Pfizer wins battle over Viagra trademark issue

A European Court has ruled that the name Viaguara cannot be registered as an EU trademark for energy and alcoholic drinks because it is too similar to Pfizer’s erectile dysfunction drug Viagra.

The EU’s General Court ruled that the similarity allowed Viaguara ‘to take unfair advantage of the distinctive character or repute of the trademark Viagra’.

Warsaw-based Viaguara SA applied for an EU trademark in 2005, but was refused. The court has now rejected the company’s appeal. The General Court ruling itself can only be appealed on points of law.

Also because of the medical implications, the court said it would be dangerous to let any confusion exist.

‘Even if the non-alcoholic drinks concerned do not actually have the same benefits as a drug to treat erectile dysfunction, the consumer will be inclined to buy them thinking that he will find similar qualities, such as an increase in libido,’ the court said.

The court concluded that Viaguara SA, by using a mark similar to Viagra was ‘attempting to ride on the coat-tails of that mark in order to benefit from its power of attraction, its reputation and its prestige’. It was also attempting to exploit, ‘without paying any financial compensation’, the marketing effort expended by Pfizer to promote its own products.

In order to avoid potential confusion among pharmaceutical brands, in a separate announcement, Thomson CompuMark, a global leader in trademark searching and brand protection solutions, has launched Global Pharmaceutical Search, a new service providing targeted, global trademark intelligence in a single online report.

Search coverage includes the firm’s proprietary, trademark office records, web and domain name coverage, and US and European regulatory and industry-specific sources, including pharmaceutical names in use. Brand owners can select the registers that match their product strategy, including the US, UK, Spain, France, Germany, Switzerland, Italy, Benelux, and Canada.

Merck to settle Vioxx suits in Canada for CAN$36.8m

Merck & Co has agreed to pay up to CAN$36.8m (US$36.5m) to resolve all lawsuits brought against it in Canada over its former arthritis drug Vioxx.

Merck voluntarily withdrew the medicine from the market in 2004 after clinical trials linked the anti-inflammatory drug to a higher risk of heart attack, stroke and death.

Under an agreement with plaintiffs in Canada, Vioxx users will share a payment of between CAN$11.3m and $26.4m depending on the number of final claimants. A further CAN$10.5m will be set aside for legal fees.

Merck said an independent administrator would evaluate claims for heart attack and sudden cardiac death on an individual basis according to the duration of Vioxx use, age and presence of risk factors. Individual awards for stroke claims will be up to CAN$5,000, the firm said.

Merck said it continues to believe that the evidence shows the company acted responsibly with Vioxx, from the careful study in clinical trials involving about 10,000 patients before its approval by regulatory authorities around the world.

‘This agreement is structured to provide certainty and finality toward resolving Vioxx cases in Canada for a fixed amount,’ said Bruce Kuhlik, executive vice president and general counsel of Merck.

The Canada deal will still have to be approved by the courts.

Drug Maker From China Pleads Guilty

GeneScience Pharmaceutical, a Chinese company, and its chief executive pleaded guilty on Wednesday to federal charges of illegally distributing human growth hormone in the United States, capping a three-year investigation.

In United States District Court in Providence, R.I., they agreed to pay $3 million toward a “Clean Competition Fund” that would support drug-free sports, and $7.2 million in criminal forfeitures.

The company founder, Lei Jin, entered a guilty plea through a lawyer and was sentenced to five years’ probation. The company pleaded guilty to a felony.

GeneScience was implicated in 2007 during “Operation Raw Deal,” a crackdown on the international trafficking of steroids and other illicit body-building drugs.

A lawyer for the company presented a $4.5 million check Wednesday as a forfeiture of assets in the plea agreement. The government had previously seized $2.7 million from New York bank accounts linked to the company’s growth hormone smuggling. The lawyer, John Tarantino, said in an e-mail that he was not authorized to comment.

Mr. Jin did not appear in court, according to Tom Connell, a spokesman for Peter F. Neronha, a United States attorney.

Human-growth hormone is banned in many sports. Mr. Neronha said in a statement, “H.G.H., when distributed and used unlawfully, poses a serious health threat, particularly to young people who ignore the risks of such substances in an effort to enhance athletic performance.”

GeneScience, which identifies itself as China’s most profitable biopharmaceutical company, had distributed a growth-hormone product called Jintropin in China and around the world through the Internet. It continues to operate in Changchun, in northern China, Mr. Connell said.

GeneScience was founded in 1996 by Mr. Jin, a Chinese citizen who held a Ph.D. in pharmaceutical chemistry from the University of California, San Francisco, and had worked as a research scientist at Genentech, one of the world’s leading producers of human growth hormones.

A government complaint says the company and Mr. Jin used e-mail aliases, offshore bank accounts and a network of drug traffickers to illegally distribute millions of dollars worth of human growth hormone in the United States. The distribution had not been approved by the Food and Drug Administration.

