Bayer sues Abbott, alleging patent infringement

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Posted on 30th December 2008 by Gordon Johnson in Uncategorized

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Date: 12/30/2008

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) — Pharmaceutical and chemical maker Bayer AG has filed a federal lawsuit alleging that drugmaker Abbott Laboratories’ best-selling drug, Humira, infringes on a decade-old Bayer patent.

The German company’s Bayer HealthCare LLC unit sued Abbott and two of its subsidiaries, claiming the popular biotech drug used to treat severe types of arthritis and other immune disorders infringes on the U.S. patent that Bayer was awarded in 1997.

Bayer’s lawsuit was filed six years after Humira was approved for U.S. sales — and in the plaintiff-friendly U.S. District Court for the Eastern District of Texas. The lawsuit seeks triple damages for past and future patent infringement, attorney fees and other relief, but does not seek to halt sales of Humira.

Humira, which is injected, is Abbott’s top revenue driver, with sales jumping 50 percent to $1.2 billion in the third quarter. In October, the company boosted its forecast for full-year sales to $4.4 billion.

Bayer does not have any products that compete with Humira, according to spokeswoman Marcy Funk.

North Chicago-based Abbott, which was sent a summons by the court on Tuesday, will “vigorously defend against this lawsuit,” spokesman Scott Stoffel said.

“Humira does not infringe Bayer’s patent and Abbott believes Bayer’s patent is invalid,” Stoffel said.

Humira is approved to treat several serious immune system disorders, including rheumatoid and other kinds of arthritis as well as Crohn’s disease. The drug carries the risk of serious, possibly fatal, infections, including tuberculosis.

The Bayer patent in question, No. 5,654,407, covers a genetically engineered antibody that binds to and blocks the action of a type of immune system cell called tumor necrosis factor, or TNF. TNF is one of the cytokines, the “messengers” of the immune system, and stimulates inflammation, a key problem in the conditions that Humira treats.

According to the lawsuit, filed on Dec. 24 in Tyler, Texas, Bayer chose to file in the Eastern District of Texas because Abbott and subsidiaries Abbott Bioresearch Center Inc. and Abbott Biotechnology Ltd. sell and advertise Humira there.

Bayer’s lead lawyer in the case, T. John Ward Jr., is the son of a federal judge in Marshall, Texas, who helped build the Eastern District into a patent lawsuit hotbed.

Humira competes with the drug Remicade, made by Johnson & Johnson’s Centocor unit. That company and New York University filed a patent infringement suit against Abbott in April 2007, also in the Eastern District of Texas. The case is ongoing, according to Stoffel.

Abbott has a number of patents that cover Humira, including a “composition of matter” patent that doesn’t expire until 2016, he said.

Bayer said its patent runs until August 2014.

Bayer’s top drugs include the erectile dysfunction treatment Levitra, the antibiotics Cipro and Avelox, contraceptives Mirena and Yasmin, and Glucobay for diabetes. The company also makes agricultural products, coatings and plastics.

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AP Business Writer David Koenig in Dallas contributed to this report.

Copyright 2008 The Associated Press.
Summary

Trials open for 9 over China tainted milk scandal

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Posted on 29th December 2008 by Gordon Johnson in Uncategorized

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Date: 12/29/2008

By CHRISTOPHER BODEEN
Associated Press Writer

BEIJING (AP) — Nine people went on trial Monday in connection with China’s tainted milk scandal, state media reported, following the announcement of steps to compensate the families of hundreds of thousands of children harmed by contaminated infant formula.

The tainted formula gave babies painful kidney stones and news of the problem sent parents around the country rushing their babies to emergency rooms for tests to see if they were affected. Chinese dairy exports such as chocolate and yogurt were also found to be tainted, triggering a slew of product recalls elsewhere in Asia and in Europe, Africa and Latin America.

At least four of the suspects on trial Monday could be given the death penalty.

Hearings were held in the northern city of Shijiazhuang, where the company at the heart of the scandal — Sanlu Group Co. — is headquartered, along with three other cities in surrounding Hebei province, according to state broadcaster CCTV and the Xinhua News Agency.

The first trials in the case began for six men on Friday.

All 15 on trial have been charged with producing and selling melamine. The industrial chemical was added to raw milk because — like protein — it is high in nitrogen and can make protein levels appear higher.

Sanlu’s chairwoman and general manager, Tian Wenhua, is scheduled to go before a Shijiazhuang court Wednesday.

At least six babies died and 294,000 other children suffered kidney and urinary problems from drinking the baby formula made from the contaminated milk.

The four suspects in the Shijiazhuang trial are accused of endangering public safety and could face sentences ranging from 10 years in prison to the death penalty. It identified them as Gao Junjie, his wife Xiao Yu, Xue Jianzhong, and Zhang Yanjun.

The four are accused of having produced 200 tons of a mixture of melamine and malt dextrin, a food additive made from starch, that they marketed to milk producers, according to the reports.

