The point that I am trying to make is that the '414 patent was interpreted with very broad claims. The court granted TRCA the right to any method of expressing full length IGF with the proper amino terminus sequence as a fusion partner or directly AND in any prokaryotic organism. These are the kinds of claims given to the first person to clone a gene and/or express the protein in a specific organism. In fact, Genentech tried to claim expression in yeast, which interfered with Chiron's patent. Those claims were proven to be invalid because Genentech did not show bioactivity of its protein before the patent was filed. Which is an interesting point that the judge seized on here. From her ruling: ""The Court construes the term "human IGF-I," in claim 1, and
term "mature human IGF-I," in claim 9, to refer to bioactive
material.""
Genentech did not clone the IGF gene and there are clearly many cases in the literature of other people attempting to express IGF in E. coli as a fusion protein so this is not a new idea. Genentech used an e coli signal sequence ligated to a protease cleavage site ligated to the IGF gene. This was not new technology, and was not a novel idea. Why should TRCA get a broad patent claim? Genentech should be able to protect their exact method of expression because they invented it, but to extend the patent to prevent other companies from developing their own method is not right.
You can come up with all kinds of arguments as to how Genentech's '414 patent differs from previously invented systems, but the fact is that other people were working on this problem. To give broad claims does not fit with what I know about patent law.
In addition, we know that the patent is controversial as it was not allowed in Europe due to prior art. We know that it took over 6 years to get the patent issued, 6 years during which Insmed was developing its own methods.
Claim 1 provides, "A process for producing human IGF-I
comprising preparing a replicable expression vector capable of
expressing the DNA sequence encoding human IGF-I in a prokaryotic host cell, transforming a prokaryotic host cell culture with said vector to obtain a recombinant host cell, culturing said recombinant host cell culture under conditions permitting expression of said human IGF-I-encoding DNA sequence to produce human IGF-I, and recovering said human IGF-I."
Claim 5 provides, "A method for producing human IGF-I
comprising preparing a replicable expression vector capable of
expressing in prokaryotic cells a DNA sequence encoding a fusion protein comprising the amino acid sequence of mature human IGF-I and a bacterial protein, transforming prokaryotic cells with said vector, culturing said transformed cells under conditions permitting expression of said DNA sequence to produce the fusion protein, recovering the fusion protein from the culture, and cleaving the fusion protein to obtain mature human IGF-I, wherein the prokaryotic cells are capable of such expression and of processing the IGF-I."
Claim 9 discloses, "A process for producing mature human IGF-I
comprising culturing a recombinant prokaryotic host cell,
transformed with a replicable expression vector capable of
expressing in a suitable host cell a DNA sequence encoding a fusion protein comprised of human IGF-I fused at the N-terminus of the IGF-I to amino acid sequence exogenous to human IGF-I, under conditions permitting expression of the DNA sequence, and cleaving the fusion protein to release mature human IGF-I having the proper amino terminus (gly)."
The Court construes the term "human IGF-I," in claim 1, and
term "mature human IGF-I," in claim 9, to refer to bioactive
material.
Accordingly, the Court construes
the term "expression" used in claim 1 as covering both fusion and
direct expression.
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