Watson Pharmaceuticals Inc. (WPI) may begin immediately marketing a generic version of Takeda (4502) Pharmaceutical Inc.’s diabetes drug Actos, a federal judge ruled, handing the U.S. Food and Drug Administration a defeat.
U.S. District Judge Amy Berman Jackson in Washington yesterday overturned an FDA decision that kept Watson from sharing the exclusive period granted companies that are first to file for the right to market generic versions of branded drugs. Actos is the world’s top-selling diabetes medicine.
Jackson ordered the FDA to immediately allow Watson to participate in what remains of the 180-day exclusivity period awarded previously to competitors Mylan Inc. and Ranbaxy Laboratories Ltd. Only the order was made public. Jackson sealed her opinion, pending arguments by the parties, because trade secrets were disclosed in the litigation.
Watson sued the FDA in August, claiming the agency’s decision to bar it from participating in the exclusivity period was “arbitrary, capricious and contrary to law,” according to the company’s complaint.
Sandy Walsh, a spokeswoman for the FDA, said she was unable to comment immediately on the ruling.
Actos is the trade name of pioglitazone hydrochloride, the diabetes medicine marketed by Osaka, Japan-based Takeda. Actos had sales of about $3.4 billion in 2009, Watson said in court papers, citing market researcher IMS Health.
Watson and its two competitors reached a settlement with Takeda in 2010 after “protracted” patent litigation, which allowed it to start selling the generic version of the drug on Aug. 17, 2012, according to court documents. Based on the settlement and communications with the FDA, the Parsippany, New Jersey-based company was preparing to sell its pioglitazone product and promised delivery to customers, according to the complaint.
In August, the FDA “informed Watson it had reached a decision to award another filer or filers a period of 180-day exclusivity,” according to Watson’s complaint. “FDA has failed to provide any explanation or basis for its determination,” the company claimed.
Generic-drug companies are given six months of limited competition under the Hatch-Waxman Act, passed in 1984 to promote quick applications that will lower the price of drugs. The concession gives drugmakers the ability to keep prices close to the branded level and set up distribution networks before others enter the market. When more than one company files at the same time, they may be granted shared exclusivity by the FDA.
The case is Watson Laboratories Inc. v. Sebelius, 1:12-cv- 01344-ABJ, U.S. District Court, District of Columbia (Washington).
Volcano Pursues Countersuit Against St. Jude in Patent Trial
Volcano Corp., a maker of cardiac catheter devices, asked a jury to find that its patents were infringed by rival St. Jude Medical Inc. (STJ) three days after defeating patent claims brought by St. Jude.
St. Jude, based in St. Paul, Minnesota, initially sued San Diego-based Volcano in federal court in Wilmington, Delaware, in July 2010, alleging violation of patents for wires threaded through blood vessels for diagnosis of heart disease. Volcano countersued, pursuing claims over three patents against St. Jude.
After a week-long trial, a jury decided Oct. 19 that Volcano didn’t infringe two St. Jude patents and that two others were invalid, according to a Volcano filing. Trial on Volcano’s claims began yesterday with a new jury.
Volcano “invented the technology” for the wires and sensors, its lawyer, Frank E. Scherkenbach, told jurors in his opening statement. He said St. Jude’s products “perform substantially the same way.”
St. Jude is “a true innovator,” countered lawyer John Allcock, representing St. Jude, in his initial presentation to the jury. “They came up with a revolution” in heart treatment.
U.S. District Judge Richard G. Andrews ordered two trials, the latest scheduled to last through the week.
St. Jude, with about $5 billion in revenue last year, said last week it may get a regulatory warning letter about a defibrillator factory in California.
Volcano, with $343.5 million in 2011 revenue, said Oct. 4 it had received clearance to sell a new Visions ultrasound catheter in the U.S. and Europe to help diagnose large-vessel disease.
The original case is St. Jude Medical v. Volcano Corp. (VOLC), 10- cv-631, U.S. District Court, District of Delaware (Wilmington).
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Nordstrom Sues NoMoreRack for Infringing ‘Rack’ Trademarks
Nordstrom Inc., the Seattle-based fashion retailer, sued the operator of a Canadian flash sale site for trademark infringement.
The company objects to the domain name and brands used by NoMoreRack Retail Group Inc. of Vancouver, British Columbia.
According to the complaint filed Oct. 19 in federal court in Seattle, the Canadian company is trying to piggyback on the fame associated with the Nordstrom Rack discount stores. Nordstrom says it now has more than 100 off-price Rack stores in the U.S. and that this unit of the company has become a $2 million-a-year enterprise.
