Shares of BioDelivery Sciences rose Monday after the Raleigh company reported that the U.S. Patent Office rejected a patent infringement claim against the company.
BioDelivery reported that the U.S. Patent & Trademark Office has rejected all 191 claims by MonoSol RX that the manufacturing process for BioDelivery's oral pain patch for cancer patients, Onsolis, infringed on MonoSol patent No. 7,824,588. However, the ruling didn't deal with all the claims Indiana-based MonoSol made.
"This is a very significant and positive development for BDSI and its commercial partners involved in this case," CEO Mark Sirgo said in a prepared statement. "We intend to continue to aggressively pursue whatever actions are necessary to defend our position and expect that all of MonoSol's claims will ultimately be defeated."
MonoSol sued BioDelivery for patent infringement in federal court in New Jersey in November 2010, seeking unspecified damages and an injunction barring future infringement of MonoSol patents. BioDelivery maintained that it is not infringing on MonoSol's patent and contended that the company's patent is invalid.
In September, MonoSol amended its complaint to include two additional patents, which BioDelivery also maintains it is not infringing.
Source: http://www.newsobserver.com/2011/11/29/1677369/raleigh-company-wins-patent-round.html#ixzz1f5LUOEcL
Showing posts with label Patent News. Show all posts
Showing posts with label Patent News. Show all posts
Patent News | "Lipitor's patent loss is consumers' gain"
By: By Duke Helfand, Los Angeles Times
Category : Patent News
For millions of Americans, prescription drugs are about to get a lot cheaper.
Patents on some of the most popular medications will expire over the next few years, giving consumers access to less expensive generic versions — and costing the pharmaceutical industry an estimated $100 billion in lost sales through 2015.
Lipitor, a cholesterol-fighting medication that is the top-selling prescription drug of all time, lost its patent protection Wednesday. The drug's manufacturer, Pfizer Inc., already has slashed its price to as little as $4 a month for privately insured patients, the majority of Lipitor users. That's down from typical co-pays of $25 to $45.
In the months to come, patents will expire on other popular drugs including Lexapro, used to treat depression, and Plavix, which is widely prescribed for blood thinning. Asthma sufferers will be able to get generic versions of Singulair next summer.
Experts say the timing is largely coincidental but will pay big benefits: Prices typically fall as much as 90% when generics come on the market.
"It's great news for patients because they are going to experience savings that I call the patent dividend," said Michael Kleinrock, director of research development at the IMS Institute for Healthcare Informatics, which tracks the pharmaceutical industry.
Wisconsin retiree Gloria Schmid, 68, said the lower price would help her afford her Lipitor prescription on a tight budget. She has been paying $63 a month for the medicine even with insurance.
"That would be marvelous," Schmid said of the savings. "As you get older, your resources get to be less and less. That's what worries me."
But the patent expiration pose a challenge for the drug companies, which have come to expect large payoffs for their patented medicines.
IMS estimates drug companies will lose $100 billion in revenue over the next four years, and that will diminish the money available to develop the next generation of popular drugs. Generics make up 79% of all prescription medications dispensed in the U.S.
In addition, much of the pioneering pharmaceutical work underway is for treating diseases that afflict fewer people, such as certain cancers, and probably won't lead to drugs with huge sales figures.
"The era of blockbuster drugs is gone," said Alexander Kandybin, a partner and health specialist at Booz & Co., a management consulting firm in New York. "The pipeline will not replace that revenue. It's inherently unpredictable how the industry is going to evolve over the next five years."
Drug makers also are encountering tougher regulatory scrutiny, growing competition from manufacturers in the U.S. and overseas and resistance from cost-conscious health insurers.
To counter these forces, drug companies are fighting to protect the markets they already have.
Pfizer has rung up an estimated $80 billion in sales of Lipitor and has launched an aggressive campaign against generic competition.
The New York drug maker is offering sharp discounts on Lipitor through pharmacy benefit companies, as well as producing an "authorized" generic version and charging just $4 monthly co-pays for privately insured customers who get discount cards to purchase the brand-name pills.
