Mylan Inc. sued the U.S. Food and Drug Administration, seeking to block India’s Ranbaxy Laboratories Ltd. (RBXY)’s exclusive rights to sell a generic version of Pfizer Inc. (PFE)’s cholesterol pill Lipitor, the world’s best- selling medicine.
Mylan and other generic-drug makers should be allowed to enter the market as soon as Lipitor’s patent expires in June because of manufacturing violations at two Ranbaxy factories in India, Mylan said in a complaint filed March 18 in federal court in Washington. Ranbaxy, 64 percent owned by Tokyo-based Daiichi Sankyo Co., fell the most in almost two years in Mumbai.
Ranbaxy has said it’s entitled to 180 days of marketing exclusivity as a reward for being the first to challenge the Lipitor patents. The drugmaker, based in Gurgaon near New Delhi, reached an agreement with Pfizer in 2008 to sell copies of the medicine beginning Nov. 30. The FDA has yet to clear any of the generic competitors as equivalent to brand-name Lipitor.
“It’s the first time someone is openly challenging Ranbaxy’s exclusivity for Lipitor,” said Bino Pathiparampil, a Mumbai-based analyst at India Infoline Ltd. “It is incrementally negative for sure” for Ranbaxy.
Ranbaxy declined to comment on the lawsuit in an e-mail statement.
The six-month period of exclusivity could add as much as $585 million to Ranbaxy’s sales, according to the median of four analysts’ estimates taken before yesterday’s lawsuit. That would make the generic version the biggest product in the Indian drugmaker’s history. Ranbaxy had sales of 85.5 billion rupees ($1.9 billion) last year.
In its complaint, Mylan contends that Ranbaxy isn’t eligible for that marketing exclusivity because of “false and unreliable data” from its manufacturing site in Paonta Sahib, India, used in Ranbaxy’s application for generic Lipitor.
“FDA’s indecision is depriving millions of Lipitor patients access to lower-cost generic Lipitor,” Mylan, based in Canonsburg, Pennsylvania, said in its complaint. It’s “costing the public billions of dollars in savings, and costing generic manufacturers billions of dollars in lost sales.”
Mylan wants a court to force the FDA to say publicly whether Ranbaxy’s application “is tainted by Ranbaxy’s misconduct” and that therefore the application must be denied and the 180-day reward voided. A victory for Mylan would let it enter the market in June, when some of the Lipitor patents expire.
Ranbaxy is working with regulators to resolve outstanding questions and is confident that it will get the FDA approval for its copy this year, Chuck Caprariello, a company spokesman, said in an interview last month.
Lipitor sales fell 6 percent to $10.7 billion last year as generic competitors arrived in Spain and Canada. New York-based Pfizer’s product has been the world’s biggest-selling medicine for the past 10 years.
The case is Mylan Pharmaceuticals Inc. v. U.S. Food and Drug Administration, 11-566, U.S. District Court for the District of Columbia (Washington).
Microsoft Seeks to Block Imports of Barnes & Noble’s Nook
Microsoft Corp. said it filed patent-infringement claims yesterday against Barnes & Noble Inc. (BKS), seeking to block U.S. imports of the Nook e-reader in the latest legal dispute over the Android operating system.
Microsoft said it filed complaints with the U.S. International Trade Commission in Washington and in federal court in Seattle against Barnes & Noble and the Nook’s manufacturers, Foxconn International Holdings Ltd. (2038) and Inventec Co. Ltd. after yearlong licensing talks failed.
The Nook uses Google Inc. (GOOG)’s Android operating system, and is infringing patents “that are essential to the user experience,” Microsoft said in a statement. Microsoft, which makes the rival Windows-based operating system, filed a complaint in October against Motorola Mobility Holdings Inc. over Android-based smartphones.
“The Android platform infringes a number of Microsoft’s patents, and companies manufacturing and shipping Android devices must respect our intellectual property rights,” Horacio Gutierrez, Microsoft’s deputy general counsel for intellectual property and licensing, said in a statement.
Redmond, Washington-based Microsoft has created a patent- licensing program just for Android device manufacturers, Gutierrez said. HTC Corp., which makes phones for both the Android and Windows systems, signed a license with Microsoft last year.
Mary Ellen Keating, a spokeswoman for Barnes & Noble, declined to comment. The Nook is Barnes & Noble’s best-selling product, and sales of the device last quarter drove the company’s first increase in same-store sales since 2007.
Barnes & Noble, the largest U.S. bookstore chain, suspended its dividend last month to invest in its digital unit as more consumers shift to reading e-books.
Foxconn, based in Shenzhen in southern China, is also the world’s biggest contract maker of mobile phones. Inventec, based in Taipei, also makes laptop computers.
In the civil suit, Microsoft claims infringement of five patents and seeks cash compensation and a court order blocking further use of the patented technology.
The disputed patents cover a control window for display tabs that help users find information; get faster downloads of Web pages; and select text and annotate it without changing the underlying document, Microsoft said.
The suit mirrors claims made with the ITC, an independent agency that has the power to block imports of products that infringe U.S. patents. A copy of the ITC complaint wasn’t immediately available.