In its pleadings, Nordstrom said that from 15 percent to 20 percent of the goods sold at its Rack units were originally offered in Nordstrom stores, with the remainder being special- purchase merchandise Nordstrom acquired from manufacturers especially for its off-prince unit.
NoMoreRack began offering so-called flash sales in about 2010, Nordstrom said, explaining these are sites where particular sets of merchandise are sold for a short period of time for deeply discounted prices.
The Canadian company is accused of choosing its name “with the intent of trading off the goodwill” associated with Nordstrom’s Rack marks. Nordstrom said it’s harmed by this action and the public is confused.
The two companies have, to no avail, tried to resolve the conflict, Nordstrom said. The Seattle company asked the court for orders barring what it says is infringement of its marks, and awards of money damages, attorney fees and litigation costs.
NoMoreRack didn’t respond immediately to an e-mailed request for comment.
The case is Nordstrom Inc. (JWN), v. NoMoreRack Retail Group Inc., 2:12-cv-01853, U.S. District Court, Western District of Washington (Seattle).
Ferrero Told Pursuing Infringement Damages May Be Waste of Money
Ferrero SpA, the Italian confectioner, has been advised to “just move on” instead of trying to seek damages in a Singapore trademark case involving the “Nutella” trademark, AsiaOne.com reported.
An appellate court in Singapore said that even though the cafe that had offered an espresso drink known as “Sarika’s Nutello” was found to have infringed, that Ferrero might find it expedient not to incur more costs in seeking a damages award, according to AsiaOne.com.
The offending cafe last offered the drink more than two years ago, according to the court, AsiaOne.com reported.
Earlier Singapore’s High Court had found infringement and that at least 30 percent of the potential consumers would be likely to assume some connection existed between Ferrero and the cafe, according to AsiaOne.com.
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ALRC May Have Anti-Copyright Bias, Content Industries Claim
A group appointed to review Australia’s copyright law is accused of conflict of interest and anti-commercial bias, the Australian reported.
A coalition of content industries claims the members of the Australian Law Reform Commission -- academics, consumer advocates and bureaucrats -- lack experience in and understanding of the commercial sphere, according to the newspaper.
They claim no one on the committee will be “directly impacted” by any changes in the law, the newspaper reported.
Rosalind Croucher, who heads the committee, said in response that the committee has agreed to establish set up a group for the entertainment industry to provide input, according to the Australian.
Universal, Pennsylvania Mother Await Case Dismissal Ruling
Universal Music Group’s motion to dismiss a case brought by a mother over a video of her dancing toddler has been argued and is now under submission to a federal judge in San Jose, California.
Stephanie Lenz of Gallitzin, Pennsylvania, sued the music company in July 2007 after Google Inc.’s YouTube video-sharing site removed a video she posted. Universal had objected to Lenz’s use of Prince’s song “Let’s Go Crazy” to accompany her brief piece showing her toddler dancing, and filed a takedown request under the Digital Millennium Copyright Act.
She claimed that copyright law’s “fair use” provision permitted her use of the music.
In March 2012 the court ruled that Lenz -- who is being assisted by the San Francisco-based digital-rights group Electronic Frontier Foundation -- didn’t file the suit in bad faith. Universal at that time had also asked for a dismissal of the case.
According to an Oct. 16 court filing, both parties submitted oral arguments on Universal’s request to dismiss the case. The judge said he will issue a written ruling.
Lenz’s 30-second video is presently available on YouTube.
The case is Lenz v. Universal Music Group Inc., 5:07-cv- 03783, U.S. District Court, Northern District of California (San Jose).
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Trade Secrets/Industrial Espionage
Duke Energy Must Disclose Merger-Related E-Mails, NCUC Orders
Duke Energy Corp. (DUK), a Charlotte, North Carolina-based energy utility company, was ordered to release internal e-mails discussing its $32 million merger with Progress Energy and the firing of Progress’s Chief Executive Officer Bill Johnson, the Charlotte News Observer reported.
The North Carolina Utilities Commission rejected the company’s contention that these e-mails should be protected from disclosure because they contain company trade secrets, according to the News Observer.
The commission said in an Oct. 19 order that there was no evidence that anyone could benefit economically from disclosure of the e-mails, the newspaper reported.
The order gave Duke 10 days to reveal the e-mails or go to court and try to halt their disclosure, according to the News Observer.
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