Medical Device Link.

Originally Published IVD Technology July 2004

INDUSTRY NEWS

Ever since the sequencing of the human genome was completed, the issue of granting patents and licenses for genomic technologies has been a source of debate and controversy. This debate continues even today. A government official stated in a recent talk that any commercial benefits generated from genomic inventions should be balanced with public health concerns.

At the annual meeting of the Association of University Technology Managers (Northbrook, IL), Jack Spiegel, PhD, a senior advisor for technology transfer operations in the Office of Technology Transfer at the National Institutes of Health (NIH; Bethesda, MD), gave a presentation on “Best Practices for Licensing of Genomic Inventions.” In his presentation, he spoke about principles that academic institutions receiving government grants should consider when deciding how to license their genomic technologies. At the meeting, Spiegel also distributed a draft document that describes and outlines such principles.

“The licensing of genomic technologies presents a formidable challenge for academic and government technology transfer programs,” says the NIH draft. “This follows from the complexities in bringing such technologies to the marketplace in a manner that maximizes the benefits to the public.” 

According to the draft, examples of genomic inventions include genetic technologies and materials (e.g., cDNAs, expressed sequence tags, haplotypes, antisense molecules, small interfering RNAs, and full-length genes and their expression products), as well as methods and instruments for sequencing genomes, quantifying the amount of nucleic acid molecules, and detecting single nucleotide polymorphisms (SNPs) and other genetic modifications. Companies have primarily used genomic technologies for developing nucleic acid–based diagnostics, potential gene therapy applications, and new DNA- and RNA-based therapeutics. 

The draft states that universities have granted exclusive licenses for several cancer-susceptibility genes to IVD companies during the past few years. The ability to secure an exclusive license on all types of diagnostic kits for testing particular mutations in a common cancersusceptibility gene is an attractive business prospect for IVD companies. However, such exclusive arrangements may not be in the best interests of public health.

“Anecdotal and empirical data are beginning to reveal a pattern of exclusive licensing practices for genomic technologies at U.S. academic and nonprofit institutions that could have detrimental short-term and long-term effects on both the quantity and quality of healthcare products and services,” says the draft.

The draft adds that without a variety of other tests on the market, patients, clinicians, and hospitals have no other choice but to purchase tests developed by an exclusive licensee. Consequently, public health may suffer if the only available test is not as good as it could have been with other competing products on the market.

“Absent the freedom to operate in the field of diagnostics, no other companies would have the option to try to develop better, cheaper, and more-accurate tests,” says the draft. “Choice among competing products is a time-tested warranty of quality.”

In the draft, NIH recommends that universities “seek patent protection for inventions that require significant further research and development by the private sector in order to reach practical and commercial applications.” NIH also suggests nonexclusive licenses for “background rights,” “broad enabling technologies,” and “research use.”

When granting exclusive licenses for genomic technologies, NIH recommends that academic institutions should “ensure expeditious development” of the genomic invention by using milestones and benchmarks, performance-based royalty payments, and sublicensing rights to the licensee. Such exclusive licenses should also address public health needs, and should “protect research uses; seek a fair return on the public investment; recognize public health goals; and enhance public access and availability.”

“Like other emerging technology areas, genomic inventions tend to enjoy broad patent protections,” says the draft. “It is a challenge to the public health–oriented technology transfer process to balance the rewards of broad intellectual property protection afforded to founders of enabling genomic inventions with the benefits of fostering opportunities to those striving to improve upon those innovations.”

For more information about NIH’s Office of Technology Transfer, visit the office’s Web site at http://ott.od.nih.gov. 

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