Orexo: Favorable outcome from Zubsolv® patent infringement litigation against Actavis
2016年11月16日 - 5:08PM
ビジネスワイヤ(英語)
Regulatory News:
Orexo AB (publ.) (STO:ORX) announces that the United States
District Court for the District of Delaware ruled in Orexo’s favor
in one of the patent infringement litigations against Actavis
Elizabeth LLC (“Actavis”) regarding Zubsolv in the US. The other
litigations regarding infringement by Actavis on Orexo’s IP for
Zubsolv continues.
Orexo commenced this patent infringement litigation in June 2014
in response to Actavis’s Abbreviated New Drug Application (“ANDA”)
seeking approval to market and sell generic versions of Orexo’s
patented Zubsolv 1.4/0.36 mg and 5.7/1.4 mg buprenorphine/naloxone
products. The Orexo patents in the litigation were US Patent No.
8,454,996 (expiring in September 2019) and US Patent No. 8,940,330
(expiring in September 2032).
The Court held that Orexo’s ‘996 US patent is valid and
infringed by Actavis’s generic Zubsolv 1.4/0.36 mg and 5.7/1.4 mg
buprenorphine/naloxone products. The Court also held that Orexo’s
‘330 US patent is invalid. The decision prevents Actavis from
commercializing their products in the US before September 24, 2019.
However, and importantly, Actavis generic Zubsolv entry on the US
market can be postponed until late 2032 if the decision regarding
validity of the ‘330 patent is reversed on appeal, or if a
favorable decision is reached in the separate litigation involving
Orexo’s US Patent No. 9,259,421. Also, another Zubsolv patent, US
Patent No. 9,439,900, expiring in September 2032, was recently
issued.
Orexo has throughout the patent litigation process maintained a
strong confidence in the strength of our intellectual property.
This first decision by the court enables Orexo to continue to
execute on our strategy for Zubsolv, and making this product the
preferred treatment for more patients. Orexo will continue to
vigorously defend Zubsolv in the other on-going litigation
processes against Actavis and will consider whether to appeal the
portion of the decision relating to the validity of the ‘330
patent.
“With the validation and proven infringement of the ‘996 patent
we will be able to continue our current strategy and leverage the
opportunities arising from patients gaining expanded access to
treatment in the US until at least late 2019. While I am
disappointed with portions of the court’s decision not to confirm
the validity of the ‘330 patent, I maintain confidence in the
strength of our new ‘421 and ‘900 patents and we are reviewing the
possibilities to reverse the ‘330 decision through appeal with our
lawyers. A positive outcome in the litigation of the new patents
will sustain the exclusivity of Zubsolv until 2032.” says Nikolaj
Sørensen, CEO and President of Orexo AB.
Teleconference
CEO and President Nikolaj Sørensen and EVP and CFO Henrik Juuel
will hold a teleconference today, November 16, 2016, at 3.30pm
CET.
All questions related to the teleconference had to be sent in
advance to ir@orexo.com at latest 2.30pm CET.
To attend to the conference please just dial: (SE) +46
8 5059 63 06, (UK) +44 20 31 394 830 or (US)
+1 866 928 7517.
About Orexo
Orexo is a specialty pharmaceutical company commercializing its
proprietary product Zubsolv® for treatment of opioid dependence in
the US. Zubsolv is an advanced formulation of buprenorphine and
naloxone using Orexo’s unique knowledge and expertise in sublingual
drug delivery. R&D is focusing on reformulation of known
substances to new improved products that meet great unmet medical
needs by using its patented proprietary technologies. Orexo’s
share is listed on Nasdaq Stockholm Exchange Mid Cap (STO:ORX) and
is available as ADRs on OTCQX (ORXOY) in the US. Orexo’s global
headquarters and R&D are based in Uppsala, Sweden.
For more information about Orexo, please visit www.orexo.com or
follow us on Twitter or LinkedIn. For further information about
Zubsolv in the US, please visit www.zubsolv.com.
This information is information that Orexo AB (publ.) is obliged
to make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the contact persons set out above, at 8.55am CET on November 16,
2016
This information was brought to you by Cision
http://news.cision.com
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version on businesswire.com: http://www.businesswire.com/news/home/20161116005627/en/
Orexo AB (publ.)Nikolaj Sørensen, CEO and PresidentTel: +46
(0)18 780 88 00Email: ir@orexo.comorHenrik Juuel, EVP and
CFOTel: +46 (0)18 780 88 00Email: ir@orexo.com
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