Monday, June 20, 2005

Aftermath of Purdue Pharma patent loss on OxyContin

The case between Purdue Pharma and Endo turned on inequitable conduct, specifically on what it meant to represent to the patent examiner that one had made a "discovery."

Elsewhere, I will be discussing an interesting parallel to the discovery of the buckyball (aka, buckminsterfullerene, C60), wherein the discoverers merely repeated the experiment of prior workers, obtained basically the same experimental results, but had a quite different interpretation.

For the moment, note the business and human consequences of the patent decision.

From the Fairfield County (CT) Business Journal:

With Stamford-based Purdue Pharma L P. losing an appeal in federal court to protect its patent on the brand-name pain medication OxyContin, more than 1,000 of its workers will feel the ache.

The drug manufacturer said it would layoff half of its U.S. work force in the next few weeks. The company employs 720 people in Stamford and 150 at a facility in nearby Ardsley, N.Y., but how many local employees may lose jobs was unclear.

James W. Heins, Purdue's director of public affairs, said information on how those facilities would be impacted was not yet available.

"The 50 percent reduction will be across the company's total U.S work force of 2,154 people, but it won't necessarily affect half of the Stamford workers," he added.

The cuts are in response to the expected impact on the company's revenues when competitors begin to sell generic alternatives to the drug for as little as one-third the price.

On June 7, a panel of three judges of the U.S. Court of Appeals upheld a U.S. District Court's decision in January 2004 that certain Purdue's patents for OxyContin tablets could no longer be enforced.

The appeals court supported an earlier ruling that said the company misled the patent office in its application by claiming the drug was unique because it was effective in very low dosages. The judges ruled that Purdue had no clinical evidence to support that claim before the patents were issued.

Following the decision, Endo Pharmaceutical Holdings Inc. of Chadds Ford, Pa., announced that it would immediately launch generic versions of all four strengths of OxyContin.

In a written statement, Purdue Pharma said it believes its patents were properly obtained and are enforceable. The company will seek a rehearing of this decision by all 12 appellate court judges.

"In our opinion, and that of our legal advisers, this decision is contrary to principles of patent law established by the Federal Circuit as well as by the Supreme Court of the United States," Howard Udell, executive vice president and chief legal officer at Purdue, said in the statement.

HQ could be sold

According to Heins, Purdue's headquarters houses employees in marketing, medical affairs, information technology, general administration, law, human resources and some in clinical development.

He acknowledged that the company is "exploring a number of options" regarding the headquarters. He said the company plans to stay in Stamford, but declined to give details when asked if Purdue would sell the building or lease portions of it.

Purdue Pharma and Purdue Frederick Co. purchased One Stamford Forum, the distinctive tiered office tower near I-95, from GTE in 2000.

Some local commercial real estate brokers speculated the company could sell the building to take advantage of the recent trend of local office properties fetching top dollars from foreign investment groups. The company could potentially lease back part of the building since the new owner would want tenants in the building.

Back to the drawing board

"While we are disappointed with this outcome, we have taken certain precautionary steps to prepare for the possibility of such a decision," president and chief executive officer Michael Friedman said in a statement. "We intend to continue the production and sale of our branded OxyContin product line. Additionally, as part of our contingency planning, we have entered into an agreement with IVAX Pharmaceuticals that allows IVAX to distribute authorized generic versions of OxyContin tablets in all four strengths. This will enable Purdue to introduce a quality product in the growing generic segment of the $2 billion oxycodone extended-release product category."

Immediately after that announcement, Endo said it would sue to prevent Purdue Pharma from authorizing its own lower-cost version.

Purdue said it is actively engaged in discussions with several other pharmaceutical companies to add other medications to its product portfolio.

"We're going to be smaller, but we are going to remain a viable company and we plan to emerge even stronger in a couple of years," noted Heins, who said the company has ongoing research and development efforts, but he could not discuss those details.


Blogger Sharon said...