Google, the world’s largest Internet search company, bought start-up Android Inc. in 2005, bringing in co-founder Andy Rubin, who currently spearheads Google’s Android efforts. Rubin’s team developed Android as an open operating system, which could be used and enhanced by anyone.
Oracle Corp. (ORCL), the world’s second-biggest software company, sued Google last year, claiming the Android system was developed using the Java programming language Oracle obtained when it bought Sun Microsystems Inc.
The civil case is Microsoft Corp. v. Barnes & Noble Inc., 11cv343, U.S. District Court for the Western District of Washington (Seattle).
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Jimmy Buffett’s Margaritaville Seeks ‘Tiger Blood’ Trademark
Margaritaville Enterprises LLC, the Florida company associated with singer Jimmy Buffett, has applied to register “Tiger Blood” as a trademark, according to the database of the U.S. Patent and Trademark Office.
Two applications, filed March 12, are for the use of the mark with energy drinks and vodka. The term has been used frequently by actor Charlie Sheen to refer to a tropical juice made by Xango LLC of Lehi, Utah.
A number of other applications were filed in early March to register “Tiger Blood” as a trademark. Crebit LLC of Newton, Pennsylvania, filed an application March 6 to register the term for “Nutritional Supplements in liquid form and non-liquid form that relieve or prevent fatigue.”
Harcos LLC of Santa Monica filed an application the next day to use the term with dietary and nutritional supplements and on March 8 Advanced Health Sciences of Richmond, Ohio, applied to register the term for the same uses.
On that same day, a group of four applicants said they want to register the term to be used for “beauty beverages.” Several applications were filed by others that same week to use the term on T-shirts and other clothing items.
The TMZ.com celebrity gossip site reports that Xango’s makers are “very nervous” about any association with Sheen, who was recently fired from CBS Corp. (CBS)’s “Two and a Half Men” television program.
Xango didn’t respond immediately to an e-mailed request for comment.
City Of Hope Sues Morris Publishing Over Trademark
Closely held Morris Publishing Group LLC of Augusta, Georgia, is accused of infringing the “City of Hope” mark. The hospital objects to a civic-journalism project of Morris Publishing’s Florida Times-Union newspaper that is called “City of Hope.”
According to the complaint filed in federal court in Jacksonville, Florida, in addition to using the words “City of Hope,” the stick figure that accompanies the words in the newspaper project’s logo is similar to the images used by the hospital.
The hospital says that while it “commends” the publishing company and its Jacksonville newspaper for using “considerable resources to further efforts to research educational issues and find solutions,” the public is likely to be confused by the name and logo similarity.
The publishing company has refused to change the name of its project, according to a letter it sent the hospital that is Included in the court filing. According to the letter, sent by Timothy E. Moses of Hull Barrett PC of Augusta, the logos are not the same, they don’t represent similar services, and they’re used in different geographical areas.
People looking for City of Hope and information about cancer research “would not spend two seconds” looking at the newspaper’s City of Hope website, Moses said in the letter.
City of Hope asked the court to bar the newspaper’s use of “City of Hope” and for an award of the newspaper’s profits derived from the alleged infringement. Additionally, the hospital asked for money damages, attorney fees and litigation costs and for an order for the newspaper to provide and pay for corrective advertisements.
The case is City of Hope v. Morris Publishing Group LLC, 3:11-cv-00190-HLA-0MCR, U.S. District Court, Middle District of Florida (Jacksonville).
Apple Sues Amazon.com Over Use of ‘App Store’ Trademark
Apple, in a complaint filed March 18, accused Amazon.com of trademark infringement and unfair competition and asked for a court order to prevent the company from using the “App Store” name as well as for unspecified damages.
Apple’s App Store offers software downloads by the company and by third-party developers for users of its iPhones, iPods and iPads. There have been more than 10 billion downloads through the service since it was started in 2008, Apple said in the complaint.
Amazon.com since January has started to solicit developers for a future mobile software download service, Apple said. Amazon.com has used “Amazon Appstore Developer Portal” and “Amazon Appstore” in connection with this service, according to the complaint.
Amazon.com representatives didn’t immediately return a call for comment.
Microsoft Corp. (MSFT) is attempting to block Apple’s registration of “app store,” claiming in filings to the U.S. Patent and Trademark Office that the term is now too generic to be afforded protection. In return, Apple has filed documents with the patent office reminding Redmond, Washington-based Microsoft of its own difficulties in trying to register “Windows,” a term opponents also claimed was too generic.
The case against Amazon is Apple v. Amazon.com, 11-1327, U.S. District Court, Northern District of California.
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Winston & Strawn Adds O’Melveny’s Enzminger to IP Practice
Winston & Strawn LLP hired David Enzminger for its Los Angeles IP practice, the Chicago-based firm said in a statement yesterday.
Enzminger, a litigator, has represented clients from the telecommunications, computer hardware and software and manufacturing industries. In addition to patent litigation, he has also handled trademark, trade secret and antitrust cases.
He joins Winston & Strawn from Los Angeles-based O’Melveny & Myers LLP.
Enzminger has an undergraduate degree from the University of Redlands and a law degree from Arizona State University.
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