Right now there are just two other players. For the next six months, Ranbaxy Laboratories of India and Watson Pharmaceuticals of New Jersey get to market generic versions of the drug. Lipitor prices for those without insurance are not expected to drop sharply until next June, when other drug makers can bring their versions to market.
A Pfizer spokesman said consumers can expect to buy brand-name Lipitor for less than they pay for a generic version.
"Our strategy during the 180-day period is to help patients who want to stay on Lipitor have access to the brand after loss of exclusivity," spokesman MacKay Jimeson said. "Our programs, which are designed to offer Lipitor at or below generic cost during the 180-day period, will not increase costs for the significant number of payers participating in our programs."
Analysts have suggested that Pfizer could retain as much as 40% of its Lipitor volume in the coming months. But revenue will eventually plunge in the same way the price of other brand-name drugs fall when they lose their patents.
Other prescription drugs facing patent expirations next year are Actos, Seroquel, Diovan and Geodon.
"It's going from competing for dollars to competing for pennies," said Joel Hay, a professor of pharmaceutical economics and policy at USC. "That's got the brand-name industry in a quandary."
As generics come to market, patients' savings will vary based on several factors, including whether they have health insurance and how they obtain their medicine.
The uninsured will also benefit. Patients who take the coronary drug Plavix, for example, now pay an average of $172 a month at the pharmacy, according to the IMS healthcare institute. Generic versions could cut that bill to less than $20 if the past is any guide.
Source: http://www.latimes.com/business/la-fi-drug-patents-20111201,0,3498646.story
Category : Patent News
 |
| Lipitor Patent News |
Patents on some of the most popular medications will expire over the next few years, giving consumers access to less expensive generic versions — and costing the pharmaceutical industry an estimated $100 billion in lost sales through 2015.
Lipitor, a cholesterol-fighting medication that is the top-selling prescription drug of all time, lost its patent protection Wednesday. The drug's manufacturer, Pfizer Inc., already has slashed its price to as little as $4 a month for privately insured patients, the majority of Lipitor users. That's down from typical co-pays of $25 to $45.
In the months to come, patents will expire on other popular drugs including Lexapro, used to treat depression, and Plavix, which is widely prescribed for blood thinning. Asthma sufferers will be able to get generic versions of Singulair next summer.
Experts say the timing is largely coincidental but will pay big benefits: Prices typically fall as much as 90% when generics come on the market.
"It's great news for patients because they are going to experience savings that I call the patent dividend," said Michael Kleinrock, director of research development at the IMS Institute for Healthcare Informatics, which tracks the pharmaceutical industry.
Wisconsin retiree Gloria Schmid, 68, said the lower price would help her afford her Lipitor prescription on a tight budget. She has been paying $63 a month for the medicine even with insurance.
"That would be marvelous," Schmid said of the savings. "As you get older, your resources get to be less and less. That's what worries me."
But the patent expiration pose a challenge for the drug companies, which have come to expect large payoffs for their patented medicines.
IMS estimates drug companies will lose $100 billion in revenue over the next four years, and that will diminish the money available to develop the next generation of popular drugs. Generics make up 79% of all prescription medications dispensed in the U.S.
In addition, much of the pioneering pharmaceutical work underway is for treating diseases that afflict fewer people, such as certain cancers, and probably won't lead to drugs with huge sales figures.
"The era of blockbuster drugs is gone," said Alexander Kandybin, a partner and health specialist at Booz & Co., a management consulting firm in New York. "The pipeline will not replace that revenue. It's inherently unpredictable how the industry is going to evolve over the next five years."
Drug makers also are encountering tougher regulatory scrutiny, growing competition from manufacturers in the U.S. and overseas and resistance from cost-conscious health insurers.
To counter these forces, drug companies are fighting to protect the markets they already have.
Pfizer has rung up an estimated $80 billion in sales of Lipitor and has launched an aggressive campaign against generic competition.
