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With Roche s Key PCR Patents Now Expired, What is Upshot for Genomics?

NEW YORK, March 29 (GenomeWeb News) - Roche's core PCR patents expired yesterday. The event will save millions of dollars a year in royalties for the companies and labs that rely on the technology, while creating a challenging environment for companies developing rival platforms.

 

What do the expirations mean for genomic tool providers? BioCommerce Week, a GenomeWeb News publication, recently interviewed Harry Glorikian, a principle partner of TSG-Partners, a life-sciences strategic consultancy, who is an expert in PCR patents and their applications.

 

"I think people need to understand [that] the patent landscape and licensing arrangements set up are very complicated," Glorikian said during the interview.

 

Glorikian, who is also a former senior manager at Applied Biosystems, reviews new technologies, business development, and product and sales management for TSG. His firm advised Becton Dickinson in its acquisition of Atto Bioscience and Carl Zeiss in its purchase of Bio-Rad's confocal microscopy business.

 

At the end of this interview is a sidebar describing all of the PCR patents that expired yesterday. Click here for the complete interview.

Why should people be interested in hearing what you think [about the PCR patents]?

Just because a few patents go away doesn't mean the bottom falls out from underneath the way this was structured in the first place. The group that is probably going to be hurt the most is the basic research area, or the area [where] ABI has the most at stake.

Why?

Because of the way that the agreement is set up between ABI and Roche. There are two sets of patents: the process patents and the instrument patents. The instrument patents are assigned to Applied Biosystems, and the process patents are assigned to Roche. The fields of use defined by the fields of agreement are such that Roche has rights to human diagnostics, veterinary, and human paternity, and AB has exclusive deals in R&D, QA/QC, forensics, environmental, agricultural, etc.

How will that affect basic researchers?

If you make a complete kit, it has the primers, and it has 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. 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.

This is a highly complicated area. People shouldn't jump to any conclusions because a piece of this is going away. They should step back and look at their product and what they want to accomplish and ask, 'What do I need to do what I want to do?' The basic process patents go away, but the polymerase patents are still in effect for thermal-stable polymerases. The thermal cycler patents are still valid.

So if you are creating a complete instrument, you are going to need the thermal cycler license and you are going to need a polymerase license. And, this is just basic PCR, not real-time PCR. That's another whole layer on top of that. If someone is going to do a quantitative assay, you have flopped into the real-time space, which the fact that some of these patents are going away, doesn't impact that world at all.

So, what happens on March 28?

I do believe [the patent expirations] will have impact on the basic research and certain parts of the applied markers - forensics and agriculture areas. But for the diagnostics market, I don't know if Roche is making any fundamental change to its licensing program. They haven't said anything publicly.

What are the global implications?

If you are a global company and you want to sell in the
US, depending on what you are trying to make, whether it is a diagnostic kit or a research kit, you are still going to need rights. Certain patents are still enforceable in some of the largest areas of the world.

If you are a regional company, and there is no patent protection there, you can probably get away with it. If you are making a thermal cycler in Europeand you are only selling a thermal cycler in Europe, because the patent was overturned, you can get away with that because the patent was overturned.

But if you are going to sell in the United States, you are going to need a license. Every company that enters this space needs to ask, 'What is it I am trying to do? What product am I trying to create? What do I need to do to legally maneuver in this space?' If you are creating a diagnostic, you still need a polymerase license from Roche in the diagnostics area for the polymerase, and you will need a thermal cycler license. So it's not as simple as people would like to believe.
 
Where are the opportunities for the tools companies?

All have different technologies and all of them are going to be applicable. BD is already an active player in the diagnostics arena with [its] flow platform. Looking at the mass spec area, mass spec is gaining in the clinical area because of its quantitative capability. Neo-natal screening is the perfect example, or applications for drugs of abuse or therapy monitoring. For the ABs of the world, they have already made their bets by forming Celera Diagnostics 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 or ag.

Are there disruptive technologies?

There are a whole host of them that could potentially be disruptive. It will come down to the money that is put behind the technology. As much as Affymetrix would like to have its chip become the gold standard, that is a very difficult row to hoe because quantitative information based on TaqMan is the gold standard.

 


 

Following is a list of the Roche US patents on PCR that expired on March 28:

  • 4,683,195 Process for amplifying, detecting, and / or cloning nucleic acid sequences
  • 4,683,202 Process for amplifying nucleic acid sequences
  • 4,965,188 Process for amplifying, detecting, and / or cloning nucleic acid sequences using a thermostable enzyme
  • 6,040,166 Kits for amplifying and detecting nucleic acid sequences including a probe
  • 6,197,563 Kits for amplifying and detecting nucleic acid sequences
  • 4,800,159 Process for amplifying, detecting, and / or cloning nucleic acid sequences
  • 5,008 182 Detection of AIDS-associated virus by PCR
  • 5,176,995 Detection of viruses by amplification and hybridization
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