Medicines Co. won a court ruling that may provide an additional four years of patent protection on its anticoagulant drug Angiomax, which accounts for almost all of the company’s revenue.
U.S. District Judge Claude Hilton in Alexandria, Virginia, said the Patent and Trademark Office misinterpreted federal law when it found that Medicines Co. missed a deadline to file to extend the patent term.
Medicines Co. sued in March after the patent office refused to grant the extension and instead said the patent would expire May 23. Under that decision, generic versions could have been sold as early as November. U.S. sales of Angiomax accounted for 95 percent of Medicine Co.’s revenue last year.
The company said the patent should remain in effect until December 2014 to compensate for the time it took to get regulatory approval for Angiomax.
The dispute focused on how government agencies calculate deadlines. Under federal law, drugmakers have 60 days to seek extensions on the life of their patents to compensate for the time it takes to get regulatory approval for medicines. Angiomax was approved by the Food and Drug Administration in December 2000 and the company sought the extension.
The patent office said that the application was two days late and refused the request. Parsippany, New Jersey-based Medicines Co. denied that it missed the deadline, saying the FDA and patent office counted wrong.
“Congress intended for the applicant to have 60 days,” Hilton wrote. “The PTO interpreted the statute in a manner that deprives the applicant the 60 days that Congress intended for them to receive.”
Part of the argument has been whether the 60-day requirement means calendar days or business days. Hilton said it should mean business days.
Yesterday Judge Hilton ordered the patent office “to consider the Medicines Company’s patent term extension application timely filed.”
Teva Pharmaceutical Industries Ltd., the world’s biggest generic-drug maker, and Fresenius SE’s APP Pharmaceuticals are seeking to sell copies of Angiomax and oppose any extension. Medicines Co. has sued the companies, claiming the generic versions would infringe another patent that expires in 2029.
The patent covers the composition of matter, meaning the drug’s active ingredient, and “is the one that’s considered unassailable” to blocking generic competition, Chief Executive Officer Clive Meanwell said in a March 22 interview.
Angiomax had U.S. sales of $382.9 million, or 95 percent of total revenue, and $18.3 million outside the U.S. in 2009. The company’s only other medicine, Cleviprex to control severe blood pressure in people having a stroke or heart attack, was introduced in September and has since been subject to recalls.
Medicines Co. has cut 61 jobs and halted trials of Angiomax for open-heart surgery, clogged arteries in the legs and in preventing strokes, Meanwell said in March. The medicine is injected in patients undergoing emergency angioplasty surgery to reduce heart attacks or blood clots during the procedure.
The case is The Medicines Co. v. Kappos, 10cv286, U.S. District Court for the Eastern District of Virginia (Alexandria).
Patients Ask Government to Open Genzyme’s Fabrazyme Patents
A group of patients with a rare enzyme disorder have asked the Department of Health and Human Services to break Genzyme Corp.’s exclusive license to the patent for the drug that treats their illness.
The patient group, represented by C. Allen Black Jr., of Allison Park, Pennsylvania, said Genzyme’s Fabrazyme is the only effective treatment for Fabry disease. They submitted their petition to the government Aug. 2.
Their disorder, the result of a genetic defect, leaves patients missing an enzyme needed to metabolize fats properly and leads to kidney failure and degenerative heart disease. The disease affects 1 in 40,000 to 60,000 males, and, less frequently, females, according to the National Institutes of Health. Untreated, most patients with the disease don’t live past the age of 50.
Genzyme, based in Cambridge, Massachusetts, and the world’s largest maker of enzyme-replacement therapies, began rationing Fabrazyme after production was cut following the discovery in June 2009 that the plant where the drug was produced was contaminated with a virus. Then in November contaminants were found in a batch of Genzyme’s Fabrazyme. Genzyme is still unable to meet the demand for the drug, and members of the patient group say their dosage has been cut by 70 percent, leaving them with a return of symptoms and risk of cardiac and renal failure.
In June, the company said in a regulatory filing that it couldn’t produce enough Fabrazyme to meet demand for the next three months. The company agreed to pay $1.75 million to the U.S. government for manufacturing violations at the plant, and must have special government oversight of its manufacturing process for seven years, according to the petition.
The patient group asked that Genzyme’s exclusive license to patents 5,356,804 and 5,560,757 be opened so that “responsible entities” could use the technology to make, import, export and sell the drug. Under a provision of the 1980 Bayh-Dole Act that permits entities whose research is funded with federal dollars to retain title to inventions stemming from that research, the patients are asking that additional licenses be granted.
“If we are able to interest manufacturers, we can end or lessen the shortage,” Black said in an e-mail. In the event Genzyme rectifies its problem, a backup supplier is needed so that if the company runs into trouble again, “there is still a drug source for patients.”
According to the database of the U.S. Patent and Trademark Office, the two patents were issued to the Mt. Sinai School of Medicine of the City University of New York.
