FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of March 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
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by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
US court decision
favours Symbicort patents
3 March 2021 07:00 GMT
US court decision
favours Symbicort in patent litigation
The US District Court for the Northern District of West Virginia
has decided in favour of AstraZeneca in litigation against Mylan
Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery L.P.
(Kindeva), determining that asserted claims in three of
AstraZeneca's patents protecting Symbicort (budesonide/formoterol) in the US are not
invalid.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business
Unit, said: "AstraZeneca is pleased with the Court's decision, and
we maintain full confidence in the strength of our intellectual
property rights protecting Symbicort."
Symbicort US patent trial
In October 2018, AstraZeneca initiated litigation against Mylan and
subsequently against 3M Company (3M) asserting infringement of
various US patents covering Symbicort. In July 2020, Kindeva was added as a defendant
in the action. 3M was voluntarily dismissed from the
case.
In September 2020, Mylan and Kindeva stipulated to patent
infringement to the extent that the asserted patent claims were
found to be valid and enforceable, but reserved the right to seek a
vacatur of the stipulation if the US Court of Appeals for the
Federal Circuit reverses or modifies the District Court's claim
construction. At trial, Mylan and Kindeva contended that each
asserted patent claim is invalid under the US patent
laws.
Symbicort
Symbicort (budesonide/formoterol) is a
combination formulation containing budesonide, an inhaled
corticosteroid that treats underlying inflammation, and formoterol,
a long-acting beta2-agonist bronchodilator with a fast onset of
action, in a single inhaler. Symbicort was launched in 2000 and is approved in
approximately 120 countries to treat asthma and/or chronic
obstructive pulmonary disease (COPD) either
as Symbicort Turbuhaler or Symbicort pressurised metered-dose inhaler (pMDI). In
the US, Symbicort is only approved for use in a pMDI. In
January 2020 AstraZeneca entered an agreement with Prasco, LLC
to distribute an authorised-generic version
of Symbicort in the US.
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology is one of AstraZeneca's three therapy
areas and is a key growth driver for the Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage. The Company aims to transform the treatment of
asthma and COPD by focusing on earlier biology-led treatment,
eliminating preventable asthma attacks, and removing COPD as a
top-three leading cause of death. The Company's early respiratory
research is focused on emerging science involving immune
mechanisms, lung damage and abnormal cell-repair processes in
disease and neuronal dysfunction.
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immunology-driven disease areas. The
Company's growing presence in immunology is focused on five mid- to
late-stage franchises with multi-disease potential, in areas
including rheumatology (including systemic lupus erythematosus),
dermatology, gastroenterology, and systemic eosinophilic-driven
diseases. AstraZeneca's ambition in Respiratory & Immunology is
to achieve disease modification and durable remission for millions
of patients worldwide.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
03 March
2021
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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