10. Final Thought 1: I believe ARC-520 is being made in Germany. Ongoing clinical trials are in Hong Kong. Neither are subject to USA patent jurisdiction.
11. Final Thought 2: $ARWR will enjoy FDA infringement “Safe Harbor” for USA clinical trial activities for foreseeable future. 35 USC §271(e)(1) “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . .solely for uses reasonably related to the development and sub¬mission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
12. Final Thought 3: $ALNY and $ARWR are friends – to a degree. In January 2012, Arrowhead granted Alnylam Pharmaceuticals, Inc., (“Alnylam”) a license to utilize the Dynamic Polyconjugate delivery technology for a single RNAi therapeutic product. Alnylam is collaborating with Arrowhead to develop this technology for an undisclosed target in its "Alnylam 5x15" pipeline.
In then end, with all the existing IP cross-licensing, (especially the #HBV co-devel agreement between $ALNY and $ARWR) and overlapping HBV patent claim scope, it makes little sense to “patent-block” each other. Way too much #RNAi money to be made. Any possible final legal decisions (including distant CAFC appeals) will occur well into the future, long after $ARWR ARC-520 demonstrates clinical efficacy. Patents may be invalidated or held unenforceable, contract terms disputed, and so on.
Besides, this is just HBV. $ARWR DPC tech is broadly applicable to myriad diseases.
Look at it as a buying opportunity based on the oldest market inefficiency known to man – fear mongering.
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