The expiration of Roche's US patents sets up a complex situation for basic researchers in the laboratory, who have had to previously negotiate the tricky arrangement between the company and Applied Biosystems (ABI).
As of March 28, the instrument patents were assigned to Applied Biosystems, which included exclusive deals in R&D, QA/QC, forensics, environmental and the agricultural division. Roche's patents were assigned to processes within the human diagnostics, veterinary, and human paternity sector.
The multifaceted arrangement between Applied Biosystems and Roche is certain to have played a role in the legal disputes that have arisen during the last two years. In October 2003, Appelera, unsuccessfully sued Hoffman-La Roche in a long-running case.
Appelera Corp, the parent of life sciences instrumentation and reagent company Applied Biosystems, has filed a complaint against Roche in the Calfornia Superior Court. Applied Bio had sold PCR technologies licensed from Roche, including the Taq DNA polymerase enzyme central to PCR, for several years.
An additional legal challenge brought in the US by Promega, which strove to overturn Applied Biosystem's patents on technology used in gene amplification using polymerase chain reaction (PCR), was also unsuccessful.
Promega had sued Applied Biosystems and Hoffman-La Roche in the long-running case, which recently came to a close in Europe. It centred on patents relating to process enzymes used in PCR, including Taq polymerase, used in clinical testing and drug discovery.
PCR is a nucleic acid amplification technology that allows minute amounts of genetic material to be amplified into billions of copies in just a few hours, facilitating the detection of the DNA or RNA of pathogenic organisms even before antibodies to these organisms are formed. It is also used in biological research and drug target discovery efforts.
Harry Glorikan, a partner of TSG-Partners, a life-sciences strategic consultancy, told the GenomeWeb News publication, Biocommerce Week, that he thought the group that was most going to be affected by this development was the basic research area, or the area where ABI has the most at stake.
"If you make a complete kit, it has the primers, a polymerase. So, if you are talking about a research kit, then people are probably going to be able to sell into the research market without an ABI license for the basic process," he said.
"They are still going to need a license for basic research from Roche to sell into the R&D market for the polymerase. So instead of paying for more than one master, you may only have to pay one."
He said in the interview that even though a company was going to sell in the United States a license would still be needed. If a company were creating a diagnostic, for example a thermal cycler, a ploymerase licence would still be needed from Roche in the diagnostics area for the polymerase, in addition to a thermal cycler license.
The expiration of Roche's patents is certain to create a wealth of opportunities for toolmakers and providers. A prime example is mass spectrometry, which is gaining in the clinical arena because of its quantitative capability.
Applied Biosystems has taken an alternative route and formed Celera Diagnostics. It has been formed because the regulatory requirements of Celera Diagnostics are very different from what they would be for AB as a research company.
"We watch that area a lot because all these research companies have products that could have impact on the diagnostics arena or the applied areas like forensics or food," Glorikian said.