Between November 2007 and August 2008, they sold 110 tons to milk producers — including Sanlu — for a total of 1.23 million yuan ($180,000), the reports said.

Although melamine, a common industrial chemical used to make plastics and fertilizer, is legal to produce and sell in China, CCTV said the court believed the men’s actions had “greatly harmed the health and safety of the consumers, especially infants, therefore violating the criminal law of China.”

It was unclear if CCTV was quoting the court. Calls to the Intermediate People’s Court went unanswered.

Xinhua said the other five are charged with producing and selling poisonous food, but did not give their names or other details.

The trials come amid moves by authorities to end a national disgrace that highlighted widespread problems with food safety and corporate and governmental malfeasance.

On Saturday, China’s Dairy Industry Association said 22 dairy producers would make a one-time cash payment to families of victims and establish a fund to cover medical bills for future health problems.

Lawyers — who are seeking to bring a lawsuit against the companies involved — say they understand most children who suffered kidney stones from the tainted milk would get 2,000 yuan ($290), while sicker children would be paid 30,000 yuan ($4,380).

Chinese courts have rejected all claims filed by the victims’ families, including a lawsuit filed this month by lawyers representing 63 defendants that sought nearly 14 million yuan ($2 million) in compensation from Sanlu.

The state-owned company has been declared bankrupt according to New Zealand’s Fonterra Group, which owns a 43 percent stake in Sanlu.

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Associated Press researcher Yu Bing contributed to this report.

Copyright 2008 The Associated Press.

Nearly 5,000 Chinese officials punished for corruption

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Posted on 26th December 2008 by Gordon Johnson in Uncategorized

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Date: 12/26/2008 6:54 AM

BEIJING (AP) — Nearly 5,000 higher-level Chinese government officials were punished for corruption over the past year, state media reported Friday.

The officials — all above the county-head level — were involved in corruption, bribery, acting against the public interest and other violations of discipline or the law said Gan Yisheng, deputy head of the Communist Party’s Central Commission for Discipline Inspection, according to the official Xinhua News Agency.

In the worst cases, a total of 801 officials were legally prosecuted for crimes, he said. He vowed to step up anti-graft efforts and “win trust from the people with actual results.”

Gan said government inspection departments investigated 144,000 cases that led to penalties for 146,000 lower-ranking government officials. Losses of 6 billion yuan ($900 million) were recovered through the anti-corruption efforts.

Copyright 2008 The Associated Press.

Plaintiffs' Radiation Cases Survive Supreme Court Review

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Posted on 15th December 2008 by Gordon Johnson in Uncategorized

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Date: 12/15/2008 9:25 PM

BC-Hanford Downwinders/373

Court raises hopes of Hanford radiation plaintiffs

SPOKANE, Wash. (AP) — A U.S. Supreme Court decision Monday raised hopes that as many as 2,000 plaintiffs could be compensated for health problems they blame on radiation from a Washington state nuclear site instrumental in the Manhattan Project and the Cold War.

The court issued a one-line denial of an appeal by contractors who worked at the Hanford nuclear reservation. The contractors — E.I. Du Pont De Nemours & Co., General Electric Co. and UNC Nuclear Industries Inc. — were challenging a lower-court ruling last spring that sided largely with the plaintiffs.

The people exposed to radiation lived in eastern Washington, eastern Oregon and Idaho, downwind of Hanford, as the U.S. government was developing atomic bombs in the 1940s.

The government did not disclose until 1986 that radiation had been released at the site, and since then the “downwinders” have sought compensation for thyroid cancer and other conditions they believe were caused by the exposure.

“This is very exciting for us,” Richard Eymann, one of the plaintiffs’ lawyers in the long-running case, told The Spokesman-Review of Spokane. “With a new administration coming in, we want a serious look at compensation for these people after years of litigation.”

So far, the plaintiffs have not agreed to a settlement offer by the contractors that would compensate them based on the amount of radiation they likely received and the illnesses they have, said Kevin Van Wart, lead attorney in Chicago for the Hanford contractors.

An agreement for the government to pay any liabilities of the contractors dates to the Manhattan Project.

Last spring, the 9th U.S. Circuit Court of Appeals upheld monetary awards for two “bellwether” plaintiffs, rejected the contractors’ claim of immunity from lawsuits because they were working for the government, and ruled that the deadline for individuals pursuing claims hadn’t expired.

With the appeal denied, “it’s back to the races,” Van Wart said. “We’ll be back in court (in Spokane) and we’ll start addressing the individual cases.”

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Information from: The Spokesman-Review, http://www.spokesmanreview.com

Copyright 2008 The Associated Press.
Summary

China court refuses to accept tainted milk lawsuit

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Posted on 8th December 2008 by Gordon Johnson in Uncategorized

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Date: 12/8/2008

By HENRY SANDERSON
Associated Press Writer

BEIJING (AP) — A court on Monday refused to accept a lawsuit filed against a Chinese dairy by dozens of families who said their children were sickened or killed by tainted milk, lawyers involved in the case said.