The clean competition fund, to be administered by the Rhode Island Community Foundation, would support antidoping in sports, drug screening and clinical research into the long-term effects of human growth hormone, according to a court filing.

A lawyer representing GeneScience did not return phone calls or e-mail.

Grizzly struts his stuff at Harford pharmaceutical firm

His soft brown image has graced the cover of National Geographic. He's a perennial on wildlife calendars, the star in several public service spots to promote bear safety and the mascot for a line of hunting apparel. His is the furry face producers and advertisers turn to when they need a teeth-baring, menacing grizzly.

But at 15, Brody the bear is approaching middle age and dealing with arthritis, which could sideline his career. A pharmaceutical company in Harford County has developed a nutritional supplement for horses that is helping the 1,400-pound Kodiak bear move painlessly and with more agility, his trainer, Jeff Watson, said. Brody prefers his twice-daily Cosequin covered in spaghetti sauce and spread on whole-wheat bread.

To thank Nutramax Laboratories personally, Watson drove Brody 700 miles from his home base in Indiana to the Edgewood company for a private show Wednesday.

Since Brody never left his 26-foot-long cage, the meet and greet with a few hundred employees was confined to the company parking lot. Watson used food to coax the animal into performing, knowing Brody could smell savory fried chicken, his on-the-road fare.

"He knows the food is gonna get good," Watson said. "Eating is his favorite pastime."

Watson contacted Nutramax after using its product, and the company invited him to visit. It was his idea to bring along the bear that he has trained since Brody was a 2-month-old, 10-pound cub. He wanted to demonstrate the bear's increased mobility since taking the supplement, he said, and Brody travels well.

He has appeared on "Good Morning America," the "Tonight Show" and with Chuck Norris and Chris Matthews.

Chris Glase, Nutramax director of corporate services, told the approximate 240 employees a grizzly would be in their midst for the day and quickly squelched several requests for in-cage meetings. A few employees brought children from home and others videotaped Brody for kids who could not miss school. Nathan Schuckmann, 8, who was visiting with family on their way home to St. Louis, took dozens of photos.

"I will remember Edgewood," he said, planning to switch his tiger sweatshirt for a bear one, in honor of his new favorite animal.

Brody stood to his nearly 8-foot stature and dropped his jaw to reveal fearsomely sharp teeth all for the promise of poultry, fried and raw. The audience applauded loudly as the bear offered his paw and shook his head for more treats. Watson was ever wary of the yellow jackets nearby. A bee sting, say on that long tongue, can quickly alter any bear's good humor and provoke a powerful, hurtful reaction, like a swat at the nearest object — most likely the trainer.

In the course of an hour, the bear went through 50 pieces of fried chicken and countless pounds of raw chicken — bones and all. He was offered thick raw carrots, which Brody eschewed and ultimately sat on. After his hefty meal, he took a siesta.

"I think he just ate half a Perdue farm and then laid down for a little nap," said Kirsten Dresser, a sales associate. "I love the way he curls his toes and puts a paw across his face."

Sometimes people see Brody as an overgrown pet, Watson said.

"I just want a little bear hug," said Jeannie Willems, a licensed veterinary technician. "As long as Jeff is right there in the cage, I would get in there with them."

His audience gushed over Brody's lustrous brown coat, his soft amber eyes, curved ears and his slightly upturned nose. "He is a touch magnet," Watson said, as he restricted access to the cage.

When Watson placed his head inside that gaping ursine mouth and rode briefly on Brody's back, he may have enforced that docile teddy bear image the public loves.

"If bears could be domesticated, a lot of people would want one," he said. "He might look cute and cuddly, but he is a tough, wild animal and an opportunistic feeder."

Watson had spread Brody's portfolio across several tables. An impressive resume includes movies like "Grizzly Park" and "The Li'l River Rats," TV and countless commercial credits.

"Does Brody have a girlfriend?" one woman asked.

"No, no family ties," Watson said. "He is taking applications but, for now, prefers to stay focused on his career."

R.I. gains share of drug settlement

The state is receiving $578,295 from a settlement with Novartis Pharmaceuticals Corp. to settle allegations that it engaged in an off-label marketing campaign that improperly promoted one of its drugs, Trileptal, and “engaged in unlawful kickback schemes” to induce doctors to prescribe that drug as well as five others, Attorney General Patrick C. Lynch announced Friday.

Lynch said in a news release that his office will forward $244,391 of that money to the state Department of Human Services, which administers Medicaid, the joint federal-state health insurance program for low-income Americans and certain people with disabilities. The balance of the settlement allocated to Rhode Island represents the federal portion of the Medicaid recovery and will go to the U.S. Department of Human Services.

“This is yet another in a long line of settlements with pharmaceutical companies that are boosting their profits at the expense of a program designed to assist the most vulnerable and needy Americans,” said Lynch. “While the circumstances vary, sheer greed is a common denominator in the exploitation of Medicaid by pharmaceutical manufacturers.”