The New York drug maker is offering sharp discounts on Lipitor through pharmacy benefit companies, as well as producing an "authorized" generic version and charging just $4 monthly co-pays for privately insured customers who get discount cards to purchase the brand-name pills.
Right now there are just two other players. For the next six months, Ranbaxy Laboratories of India and Watson Pharmaceuticals of New Jersey get to market generic versions of the drug. Lipitor prices for those without insurance are not expected to drop sharply until next June, when other drug makers can bring their versions to market.
A Pfizer spokesman said consumers can expect to buy brand-name Lipitor for less than they pay for a generic version.
"Our strategy during the 180-day period is to help patients who want to stay on Lipitor have access to the brand after loss of exclusivity," spokesman MacKay Jimeson said. "Our programs, which are designed to offer Lipitor at or below generic cost during the 180-day period, will not increase costs for the significant number of payers participating in our programs."
Analysts have suggested that Pfizer could retain as much as 40% of its Lipitor volume in the coming months. But revenue will eventually plunge in the same way the price of other brand-name drugs fall when they lose their patents.
Other prescription drugs facing patent expirations next year are Actos, Seroquel, Diovan and Geodon.
"It's going from competing for dollars to competing for pennies," said Joel Hay, a professor of pharmaceutical economics and policy at USC. "That's got the brand-name industry in a quandary."
As generics come to market, patients' savings will vary based on several factors, including whether they have health insurance and how they obtain their medicine.
The uninsured will also benefit. Patients who take the coronary drug Plavix, for example, now pay an average of $172 a month at the pharmacy, according to the IMS healthcare institute. Generic versions could cut that bill to less than $20 if the past is any guide.
Source: http://www.latimes.com/business/la-fi-drug-patents-20111201,0,3498646.story
Patent News | "Lipitor goes off patent today, Pfizer vs Ranbaxy-led Indian pharma's war for blockbuster drugs intensifies"
By: Divya Rajagopal
Source: http://economictimes.indiatimes.com
Category : Patent News
MUMBAI: Indian pharma companies' quest to make millions from the sale of copycat versions of blockbuster drugs may turn out to be a flop show as innovative companies raise defences to protect their turf. The world's biggest-selling drug is going off patent today in the United States and Ranbaxy Laboratories, India's third-largest company, is still struggling to get approvals from the American regulator.
Ranbaxy, which has exclusive rights to the off-patent version of Lipitor, Pfizer's blockbuster cholesterolbusting drug, has built its business model around the generic version of Lipitor and its success rides on how much money it can make on sales of the copycat version of the drug. Till the time of going to the press, there was no word on whether a settlement had been reached and whether Ranbaxy will be able to launch its version of Lipitor soon.
As the clock ticked away on Tuesday, and rumours of Ranbaxy's settlement with the US Food and Drug Administration made the rounds, company executives declined comment and huddled together in last-minute confabulations with the US authorities. Arun Sawhney, MD of Ranbaxy, was defiant in an analyst call last week. "A lot of our plans are ready. The reality will be out soon," he said. ETlearns that officials from the USFDA had re-inspected the pharma major's Tonsa plant in Punjab which supplies key ingredients for atorvastatin, the medical name for Lipitor, indicating a possible settlement.
Failure to launch the generic version of Lipitor will devastate the company, which has spent millions of dollars in product development and legal costs. It will also raise a huge question mark over the Indian pharmaceutical industry's capability to generate big bucks out of high-value products going off patent in the next five years.
"Ranbaxy has lost the plot," said Surjit Pal, analyst at Elara Capital, which on Tuesday cut the company's EPS target to Rs 15 from Rs 25. Its report told investors to sell the stock, the second such recommendation on Tuesday after Deutsche Bank. "There is nothing left for Ranbaxy with regards to Lipitor now," said NR Munjal, managing director, In-Swift.
