Amarin - The Science Of Lipid Therapy (Seite 42)
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Antwort auf Beitrag Nr.: 67.337.268 von bernie55 am 06.03.21 00:05:30Es wird erklärt, wie Vascepa jedes Jahr Hunderttausende von Amerikanern vor Herzinfarkten oder Schlaganfällen bewahren kann, wenn die Generika lange genug vom Markt ferngehalten werden, damit die Firma für ihre neue Indikation werben kann. Und dann wird sehr gut erklärt, warum die untere Instanz sich geirrt hat und wie die Amerikaner vielleicht nie von einem lebensrettenden Medikament erfahren, weil Generika zu früh zugelassen werden.
Hier ein Auszug der Amicus Petition
A. The Federal Circuit’s Burden-Shifting
Test Violates This Court’s Precedents.
The point of the obviousness inquiry is to identify
advancements that are so slight or trivial that they
would have occurred without the need for patent
protection. See Hotchkiss v. Greenwood, 52 U.S. 248,
267 (1850) (concluding that a clay doorknob was not
entitled to patent protection because the improvement
was merely the “work of the skillful mechanic, not that
of the inventor”). Section 103 of Title 35 directs that a
claim is obvious “if the differences between the subject
matter sought to be patented and the prior art are
such that the subject matter as a whole would have
been obvious at the time the invention was made to a
person having ordinary skill in the art to which said
subject matter pertains.” 35 U.S.C. § 103. The burden
of proving obviousness is supposed to remain at all
times with the patent challenger. “y its express
terms, [35 U.S.C.] § 282 establishes a presumption of
patent validity, and it provides that a challenger must
overcome that presumption to prevail on an invalidity
defense.” Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S.
91, 100 (2011).
As interpreted by this Court, federal law requires
a court asked to invalidate a patent to take account of
all relevant factors, including objective indicia of nonobviousness. See Graham v. John Deere Co. of Kan.
City, 383 U.S. 1, 17–18 (1966). The factors bearing on
obviousness are to be considered in their totality,
weighed together with the burden of persuasion
squarely on the patent challenger. See KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 406 (2007); Graham, 383
U.S. at 17–18. In rejecting the position that a patent
challenger is capable of “shifting both the burden of
production and the burden of persuasion” to the
patentee upon a certain showing, Microsoft, 564 U.S.
at 103 (internal quotation marks omitted), this Court
has affirmed that “a defendant raising an invalidity
defense b[ears] ‘a heavy burden of persuasion,’
requiring proof of the defense by clear and convincing
evidence,” id. at 102 (quoting Radio Corp. of Am. v.
Radio Eng’g Labs., 293 U.S. 1, 8 (1934), as modified
on denial of r’hrg (Oct. 8, 1934)).
Instead of anchoring its analysis to the
presumption of validity and a patent challenger’s
burden to show obviousness clearly and convincingly,
the Federal Circuit’s approach relies on an improper
burden-shifting framework. Under that approach, as
long as the patent challenger makes a prima facie
showing of obviousness, the burden of production—
and in effect persuasion—shifts to the patent holder to
prove that secondary considerations refute that prima
facie showing. See App. 81a; see also Pet. 26, 29. By
shifting the burden and discounting objective indicia
of non-obviousness, the Federal Circuit’s test raises a
particular risk of impermissible hindsight bias. Under
the Federal Circuit’s approach, patents on even the
most novel inventions risk being invalidated when
challenged.
B. This Case Presents an Ideal Vehicle for
Addressing the Question Presented.
This case presents an ideal vehicle for the Court
to clarify the proper standards for determining when
a patented invention is obvious. The case brings into
sharp focus the serious consequences of the Federal
Circuit’s burden-shifting approach, which relaxes the
standards for demonstrating obviousness. There also
can be no doubt that the time is ripe for this Court’s
intervention. Despite the extraordinary importance of
this case, the Federal Circuit views its burden-shifting
approach to be so entrenched that it summarily
affirmed without even issuing an opinion.
If Amarin’s drug is not entitled to patent
protection, no drug manufacturer can be confident
that its patented inventions will withstand an
obviousness defense. Amarin’s drug indisputably
addresses a previously unmet medical need and took
hundreds of millions of dollars to develop.
https://www.supremecourt.gov/DocketPDF/20/20-1119/170936/202…
Hier ein Auszug der Amicus Petition
A. The Federal Circuit’s Burden-Shifting
Test Violates This Court’s Precedents.
