Thank you for sharing!

Your article was successfully shared with the contacts you provided.
When the U.S. Patent and Trademark Office abandoned its 1995 Utility Examination Guidelines in January 2001, it radically reinterpreted case law to accommodate the viewpoint that human genes should not be patented. Health advocacy groups, including the National Institutes of Health, had lobbied the patent office vigorously for the change. And since the new guidelines have issued, the patent office has aggressively used the guidelines to reject biotechnology patent applications. The new guidelines changed the concept of patent utility. Now utilities asserted in the patent application specification must be credible, specific and substantial. Neither the new “specificity” requirement nor the newly invigorated “substantiality” requirement is legally sound. But the patent office’s greatest vulnerability on the utility issue may lie in its use of the 2001 standards to disproportionately reject biotechnology inventions. In its 1995 guidelines, the patent office required that an applicant assert with specificity why an invention is useful. In its 2001 guidelines, the patent office focused on the utility asserted, rather than the assertion of utility. It is no longer sufficient to describe a utility that is applicable to a broad class of invention. Now applicants are required to show how a specific utility is related to the subject matter. This revision is logically unsupportable and probably legally unsupportable, too. It is difficult to imagine an invention whose usefulness is not, on some level, shared by other methods or compositions. Indeed, a primary organizing principle underlying the patent office’s classification system is that various classes share a common utility: All inventions classified within class 002 (apparel) share the utility of serving as garments, and all inventions that are classified within class 005 (beds) share the utility of providing a platform for sleep. Although the guidelines do not explicitly require a unique utility, the guidelines are unclear about how specific a utility must be. Even if uniqueness of utility is not required, the guidelines don’t say how many other inventions can share a specific utility. The patent office’s construction of “substantial” utility is just as flawed. The U.S. Supreme Court defined substantial utility in 1966 in Brenner v. Manson as a “specific benefit … in currently available form.” The patent applicant in Brenner argued that a method for synthesizing steroids was useful because synthetic steroids were needed for further study. The Court disagreed, holding that any compound “whose sole ‘utility’ consists of its potential role as an object of use-testing” lacks patentable utility. The patent office relies on Brenner to underpin the substantial utility leg of its 2001 guidelines. The patent office asserts that if a cloned gene’s biological function is not known, then it is useful only as an object for further study. Such inventions provide no immediate benefit, lack substantial utility, and are thus unpatentable. This is not true. Cloned human genes have uses separate from their biological function. They and their fragments have become articles of commerce, available for purchase at the click of a mouse from services such as Invitrogen’s online CloneRanger service. The cloned gene’s substantial or “practical” utility, as the federal circuit calls it, is economic. Economic benefits can fully satisfy the utility requirement. In Juicy Whip v. Orange Bang (1999), for example, the Court of Appeals for the Federal Circuit held that the ability of an invention to improve sales of a mixed beverage confers utility on the invention. A year earlier, in considering the separate question of the patentability of business methods in State Street Bank & Trust Co. v. Signature Financial Group, Inc., the Federal Circuit noted that the business method at issue, a data processing system for implementing an investment structure, produces “a useful … result.” Isolated human genes and gene fragments are also routinely included as signaling components in the analytical devices known as nucleic acid microarrays. These research tools are used, in part, to monitor patterns of gene expression. Each gene newly included as a probe on such a device increases the range of gene expression that the device can detect, an immediate benefit to the research community. And to the extent that the patent office reads “substantial” to require some minimum quantum of utility, the Juicy Whip case made it clear that “the threshold of utility is not high.” In Brooktree Corp. v. Advanced Micro Devices, Inc., the Federal Circuit also said, “To violate section 101 the claimed device must be totally incapable of achieving a useful result.” The patent office’s greatest vulnerability on the utility issue, however, may lie in the unequal stringency with which it applies the guidelines. The patent office’s own press releases in 2000 and 2001 clearly, consistently, and unambiguously signal that the 2001 guidelines would be used primarily to police the patentable utility of human gene and gene-related inventions. Yet this is the very same agency that devotes two entire classes within its own classification system to “Amusement Devices,” and finds credible, specific and substantial utility in a Santa Claus detector (U.S. Pat. No. 5,523,741), and a method of exercising a cat (U.S. Pat. No. 5,443,036). Even if the patent office’s own published procedures did not mandate that the patentability standard be applied uniformly, and even if such policy were not mandated by long-established principles of federal administrative law, the patent office would nonetheless have to defend its disparate treatment of a hat simulating a fried egg (U.S. Pat. No. 5,457,821) and an isolated gene encoding a human chemokine of unproven biologic function. Cases challenging the guidelines are presently working their way through the patent office’s appeals process. If the guidelines are eventually overturned, the biotech industry may have cause to use U.S. Pat. No. 5,356,330, an “apparatus for simulating a high five.” Daniel M. Becker, M.D., works in the Palo Alto, Calif., office of Fish & Neave (www.fishneave.com), where he is of counsel. The firm represents clients challenging the patent office’s position on the patentable utility of human genes. If you are interested in submitting an article to law.com, please click here for our submission guidelines.

This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.

To view this content, please continue to their sites.

Not a Lexis Advance® Subscriber?
Subscribe Now

Not a Bloomberg Law Subscriber?
Subscribe Now

Why am I seeing this?

LexisNexis® and Bloomberg Law are third party online distributors of the broad collection of current and archived versions of ALM's legal news publications. LexisNexis® and Bloomberg Law customers are able to access and use ALM's content, including content from the National Law Journal, The American Lawyer, Legaltech News, The New York Law Journal, and Corporate Counsel, as well as other sources of legal information.

For questions call 1-877-256-2472 or contact us at [email protected]

Reprints & Licensing
Mentioned in a Law.com story?

License our industry-leading legal content to extend your thought leadership and build your brand.


ALM Legal Publication Newsletters

Sign Up Today and Never Miss Another Story.

As part of your digital membership, you can sign up for an unlimited number of a wide range of complimentary newsletters. Visit your My Account page to make your selections. Get the timely legal news and critical analysis you cannot afford to miss. Tailored just for you. In your inbox. Every day.

Copyright © 2021 ALM Media Properties, LLC. All Rights Reserved.