Rfo,
The problem with patent litigation is that one never knows how a trial will play out and what a jury will believe. However, we do know that patent litigation is part of the biotech world, especially when you are talking about a product like IGF that was chased after by so many companies. There's been a lot of work done of this molecule.
'414 -- this is a strange patent. Filed in 1983, knocked back to the patent office by the Chiron lawsuit, refiled with a priority date of 1995 and issued in 2001. Genentech has claimed expression of full length IGF with a "native" front end (amino terminus) using any prokaryote. The patent was based on expression data using a fusion protein; a prokaryotic signal sequence, a 5 amino acid space that came from a prokaryotic gene but is also found in a highly conserved region of the same eukaryotic protein, a spacer of random sequence (probably put in to make the construct in frame and amenable to protease cleavage) and the portion of hte IGF gene that represents the hormone as it circulates in humans. The problem they are going to have is that expression systems are not straightforward. There is still a lot of trial and error, because noone knows exactly why some constructs work and some don't. Based on the state of the art in 1983, there is no way that Genentech scientists would have predicted that Insmed's method of using the eukaryotic ubiquitin leader sequence would work in e. coli. There's a reason the patent was not allowed in Europe.
'151 -- the Judge wrote: Based on the intrinsic evidence presented, the Court construes the phrase "greater anabolic state in the mammal than achieved using an equivalent dose of IGF-I" to mean promote total body weight gain or statural growth that is greater than whatever total body weight gain or statural growth would be observed if the same amount of IGF-I as is present in the IGF-I/IGFBP-3 mixture were administered by the same route, regimen, and schedule of administration as used in the administration of the IGF-I/IGFBP-3 mixture. The Court will not separately construe the term "equivalent dose" because it is construed as part of the above phrase.
Pure and simple, the complex does not cause growth over and above that seen with IGF alone. BP3 actually slows down IGF's affect. The problem is that the two companies dose their drugs differently because of the side affects seen with large quantities of "free" IGF and because shots and kids don't mix well. However, there is one Japanese clinical trial that can be used to directly compare the two. In 1995, Fujisawa did a growth study with rhIGF in which patients received 150 micrograms - 200 micrograms with once a day dosing. The average growth increased by 3.6 cm/year. The clinical trial studies for iplex in which patients received once daily injections resulted in patients receiving between 80 microgram - 240 micrograms of rhIGF. The average was 206 micrograms. The average growth increased by 3.0 cm/year.
The question is will the court require Insmed to show the results of twice a day dosing as the judge says the patent requires? Or will the court say, Insmed doesn't infringe, because they have once a day dosing?
The '286 patent issue was addressed by the patent office in the early '90s when the two patents were issued. Tercica is trying to broaden the claims as allowed by the patent examiner. I have never been too worried about this one, but it helps Tercica muddy the waters.
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