The point of the obviousness inquiry is to identify
advancements that are so slight or trivial that they
would have occurred without the need for patent
protection. See Hotchkiss v. Greenwood, 52 U.S. 248,
267 (1850) (concluding that a clay doorknob was not
entitled to patent protection because the improvement
was merely the “work of the skillful mechanic, not that
of the inventor”). Section 103 of Title 35 directs that a
claim is obvious “if the differences between the subject
matter sought to be patented and the prior art are
such that the subject matter as a whole would have
been obvious at the time the invention was made to a
person having ordinary skill in the art to which said
subject matter pertains.” 35 U.S.C. § 103. The burden
of proving obviousness is supposed to remain at all
times with the patent challenger. “y its express
terms, [35 U.S.C.] § 282 establishes a presumption of
patent validity, and it provides that a challenger must
overcome that presumption to prevail on an invalidity
defense.” Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S.
91, 100 (2011).
As interpreted by this Court, federal law requires
a court asked to invalidate a patent to take account of
all relevant factors, including objective indicia of nonobviousness. See Graham v. John Deere Co. of Kan.
City, 383 U.S. 1, 17–18 (1966). The factors bearing on
obviousness are to be considered in their totality,
weighed together with the burden of persuasion
squarely on the patent challenger. See KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 406 (2007); Graham, 383
U.S. at 17–18. In rejecting the position that a patent
challenger is capable of “shifting both the burden of
production and the burden of persuasion” to the
patentee upon a certain showing, Microsoft, 564 U.S.
at 103 (internal quotation marks omitted), this Court
has affirmed that “a defendant raising an invalidity
defense b[ears] ‘a heavy burden of persuasion,’
requiring proof of the defense by clear and convincing
evidence,” id. at 102 (quoting Radio Corp. of Am. v.
Radio Eng’g Labs., 293 U.S. 1, 8 (1934), as modified
on denial of r’hrg (Oct. 8, 1934)).
Instead of anchoring its analysis to the
presumption of validity and a patent challenger’s
burden to show obviousness clearly and convincingly,
the Federal Circuit’s approach relies on an improper
burden-shifting framework. Under that approach, as
long as the patent challenger makes a prima facie
showing of obviousness, the burden of production—
and in effect persuasion—shifts to the patent holder to
prove that secondary considerations refute that prima
facie showing. See App. 81a; see also Pet. 26, 29. By
shifting the burden and discounting objective indicia
of non-obviousness, the Federal Circuit’s test raises a
particular risk of impermissible hindsight bias. Under
the Federal Circuit’s approach, patents on even the
most novel inventions risk being invalidated when
challenged.
B. This Case Presents an Ideal Vehicle for
Addressing the Question Presented.
This case presents an ideal vehicle for the Court
to clarify the proper standards for determining when
a patented invention is obvious. The case brings into
sharp focus the serious consequences of the Federal
Circuit’s burden-shifting approach, which relaxes the
standards for demonstrating obviousness. There also
can be no doubt that the time is ripe for this Court’s
intervention. Despite the extraordinary importance of
this case, the Federal Circuit views its burden-shifting
approach to be so entrenched that it summarily
affirmed without even issuing an opinion.
If Amarin’s drug is not entitled to patent
protection, no drug manufacturer can be confident
that its patented inventions will withstand an
obviousness defense. Amarin’s drug indisputably
addresses a previously unmet medical need and took
hundreds of millions of dollars to develop.
https://www.supremecourt.gov/DocketPDF/20/20-1119/170936/202…
Amarin Gets Outside Help in High Court Bid to Save Drug Patents
- Petition will Gerichte zur Anwendung von Offensichtlichkeitskriterien zurücksetzen
- Amici sagen, der Fall könnte der Medikamentenentwicklung und anderen Innovationen schaden
https://news.bloomberglaw.com/us-law-week/amarin-gets-outsid…
Sehr gut Bernie, die scripts bleiben bei Vascepa auf hohem Niveau, hochgerechnet würde Amarin knapp 700 Millionen US Dollar 2021 revenues bei diesen scripts generieren, dazu EU und China!
Die derzeitige Marktkapitallisierung ist ein Witz, Manipulation hoch 10!
Alle Biotech/Techwerte werden gerade an der Nasdaq geschlachtet, kommt schon wieder und Amarin mit der vor der Tür stehenden EU-Zulassung noch stärker!
Schönes WE allen Amarinos!
Die derzeitige Marktkapitallisierung ist ein Witz, Manipulation hoch 10!
Alle Biotech/Techwerte werden gerade an der Nasdaq geschlachtet, kommt schon wieder und Amarin mit der vor der Tür stehenden EU-Zulassung noch stärker!
Schönes WE allen Amarinos!