'Pfizer won't let Bestseller Lipitor go away so easily'
Munjal's company supplies active pharmaceutical ingredients to Pfizer. The anti-cholesterol Lipitor, which contributed close to $10 billion to Pfizer's revenues, is the world's biggest-selling drug and has generated sales of over $131 billion for the American drug giant. No other drug in the history of pharma has achieved similar numbers. "Pfizer will not let this product go away," said the promoter of one of the leading suppliers of Pfizer.
Source: http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/lipitor-goes-off-patent-today-pfizer-vs-ranbaxy-led-indian-pharmas-war-for-blockbuster-drugs-intensifies/articleshow/10924284.cms
Source: http://economictimes.indiatimes.com
Category : Patent News
MUMBAI: Indian pharma companies' quest to make millions from the sale of copycat versions of blockbuster drugs may turn out to be a flop show as innovative companies raise defences to protect their turf. The world's biggest-selling drug is going off patent today in the United States and Ranbaxy Laboratories, India's third-largest company, is still struggling to get approvals from the American regulator.
Ranbaxy, which has exclusive rights to the off-patent version of Lipitor, Pfizer's blockbuster cholesterolbusting drug, has built its business model around the generic version of Lipitor and its success rides on how much money it can make on sales of the copycat version of the drug. Till the time of going to the press, there was no word on whether a settlement had been reached and whether Ranbaxy will be able to launch its version of Lipitor soon.
As the clock ticked away on Tuesday, and rumours of Ranbaxy's settlement with the US Food and Drug Administration made the rounds, company executives declined comment and huddled together in last-minute confabulations with the US authorities. Arun Sawhney, MD of Ranbaxy, was defiant in an analyst call last week. "A lot of our plans are ready. The reality will be out soon," he said. ETlearns that officials from the USFDA had re-inspected the pharma major's Tonsa plant in Punjab which supplies key ingredients for atorvastatin, the medical name for Lipitor, indicating a possible settlement.
Failure to launch the generic version of Lipitor will devastate the company, which has spent millions of dollars in product development and legal costs. It will also raise a huge question mark over the Indian pharmaceutical industry's capability to generate big bucks out of high-value products going off patent in the next five years.
"Ranbaxy has lost the plot," said Surjit Pal, analyst at Elara Capital, which on Tuesday cut the company's EPS target to Rs 15 from Rs 25. Its report told investors to sell the stock, the second such recommendation on Tuesday after Deutsche Bank. "There is nothing left for Ranbaxy with regards to Lipitor now," said NR Munjal, managing director, In-Swift.
'Pfizer won't let Bestseller Lipitor go away so easily'
Munjal's company supplies active pharmaceutical ingredients to Pfizer. The anti-cholesterol Lipitor, which contributed close to $10 billion to Pfizer's revenues, is the world's biggest-selling drug and has generated sales of over $131 billion for the American drug giant. No other drug in the history of pharma has achieved similar numbers. "Pfizer will not let this product go away," said the promoter of one of the leading suppliers of Pfizer.
Source: http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/lipitor-goes-off-patent-today-pfizer-vs-ranbaxy-led-indian-pharmas-war-for-blockbuster-drugs-intensifies/articleshow/10924284.cms
Patent News | "Patent for Lipitor set to expire this week"
BY Tracy Connor
NEW YORK DAILY NEWS
Monday, November 28 2011, 10:57 PM
Category: Patent News
The nation’s best-selling drug is about to get a lot cheaper.
The patent for the cholesterol-buster Lipitor runs out Wednesday, when at least one generic is scheduled to hit the market.
That’s a tough pill for drug giant Pfizer to swallow — but good news for Bronx cashier Emily Flores, whose insurance no longer covers medication.
Last week, she drove to a lower-cost pharmacy in Westchester to fill her prescription and was stunned by the price of the brand-name statin.
“They wanted 500 dollars and change for a 90-day supply. I was devastated,” she said. “I told them, ‘I was expecting you to have a generic.’ He said, ‘Not yet.’”
