21.06.2022 21:16

Novartis plans to petition the U.S. Court of Appeals for the Federal Circuit for further review to uphold validity of the Gilenya® (fingolimod) dosing regimen patent

Folgen
Werbung

Ad hoc announcement pursuant to Art. 53 LR

Basel, June 21, 2021 — Today, Novartis announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a new, negative decision regarding the validity of US Patent No. 9,187,405, covering a dosing regimen for Gilenya. Novartis plans to file a petition seeking further review of this decision.

In August 2020, the U.S. District Court for the District of Delaware issued a favorable decision in the Gilenya patent litigation and a permanent injunction was granted against HEC Pharma until the expiration of the ‘405 patent in December 2027 (including pediatric exclusivity). HEC Pharma was the only remaining Abbreviated New Drug Application (ANDA) filer challenging this patent. 

In January 2022, a three-judge panel of the CAFC issued a decision upholding the validity of the dosing regimen patent. HEC filed a petition for rehearing with the CAFC, which today issued a decision from a modified panel reversing its previous decision and now finding the patent invalid.

Novartis intends to vigorously defend the validity of the patent and is considering all available options, including current plans to seek review of this decision by the full CAFC, a process which may take several months.

Previously, Novartis entered into settlement agreements with a number of ANDA filers. Those ANDA filers will be able to launch a generic version of Gilenya on an agreed upon date that is prior to the expiration of the dosing regimen patent or earlier under certain circumstances. As the formal mandate closing the appeal process has not been issued from the CAFC, the permanent injunction granted against HEC remains in place and Novartis believes that HEC and other ANDA filers are not permitted to launch a generic version of Gilenya at this time.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential,” "can,” "will,” "plan,” "may,” "could,” "would,” "expect,” "anticipate,” "seek,” "look forward,” "believe,” "committed,” "investigational,” "pipeline,” "launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com

# # #

Novartis Media Relations
E-mail: media.relations@novartis.com

Amy Wolf
Novartis External Communications
+41 79 576 0723 (mobile)
amy.wolf@novartis.com

 

Julie Masow
Novartis US External Communications
+1 862 579 8456
Julie.masow@novartis.com
Meghan O’Donnell
Novartis Division Communications
+41 61 324 9136 (direct)
+41 79 797 9102 (mobile)
meghan.odonnell@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

Central   North America  
Samir Shah +41 61 324 7944 Sloan Simpson +1 862 345 4440
Nicole Zinsli-Somm +41 61 324 3809 Alina Levchuk +1 862 778 3372
Isabella Zinck +41 61 324 7188 Parag Mahanti +1 973-876-4912

Ausgewählte Hebelprodukte auf Novartis AG
Mit Knock-outs können spekulative Anleger überproportional an Kursbewegungen partizipieren. Wählen Sie einfach den gewünschten Hebel und wir zeigen Ihnen passende Open-End Produkte auf Novartis AG
Long
Short
Hebel wählen:
5x
10x
Name
Hebel
KO
Emittent

Nachrichten zu Novartis AG

  • Relevant
  • Alle
  • vom Unternehmen
  • Peer Group
  • ?

Um Ihnen die Übersicht über die große Anzahl an Nachrichten, die jeden Tag für ein Unternehmen erscheinen, etwas zu erleichtern, haben wir den Nachrichtenfeed in folgende Kategorien aufgeteilt:

Relevant: Nachrichten von ausgesuchten Quellen, die sich im Speziellen mit diesem Unternehmen befassen

Alle: Alle Nachrichten, die dieses Unternehmen betreffen. Z.B. auch Marktberichte die außerdem auch andere Unternehmen betreffen

vom Unternehmen: Nachrichten und Adhoc-Meldungen, die vom Unternehmen selbst veröffentlicht werden

Peer Group: Nachrichten von Unternehmen, die zur Peer Group gehören

Analysen zu Novartis AG

  • Alle
  • Buy
  • Hold
  • Sell
  • ?
21.07.2022Novartis BuyJoh. Berenberg, Gossler & Co. KG (Berenberg Bank)
21.07.2022Novartis Conviction Buy ListGoldman Sachs Group Inc.
20.07.2022Novartis NeutralCredit Suisse Group
20.07.2022Novartis UnderweightJP Morgan Chase & Co.
20.07.2022Novartis SellDeutsche Bank AG
21.07.2022Novartis BuyJoh. Berenberg, Gossler & Co. KG (Berenberg Bank)
21.07.2022Novartis Conviction Buy ListGoldman Sachs Group Inc.
19.07.2022Novartis Conviction Buy ListGoldman Sachs Group Inc.
19.07.2022Novartis BuyJefferies & Company Inc.
13.07.2022Novartis Conviction Buy ListGoldman Sachs Group Inc.
20.07.2022Novartis NeutralCredit Suisse Group
19.07.2022Novartis NeutralUBS AG
01.07.2022Novartis NeutralUBS AG
22.06.2022Novartis NeutralUBS AG
27.04.2022Novartis NeutralCredit Suisse Group
20.07.2022Novartis UnderweightJP Morgan Chase & Co.
20.07.2022Novartis SellDeutsche Bank AG
19.07.2022Novartis UnderweightJP Morgan Chase & Co.
18.07.2022Novartis UnderweightBarclays Capital
15.07.2022Novartis UnderweightJP Morgan Chase & Co.

Um die Übersicht zu verbessern, haben Sie die Möglichkeit, die Analysen für Novartis AG nach folgenden Kriterien zu filtern.

Alle: Alle Empfehlungen

Buy: Kaufempfehlungen wie z.B. "kaufen" oder "buy"

Hold: Halten-Empfehlungen wie z.B. "halten" oder "neutral"

Sell: Verkaufsempfehlungn wie z.B. "verkaufen" oder "reduce"
mehr Analysen
Werbung
Werbung
Werbung
Neue Funktionen als Erstes nutzen
Sie nutzen finanzen.net regelmäßig? Dann nutzen Sie jetzt neue Funktionen als Erstes!
Hier informieren!
Werbung
Börse Stuttgart Anlegerclub
Werbung

Heute im Fokus

DAX geht fester ins Wochenende -- US-Börsen schließen in der Gewinnzone -- BaFin beklagt Mängel bei Deutsche Börse-Tochter -- freenet mit starkem Halbjahr -- VW, Bayer, Rivian im Fokus

Geplanter Konzernumbau beflügelt Peloton. Uniper könnte Versorungslage in Europa mit Tauschgeschäft verbessern. Mercedes-Benz kooperiert mit CATL bei Herstellung von E-Auto-Batterien. SAF-HOLLAND kommt bei Haldex-Übernahme voran. Jungheinrich schlägt Erwartungen. Knorr-Bremse macht deutlich weniger Nettogewinn.

Umfrage

Worüber machen Sie sich derzeit die größeren Sorgen?

finanzen.net zero
finanzen.net zero

Oskar

ETF-Sparplan

Oskar ist der einfache und intelligente ETF-Sparplan. Er übernimmt die ETF-Auswahl, ist steuersmart, transparent und kostengünstig.
Zur klassischen Ansicht wechseln