|
|
|
|
||
Re: EVAPORATE: Stopped for efficacy ... why I believe ... Relevance of MOA"I can't see a buyout until the patent issue is settled." It's always appropriate to be cognizant of IP/patent issues, especially in evaluating potential buyout scenarios. It is not uncommon, however, for buyouts to occur in pharma despite the pendency of IP litigation/patent challenges affecting the target's drugs. For example, BMY is close to completing its acquisition of CELG, and there are still unresolved patent challenges involving CELG's flagship drug Revlimid. Part of the acquiror's due diligence includes careful evaluation of the strength of IP protection of the target's assets. That is even more critical where, as in the case of Amarin, there is essentially only one asset, making IP protection of that single asset all the more important. Presumably you are referring to Amarin's pending infringement suits against West-Ward and DRL that are discussed in Amarin's latest 10-K at pp. 44-47. There, Amarin recounts the history and status of the ANDAs filed by West-Ward's predecessor, by Teva, and by DRL, the status of Amarin's infringement suits against all of them (pending in U.S. District Court in Nevada), and Amarin's settlement with Teva. Thereafter, Amarin says at p. 47: "Assuming FDA approval of a new indication based on the REDUCE-IT
clinical trial, we expect to face similar patent litigation related to
our patents covering proposed indications made possible by such study." This statement indicates they expect further patent challenges if/when the label is expanded. Hopefully that is just cautionary language and we've seen all the patent challenges that will come. Not clear from the 10-K is whether the Teva settlement encompassed any potential, additional claims that Teva might make as a result of label expansion. Hopefully it did. Does anyone know? Regardless of the scope of the Teva settlement, if after the REDUCE-IT label expansion Amarin receives additional patent challenges, it could be years before they are all resolved. Thus, if a potential acquirer wants all patent issues resolved before making an offer, unless all challenges are settled, it could be a long time before an offer is forthcoming. Also at p. 47, Amarin says, with reference to the pending infringement litigation against West-Ward and DRL: "However, based on court proceedings, we don’t expect an at-risk launch
from either generic filer before the court issues a decision on the
merits in this case, which is expected by the end of March 2020." Not discussed is what proceedings have occurred or will occur between now and March 2020 that could lead to the court's issuing a definitive decision in those cases in March. For example, is a trial scheduled? Have the parties submitted motions for summary judgment and agreed to disposition on such motions? Also, a relevant question would be whether a March 2020 decision would be postponed if either DRL or West-Ward files an additional ANDA or makes additional patent invalidity assertions in the pending litigation. Finally regarding existing patent litigation, even assuming the court were to rule definitively in March 2020 in favor of Amarin, DRL and West-Ward would have the right to appeal any such decision, though whether they would exercise such right would be known in a relatively short period (a few months). Were they to appeal, such appeals could take years to resolve. Still further, Amarin notes (p. 47) that its patents could be challenged (by anyone) at the PTAB at USPTO, using Inter Partes Review (IPR). Amarin mentions nothing, however, about any such challenges (IPRs) having been thus far filed. If their silence in that regard means that no IPRs have been filed so far, that would be very good news. Currently, almost every patent challenger who is serious timely files one or more IPRs at PTAB because it is considerably easier for them to invalidate patents at PTAB than it is in federal court (in response to an infringement suit). If no IPRs have been filed thus far (and, as noted in the 10-K, at least when sued for infringement there is a one year window following service within which an IPR must be filed), that might be interpreted as indicating that DRL and West-Ward are not pursuing their cases vigorously. No doubt, patent challenges/IP protection are very important. Unfortunately, in current times such challenges are endemic to the industry, making M&A more complicated (and sometimes M&A does not happen because of such concerns). Whether all such challenges must be resolved before an offer might be made, however, is dependent on the specific circumstances. |
return to message board, top of board |
Msg # | Subject | Author | Recs | Date Posted |
4967 | Re: EVAPORATE: Stopped for efficacy ... why I believe ... Relevance of MOA (all should read msg #4962) | Q77 | 0 | 9/22/2019 8:54:06 PM |
4975 | Re: EVAPORATE: Stopped for efficacy ... why I believe ... Relevance of MOA | ex_hacker202 | 0 | 9/23/2019 4:09:09 PM |
5018 | Re: EVAPORATE: - Patents/IP and "at-risk launch" | io_io | 9 | 9/28/2019 2:06:55 PM |