Novartis Pharmaceuticals, a U.S. subsidiary of Novartis AG, the Swiss drugmaker, announced on Sept. 30 that it had reached a $422.5-million settlement with the U.S. Attorney’s office for the Eastern District of Pennsylvania that was conducting both criminal and civil investigations of the company’s off-label promotion of Trileptal, an anti-epileptic drug approved by the FDA for the treatment of patients who suffer seizures. A government investigation found that Novartis was inducing psychiatrists and other health-care providers to prescribe Trileptal for unapproved uses such as the treatment of bipolar disorder and neuropathic pain and that it also made illegal payments to doctors so that they’d promote and prescribe Trileptal.

The U.S. Attorney’s office also alleged that the company had engaged in civil wrongdoing by providing illegal payments through mechanisms such as payments for speaker programs, advisory boards and gifts, including entertainment and travel and meals to physicians to induce them to promote and prescribe the drugs Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.

The news release put out by Novartis said it had agreed to plead guilty to a misdemeanor charge of misbranding, pay a $185-million fine in connection with promoting uses of Trileptal that were not approved in this country and to pay $237.5 million to resolve the civil allegations involving all six drugs.

Sun Pharma's victory to control Taro an opportunity?

Sun Pharmaceutical Industries Ltd won an Israeli court ruling last week, paving the way for India's top valued drugmaker to take control of Taro Pharmaceutical and boosting its outlook. The verdict eases an overhang over Sun's shares, but uncertainty over the financials of Taro and an ongoing issue with the U.S. Food and Drug Administration over the manufacturing standards at its U.S. unit are key worries for investors.

BOOSTER SHOT

K.K. Mital, head of portfolio management services at Globe capital in New Delhi, said he was asking his clients to buy the share as Taro would give the company a shot in the arm. "The court ruling in Sun Pharma's favour is a positive trigger to bring back investors' interest in the company," he said. Sun shares have climbed almost 16 percent this year, compared with a 14 percent rise in the sector index, and Mital said the price does not reflect the benefits of Taro's acquisition.

According to data from Thomson Reuters StarMine, 14 brokerages have a buy on the stock while six have a sell and 12 have a hold. The verdict will allow Sun to raise its holding in Taro, a generic drugmaker with a strong footing in the U.S. market, to more than 50 percent from 36 percent it now holds.

Sun has spent about $100 million for its current stake, and analysts see the final figure at $150 million-$250 million for the controlling holding. "Taro has a lot of synergy with Sun. It has a strong distribution strength in the U.S. which Sun can use and it has presence in key therapeutic areas," said Bino Pathiparampil, who tracks the stock at IIFL Capital. "The market is not pricing in any of this," he said, adding the deal should add more than 5 percent to Sun's shares.

WATCH YOUR STEP

However, Sun's pending manufacturing standard compliance issue with the U.S. regulator is also a worry. In mid-2009, the U.S. authorities seized drugs made by Sun's U.S. unit, Caraco, for violating manufacturing standards. Last month, the FDA issued a warning to Sun uncovering manufacturing problems at its plant in New Jersey.

"I do not see a quick resolution of the FDA issue," said Sarabjit Kour Nangra, vice president of research at Angel Broking, who rates the stock neutral. "We are not expecting a major upside from Taro. Sun's domestic business is doing fairly well. But any upside, if any, from here on will have to come purely from any exclusive drug launches," she said.

According to StarMine SmartEstimate, which gives more weight to recent forecasts of top-rated analysts, Sun shares are trading at 21.2 times price to earnings, in line with rival Ranbaxy Laboratories' 21.9 times but pricier than Dr Reddy's Laboratories' 20 times. "At current valuations, there's no room for the valuations to expand given the concerns and the muted earnings growth that is expected over the next two years," Nangra said.

Teva Pharmaceutical Industries Broke Out After Court Ruling

Teva Pharmaceutical Industries announced Tuesday morning that the U.S. District Court for the Southern District of New York denied a motion for summary judgment, filed by Sandoz Inc./Momenta Pharmaceuticals Inc., that the patents at issue are invalid for indefiniteness.

Teva Pharmaceutical broke out sharply to the upside around mid-morning Tuesday and finished higher by 1.34 at $53.12 on above average volume. The stock has been climbing for the past week and set a month and a half high.

Eli Lilly Wins Evista Patent Ruling in Teva Case

Eli Lilly & Co. won a ruling that its patents for its Evista osteoporosis treatment are valid, blocking an attempt by Teva Pharmaceutical Industries Ltd. to sell a generic version of the bone-loss drug.

U.S. District Judge Sarah Evans Barker in Indianapolis, in a ruling yesterday, barred Teva from selling the drug in the U.S. before Eli Lilly’s patents have expired. The judge in April temporarily barred Teva from launching its product until she reached a final decision.