Genzyme didn’t immediately respond to an e-mailed request for comment. In a June 29 regulatory filing, the company said it would have a shortage of the drug through September, making Fabrazyme unavailable “in many regions.” The company said it expected the available supply of the drug “will increase later in the year.”
The Massachusetts company has begun takeover talks with Sanofi-Aventis SA.
Boeing Receives U.S. Patent on Pivotable Aircraft Engine
Boeing Co., the world’s biggest aerospace company, received a patent for a technology that permits an aircraft engine to pivot while in use on the aircraft.
Patent 7,766,275, one of 5,070 U.S. patents issued Aug. 3, is for an aircraft with an engine connected pivotally to the fuselage adjacent to the plane’s rear end. Having an engine that can be pivoted can facilitate maneuvers between vertical and forward flight, according to the patent.
This configuration can also improve landing and takeoff, Boeing says in the patent, and will facilitate aircraft assembly and maintenance. A pivotable engine can be accessed from the ground more easily than one in a fixed position, according to the patent.
Boeing applied for the patent in June 2006. No outside counsel is listed on the patent.
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AOL Loses Trademark Challenge Over Advertising.com
AOL Inc. lost a trademark challenge to a California advertising-services company.
The 9th U.S. Circuit Court of Appeals overturned a lower court that had ordered Advertise.com to stop using a name that was “confusingly similar” to AOL’s Advertising.com trademarks.
In the appeals court’s Aug. 3 ruling, Circuit Judge Betty B. Fletcher wrote that AOL’s advertising.com mark wasn’t sufficiently distinctive to be worthy of protection. She said the lower court abused its discretion by granting AOL’s request to bar the use of advertise.com.
The case is Advertise.com Inc., v. AOL Advertising Inc., 10-55069 and 10-55071, 9th U.S. Circuit Court of Appeals (San Francisco). The lower court case is Advertise.com Inc., v. AOL Inc., 2:09-cv-05983-VBF-CW, U.S. District Court, Central District of California (Los Angeles).
Google to Allow Trademarks as Keywords Following EU Ruling
Google Inc. will allow advertisers on its sites across Europe to use trademarked terms as “keywords” that link Internet searches to ads.
The policy change brings Google’s trademark practice in Europe in line with company rules in about 190 countries, including the U.S., Canada, the U.K. and Ireland. The change, effective from Sept. 14, follows a ruling by the European Union’s highest court in March that Google doesn’t breach EU law by selling trademark-protected names as keywords.
“This change allows us to harmonize our policies across the world,” said Ben Novick, a spokesman for Google, in a statement yesterday. “Users will benefit by seeing more relevant ads following a search on Google.”
The Luxembourg-based European Court of Justice, the highest court for the 27-nation EU, had ruled search engines such as Google could be liable for trademark breaches if they are aware of storing infringing terms and fail to act. LVMH Moet Hennessy Louis Vuitton SA had accused Google of violating the luxury- goods maker’s trademark rights by selling protected words as keywords that then link users to websites selling counterfeit items when they search under the company’s brands.
Google, which is based in Mountain View, California, gets most of its revenue from advertising.
While the March ruling cleared Google of violating EU trademark rules, it left it up to national courts to analyze on a case-by-case basis whether the role played by Google as an Internet host is “of a mere technical, automatic and passive nature” in processing potentially infringing data.
Google said yesterday any trademark owner that believes a third-party ad in Europe confuses users about the origin of the good or service can also file a complaint. The ad will be removed if Google agrees, it said.
The March ruling had been the first time the EU’s top court ruled on the rights of companies such as LVMH to prevent search engines in the 27-nation region from distributing protected names as keywords.
Google stores ad content on its systems, which the court said may make the company liable for trademark breaches if national judges find it plays an “active role” in creating the promotions.
LVMH had accused Google of violating the luxury-goods maker’s trademarks by linking users who search for “Vuitton” and “LV” to Web sites selling counterfeit fashion accessories.
Puma Sued, Accused of Infringing Keds’ Stripe Trademark
The case involves a stripe used on Keds shoes. Stride Rite’s SR Holdings LLC, which holds the trademark, said the “power stripe” at issue has been used on Keds footwear since 1968.
Puma’s Alexander McQueen Scarred Street Shoes contain “numerous replicas” of the stripe, according to the complaint filed Aug. 3 in federal court in Boston. Puma hired U.K. designer Alexander McQueen in 2005 to create a line of shoes. McQueen died in February 2010.
SR claimed Puma has been aware of the alleged infringement since June 2009 and “refused to cease selling shoes that bear SR’s protected design,” according to court papers. The alleged infringement is confusing customers and “greatly and irreparably damaging” SR, the company said.
In addition to seeking a court order barring future infringement of the trademark, SR asked the court to demand impounding and destruction of all allegedly infringing Puma products and promotional materials. The company also asked for money damages, including extra damages to punish Puma for its actions, and for awards of attorney fees and litigation costs.
The case is SR Holdings LLC v. Puma North America Inc., 1:10-cv-11301, U.S. District Court, District of Massachusetts (Boston).
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