Flores, 63, left empty-handed and talked with her doctor about taking an alternative drug to prevent a heart attack or stroke.
“But now I might be able to afford it,” she said.
New York-based Pfizer rakes in $11 billion a year from Lipitor, thanks to the two-decade monopoly that ends this week.
Only two generics will be on the market for the first 180 days, and prices are expected to drop 10% in that time. When the rest of the generic equivalents roll out in June, the real discounts kick in.
During the 180-day period, Pfizer hopes to stop customers from bolting by keeping down retail costs for the brand-name drug.
It’s touting a co-pay card that patients can use to lower a $50 copay to $4, and a new low-cost mail-order service.
The company also is trying to cut deals with insurance companies to offer Lipitor as cheaply as generics.
It’s even exploring the possibility of applying for over-the-counter status for Lipitor — though the feds have shot down similar efforts by other statin makers.
At Montefiore Medical Center in the Bronx, Dr. Robert Ostfeld welcomes the expiration of a patent that has kept prices too high for some of his patients.
“Generics are nearly, if not completely, identical to the non-generic version,” the cardiologist said.
“It’s sad when patients have to legitimately choose between paying rent and taking a statin.”
Jadwiga Szyr, 62, a program manager at a Brooklyn senior center, has been forced to make tough choices.
When her insurance stopped covering Lipitor, she couldn’t afford the $180 a month her pharmacy charged. She switched to a different statin, which she says has been less effective.
“I would like to go back to taking the Lipitor,” she said. “Maybe I can now.”
Source Url: http://www.nydailynews.com/life-style/patent-lipitor-set-expire-week-article-1.983733?localLinksEnabled=false
NEW YORK DAILY NEWS
Monday, November 28 2011, 10:57 PM
Category: Patent News
 |
| Lipitor Patent News |
The patent for the cholesterol-buster Lipitor runs out Wednesday, when at least one generic is scheduled to hit the market.
That’s a tough pill for drug giant Pfizer to swallow — but good news for Bronx cashier Emily Flores, whose insurance no longer covers medication.
Last week, she drove to a lower-cost pharmacy in Westchester to fill her prescription and was stunned by the price of the brand-name statin.
“They wanted 500 dollars and change for a 90-day supply. I was devastated,” she said. “I told them, ‘I was expecting you to have a generic.’ He said, ‘Not yet.’”
Flores, 63, left empty-handed and talked with her doctor about taking an alternative drug to prevent a heart attack or stroke.
“But now I might be able to afford it,” she said.
New York-based Pfizer rakes in $11 billion a year from Lipitor, thanks to the two-decade monopoly that ends this week.
Only two generics will be on the market for the first 180 days, and prices are expected to drop 10% in that time. When the rest of the generic equivalents roll out in June, the real discounts kick in.
During the 180-day period, Pfizer hopes to stop customers from bolting by keeping down retail costs for the brand-name drug.
It’s touting a co-pay card that patients can use to lower a $50 copay to $4, and a new low-cost mail-order service.
The company also is trying to cut deals with insurance companies to offer Lipitor as cheaply as generics.
It’s even exploring the possibility of applying for over-the-counter status for Lipitor — though the feds have shot down similar efforts by other statin makers.
At Montefiore Medical Center in the Bronx, Dr. Robert Ostfeld welcomes the expiration of a patent that has kept prices too high for some of his patients.
“Generics are nearly, if not completely, identical to the non-generic version,” the cardiologist said.
“It’s sad when patients have to legitimately choose between paying rent and taking a statin.”
Jadwiga Szyr, 62, a program manager at a Brooklyn senior center, has been forced to make tough choices.
When her insurance stopped covering Lipitor, she couldn’t afford the $180 a month her pharmacy charged. She switched to a different statin, which she says has been less effective.
“I would like to go back to taking the Lipitor,” she said. “Maybe I can now.”
Source Url: http://www.nydailynews.com/life-style/patent-lipitor-set-expire-week-article-1.983733?localLinksEnabled=false
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