The ruling provides protection for Evista through March of 2014, Indianapolis-based Eli Lilly said in a statement. Evista, in which the key ingredient is raloxifene, generated $1.08 billion in global sales last year, the company reported Jan. 29. That includes $700.5 million, or an average of almost $2 million a day, in the U.S.

“We are pleased with the court’s rulings on Evista’s method-of-use patents,” Robert A. Armitage, Eli Lilly’s general counsel, said in the statement yesterday. “We have always been very confident that these patents are valid and enforceable and today’s court ruling sends a clear message on the strength of those patents.”

FDA Approval

Teva, based in Petah Tikva, Israel, received U.S. Food and Drug Administration approval for its generic version of the drug just before the nonjury trial began in March.

Teva, which alleged Lilly’s patents are obvious variations of already known science, had been prepared to begin marketing the drug immediately prior to the Barker’s April ruling blocking the release.

Lilly countered that prior know-how wouldn’t have led drug companies to come up with raloxifene and its property should be protected. Barker agreed, finding Teva infringed its patents and barring Teva from manufacturing and selling the raloxifene product.

“Teva has failed to meet its burden to demonstrate by clear and convincing evidence invalidity of the bone loss patents on the basis of obviousness,” Barker wrote in her 120- page decision.

Teva plans to appeal the ruling, the company said in a statement.

Lilly fell 4 cents to $32.41 at 10:03 a.m. in New York Stock Exchange composite trading.

Teva American depositary receipts, each representing one ordinary share, rose 15 cents to $50.76 in Nasdaq Stock Market trading.

The case is Eli Lilly v. Teva, 06-cv-01017, U.S. District Court, Southern District of Indiana

Major Rollback of Pharmaceutical Bench Mark Prices Approved by Federal Court of Appeals

BOSTON, - Purchasers of pharmaceutical drugs including consumers and health plans will soon enjoy a rollback of benchmark prices of some of the most common prescription medications after a Federal Appeals Court last week affirmed the approval of a settlement with two leading drug-pricing publishers, First DataBank, Inc. and Medi-Span, a division of Wolters Kluwer Health, Inc.

The court's approval clears the way for the pricing rollback to go into effect on Sept. 26, 2009, and could save consumers and other purchasers hundreds of millions of dollars.

The settlement stems from a 2005 class-action lawsuit brought on behalf of health benefit plans and consumers against First DataBank (FDB) and McKesson Corporation, a large pharmaceutical wholesaler. According to the suit filed by Hagens Berman Sobol Shapiro, plaintiffs claimed that the majority of brand name drugs are reimbursed based on a pricing benchmark known as the "average wholesale price" or AWP, a benchmark that the suit claimed was manipulated by the defendants to boost profits.

District Judge Patti Saris of the District of Massachusetts summarized the allegations in her approval order, "[t]ypically, a drug's wholesale acquisition cost or 'WAC' was understood as the price wholesalers paid to purchase a drug from the manufacturer; the WAC was then marked up by a fixed percentage to derive the AWP. Beginning in 2001, FDB and McKesson reached a secret agreement to raise the markup between WAC and AWP from its standard 20 percent to 25 percent for more than 400 drugs. The scheme resulted in higher profits for retail pharmacies that purchased drugs on the basis of WAC but are reimbursed on the basis of AWP."

On June 6, 2007, HBSS settled claims with FDB, a subsidiary of Hearst Corporation. Under the agreement, FDB agreed to rollback pricing by five basis points, from 1.25 to 1.20. The markup over WAC was used to calculate the AWP, the reimbursement benchmark for most widely used prescription drugs, which, in turn, would reduce the price of most medications by four percent. In a later lawsuit, the other large supplier of electronic data files, Medi-Span, agreed to a similar rollback.

First DataBank and Medi-Span have indicated that in addition to the drugs included in the settlement, they also intend to independently rollback the AWP benchmark price of other drugs not covered by the settlement, which should create cost-savings on a much broader range of prescription medications.

An alphabet soup of associations representing the pharmacies and pharmacy benefit managers fought the proposed rollback before federal trial and appellate courts. The National Association of Chain Drugstores, the Pharmaceutical Management Association, the National Community of Pharmacists Association, and others claimed either that small pharmacies would be put out of business through implementation of the rollback, or that the savings to the health plans and consumers would not be large enough to justify the settlement.

The courts rejected these claims and in a ruling on Sept. 4, 2009, affirmed the approval of the settlement. The First Circuit Court of Appeals stated:

"In principle, the rollback makes some sense: it

should -- to the extent that process remain above

some hypothetical market level -- wash out any

remaining inflation for the future; and, to the

extent it forces prices temporarily below the market

level, it will take back some of the windfall profits

obtained (even if innocently through another's fraud)

and give some compensation for past overcharges. The

market forces that eroded excess gains in the past

should also in the future redress unduly low

reimbursement; and to the extent that those forces

operate symmetrically, the gains and the losses may

even tend to balance out."