Sripts for week ending February 26, 2021: ( von rafunrafun auf ihub)
Vascepa
TRx 83,843; +12.8%
NRx 39,315; +19.1%
Ref 44,529; +7.70%
Generic Vascepa
TRx 8,720; +0.1%
NRx 5,040; +3.9%
Ref 3,680; -4.8%
Lovaza (Generic & Brand)
TRx 62,454; +9.80%
NRx 32,514; +15.2%
Ref 29,941; +4.50%
Vascepa
TRx 83,843; +12.8%
NRx 39,315; +19.1%
Ref 44,529; +7.70%
Generic Vascepa
TRx 8,720; +0.1%
NRx 5,040; +3.9%
Ref 3,680; -4.8%
Lovaza (Generic & Brand)
TRx 62,454; +9.80%
NRx 32,514; +15.2%
Ref 29,941; +4.50%
Antwort auf Beitrag Nr.: 67.298.199 von Stevo0815 am 04.03.21 09:24:09
Bei der vielfältigen !!! Wirkungsweise von Vascepa und den sich daraus ergebenden Vermarktungs-Aussichten in Europa ( ab 4/21) , USA , Kanada , China ( ab 12/21 ?) etc. ist es m.M.n. durchaus denkbar, dass ein BP Interesse daran haben könnte, AMRN zu übernehmen.
Und wie immer:
Time will tell
Zitat von Stevo0815: Dem kann ich mich nur anschließen, aber wäre Amarin in der Verfassung wirklich ein Übernahmekandidate?
Ich hoffe auf die europäische Zulassung . wovon wir jetzt doch nach der CHMP Empfehlung alle ausgehen
...........und stapel lieber tief.
Bei der vielfältigen !!! Wirkungsweise von Vascepa und den sich daraus ergebenden Vermarktungs-Aussichten in Europa ( ab 4/21) , USA , Kanada , China ( ab 12/21 ?) etc. ist es m.M.n. durchaus denkbar, dass ein BP Interesse daran haben könnte, AMRN zu übernehmen.
Und wie immer:
Time will tell
Trading Spotlight
Antwort auf Beitrag Nr.: 67.295.916 von lobberland am 04.03.21 07:21:34
Lobby , ich würde sagen.....mehr als perfekt...😉
Zumindest scheinen ja 5 Punkte der Hypothesen in dem Artikel bei AMRN zu "greifen" - was aber nicht heißen soll, dass ein Buyout schon im Anmarsch ist.
1. Das Management unternimmt keine Anstrengung , den Aktienkurs zu verteidigen
2. Beiträge in den sozialen Medien sind übermäßig pessimistisch und fordern die Absetzung des CEOs.
3. Wilde Schwankungen des Aktienkurses.
7. Bizarrer Kursverlauf vor bevorstehenden Meilensteinen.
10. Ihre Aktie hat sich von der Realität abgekoppelt
Zitat von lobberland: Das wäre perfekt ☺
Lobby , ich würde sagen.....mehr als perfekt...😉
Zumindest scheinen ja 5 Punkte der Hypothesen in dem Artikel bei AMRN zu "greifen" - was aber nicht heißen soll, dass ein Buyout schon im Anmarsch ist.
1. Das Management unternimmt keine Anstrengung , den Aktienkurs zu verteidigen
2. Beiträge in den sozialen Medien sind übermäßig pessimistisch und fordern die Absetzung des CEOs.
3. Wilde Schwankungen des Aktienkurses.
7. Bizarrer Kursverlauf vor bevorstehenden Meilensteinen.
10. Ihre Aktie hat sich von der Realität abgekoppelt
Dem kann ich mich nur anschließen, aber wäre Amarin in der Verfassung wirklich ein Übernahmekandidate?
Ich hoffe auf die europäische Zulassung und stapel lieber tief.
Ich hoffe auf die europäische Zulassung und stapel lieber tief.
Antwort auf Beitrag Nr.: 67.295.181 von bernie55 am 04.03.21 00:22:39Das wäre perfekt 😊
Antwort auf Beitrag Nr.: 67.258.158 von lobberland am 01.03.21 22:47:40Vielleicht leidet sie unter folgendem Syndrom....
10 Signs Your Company is About to be Acquired
Written By David Ston
Ein wirklich interessanter Artikel....👍
https://www.griproom.com/fun/10-signs-your-company-is-about-…
10 Signs Your Company is About to be Acquired
Written By David Ston
Ein wirklich interessanter Artikel....👍
https://www.griproom.com/fun/10-signs-your-company-is-about-…
Was hat unsere Diva denn heute wieder 🥴
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Amarin - The Science Of Lipid Therapy
