Gilead Sciences Inc. (GILD) and units of patent-partner Roche Holding AG (ROG) sued Indian generic drugmaker Natco Pharma Ltd. (NTCPH) for allegedly infringing a U.S. patent for the Tamiflu influenza medication.
Gilead, which gets royalties from Roche Holding for the drug, asked for a court order to block other versions of Tamiflu until the 1998 patent expires in 2017, according to a filing March 14 in federal court in Wilmington, Delaware.
“This action arises because of Natco’s efforts to gain approval from the U.S. Food and Drug Administration to market generic copies” while claiming the Gilead patent isn’t valid, according to the complaint.
In February, Natco became the first company to file an application with U.S. regulators for a generic version of Tamiflu, which logged about $1 billion in U.S. sales in 2009.
Rajeev Nannapeneni, chief operating officer of Natco in Hyderabad, said in a phone interview that he didn’t know about the lawsuit and couldn’t comment further.
The disputed patent -- 5,763,483 -- was issued in June 1998.
The case is Gilead v. Natco, 11cv221, U.S. District Court, District of Delaware (Wilmington).
Astellas Sued for Alleged Scheme to Delay Prograf Generics
Astellas Pharma Inc. (4503) was sued by a drug wholesaler over an alleged scheme to delay generic versions of the immune- suppressant Prograf.
Astellas illegally maintained a monopoly on the market for tacrolimus, which it sells as Prograf, for almost two years by filing a “sham” petition with the U.S. Food and Drug Administration to require safety and efficacy tests for the generics, Louisiana Wholesale Drug Co. said in the complaint.
“The only material difference between generic drugs and their brand name counterparts is price,” lawyers for the wholesaler said in the complaint filed March 15 in federal court in Wilmington, Delaware. “Astellas was keenly aware that it would lose a substantial amount of its sales of Prograf very quickly once AB-rated generics came to market.”
Prograf, given to transplant patients to avoid organ rejection, has faced generic competition since August 2009 in the U.S. when Novartis AG (NOVN)’s Sandoz unit began selling the first copy of the drug. That month, the FDA also denied Astellas’s petition, filed in 2007, which included a request that the regulator require doctors be notified whenever a substitute oral medicine is about to be provided to a transplant patient.
Stan Neve, a spokesman for Tokyo-based Astellas, didn’t immediately return a phone call seeking comment.
The delay in bringing generics to market allowed Astellas to overcharge direct purchasers of Prograf by millions of dollars, Louisiana Wholesale said in the complaint. The company is seeking to represent all direct purchasers in recouping unspecified damages.
On March 7, the U.S. Supreme Court rejected an appeal yesterday from Louisiana Wholesale Drug that sought to press an antitrust suit over a 1997 settlement between Bayer and Barr Laboratories Inc., now part of Teva Pharmaceutical Industries Ltd. (TEVA)
That case was Louisiana Wholesale Drug v. Bayer, 10-762. The new case is Louisiana Wholesale Drug Co. v. Astellas Pharma US Inc., U.S. District Court, District of Delaware (Wilmington).
Rambus Renews Toshiba Patent License Accord for Five Years
Rambus, based in Sunnyvale, California, said in a statement yesterday that it will receive royalty payments based on the shipment of these devices for five years.
The company gets revenue from licensing designs for interfaces that connect semiconductors and from royalty payments for patents it claims cover fundamentals of all memory chips designs.
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Apple Seeks to Register Former Logo as European Mark
The green-skinned apple image was previously used as a logo by the Beatles’ record label Apple Corps Ltd., according to CNet News. Apple Inc., based in Cupertino, California, applied to register the mark in Europe for a range of classifications including games, computer hardware and advertising, CNet News said.
In 2007, Apple filed an application with the U.S. Patent and Trademark Office indicating that it had been transferred the right to use the former Apple Corps logo, according to CNet News.
SRI’s Cleveland Golf Wins Trademark Case Against Web Host
SRI Sports Ltd. (7825)’s Cleveland Golf unit won a trademark- infringement case against a web-hosting firm that supported a website where fake clubs were sold.
Bright Builders Inc., of Orem, Utah, which hosted the www.copycatclubs.com website, was ordered to pay the club company $770,750 in damages. The South Carolina resident who sold the fake clubs was hit with a $28,250 damages judgment.