Separately, Massachusetts Federal Judge Patti J. Saris approved the settlement with the second defendant, McKesson, for $350 million on behalf of the health benefit plans and consumers nationwide.

"The impact of this settlement is very significant for all who have paid for brand name drugs," said Steve Berman, a lead counsel and managing partner at Hagens Berman Sobol Shapiro.

"The First DataBank and Medi-Span settlement shows all payers that the markup differences between WAC and AWP are entirely artificial and thus should be adjusted to ensure the lowest payment for prescription drugs," said Thomas M.Sobol, a lead attorney and managing partner of the Cambridge office of Hagens Berman Sobol Shapiro.

Suit against Pharmaceutical Alternatives dismissed

A civil suit against Pharmaceutical Alternatives Inc. was dismissed in Coshocton County Common Pleas Court this week

The motion to dismiss was filed by Jennifer Monty, an attorney with the Cleveland-based firm of Weltman, Weinberg and Reis Co., representing MedSearch Staffing Services, also of Cleveland.

MedSearch filed the suit June 30, 2008, seeking payment for $8,415, claiming Pharmaceutical Alternatives, doing business as Miller Pharmacy, wrote a check for that amount knowing it would not be honored by the bank, according to court documents.

The case was scheduled for a jury trial Friday morning.

"They had been paid for more than a a year," said Bob Skelton, attorney for Miller Pharmacy.

MedSearch was suing for the amount the check was to have covered, plus 8 percent annual interest, plus attorney fees and court costs, which amounted to $16,830, for a total judgment of $25,245.

In the court documents, Pharmaceutical Alternatives denied doing business as Miller Pharmacy. Though they share the same address for a principal office location -- 234 Main St. -- Miller Pharmacy of Coshocton has been incorporated since 1956 and Barbara Miller is listed as having sole proprietorship of the independent retail pharmacy, according to business filings available through the Ohio Secretary of State's Web site.

Pharmaceutical Alternatives, Inc., was incorporated in 1987, according to its articles of incorporation. B. Elise Miller is listed as the sole incorporator.

Pharmaceutical Alternatives was doing business as Three Rivers Infusion & Pharmacy Specialists until a bankruptcy court ordered the business shut down earlier this year.

The company had filed for Chapter 11 bankruptcy protection late last year, but a trustee stepped in after Elise Miller failed to follow directives of the court.

"The debtor is enjoying the benefits of bankruptcy protection without complying with the requirements of the Bankruptcy Code or the U.S. Trustee Guidelines," bankruptcy court documents state.

A suit also was brought against B. Elise Miller this week by the U.S. Department of Labor. The federal agency is seeking recovery of Individual Retirement Account funds for Three Rivers Infusion employees through the U.S. District Court Southern District Court of Ohio.

The lawsuit states Miller withheld the contributions or failed to remit them in a timely fashion from Aug. 5, 2005, to Jan. 16, 2009, and it seeks to recover all the assets owed to the retirement plan.

SC AG negotiates settlement with pharmaceutical giant

South Carolina Attorney General Henry McMaster says his office is negotiating a settlement with pharmaceutical giant Pfizer.

The drug maker was previously ordered to pay $2.3 billion because of illegal sales tactics, including $331 million to 49 states for their Medicaid programs.

South Carolina was the only state not included in that settlement.

McMaster says he thinks his office can get more money by negotiating their own deal but the attorney general did not say how much.

Negotiations have been going on since spring.

Pharmaceutical giant Pfizer settles with Justice Department, to pay 2.3 Billion in fines

In a record settlement, the U.S. Justice department announced on September 2nd that a settlement has been reached in its prosecution of fraudulent activities by the pharmaceutical company Pfizer and its subsidiaries. The charges included fraudulent marketing and related fraudulent medical insurance claims, as well as kickbacks to healthcare providers for prescribing Pfizer medicines. Pfizer has agreed to pay $1.3 billion in criminal fines and $1 billion for civil violations. Pfizer illegal drug promotion activities included the medicines Bextra, Geodon, Zyvox, and Lyrica. The civil settlement will have Pfizer pay $669 million to Federal agencies and $331 million to state Medicaid programs.

Many of the charges involved promotion of drugs for uses that were not approved by the FDA or other regulatory bodies that set medical treatment standards. This practice of promoting medications for a variety of conditions where benefits and risks have not been sufficiently studied, in order to increase sales and profits, has become a common form of unethical behavior by pharmaceutical companies. Unfortunately, company practices are difficult to monitor. The Pfizer case had been investigated for years following whistleblower tips about the illegal activities. Even when caught and forced to accept fines for these activities the companies may still reap profits well beyond the cost of fines and litigation. Government funds for research and drug development continue to be provided to companies that have been caught engaging in criminal activities, so it seems that existing penalties are not a sufficient deterrent to effectively diminish these corrupt practices.

