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Thursday, February 14, 2019 3:53:38 PM
Challenge to US Patent
On April 30, 2018, the Company received notice that Mallinckrodt Pharmaceuticals Ireland Limited had petitioned the US Patent and Trademark Office (USPTO) to institute an Inter Partes Review of BioVie’s US Patent No. 9,655,945 titled “Treatment of Ascites” (the ‘945 patent). Inter Partes Review is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review the patentability of one or more claims of a patent. Such review is limited to grounds of novelty and obviousness on the basis of prior art consisting of patents and printed publications.
On August 15, 2018, BioVie submitted a Preliminary Response to the PTAB providing a rationale as to why, in the Company’s opinion, Mallinckrodt’s request to institute the IPR should not be granted. On November 14, 2018, the PTAB granted institution of the IPR challenge after determining that there was a reasonable likelihood of success in proving that at least one of the Company’s 14 claims was unpatentable. BioVie will seek to defend the ‘945 patent and/or pursue a favorable settlement. As of December 31, 2018, no adjustments or accruals are reflected as the Company is unable to determine a likely outcome at this time.
https://www.sec.gov/Archives/edgar/data/1580149/000152013819000027/bivi-20181231_10q.htm
Only one claim if MNK succeeds isn't enough. I smell licensing deal here or buyout! Biovie (BIVI) is the most undervalued NASH related stock, IMO.
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