A Diagnostics & Imaging Week

Applied Biosystems Group (Foster City, California), an Applera (Norwalk, Connecticut) business, reported that Applera has reached an agreement with Hoffmann-La Roche (Basel, Switzerland) to expand their licensing program for polymerase chain reaction (PCR) technology to incorporate enabling patents for real-time PCR and other PCR-related technology.

Thus, Applera and Roche said they have reached a settlement financial terms not disclosed of their outstanding litigation and arbitration related to contracts involving rights to PCR and real-time PCR.

Applied Biosystems will be authorized by Roche to be the sole licensor of Roche patents covering reagents and methods for practicing PCR and real-time PCR in the life science research and applied fields. In real-time PCR, the amplified DNA is detected during the PCR process instead of at the end of the amplification process.

"Real time facilitates a number of important additional applications for PCR in biological research and standardized testing, including gene expression quantitation and genotyping," said Paul Grossman, PhD, vice president, strategic planning, business development and intellectual property at Applied Biosystems.

Catherine Burzik, president of Applied Biosystems, said, "We believe licensing real-time PCR reagents and patents will enable broad commercial access to this second-generation PCR technology and will accelerate the pace of life science research . . . [W]e also expect it will generate significant income . . . that should substantially offset income lost from expiring first-generation PCR patents."

Roche and Applera also agreed to the terms of a diagnostic license to Applera under Roche's nucleic acid technology patents.

In other legalities:

Stratagene (La Jolla, California) reported that it has filed suit against Third Wave Technologies (Madison, Wisconsin), charging alleged infringement of patents covering its proprietary FullVelocity technology for the quantitative detection of nucleic acids.

Filed in the U.S. District Court for the District of Delaware, the suit seeks monetary damages as well as a permanent injunction against continued infringement by Third Wave for the sale of certain of its Invader products.

FullVelocity is a reagent system for quantitative polymerase chain reaction (PCR) and QRT-PCR that delivers specific, reproducible results with shorter run times than competing technology. FullVelocity enables users to make numerous copies of a gene, accurately and quickly, and to analyze DNA and RNA to gain an understanding of what genes do and how they are related and work together. Stratagene has four U.S. issued patents on the technology with additional patents pending.

Stratagene's life science research unit manufactures products used throughout the academic, industrial and government research sectors in fields spanning molecular biology, genomics, proteomics, drug discovery and toxicology.

Repligen (Waltham, Massachusetts) reported that it has resolved its dispute with an unnamed former licensor of SecreFlo, a diagnostic form of secretin. Repligen will receive a payment of $750,000 and will continue to market SecreFlo "for the next several years" under a royalty structure.

Repligen terminated its 1999 SecreFlo licensing agreement in early 2004, alleging that the licensor failed to meet its obligations related to product and clinical development. Repligen will be relieved of its disputed obligation to pay about $1.2 million in royalties related to sales from February 2004 to March 2005. This will be recorded as other income in 1Q06.

SecreFlo is FDA-approved as an aid in diagnosing chronic pancreatitis and gastrinoma (a form of cancer) and to aid during endoscopic retrograde cholangiopancreatography, a gastrointestinal procedure.

Repligen develops therapeutics for neuro-psychiatric disorders and autoimmune disease, with particular emphasis on applications for children.