jelly, drbio, abharploonta,
My view after a lot of review seems to generally parallel what you have expressed.
My understanding, based on dealing with patents in the tech side of the pharma industry (but not expert not being either lawyer nor biochemist), is that Tercica has two basic issues to overcome:
1. '414 Invalidity by lack of enablement: The "human IGF-1" or "mature human IGF-1" in the '414 must, according to the Court, be shown to have bioactivity. My understanding is that Genetech had only some equivocal rat model data, and no human bioactivity evidence at the time of the patent. This leaves a substantial "enablement" issue, which I believe survives the literal infringement findings, and may still lead to invalidating the '414 patent at trial.
2. '151 Invalidity by lack of enablement: The '151 patent, which deals only with USES of the IGF/IGFBP3 complex, had no data at the time of filing the patent demonstrating the central claim that IGF-equivalent doses of complex resulted in "greater anabolic state in a mammal" vs IGF-1 alone. The 2 companies at the Markman hearing apparently did not disagree over the basic meaning of that comparative claim - although they argued alot about exactly what type of data (such as simple body weight) would constitute a factual showing of that "greater anabolic state".
Also, as a use claim, wouldn't Tercica/Genetech have to prove that Insmed actually claimed "greater anabolic state" to infringe this one? FDA clearly stated for the official record that they do not see any dose-for-dose difference in safety or efficacy - surely that could supports the non-infringement position as a body of extrinsic expert opinion?
3. I don't know what to make of the '287 patent, dealing with production methods for BP3. I had thought that one was weak because Insmed has its own issued patent for BP3 expression. But the Markman results say nothing about content or literal infringement there. So I can't tell whether this one is a real threat.
I know there are numerous potential interactions between the specification and claims which are beyond my ability to assess. No one on any MB has the ability to truly figure this out - too complex and that's what a trial is for.
Is my outline on basic issues roughly on track re your thinking? Have I completely missed a basic? Do you think the '287 offers any threat?
I know these are unfair big questions; Nonetheless, we all have to decide what we believe, incomplete as our understanding may be. Can't help looking for some basic comparisons of views...
cheers - appreciate any feedback
