›AstraZeneca upbeat on Crestor patent as trial ends
11:24am EST
* U.S. trial ends two days early, judgment due by July
* Analysts see odds in Astra's favour but case is tight
* Loss of patent would deprive Astra of top sales driver
By Ben Hirschler
LONDON, March 4 (Reuters) - AstraZeneca <AZN.L> said on Thursday it was confident of retaining exclusivity on its top-selling cholesterol drug Crestor, after a U.S. trial testing the patent wrapped up two days early.
The case hinges on the intentions of three Japanese staff at Shionogi <4507.T> who worked on patent applications almost two decades ago, before the medicine was licensed to AstraZeneca.
A group of generic challengers argued in the trial, which ended on Wednesday, that the patent was fraudulently obtained, improperly reissued and protected an obvious invention.
But AstraZeneca said it believed the evidence showed no one at Shionogi deliberately concealed information from the U.S. patent office.
"The defendants, in our view, failed to prove their claims. We have, and will continue to, aggressively defend our patent," the drugmaker said in an emailed statement.
Lawyers for the generics companies also put a confident face on the proceedings.
"We are very pleased with the way the evidence went in, particularly the expert testimony on obviousness and the lack of secondary considerations," said Tom Heneghan, an attorney with Merchant & Gould, representing Aurobindo Pharma <ARBN.BO>.
Most industry analysts think AstraZeneca probably has the edge -- but the case is tight and the verdict will depend in part on the degree of intent that the judge decides needs to be shown to prove unfair conduct.
"On balance we believe that AstraZeneca is more likely to prevail than not," Royal Bank of Scotland analysts said in a note on Thursday.
The judge in the Delaware trial, Joseph Farnan, is due to give his verdict before he retires in July.
AstraZeneca's sales of Crestor are forecast to rise to $6.5 billion in 2013 from $4.5 billion in 2009, according to consensus estimates from Thomson Reuters, making it the company's most important sales driver.
But those numbers would be blown out of the water if generics were to enter the all-important U.S. market in mid-2010, instead of after the patent's scheduled 2016 expiry.
The arrival of generic Crestor would also be damaging indirectly to other drugmakers like Pfizer <PFE.N> and Merck & Co <MRK.N>, which have other branded cholesterol medicines whose sales could suffer.
Crestor's generic challengers include Apotex, Aurobindo, Mylan <MYL.O>, Par Pharmaceuticals <PRX.N>, Novartis's <NOVN.VX> Sandoz, Sun Pharmaceutical Industries <SUN.BO>, Teva Pharmaceutical Industries <TEVA.TA> and Watson Pharmaceuticals' <WPI.N> Cobalt.‹
›Tue Jun 29, 2010 6:07pm EDT By Bill Berkrot and Tom Hals
NEW YORK/WILMINGTON, Del., June 29 (Reuters) - A U.S. judge handed AstraZeneca Plc (AZN) a huge victory on Tuesday, finding that the patent on its multibillion-dollar cholesterol fighter Crestor is valid, sending the the British drugmaker's shares up 9 percent.
While industry observers widely believed AstraZeneca was likely to win the case, billions of dollars were at stake [duh] since more than 80 percent of a branded drug's sales quickly evaporate when faced with generic competition.
Judge Joseph Farnan, of the U.S. District Court in Delaware, ruled that generic drugmakers who challenged the patent failed to prove it was invalid because it was an obvious invention. Farnan also ruled that "defendants have not established, by clear and convincing evidence, that the 314 patent is invalid as an improper reissue" of an older patent.
"Judgment will be entered in favor of Plaintiffs and against Defendants on the issues of invalidity and unenforceability of the 314 patent," Farnan concluded in his 44-page ruling.
Crestor, which belongs to the world's most widely used class of medicines called statins, had sales of $4.5 billion in 2009 and is forecast to reach global sales of $6.5 billion in 2013, according to estimates compiled by Thomson Reuters.
"AstraZeneca is pleased with the court's decision upholding the validity of the 314 substance patent," Chief Executive Officer David Brennan said in a statement.
"The court's decision reaffirms the strength of the intellectual property protecting Crestor," Brennan added.
The upheld U.S. patent protecting Crestor, known chemically as rosuvastatin, does not expire until 2016, meaning generic versions will likely not hit the U.S. market before then.
"They have more clarity on the sustainability of the $2 billion-plus of cash flow that the drug generates in the U.S.," said Leerink Swann analyst Seamus Fernandez.
AstraZeneca shares traded on the New York Stock Exchange closed up $4.02, or 9 percent, at $48.74 after the ruling.
The 9 percent jump "looks like a little bit of an overreaction to the positive news," said Morningstar analyst Damien Conover, noting that generic competition for top-selling Astra products still looms, such as its antipsychotic Seroquel next year and Nexium acid reflux drug around 2015.
"I still think there's some rocky waters ahead for the company," Conover said.
AstraZeneca brought the case against several companies seeking to sell cheap versions of Crestor. They included Mylan Inc (MYL.O: Quote, Profile, Research, Stock Buzz), Teva Pharmaceutical Industries Ltd (TEVA.TA: Quote, Profile, Research, Stock Buzz), Sun Pharmaceutical Industries Ltd (SUN.BO: Quote, Profile, Research, Stock Buzz), Aurobindo Pharma Ltd (ARBN.BO: Quote, Profile, Research, Stock Buzz), Par Pharmaceutical Cos (PRX.N: Quote, Profile, Research, Stock Buzz), Watson Pharmaceuticals Inc's (WPI.N: Quote, Profile, Research, Stock Buzz) Cobalt unit, Sandoz -- the generic division of Novartis AG (NOVN.VX: Quote, Profile, Research, Stock Buzz) -- and Toronto-based privately held Apotex.
They either could not immediately be reached or declined to comment on the ruling.
In attempting to prove the Crestor patent was invalid, the generic drugmakers attacked it on the grounds it was an obvious invention, was fraudulently obtained and improperly reissued. The rosuvastatin patent was originally obtained by Japan's Shionogi Seiyaku Kabushiki Kaisha.
The generic drugmakers argued that Shionogi's legal team withheld documents from the U.S. Patent and Trademark Office in order to obtain the patent through deception, but the judge did not buy that argument.
In his ruling, Farnan accepted AstraZeneca's evidence which he said showed instead "a time of confusion, personnel change, and overwork in the Shionogi Patent Department" that led to their lack of disclosures.‹
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