UPDATE: Leerink Swann Sees Amarin (AMRN) Getting USPTO Approval, But '889 App Will Be Lengthy

March 9, 2012 10:26 AM EST
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(Updated - March 9, 2012 10:28 AM EST)

Amarin Corp. (Nasdaq: AMRN) is making a nice bounce Friday morning following a notable slide Thursday on reports it's development process is like the Road Runner to the USPTO's Wile E. Coyote.

The WSJ reported that Amarin is making drugs that are ready to come to market quicker than it can secure patents for them, meaning potentially billions in lost revs as generic version creep in.

Friday, firm Leerink Swann issued some comments on the phenomenon. The firm rates Amarin at Outperform with a price target of $25 on the stock.

The bottom line: "We hosted a call with two MEDACorp patent specialists to discuss the current state of patent prosecution for AMR101. Both attorneys believe AMRN will ultimately prevail, but may need to take the lengthy appeals route for the '889 application. However they expect an office action on the '598 formulation patent application sooner, potentially before Memorial Day, since it has been already 9 months since the last interaction with the PTO and this particular examiner does not appear to be as negatively entrenched."

Leerink notes that the current patent examiner is "completely entrenched in his opinion, it is unlikely he will change his mind, regardless of the evidence/ arguments presented by AMRN going forward. The appeals process is one way to change the patent examiner, and AMRN's odds on appeal may be pretty good, although it won't get resolution within the next couple years."

Two more key points Leerink makes are:
  • We believe AMRN is likely to see an office action regarding the potentially "stronger" '598 formulation application soon; and

  • We believe the patent runway may extend beyond the 7/26 PDUFA since AMR101 may qualify for 5 years of NCE exclusivity similar to other "subsumed" drugs such as Lovenox.


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