As within other categories of crime, the abuses exposed in cases such as this one involving Pfizer may be merely the tip of the iceberg. Corruption of drug research, FDA approvals, and product marketing is seen by some as being so entrenched in the health care system that little information about drugs provided to doctors and consumers can be considered reliable. This distrust of pharmaceutical drugs is fueling a growing public demand for natural supplements and alternative therapies. Yet, even in these areas there are profit motives involved and cases of unethical activity that consumers need to be aware of. The best way for consumers to protect themselves is to find a variety of information sources and learn to discern which information is most accurate and reliable. Even a government free of corruption would likely not have adequate resources to effectively police corrupt corporations.

J&J Wins Appeal Reviving Patent on Ultracet Drug

Johnson & Johnson won an appeals court ruling that it can try to use its patent on the Ultracet painkiller to block generic-drug makers including Teva Pharmaceutical Industries Ltd. from selling copies of the drug.

The U.S. Court of Appeals for the Federal Circuit in Washington overturned a finding that the patent was invalid and sent the case back to a lower court for trial. The court did affirm that one aspect of the patent was invalid.

Teva’s Barr unit and Caraco Pharmaceutical Laboratories Ltd. have been selling copies of the medicine for more than three years. New Brunswick, New Jersey-based J&J, the world’s largest health-products company, was trying to get the generic medicines pulled from the market.

Ultracet combines acetaminophen, the main ingredient in Johnson & Johnson’s Tylenol, with tramadol hydrochloride, a compound used in the painkiller Ultram. The patent, which expires in August 2011, covers the ratio between the two components.

The Federal Circuit, in a 2-1 ruling, said there were “material questions of fact” as to whether the combination would have been obvious to researchers. Circuit Judge Haldane Robert Mayer disagreed, saying the patent “does nothing more than combine two well-known pain relievers” into a single tablet.

‘Pleased With Decision’

Johnson & Johnson is “pleased with the decision and looks forward to the additional court proceedings,” said Greg Panico, a spokesman for the company.

Teva spokeswoman Denise Bradley declined to comment, and a representative for Caraco didn’t immediately return a call seeking comment.

Detroit-based Caraco is owned by Sun Pharmaceutical Industries Ltd. of Mumbai. Teva, based in Petah Tikva, Israel, is the world’s biggest generic-drug maker.

The case is Ortho-McNeil Pharmaceutical Inc. v. Teva Pharmaceutical Industries Ltd., 2008-1549 and 2008-1550, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Ortho-McNeil Pharmaceutical Inc. v. Kali Laboratories Inc., 6cv3533, U.S. District Court for the District of New Jersey

Caraco Pharmaceutical Laboratories Ltd. CPD ,The lawsuit alleges the Company failed to disclose problems

Caraco Pharmaceutical Laboratories Ltd. CPD - Holzer Holzer & Fistel, LLC proclaim that a class action lawsuit has been filed in the United States District Court for the Eastern District of Michigan on behalf of purchasers of Caraco Pharmaceutical Laboratories, Ltd. ("Caraco" or the "Company") (AMEX: CPD) who acquired shares between May 29, 2008 and June 25, 2009, inclusive (the "Class Period"). The lawsuit alleges the Company failed to disclose problems it was having complying with certain FDA regulations. Further, the complaint alleges that Caraco misrepresented or failed to disclose material information relating to its efforts to obtain FDA approval for certain of its drugs.

If you purchased shares of Caraco common stock during the Class Period, you have the legal right to petition the Court to be appointed a "lead plaintiff." A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. Any such request must satisfy assured criteria and be made no later than September 15, 2009. Any member of the purported class may move the Court to serve as lead plaintiff through counsel of their option, or may choose to do nothing and remain an absent class member.

Merck Patent on Singulair Asthma Medicine Upheld

Merck & Co. won a court ruling that prevents Teva Pharmaceutical Industries Ltd. from selling a copy of Merck’s best-selling drug, the asthma and allergy treatment Singulair, until August 2012.

U.S. District Judge Garrett E. Brown Jr. in Trenton, New Jersey, today rejected Teva’s arguments that the patent on the main ingredient of the medicine is invalid or unenforceable. The judge said Teva can’t sell a generic version of the drug until the patent expires. Teva, the world’s biggest generic-drug maker, said it is reviewing the decision.

The ruling involving a medicine that had 2008 sales of $4.3 billion gives Merck a needed victory as it faces the loss of patent protection in the next five years on drugs with more than $8 billion in annual sales. The Whitehouse Station, New Jersey- based company is buying rival Schering-Plough Corp. and cutting jobs to boost profits.

The patent covers montelukast, the active ingredient in Singulair. The medicine, approved by the U.S. Food and Drug Administration in 1998, is based on research that showed one way to treat the disease is to block leukotrienes, compounds that cause muscle contraction and increase secretions in the lungs.

