University Sues Makers of Heart-Healthy Cookies

In a complaint filed September 7 in the Western District of Wisconsin, Brandeis University joins its exclusive licensee (GFA Brands) in suing a number of cookie companies, including Keebler, Famous Amos, Nestlé's and Pillsbury for infringing its patents directed towards methods of "Increasing the HDL Level in the HDL/LDL Ratio in Human Serum by Balancing Saturated and Polyunsaturated Dietary Fatty Acids." As an example, one of the asserted claims is claim 7 of US patent 5,843,497, which recites:

7. A prepared food product, comprising a cholesterol-free fat composition suitable for human or animal ingestion for increasing the HDL concentration and the HDL/LDL concentration ratio in the blood serum, comprising one part by weight polyunsaturated fat and at least one part by weight cholesterol-free saturated fat, where said fat composition comprises linoleic acid and at least one saturated fatty acid selected from the group including lauric acid, myristic acid, and palmitic acid, said linoleic acid constituting between 15% by weight and 40% by weight of the fat in said fat composition and said saturated fatty acid constituting between 20% and 40% by weight of the fat in said fat composition.

Thanks to Docket Report (a service of Docket Navigator) for making me aware of the complaint, which is available here.

One might question the University's decision to patent and exclusively license this discovery, and then proceed to join in a lawsuit against cookie manufacturers apparently employing the fruits of university research in an attempt to make healthier cookies. In an article I published a few years ago with Josh Sarnoff entitled Recent Developments Affecting the Enforcement, Procurement and Licensing of Research Tool Patents (available here), we discussed the policy behind the Bayh-Dole Act, which was primarily intended to increase access to, and the dissemination of, federally-funded University research.

Prior to buy Bayh-Dole, there was a sense that much of the fruits of University research was essentially left sitting on the shelf, due to insufficient incentives for the investment necessary to translate basic University research into useful commercial products. In order to increase the social benefit to be derived from federally funded University research, Bayh-Dole facilitated the ability of universities to patent and license discoveries coming out of such research. But, at least to my understanding, the primary policy justification was not to simply create profit centers for Universities, but rather to permit universities to license patented technologies to companies in the private sector who might only be willing to invest in the commercialization of these technologies if there was some patent protection in place. A good example would be a potentially useful pharmaceutical compound - without a patent in place, few companies would be willing to make the substantial investment the would be required to develop and bring to market a drug based on the compound.

In recent years, there has been much criticism of the manner in which some University technology transfer offices operate, and allegations that university patenting and licensing practices at times impede rather than promote dissemination of the fruits of federally funded University research. For example, in congressional hearings held to address the alleged problem of "gene patents," much of the testimony seemed to suggest that it was University patenting and licensing processes that were more problematic than gene patents per se. In an article I published on human gene patent litigation a few years ago (available here) I found that every gene patent litigation involving genetic diagnostic testing (which is the most controversial use of gene patents) involved gene patents arising out of University research.

In 2007, the trustees of the Association of University Technology Managers (AUTM) published a white paper entitled In the Public Interest: Nine Points to Consider and Licensing University Technology. Point 2 states in part that:

When significant investment of time and resources in a technology are needed in order to achieve its broad implementation, an exclusive license often is necessary and appropriate. However, it is important that technology transfer offices be aware of the potential impact that the exclusive license might have on further research, unanticipated uses, future commercialization efforts and markets. Universities need to be mindful of the impact of granting overly broad exclusive rights and should strive to grant just those rights necessary to encourage development of the technology.

In other words, University technology transfer offices are encouraged to only grant exclusive licenses in technology when a "significant investment of time and resources in a technology are needed in order to achieve its broad implementation." To the extent the patents are licensed exclusively, the University "should strive to grant just those rights necessary to encourage development of the technology."

In this case, the patented technology does not seem to be the type that required a significant investment of time or resources in order to be implemented, as evidenced by the large number of nonlicensed cookie manufacturers who are allegedly employing the suggested "balance of saturated and polyunsaturated dietary fatty acids" in their cookies, presumably in an effort to provide safer products for consumers.

One might question whether the decision of Brandeis University to exclusively license a patent covering these healthy products was the proper decision, or even whether this might be the sort of technology that would be better left unpatented, particularly if one views the University's primary mission as generating and disseminating useful discoveries such as this.