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Q&A: Biotech Patent Guru Discusses Possible Proteomics Patent Wars

NEW YORK, March 8 - Leslie Misrock, a 73 year-old partner at Pennie & Edmonds in New York who has been called the father of Biotechnology Patent Law, is concerned about proteomics. With decades of biotechnology litigation under his belt, Misrock has warned industry leaders that battles over protein patents could stop proteomics dead in its tracks. This week, Genomeweb caught up with Misrock to discuss this issue.

GW: At a recent New York Academy of Sciences panel, you said that proteomics could end up in the courtroom, rather than the lab, due to fights over patents on proteins. Why are you so concerned?

Misrock: If there's a series of patents that issues, and [the proteomics companies] aggressively want to enforce those patents to get commercial advantage, this will act to divert assets that should be put into the business and the science, to be spent on lawyers. Now it's unique for a lawyer to be saying this but I'm thinking about the national interest.  

GW: How likely do you think this is to happen in proteomics?

Misrock: I have heard from a person whose judgment I really respect that he thinks the number of proteomics companies is going to devolve to about two or three, [including] certainly Celera. Many companies are bulking up in this field by acquiring other companies, or hoping for a series of mergers where there is a complementary technology as opposed to supplementary technologies. Were this to occur then you would have large entities, but if you have a whole series of small entities depending on the intellectual property rights, you have what happened in the early days of the polyurethane industry. Constant litigation. If there is constant litigation, this will have a chilling effect on the science.

GW: What happened to the companies in the early polyurethane industry? 

Misrock: They either all went out of business, or by merger went into [some other company], and the developments became less and less important. Now, you'd never see a case on polyurethane. 

GW: In genomics, there have been a number of patent infringement lawsuits, including still ongoing battles over Affymetrix's microarray technology. What effect that has this had on the industry?

Misrock: It hasn't stopped it. On the other hand, the question of litigation in genomics will pale with respect to litigation in proteomics.

GW: Why?

Misrock: Just because there are that many more methods in determining interactions between proteins, and between proteins and genes. So the tools will become important.

GW: The tools? You mean the algorithms for predicting these interactions?

Misrock: The algorithms. Or methods of screening. Some of the problem I see is, there will be a tendency to get broader and broader coverage. We even now have a case of State Street Bank vs. Signature Financial . It is a financial industry case, but the rules are such in that they deal with the patentability of algorithms, and [the judges in this case] say if they are useful, they are important.  

GW: Incyte Genomics has a huge portfolio of gene patents, and they have said they believe the gene patents on their full-length genes cover the proteins encoded by those genes. With that in mind, couldn't there be some conflict between the holders of gene patents and holders of protein patents?

Misrock: The answer is yes. Potentially.

GW: So if Company A has the full-length gene patent and Company B tries to patent the proteins that happen to be encoded by this gene, they could be fighting over this?  

Misrock: Yes, although quite frankly the second company that got the protein necessarily had to make the protein from the gene. So it may be a contest of who got the gene first, if you get into interferences. Interferences are contests between two or more people claiming that they are first to invent. We understand there are thousands of interferences pending in the Patent Office in the whole area of biotechnology. The Patent Office is notoriously slow in resolving questions of first invention. You could have something pending in the Patent Office for years and years and years. Everyone goes along his or her merry way, and it turns out a patent issues years from now. Then people begin to allege it's a submarine patent

GW: What's a submarine patent?

Misrock: It's just lying quietly and nobody knows about it except a few  people. There have been people who attempt to get submarine patents, who write materials up so broadly and they attempt to enforce those things. They're in the business of litigation. 

GW: So what should proteomics companies do to avoid getting "submarined" by their own patent battles?

Misrock: My recommendation is that this industry ought to talk about the potential problem of litigation that might cover the tools of proteomics and genomics. Nothing may come of it, but on the other hand, there might be some resolution.

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