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FL: Patent number 5,445,934 for the GeneChip® array is titled Array of oligonucleotides on a solid substrate. What are the practical applications for the GeneChip® array?
Companies and universities use the GeneChip® array in the laboratory for research, particularly for drug discovery purposes and detecting polymorphisms. The GeneChip® array is also used for diagnostic purposes; however, more diagnostic applications will likely be developed in the future. Researching drug discovery is the most common application at present.
FL: And, that would be to measure the effect of a particular drug on a certain set of genes?
Yes.
FL: What was the process for taking the technology from the Affymax labs to Townsend? Was there an ongoing engagement between Affymax and Townsend at the time?
Townsend had been working with Affymax since its inception. Affymetrix was spun out of Affymax later. When the patent was filed originally in 1989, Affymax was a fairly new company, and this was their first major patent filing. The people at Townsend who were responsible for initiating this patent were William M. Smith and Vern Norviel. Bill Smith is still with Townsend, and Vern Norviel went on to become in-house counsel at Affymetrix.
FL: Were their backgrounds similar to yours? Was it in genetics?
Vern Norviel, who did most of the writing, has a background in chemical engineering. He also did quite a bit of electrical engineering work. At the time, this was his first foray into the biotech arena.
FL: Just looking at the patent, it seems to require a certain level of expertise in this area in order to draft it and understand the language. It more resembles a chemistry text than a document in plain English.
Yes, that is probably true to say.
FL: For more established fields, it is probably easier to find someone within a law firm with the same degree of expertise. But for cutting edge fields, it must be more of a challenge.
Well, it is true to say that this application involved somewhat of a merger of different technologies: semiconductor-type photolithography with chemistry. At the time, there were probably only a few people that could have handled understanding and writing about this technology. Vern, the person who did write it, had the right kind of background. His background included both chemical engineering and electronics.
FL: What was significant about this patent?
This was the first patent issued that covered a GeneChip® array. It was effectively the first of a genre of patents. A number of patents in this area have been issued subsequently to Affymetrix and others. However, this was the first GeneChip® array patent to be issued on an array itself, at least in the United States and in this field.
FL: What difficulties do you face if you're first in the class? Is there a difficulty because the U.S. Patent and Trademark Office may not have seen anything like this before?
Yes. That is basically the difficulty. In some ways, it is easier being first in the class because there is no one before you. But you do experience some difficulties in that the patent office simply is not used to seeing inventions of that kind.
FL: What was Townsend's process?
Our process is the same as for a typical patent application. Namely, there is some backwards and forwards communication with an examiner from the patent office. The difference is for some inventions, the examiners see a lot of inventions and you know pretty much what to expect and what you need to do to get the case allowed. For this patent, it was probably the first time the examiner looked at this type of invention. There was quite a bit of back-and-forth before the patent was allowed; although an appeal was not needed.
FL: For a biotech company, what's the process for identifying new patents? Is it somewhat of a process done in-house where the in-house counsel would interview their engineers and then get together with Townsend or is outside counsel more involved upfront?
This process typically changes during the development of a company. For companies in their infancy, scientists at the company complete an invention disclosure form, which is basically a summary of what the scientists believe they invented. Usually, a committee within the company then considers the inventions. A company scientist, a representative of company management, and usually an outside patent counsel—say, someone from Townsend—would sit on that committee. So, there are at least three people. They would consider a number of these documents on a monthly or perhaps quarterly basis and would decide which inventions to file and which to hold. And, at that point, it would come to Townsend for drafting. This is the typical process for earlystage companies.
As a company matures, they typically hire an in-house patent counsel. The process for evaluating whether an application is filed, still occurs but without involvement from outside counsel until the company has made the decision to file a patent application. And, at that point, the outside counsel interviews the scientists responsible for the invention. We then proceed to draft the application and have it reviewed by the scientists. It not uncommon for there to be back-and-forth dialogue about the invention until the application is completed and filed. When there is extreme time pressure this process may occur in a single day, but about one to three months is more typical.
FL: Has there been any litigation involving this patent?
There's been a lot of litigation involving the patent. Affymax asserted its patent against both Hyseq and Incyte on the basis that they infringed the patent. The litigation settled without a trial, and remains in force today.
Originally founded in the 1860s, Townsend and Townsend and Crew LLP focuses on intellectual property law, teaming with inventors, entrepreneurs, scientists and investors to protect their innovative products and ideas. The firm offers a full range of intellectual property, prosecution and litigation services, with additional expertise in antitrust and other complex business litigation issues. With offices in San Francisco, Palo Alto,Walnut Creek, Denver and Seattle, Townsend has more than 150 attorneys,many of whom have advanced technical degrees and extensive scientific and business experience. For more information, visit the firm's Web site located at www.townsend.com.
Dr. Liebeschuetz regularly prosecutes patents for clients in the United States and abroad. He has performed infringement and patentability studies on behalf of clients. In addition, he prepares oppositions, opinions on validity and infringement and due diligence reviews, and guides clients through the development and negotiation of technology licensing agreements. His background in the study of genetics gives him particular experience in the areas of antibodies, combinatorial synthesis/screening, phage display, transgenic animals, probe arrays and DNA-based diagnostics.