires without follow up, the inventor loses the claim to the earlier priority date and may risk losing claims of novelty for the invention.
In our world of early-stage companies, solidity of IP position may be the only true asset possessed by a company, and is often a key to seeking institutional investment, co-development partnerships and licenses. Establishment of a solid IP estate confers freedom to operate (FTO) to the owner as well as constituting a significant barrier to entry to competitors. Companies often seek an FTO opinion from their patent counsels to provide some assurance that they are not infringing on patents held by others, although these opinions are just that; FTO is never really assured until prosecuted.