I do not understand why people have to sue drug companies, all they do is pass the cost on to the poor. If people would take responseabilty for their medication and not abuse or sell them, people who really need this type of meds would not be treated like drug seekers. I have been on high doses of oxicotin for years " I do not see anybody getting high on this drug" If they do then they are not in pain and do not need to recieve this type of drug. People need to wake up and stop blaming some one else for their addiction. No one worries about addiction to other things like coca-cola, ciggeretts, love, gambling, anything a person can use to make them feel better is addictive, SO STOP BLAMING PURDUE.. People these drug company are going stop trying to find answers for pain and other condition if they are going to be sued. Doctor's need to know that any drug is addictive,BE RESPONSIBLE ON HOW YOU PRESCRIBE IT. This type of meds is not for a wrist injury.IT IS FOR SEVIER CHRONIC PAIN. Help people who benefit from OXYCONTIN.

8:38 PM  
Blogger Melanie said...

I'm glad that you have had a positive experience with Oxycontin. Many people who I knew and loved did not.

And had Purdue been honest from the get go and didn't launch a never before seen marketing campaign directed at doctors all over the country pointing out that Oxycontin was "Non-Addictive and could be used to treat moderate to severe pain" we might now be in the position we are in today.

I agree that people should take responsibility for their medication and not abuse or sell them. In a perfect world we wouldn't have to worry about addiction. But it is a fact of life as much as cancer and chronic pain is.

I don't think that lawsuits are trying to pass on expenses but are trying to get the drug company - Purdue to take ownership for their part in the epidemic we're in right now.

They told the doctors a few magic words - "Non-Addictive" couple that with classifying it for moderate - severe pain. And unknowing doctors across the country were thrilled that they had this new wonder drug - this "Non-Addictive" medicine that could help their patients deal with moderate pain as well as the severe pain they see.

There were pill seekers before Oxys and sadly I think there may be forever. I'm sorry that other people's addiction and pill seeking causes those who are in real pain and need these medicines to be looked at like drug seekers. Having one very good doctor who is informed about the pain medication available for them to treat with and who is also schooled in pain management and addiction should be able to tell the difference between the two types of patients. Some people need meds to live a life without pain (or with less pain than they experience without medication) others need treatment for their addiction and need to find many ways to manage their pain that doesn't put them in danger.

You made a great point pointing out your fear that drug companies will stop looking for pain or other conditions because of these lawsuits. This is something to worry about - a valid point. But I don't see it actually happening. There are plenty of drug companies that start out with the greatest of intentions. But somewhere between the researchers and the marketers and accountants decisions need to be made about pricing and how to get the word out about these drugs that they are proud of and hope to help hundreds of thousands of people with. And there will always be another company coming along to try to make a better drug. That's the beauty of competition. But since drugs are so expensive to research and develop cost always has been and will be a factor.

Had Purdue not been so hell bent on trying to set themselves apart from the competition in the pain management options for doctors and patients that consist of narcotic or opiate drugs - had they had more facts to back up their claims of this new drug being "Non Addictive" or reserved their drug for severe pain only and addressed the potential for addiction and diversion for street use- then doctors would have been less likely to prescribe so freely for every patient that came in with an ass ache or tooth ache. They had a drug company located right here in the United States, a company with excellent doctors and researchers and a company with an excellent reputation telling them that this drug was safe to give to clients without fear of abuse or addiction - to help not only those patients with terminal illnesses and unbearable pain but to finally help those in constant, chronic pain but pain that doctors had previously been hesitant to prescribe Percocet, Vicodin or Morphine because of the fear of addiction.

The reality is that Doctors and patients need to be aware that any drug can be addictive. But I disagree with one point you made. You wonder why people sue, why people don't take responsibility for their medication and why people feel the need to blame someone else for their addictions. The answer is that Purdue is to blame. Even if they didn't know before the drug was out there that people were getting addicted they certainly did know how widely their drug was being prescribed and they put profits before people when they chose to try to hide the fact that they were wrong in their marketing campaign to doctors. And for a few years before these lawsuits (many that Perdue won in the early years) more and more people were being treated with Oxycontin. And sadly many of them became addicted, overdosed and died. While Perdue could have simply put the same effort into letting the doctors know that they had been wrong about the drug being non addictive and that it might be wise to re-classify their drug for severe pain only. If the doctors looked at Oxycontin and prescribed it like they did Morphine, Percocet and Vicodin - many people wouldn't be living the horrible existence they do today.

Again I am so happy that you have had a good experience with this drug. I wish it was the case for the people I knew and loved who lost their lives to addiction that started with Oxycontin.