Merck “put forth sufficient evidence of the failed attempts of others to develop a leukotriene antagonist,” Brown said in his opinion.

Patent Review

The U.S. Patent and Trademark Office is taking a second look at the patent to see if there’s prior know-how indicating it didn’t cover a new invention. Merck told the court the agency almost always grants requests to reconsider patents. The patent remains valid throughout that process.

“We invest heavily in the research and development that is needed to discover innovative medicines like Singulair, and we will vigorously defend our intellectual property rights,” Merck General Counsel Bruce Kuhlik said in a statement after the ruling.

Merck rose 77 cents, or 2.5 percent, to $31.48 in New York Stock Exchange composite trading. Teva’s American depositary receipts, each representing one ordinary share, rose 66 cents to $51.45.

More than 22 million people in the U.S. have asthma, a chronic disease caused by inflammation of the bronchial tubes, according to the American Lung Association. Narrowed airways can cause coughing and chest tightness and hamper breathing, and in extreme cases it may limit the flow of oxygen to vital organs and lead to death. There is no cure.

Merck Cuts

Teva, based in Petah Tikva, Israel, said in a statement that it’s “currently reviewing the court’s decision to determine its next course of action.”

Singulair accounted for about 18 percent of Merck’s $23.9 billion in 2008 revenue. Schering-Plough shareholders approved Merck’s $46.7 billion takeover offer this month.

Schering-Plough has said it plans to file for approval of seven drugs, which may each generate more than $1 billion in peak annual sales. Merck plans to eliminate 16,000 positions as part of the merger and to help stem the generic losses.

The case is Merck Sharp & Dohme Pharmaceuticals SRL v. Teva Pharmaceuticals USA, 07cv1596, U.S. District Court, District of New Jersey (Trenton).

U.S. sues Teva Animal Health for alleged drug act violations

The federal government today sued Teva Animal Health Inc., saying government inspections had uncovered adulterated animal drugs at the company’s main facilities in St. Joseph.

The lawsuit, filed in the U.S. District Court for the Western District of Missouri, charged that three inspections by the Food and Drug Administration between 2007 and 2009 “documented numerous” Good Manufacturing Practice violations at the facilities.

Denise Bradley, a spokeswoman for the company, said Teva "regretted the deficiencies in our manufacturing practices and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements."

Bradley said those actions included a "complete analysis of each individual product, retraining all of our production employees and revalidating our equipment, processes and methods."

Among other violations, the government's suit alleged that Teva had failed to:

Reject drug products that did not meet established specifications;

Assure that products had the “identity, strength, quality and purity” they are represented to have;

Conduct adequate equipment maintenance;

Provide adequate training for employees; and

Establish a quality control unit.

The suit charged that Teva officials had taken part in five regulatory meetings with the FDA between June 2007 and June 2009 but had “shown that they are unwilling or unable to take the necessary steps to prevent recurrence” of Good Manufacturing Practice violations.

Besides naming Teva Animal Health, the suit names three Teva officials as defendants: David S. Cunningham, president of Teva Animal Health; Kenneth P. Lavin, senior director of regulatory compliance at Teva Pharmaceuticals USA, which owns Teva Animal Health; and Ronald A. Schultz, senior vice president of quality at Teva Pharmaceuticals USA.

A unit of Israeli pharmaceutical giant Teva Pharmaceutical Industries, Teva Animal Health is the largest manufacturer of generic drugs for animals in the United States. Formerly IVX Animal Health, the company was acquired by Teva in 2006.

Sunesis adds to board after private placement

New Enterprise Associates, which invested $2.3 million in Sunesis Pharmaceuticals Inc. during a recent private placement, put Helen Kim on the Sunesis board.

Kim is CEO of TRF Pharma Inc., a privately held business. In the past she was president and CEO of Kosan Biosciences Inc., which was sold to Bristol-Myers Squibb (NYSE: BMY) in 2008.

She also worked previously for Chiron Corp., Protein Design Labs, Affymax and Onyx Pharmaceuticals.

Dan Swisher is CEO of South San Francisco-based Sunesis (NASDAQ: SNSS).

Earlier this month Johnson & Johnson Pharmaceutical Research & Development LLC terminated a research deal between the two that dates back to May 3, 2002. Though Sunesis was paid some money up front and through 2005 under that deal, it hadn’t been paid anything since December 2005.

Johnson & Johnson gave 180 days notice, so that deal ends Jan. 13, 2010.

Caraco Pharma Now Faces Class Action Lawsuits

The Detroit generic pharmaceutical maker Caraco Pharmaceutical Laboratories Ltd. (NYSE Amex: CPD) said Friday that two purported class action lawsuits had been filed against it in federal court in Detroit on July 17 and 23.

