Ucb's Vimpat Patent
UCB is a Belgium-based biopharmaceutical too specialty chemic fellowship that specialises inwards ii therapeutic areas: diseases of the fundamental nervous organization too immunology. The primary fundamental nervous organization speciality is epilepsy too the primary drug inwards this expanse is Vimpat. (UCB revenue mostly comes from 4 drugs of which Vimpat is one.)
We went to see UCB once, a mutual frigidity too moisture wintery hateful solar daytime where nosotros got modestly lost inwards Belgium.
The investor relations people were straightforward. We were novel to the flush too our notes dry reason clearly that generic challenges to the Vimpat patent were the primary deport flush for the stock. Our notes also speak about Keppra - some other epilepsy drug. When it went off patent revenues dropped substantially. Keppra was an famous "patent cliff" drug.
The opportunity to Vimpat has been reflected inwards the press too. Fierce Pharma - an manufacture rag - reports that August fifteen this twelvemonth was the best hateful solar daytime for UCB inwards years as a Delaware District Court had rejected challenges to the Vimpat patent. Notwithstanding this, Fierce Pharma noted that the patent soundless faced challenges. To quote:
As noted Argentum Pharmaceuticals won an inter-parties review of Vimpat's patent. Argentum's press release however noted an fifty-fifty to a greater extent than aggressive request. To quote:
Given the afterthought nature of that asking I suspect fifty-fifty Argentum volition hold upwardly surprised that the ex-parte review rejected all 13 claims of the Vimpat patent.
In other words the Patent Office has thrown out the patent.
This is all inwards a missive of the alphabet dated five Dec 2016 (that is but a few days ago). You tin give the axe detect that letter here. And according to that missive of the alphabet UCB has entirely ii months to dispute the full rejection of the patent past times the patent office.
This rejection volition of course of teaching hold upwardly followed past times Argentum too Mylan (and likely other companies) commencing distribution of a generic for Vimpat. Mylan were behind the above-mentioned courtroom challenge.
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It is - given the significance of this to the trouble concern - mayhap a niggling odd that UCB has made no press release.
--
Is this the outset of a new, to a greater extent than aggressive patent office?
The political pressure level inwards the US of America to practise something to trim drug prices is large. In the past times election this was i expanse of close universal agreement.
I am wondering whether nosotros are going to come across this variety of activity past times the Patent Office to a greater extent than widely.
If the tendency is to a greater extent than widespread it could hold upwardly bad intelligence for pharma investors generally.
John
We went to see UCB once, a mutual frigidity too moisture wintery hateful solar daytime where nosotros got modestly lost inwards Belgium.
The investor relations people were straightforward. We were novel to the flush too our notes dry reason clearly that generic challenges to the Vimpat patent were the primary deport flush for the stock. Our notes also speak about Keppra - some other epilepsy drug. When it went off patent revenues dropped substantially. Keppra was an famous "patent cliff" drug.
The opportunity to Vimpat has been reflected inwards the press too. Fierce Pharma - an manufacture rag - reports that August fifteen this twelvemonth was the best hateful solar daytime for UCB inwards years as a Delaware District Court had rejected challenges to the Vimpat patent. Notwithstanding this, Fierce Pharma noted that the patent soundless faced challenges. To quote:
UCB isn’t totally out of the woods, though. In belatedly May, New York-based generics maker Argentum Pharmaceuticals won an inter partes review of Vimpat’s patent protection past times the U.S. Patent & Trademark Office (PTO)’s Patent Trial & Appeal Board (PTAB). And that conclusion may non hold upwardly handed downwards until side past times side May.
Still, court’s conclusion is a “long-awaited persuasion boost” for UCB, whose shares had fallen past times nearly 17% then far this year, Citigroup analysts wrote inwards a Mon banking concern annotation seen past times Bloomberg. Despite the lingering opportunity of patent invalidation, they wrote, “we facial expression marketplace confidence to improve.”
As noted Argentum Pharmaceuticals won an inter-parties review of Vimpat's patent. Argentum's press release however noted an fifty-fifty to a greater extent than aggressive request. To quote:
Argentum also filed an ex parte reexamination asking against this same patent that raises additional grounds of unpatentability than those inwards the IPR. A conclusion past times the PTO on Argentum's reexamination asking is due no after than July 29, 2016.This is mentioned every bit afterthought inwards the press unloose because it is a actually aggressive claim. Argentum asked the Patent Office itself to review the patent it previously granted too presumably throw out the master copy patent.
Given the afterthought nature of that asking I suspect fifty-fifty Argentum volition hold upwardly surprised that the ex-parte review rejected all 13 claims of the Vimpat patent.
In other words the Patent Office has thrown out the patent.
This is all inwards a missive of the alphabet dated five Dec 2016 (that is but a few days ago). You tin give the axe detect that letter here. And according to that missive of the alphabet UCB has entirely ii months to dispute the full rejection of the patent past times the patent office.
This rejection volition of course of teaching hold upwardly followed past times Argentum too Mylan (and likely other companies) commencing distribution of a generic for Vimpat. Mylan were behind the above-mentioned courtroom challenge.
--
It is - given the significance of this to the trouble concern - mayhap a niggling odd that UCB has made no press release.
--
Is this the outset of a new, to a greater extent than aggressive patent office?
The political pressure level inwards the US of America to practise something to trim drug prices is large. In the past times election this was i expanse of close universal agreement.
I am wondering whether nosotros are going to come across this variety of activity past times the Patent Office to a greater extent than widely.
If the tendency is to a greater extent than widespread it could hold upwardly bad intelligence for pharma investors generally.
John
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