The 63 defendants in the first-known group lawsuit stemming from the scandal, including the parents of two children who died, were seeking nearly 14 million yuan ($2 million) in compensation from state-owned Sanlu Group Co., Beijing-based lawyer Xu Zhiyong said.

The dairy based in the northern Chinese city of Shijiazhuang was at the center of China’s worst food safety crisis in years, in which six babies are believed to have died and nearly 300,000 became sick with urinary problems after drinking infant formula tainted with the industrial chemical melamine.

Three of six defense lawyers presented the suit to the Hebei Supreme Court’s registry office on Monday but were told it could not be accepted because government departments were still investigating.

“We think it was their excuse for not accepting the case. We will continue to push the case and give them pressure,” said activist lawyer Li Fangping, who helped organize the case.

The court in Hebei, the province where Sanlu is based, took the documents, lawyers said.

“We presented our documents and we expressed our concern. We will keep contacting them to see what’s the progress,” attorney Lan Zhixue said.

China’s Health Ministry acknowledged last week that six babies likely died, twice the previous figure, and 294,000 babies suffered urinary problems from drinking contaminated infant formula, a six-fold increase from its last tally in September.

The government has said that Sanlu knew as early as last year that its products were tainted with melamine and that company and local officials first tried to cover it up.

Like a number of major dairies, Sanlu was said to have excellent quality controls that allowed it to enjoy a government-granted inspection-exempt status.

So far there has been no word on compensation for the sick babies, apart from an offer of free medical care. At least a dozen individual cases have been filed against Sanlu but are caught in a legal limbo, while lawyers who have volunteered to help families have been pressured to drop their work.

Courts often turn down group suits, preferring to deal one-by-one with cases to appear more productive and avoid running afoul of Communist Party officials, who ultimately control the judiciary.

Hearing a group case on tainted milk would also bring sensitive issues of culpability out in court. The central government said it only learned of the scandal Sept. 8 — it does not say how — even though inspection, health and other government departments in Hebei province and Beijing knew earlier.

The lawyers were told by the Shijiazhuang prosecutor’s office that criminal cases involving Sanlu milk were still being discussed and have not begun to be prosecuted.

The suit lays out eight compensation packages, depending on the severity of illness, and seeks a total of 6.82 million yuan ($991,000) for medical fees, cost of food and transportation fees for the group, as well as 6.91 million yuan ($1 million) for psychological damage.

Xu said there were two cases of deaths among the claimants, one in Henan province and another in Gansu province.

The illnesses of so many children highlighted the widespread practice of adding melamine — often used in manufacturing plastics — to watered-down milk to fool protein tests. Melamine is rich in nitrogen, which registers as protein on many routine tests.

Though melamine is not believed to be harmful in tiny amounts, higher concentrations produce kidney stones, which can block the ducts that carry urine from the body, and in serious cases can cause kidney failure.

Copyright 2008 The Associated Press.

FDA: Risks of new asthma drugs vary

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Posted on 5th December 2008 by Gordon Johnson in Uncategorized

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Date: 12/5/2008 2:54 PM

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — The blockbuster asthma drug Advair does not appear to have an increased risk of serious complications seen with similar new medicines, federal health officials said Friday.

But a less widely used medication, Serevent, had a significantly higher rate of serious complications, and even deaths, the Food and Drug Administration said. Both medicines are made by the same company, GlaxoSmithKline.

The FDA is concerned about asthma drugs known as LABAs, long-acting medications that relax tight muscles around stressed airways and free patients from the need to take a puff from their inhaler every few hours. For many asthma sufferers, that means they can sleep through the night.

But LABAs, for reasons that are still being debated, can increase risks of death and complications in some patients. The risk is lower when a LABA is used together with a steroid to treat underlying inflammation deep inside the airways.

Advair combines both kinds of medicine in one inhaler. But Serevent is a LABA-only product, although medical treatment guidelines call for patients taking the medication to also use a steroid.

The FDA analyzed reams of clinical data on four drugs: Advair, Foradil, Serevent and Symbicort. All four already carry strong warnings, but the findings could lead to more specific instructions for patients and greater restrictions on some of the medications. The agency has called a special meeting of outside advisers next week to discuss the data and make recommendations.

GlaxoSmithKline said the analysis underscored its confidence in Advair, its best-selling medication, with U.S. sales of $2.9 billion in the first nine months of this year. But a spokeswoman declined to comment on whether the data could lead to a withdrawal of Serevent, which had U.S. sales of $97 million in the same period. About 4 million U.S. patients now use the Glaxo medications.

Asthma is a chronic respiratory illness that leaves patients short of breath, wheezing, and can sometimes send them to the emergency room because of difficulty breathing. Some 22 million people in the United States suffer from asthma, and children account for nearly one out of every three patients. Nearly 3,600 people still die from asthma in this country each year, although symptoms can be controlled with medication to prevent the most serious complications.

Copyright 2008 The Associated Press.