Caraco said neither the company or the executives had ot yet been served with either suit. But even without seeing them, Caraco said it believes the suits are "without merit" and that it intends to "vigorously contest the actions."

Caraco said the suits "purport to represent the class of persons who purchased or otherwise acquired the common stock of the Company generally between May 29, 2008 and June 25, 2009."

And the suits allege that Caraco and executives "violated federal securities laws, primarily related to public statements on FDA compliance."

A Los Angeles, Calif. law firm, Glancy Binkow & Goldberg LLP, also announced last week that it had filed one of the suits on behalf of those who bought Caraco pharmaceutical sbetween May 29, 2008 and June 25, 2009.

The firm said that suit "alleges that throughout the Class Period defendants knew or recklessly disregarded that their public statements concerning Caraco’s business, operations, and prospects were materially false and misleading."

Specifically, that means failure to disclose that it had failed to meet the United States Food and Drug Administration's current Good Manufacturing Practice (“cGMP”) requirements; that the company failed to take corrective measures in order to have its manufacturing facilities comply with the FDA’s cGMP requirements; that the company had failed to remedy repeat violations of FDA regulations previously observed and documented by the FDA; yhat the foregoing significantly jeopardized the Company’s ability to gain FDA approval of pending new drug applications; and as a result, that the company would have to recall certain products.

On June 25, the FDA announced that U.S. Marshals had seized drug products manufactured by Caraco from the company’s plants. According to the FDA, this action followed Caraco’s continued failure to meet the FDA’s cGMP requirements, which assure the quality of manufactured drugs. The FDA stated that through the seizure it sought to immediately stop the vompany from further distributing drugs until there is assurance that Caraco complies with good manufacturing requirements. On this news, shares of Caraco declined $1.79 per share, or approximately 43 percent, to close on June 25 at $2.39 per share, on unusually heavy volume.

Plaintiff seeks to recover damages on behalf of class members and is represented by Glancy Binkow & Goldberg LLP, a law firm with significant experience in prosecuting class actions, and substantial expertise in actions involving corporate fraud.

Caraco Pharmaceutical facing federal securities class-action suits

Caraco Pharmaceutical Laboratories Ltd. (AMEX:CPD) has announced that two federal securities class-action lawsuits have been filed against the Detroit-based generic drug maker and two of its executive officers.

The lawsuits, which were filed on July 17 and July 23, were filed in the United States District Court for the Eastern District of Michigan.

Caraco said it has not yet been served with either suit.

Since 2005, Caraco has been cited by the Food and Drug Administration for quality control problems at its Detroit manufacturing plant. In June, the FDA and U.S. Marshalls seized more than 30 generic drugs and related ingredients because of the unresolved manufacturing problems.

Earlier this month, Caraco announced it would lay off 350 of its 650 workers because of its ongoing problems.

One of the lawsuits was filed by Los Angeles-based Glancy Binkow & Goldberg LLP, according to the complaint. It is on behalf all persons or entities that purchased Caraco securities between May 29, 2008 and June 25.

Two Caraco executives were also named in the lawsuit, CEO Daniel Movens and interim CFO Mukul Rathi.

Caraco said the lawsuits allege that during this time period defendants violated federal securities laws, primarily related to public statements about FDA compliance.

Caraco officials said in a statement that the plaintiffs' allegations are without merit and intends to vigorously contest the actions.

Caraco's stock price was $3.22 at 1:30 p.m. Friday. It has ranged from $16.40 to $1.75 the past year. Caraco's high-water mark was $18.50 on March 31, 2008.

Teva, JNJ settle birth control pill patent lawsuit

NEW YORK -Teva Pharmaceutical Industries Ltd. said Friday it will be able to launch a generic version of a popular birth control pill under terms of a patent settlement with Johnson & Johnson.

The Israeli drugmaker said it will be able to relaunch its version of the drug Ortho-Tri-Cyclen Lo on Dec. 31, 2015. Teva started selling its pill, called Tri-Lo Sprintec, earlier this month after gaining marketing approval from the Food and Drug Administration. Johnson & Johnson then sued Teva for patent infringement, and Teva halted shipments.

Teva said it will make a royalty payment to Johnson & Johnson, and in return, it will get a release for the previous sales. It did not disclose the size of the payment.

Teva, the world's largest generic drugmaker by revenue, said it will be able to launch Tri-Lo Sprintec earlier than Dec. 31, 2015, under some circumstances. It said the settlement will not take effect until a court enters a judgment upholding Johnson & Johnson's patents, which are scheduled to expire in 2019.

Ortho-Tri-Cyclen is marketed by Johnson & Johnson's Ortho-McNeill-Janssen unit, and Teva said U.S. sales were $400 million in the 12 months ended March 31.

In afternoon trading, Teva shares were unchanged at $50.19. Earlier, they set an annual high of $50.68. Johnson & Johnson stock rose 61 cents to $60.83