http://seekingalpha.com/article/4054602-kite-pharma-history-…
I found this very useful. If you are interested in Kite I suggest you consider it required reading. The author is quite knowledgeable and, more important, he is even-handed. He expresses his doubts and worries and what he sees the risks to be, but explains why he is long, and what he expects. (He doesn’t seem to have learned the typical Seeking Alpha method of either praising a stock to the skies or panning it unmercifully, which almost everyone over there except Bert seems to use).
Have a good read
Saul
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I think that the author sums things up well. I don’t agree with his thoughts on the need for more clinical data. I think they are totally there with the clinical data. In fact the longer the FDA puts of the approval, the more people will die. Make no mistake, people know about this and there is tremendous pressure to get a potential cure to the market.
That said, this is an early stage biotech, and they could do something stupid on their application and get a request for more process information or something along those lines. There are a million reasons that could be used to reject an application.
The patent is a different story. That concerns me, and that is a significant risk. I can say that if, as Kite claims, literature is out there that predates the Juno patent, Juno is screwed. It happens more often than one thinks. Even under the best circumstances, patent trials are dicey.
Best,
bulwnkl
PS Long actual KITE stocks (converted my calls yesterday :o)
Even if there’s patent trouble, it only effects the US market. Read some of the comments. They still have huge market in Europe, Japan and possibly China. I bought a small position after reading the article. If the go belly-up, it won’t hurt too badly, if the get approval it should be significant.
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My two cents on an issue I know a lot about: Kite chose to challenge the validity of the Juno (Sloan-Kettering) patent by filing a request for Inter Partes Review (IPR) in the U.S. Patent and Trademark Office (USPTO). This IPR request was limited by statute to a reconsideration of patent validity based on prior patents and printed publications, as opposed for example to prior developments in the field that may not have found their way into publications at an early enough date and therefore would need to be proven with witness testimony and internal R&D records. The Board in the USPTO rendered a decision against Kite and in favor of the validity of the Juno patent. Kite has now filed an appeal to the Federal Circuit, which probably will take 12-18 months to resolve. In December, Juno filed a lawsuit in the Delaware district court, seeking a declaration that Kite’s potential commercial product infringes. If Kite loses the Federal Circuit appeal of the USPTO decision, Kite will likely be precluded from challenging the validity of the patent based on the same prior art, or on any other prior patents or printed publications it knew about or could reasonably have uncovered and used in the IPR, in the Delaware case. Kite was supposed to raise whatever invalidity defenses it has based on prior patents and printed publications in its IPR request and generally doesn’t get a second bite at the apple in court. Of course, Kite may have other invalidity defenses it can pursue, and it may also contest infringement – I have no way of knowing at this point. It would not be surprising to see Kite take a license if the Federal Circuit appeal goes badly. In that case, Juno will be in a position to extract maximum royalties. It is almost inconceivable to me that Juno could get an injunction against Kite’s product given the public interest in such an important medical advance.
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