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Company AstraZeneca PLC
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US court says one PULMICORT patent invalid

Released 07:00 02-Apr-2013
Number 2822B07

RNS Number : 2822B
AstraZeneca PLC
02 April 2013
 



US DISTRICT COURT RULES ONE PULMICORT RESPULES® (BUDESONIDE INHALATION SUSPENSION) PATENT INVALID AND ANOTHER PATENT NOT INFRINGED

 

AstraZeneca today announced that the United States District Court for the District of New Jersey ruled that AstraZeneca's US Patent No. 6,598,603 ("the '603 patent"), protecting PULMICORT RESPULES in the US, is invalid. The Court further ruled that the generic defendants involved in the litigation do not infringe AstraZeneca's second patent, US Patent No. 7,524,834 ("the '834 patent"). 

 

"AstraZeneca strongly disagrees with the Court's decision," said Paul Hudson, Executive Vice President, North America. "AstraZeneca has full confidence in the strength of its intellectual property rights protecting PULMICORT RESPULES.  AstraZeneca is considering next steps, including an appeal of the Court's decision."

 

The decision is limited to the US and has no impact on the validity of patents related to PULMICORT RESPULES in other countries. This decision will not change AstraZeneca's revenue guidance for 2013, which is that the company anticipates a mid to high-single digit decline in revenue on a constant currency basis (Full Year 2012 PULMICORT RESPULES US sales were $136 million).  In the event that additional generics enter the market, this would materially impact royalties received on sales of Teva's generic version of PULMICORT RESPULES. These royalties represented an annualised value of approximately $260 million in 2012 under the Core Other Income line in the company's annual report and accounts. Subject to additional generics entering the market, our guidance for Core Other Income in 2013 is now that it could be significantly below $600 million. The company still expects Core EPS to decline significantly more than revenue in 2013.  

 

The patents protecting PULMICORT RESPULES expire in 2018, with paediatric exclusivity extending into 2019.

 

About the trial

AstraZeneca filed patent infringement lawsuits against Apotex Inc.; Apotex Corp.; Watson Laboratories and Breath Limited; and Sandoz, Inc., for infringement of US patents directed to methods of use and formulation and form of active ingredient (budesonide) for PULMICORT RESPULES.

 

Two of the manufacturers, Apotex and Watson/Breath, had received FDA approval. Neither manufacturer launched its generic product. Apotex was previously enjoined from launching a generic product. Under agreement with AstraZeneca, Teva has a generic PULMICORT RESPULES product in the market. 

 

At the trial, AstraZeneca contended that the defendants' generic budesonide inhalation suspension products and their use will infringe the claims of the two AstraZeneca patents, should those defendants market their generic products in the US. The defendants denied that they will infringe and asserted that each patent is invalid under the US patent laws.

 

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

 

CONTACTS

 

Media Enquiries

Esra Erkal-Paler                          +44 20 7604 8030 (UK/Global)
Vanessa Rhodes                         +44 20 7604 8037 (UK/Global)

Ayesha Bharmal                          +44 20 7604 8034 (UK/Global)

Tony Jewell                                +1 (302) 885 2677 (US)

Jacob Lund                                  +46 8 553 260 20 (Sweden)

 

Investor Enquiries

James Ward-Lilley                      +44 20 7604 8122    mob: +44 7785 432613

Karl Hård                                    +44 20 7604 8123  mob: +44 7789 654364

Colleen Proctor                           + 1 302 886 1842     mob: +1 302 357 4882

Ed Seage                                    + 1 302 886 4065     mob: +1 302 373 1361

 

2nd April 2013

 

 

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This information is provided by RNS
The company news service from the London Stock Exchange
 
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US court says one PULMICORT patent invalid - RNS