The suit was filed in August 2009 in federal court in Charleston, South Carolina. The jury delivered its verdict on March 10 and the judgment was entered March 14.
The case was Roger Cleveland Golf Co. v. Christopher Price, 2:09-cv-02119 MBS, U.S. District Court, District of South Carolina (Charleston).
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Obama Seeks Rules for Illegal Video Streaming, More Wiretaps
President Barack Obama asked Congress to clarify whether illegal video streaming for events such as the Super Bowl is a felony and to give the government broader wiretap authority in recommendations released yesterday.
The administration issued 20 legislative suggestions to lawmakers “to improve intellectual property enforcement,” Victoria Espinel, the White House intellectual property czar, said in a statement posted on the White House blog.
The proposal included measures to clarify that “in appropriate circumstances, infringement by streaming, or by means of other similar new technology, is a felony,” the statement said.
The administration also is seeking “wiretap authority for copyright and trademark offenses, which will enhance efforts to fight organized crime and bring their leaders to justice,” Espinel said in the blog post.
The Washington-based International Intellectual Property Alliance estimated in November that the unauthorized use of software within businesses has cost U.S. software companies $30 billion.
Other recommendations in the proposal included increasing criminal penalties for violating intellectual property laws, stealing trade secrets and dealing in counterfeit prescription drugs.
Lawmakers are considering ways to close down websites selling pirated content and products. Senator Patrick Leahy, a Vermont Democrat who is chairman of the Senate Judiciary Committee, plans to reintroduce a bill that would make it easier for authorities to shut so-called rogue websites, which sell stolen content and copycat products.
The U.S. Chamber of Commerce, the nation’s biggest business lobbying group, said it supported the move to clarify “criminal copyright infringement through unauthorized streaming.”
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Trade Secrets/Industrial Espionage
Toyota, Plaintiffs’ Lawyers Near Accord on ‘Crown Jewel’ Code
Toyota Motor Corp. (7203) lawyers and attorneys for plaintiffs suing the automaker over claims of unintended sudden acceleration told a judge yesterday they are close to resolving a major hurdle in pre-trial evidence-gathering.
Company attorneys said they have come up with a new concept for providing the plaintiffs’ attorneys access to Toyota’s secret source codes for the electronic throttle-control system, which the plaintiffs have said in court papers is critical to determining whether the system played a part in sudden acceleration.
The concept was described during the hearing by the lawyers as a technological procedure in which the plaintiffs’ experts will be able to analyze the source code while Toyota monitors the procedure in a way that satisfies the company’s security concerns. Both sides told the judge they were optimistic this would resolve a dispute that has lasted more than 2 1/2 months.
“This seems to be an infinitely better idea from a lot of aspects,” U.S. District Judge James V. Selna in Santa Ana, California, said at a hearing yesterday. Selna, who has been pushing to have the first cases go to trial in early 2013, scheduled a March 22 hearing to approve the final form of the proposal and iron out any disagreements.
Toyota, the world’s largest automaker, recalled millions of U.S. vehicles last year and in 2009, most for defects related to unintended acceleration. It paid a record $48.8 million in fines for how some of the recalls were conducted. The carmaker, based in Toyota City, Japan, said last month that it’s recalling another 2.17 million vehicles in the U.S. for carpet and floor- mat flaws that could jam gas pedals.
Access to the source code, which is the programming for the throttle system, has been described by the judge as one of the key issues to be resolved in order to bring the first cases to trial on schedule. The judge has ruled that the plaintiffs’ lawyers have a right to review the code to allow their experts to determine whether the system caused the acceleration problems.
Toyota lawyers have said they want sufficient safeguards to prevent the codes, which are trade secrets, from becoming public and available to their competitors.
“The source code is probably the most important part of the science aspect of this case,” Mark Robinson, one of the lead plaintiffs’ attorneys told the judge. Robinson described the new proposal as a “brilliant idea.”
Toyota’s source code is “the crown jewel of the company’s intellectual property and deserves the highest levels of protection and oversight during discovery,” Celeste Migliore, a Toyota spokeswoman, said in an e-mailed statement. “The plaintiffs’ convenience should not outweigh Toyota’s ability to rigorously guard the confidentiality of this code.”
The cases are combined as In re Toyota Motor Corp. Unintended Acceleration Marketing, Sales Practices and Products Liability Litigation, 8:10-ml-02151, U.S. District Court, Central District of California (Santa Ana).
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