yes, i agree.
i found the below post to be insightful........... form agedwardsucks, who is a patent attorney who posts on investorvillage (one of the few sane and good posters)
Msg 410519 of 410531 at 4/13/2010 7:24:40 PM by
agedwardssucks
Baxter's Gammagard, An Infringing Product
Nice data about Baxter's very old product trying to find new life and a new use as an Alz biologic. Although not in the specification exerpts that the elderly PFE canine posted earlier today, what Baxter is likely doing is potentially infringing the patents Elan gave away this past summer. Firstly, it should be noted that a pharma product cannot actually infringe a patent until it is marketed with FDA approval. Anyone is free to infringe away by making and using a product in clinical trials or other development activity that is designed to generate data to submit to the FDA. So as of now, Baxter is not an infringer, just a potential one, in my opinion.
With that said, let's look at whether or not Gammagard has freedom to operate to be sold with an approved indication to treat or prevent Alz Disease. Let's make the assumption that Gammagrad gets approved with a label copy indicating its use for treating Alz Disease.
Elan has, or rather had, existing U.S. patents with claims directed to treating Alz disease comprising administering an anitbody specific to b-amyloid. That would be the broadest scope of a method of use claim. BAP is an antibody specific to b-amyloid. Gammagard is a mixed and isolated collection of human antibodies, including antibodies to b-amyloid. Is that why Gammagard appears to show efficacy (as measured by rate of brain shrinkage) in today's news release?
But there is good news and bad news to this story. The good news is that competent in-house legal counsel is making the decisions here. That means KM is out of the loop and two strong teams at PFE and J&J are supposed to be in charge. The bad news is that by giving up control, Elan also loses the bulk of the up-side to collect mega-damages for a product likely to receive FDA approval before BAP at the rate Elan mismanaged the clinical divelopment of BAP.
I'm sure counsel at PFE realizes that the disclosure for BAP indicates that it was made in a synthetic/humanized way using the process first described in the Queen patents (those were the patents that were invalidated in Europe but KM was too scared to challenge in the US and instead paid mega-millions to PDL).
But PFE will show no such fear, after all it was PFE who tried to enforce the method of use claims for Viagra with a claim to a method of treating erectile dysfunction comprising administering a PDE5 inhibitor (Viagra, Cialis, etc. are all PDE5 inhibitors). When I was trying to license rights to a new (more potent-than-Viagra) PDE-5 ionhibitor, GSK turned tail because of this patent from PFE. Yet, this patent was just invalidated in a Patent Office reexamination proceeding despite PFE's efforts to appeal, then appeal, then appeal again. Give PFE credit for persistence, perhaps not smarts. But it did chill GSK.
So here, Baxter's Gammagrad fate is in the hands of PFE, whether or not PFE will decide to enforce the broadest method of treatment claims. After all, it was PFE who secured freedom to operate for its anti-b-amyloid antibody (currently in phase 2 trials) by turning KM into a wuss in not opposing the WYE acquisition on clear and obvious antitrust grounds. And for the record, it was this mismanagement and failure to oppose the WYE acquiisition on antitrust grounds that turned me into an alleged "basher" of management competence. So OKZ, you can rant all you want about me not knowing all the facts (I knew the fact that PFE secured freedom to operate for its antibody product without consideration), but I know the outcome, and it's ugly for me, a retail pissant shareholder. Gee thanks KM for not trying to protect our assets and then giving away the remaining assets to J&J. Haloween treats are every day at the Elan household.
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