Enzo Biochem, Inc, announced that the Board of Patent Appeals and Interferences of the United States Patent and Trademark Office has entered judgement in favour of Enzo and against Bayer HealthCare LLC in a patent interference proceeding relating to Enzo Life Science's application for nucleic acid signal amplification and Bayer's US Patent No. 5,124,246.
Subject to any requests for rehearing or appeals that Bayer might file, the effect of this judgement is that Enzo will receive a full seventeen year patent for all the inventions covered by its claims, which term will commence on the date of issuance of the patent.
"This technology is the basis for several significant products in clinical diagnostics and in the life sciences field which are currently marketed or licensed by various commercial entities," said Barry Weiner, president of Enzo.
According to trade reports, industry-wide annual sales of diagnostic products utilizing the nucleic acid signal amplification technology are estimated to exceed US$ 100 million in the United States alone.
Using Enzo's signal amplification technology, direct detection of nucleic acid can be carried out without the need for target amplification and without compromising the sensitivity of the detection assay.
Enzo developed its signal amplification technology in the early 1980s, filing its original patent application on May 5, 1983. The Patent Office granted a patent to Chiron Corporation (later acquired by Bayer Healthcare) in 1992, although Chiron's application was originally filed on October 15, 1987, nearly four and one-half years after Enzo's original filing date. An interference proceeding was declared by the Patent Office on August 7, 2006 to determine, as between Enzo and Bayer Healthcare, who made the invention first. The Diagnostics Division of Bayer HealthCare, which has since been acquired by Siemens Medical Solutions, produces the "Versant Branched DNA (bDNA) Assays" that utilizes the technology whose claim has now been resolved in Enzo's favour by the interference judgement.
Enzo Biochem is a growth-oriented integrated life sciences and biotechnology company focused on harnessing biological process to develop research tools, diagnostics and therapeutics, and serves as a provider of test services, including exotic tests, to the medical community.