Amgen Wins Patent
Case On Enbrel® (etanercept)
THOUSAND OAKS, Calif., Aug. 9, 2019 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that the U.S. District Court for the District of
New Jersey has ruled in Amgen's favor on validity of the two patents that
describe and claim Enbrel® (etanercept) and methods for making it. Amgen
affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the
owner and licensor of the two patents, Hoffmann-La Roche Inc., brought the
patent infringement action in Federal Court against Sandoz Inc., Sandoz
International GmbH and Sandoz GmbH (together, Sandoz). Before trial, Sandoz
acknowledged that its biosimilar etanercept infringes seven patent claims in
U.S. Patent Nos. 8,063,182 and 8,163,522. Trial proceeded only on Sandoz's challenges
to validity of those claims. After careful consideration, the Court found that
Sandoz had not met its burden to prove all seven asserted claims invalid.…
Novartis Pharma A.G.,
Novartis Pharmaceutical AG and Novartis AG v. TEVA Nederland B.V., District
Court The Hague, The Netherlands, Judge in Interlocutory Proceedings, 5 July
2019, Case No. ECLI:NL:RBDHA:2019:7792
Teva holds a Dutch marketing authorization for the generic
version of everolimus, named Everolimus Teva. In the SmPC and and the Patient
Information Leaflet of Everolimus Teva, it is stated that everolimus in
combination with exemestane is indicated for the treatment of hormone receptor
positive advanced breast cancer. Novartis invokes EP 603 and EP 246 and
requests an injunction against Teva for medicines containing everolimus that
are indicated for hormone receptor positive advanced breast cancer, or
-alternatively-, that Teva is ordered to remove the indication hormone receptor
positive advanced breast cancer from the marketing authorization. The
injunction is denied as the PI judge rules that there is a real and serious
chance that the invoked patents will be held invalid in proceedings on the
merits (or in opposition / appeal proceedings at the EPO) as it is sufficiently
plausible that the man skilled in the art would have tried the combination of
everolimus and exemestane / aromatase inhibitor with the expectation that this
would work in treating breast cancer…
Gilead loses key
patent claims for Sovaldi in China, opening door to earlier generic entry
A partial patent invalidation by Chinese authorities has
shaken the case Gilead has been building for its hep C star Sovaldi by removing
a key barrier to generic entry. The decision means knockoffs of the highly
effective hep C treatment can arrive as early as next year — rather than 2024,
when the patent was originally set to expire — according to the Initiative for
Medicines, Access, and Knowledge, or I-MAK. I-MAK filed one of the two requests
for patent invalidation cited in the ruling, together with Chinese drugmaker
Fujian Cosunter Pharma.…
Akebia Therapeutics®
Announces Settlement of Auryxia® Patent Litigation with Par Pharmaceutical
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Akebia Therapeutics, Inc.
(Nasdaq: AKBA), today announced that its wholly-owned subsidiary, Keryx Biopharmaceuticals,
Inc., and its licensor Panion & BF Biotech, Inc., have entered into a
Settlement and License Agreement (Agreement) with Par Pharmaceutical, Inc., an
Endo International company (Par). This settlement resolves patent litigation
brought by Keryx and Panion in response to Par’s Abbreviated New Drug
Application (ANDA) seeking approval to market a generic version of Auryxia
(ferric citrate) tablets prior to the expiration of the applicable patents. Pursuant
to the terms of the Agreement, the companies will grant Par a license to market
its generic version of Auryxia in the United States beginning on March 20, 2025
(subject to U.S. FDA approval), or earlier under certain circumstances
customary for settlement agreements of this nature…
Allergan to pay $2.7m
to settle antitrust suit over Asacol
A subsidiary of Irish pharmaceutical company Allergan is to
pay a combined total of $2.7 million to three organisations that were part of
an antitrust class against the drugmaker…
Alkermes Grants
Amneal Generic Rights for Vivitrol
Irish drugmaker Alkermes has entered into a settlement and
license agreement with American generics company Amneal in order to end the
generics maker’s inter partes review of a Vivitrol (naltrexone for
extended-release injectable suspension) patent. The deal wraps up Amneal’s
challenge of the patent and grants the company the non-exclusive right to
manufacture and market a generic version of the narcotic and alcohol addiction
treatment in the U.S. “sometime in 2028 or earlier under certain
circumstances,” Alkermes said. While there are additional terms to the
agreement, they remain confidential. Alkermes’ patent in question is set to
expire in 2029.…
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