You may also ask how can Perdue be responsible for the deaths of those who weren't prescribed their drug but became addicted from buying Oxycontin on the street and using it to get high. I don't think it's a stretch to say that these drugs wouldn't be as readily available to teenagers and young adults had the doctors prescribing believed Perdue's claim that Oxycontin was non-addictive.

When I was younger and testing limits and experimenting like so many kids do when they're young and stupid - Beer or wine coolers was my vice of choice. Sometimes I smoked pot. I have tried cocaine. Luckily I didn't get caught up in drugs or alcohol. My young cousin wasn't so lucky. He never cared much for drinking in high school. He liked music and video games better. He had great parents and a loving family. A few years back he made a terrible mistake - like I had drinking beer when I wasn't supposed to - the only difference was that he took some pills his friends have him. These pills that were made in this country and supposedly non addictive. He took them and felt incredible. He took them for three days. And when he ran out and was done - little did he know that he'd spend the next day more sick than he had ever been. Little did he know that he wouldn't be able to function without them. His bad decisions over that weekend when he was young and carefree would lead to an expensive addiction to Oxycontin - which later he found out was nothing but synthetic heroin. Before long he was buying heroin on the streets to keep up with his habit. To live life without being sick. Many failed attempts at sobriety, countless treatment programs and even more failure and struggle as he tried get his life back - lead him to believe that it wasn't possible. He took a gun to his head and shot himself rather then live through the pain he was in and the pain he was causing everyone how loved him. Yes he has to take some of the blame for taking a drug that was not prescribed to him, he also had to live with how it had turned the lives of everyone who loved him upside down each time he used.
He did take that blame on himself. Which is why he couldn't bear to live with himself anymore.

But as someone who loved him and someone who also lost many other kids and young adults from my community to suicide or drug overdose that can be traced back to Oxycontin. And watching a whole generation of addicts whose gateway drug to heroin was Oxycontin that they could no longer afford - struggling everyday to fight this addiction - makes me look for answers. And part of the answer is that if Purdue had done the right thing by correctly classifying their wonder drug for severe pain only or if they stopped to wonder when their profits went up to the billions from one year to the next - might this problem be less insignificant than it is today. When parents of teens who had died from their drugs or patients who became addicted began to question them or sue - had they taken an honest inventory of their claims and practices and took action to fix the problem rather than fighting to cover it up by suing newspapers who did stories about oxys in a negative light or trying to turn the blame onto the addict by looking into patients history of drug use and saying that someone who had a marijuana arrest years before was already an addict and wasn't their problem. Had they read these stories or lawsuits with empathy rather defensiveness. Had they not been blinded by the dollar signs that were pouring in- would my cousin be dead, would my boyfriend of 9 years be dead. This I'll never know because they never bothered to address the situation until forced to do so.

So we are both entitled to our opinions here. That's the beauty of this country. I am a firm believer in personal responsibility like you are. I think that if you burn yourself with coffee you are a moron. Unless it says iced in front of the word coffee - generally it's safe to assume that the coffee should be hot and if you spill it you will get burned.

If you eat too much McDonalds and get fat. It's not because the nutritional information wasn't on the packaging - it's because anything that tastes that good and is fried is going to go right to the hips and belly. Lawsuits like those make me sick. I'm sure I feel the same way about those as you do about the Purdue law suits.

But there's a major difference here.
Coffee=Hot is common sense as is French fries and Chicken McNuggets eaten in excess = weight gain. Nothing tastes that good without a price.

But when a drug company tells doctors Oxycontin = a Non Addictive Pain Killer. The doctors had no reason to question this it was FDA approved. And the patients who were receiving it had faith in the doctors who have faith in the FDA who have faith in the drug companies when claims are supported with evidence. But their thought that the time release nature of the oxycontin covered the non addictive claim without actual fact based studies was an example of them emphasizing the positive while downplaying the negative.

There needs to be a middle ground where those who need it get the medicine they need to treat their pain - but it is less available on the streets.

I'm a hospice volunteer. I've lost my dad and many other relatives I love to cancer. People like me who want Purdue to be accountable aren't trying to take these drugs away from those who need it. But I'm asking Purdue and the FDA to take a closer look at their products before they make or are allowed to make claims. Sometimes they only way to get someone to listen is to put a monetary penalty on the line. Money talks and in this case money will hopefully get Purdue to finally listen.

1:58 PM  

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