A US federal court hasaffirmed a ruling that Sanofi-Aventis intended to deceive the US Patent & Trademark Office in its dispute over generic versions of its Lovenox blockbuster, Reuters writes. Sanofi had sued Teva and Amphastar over their attempt to sell a generic version of the best-selling blood thinner, which generated sales of $1.1 billion in this year's first quarter.
The US Court of Appeals for the Federal Circuit ruled that Sanofi had committed "inequitable conduct" for failing to inform the patent office of info relevant to patentability. The federal court affirmed the ruling by a district court in California that there was an intent to deceive by failing to disclose dosages of the drug in certain studies, Reuters reports.
"After a trial on the matter, the district court found there was intent to deceive and held the patents unenforceable for inequitable conduct," the court wrote. "Because we find no abuse of discretion by the district court in its holding of inequitable conduct, we affirm."
One judge dissented the ruling, arguing that inequitable conduct should be reserved for only the most extreme cases of fraud and deception, which he said did not apply in this case. The dissent said the failure to disclose details on certain data by an Aventis scientist "may have been careless, but hardly culpable."
Sanofi spokesman Marc Greene tells Reuters that the drugmaker was disappointed by the ruling, and will consider its options, including requesting a rehearing before a full court, as opposed to a three-judge panel that had ruled on this case.
The FDA hasn't cleared any generic form of Lovenox yet. Making a generic of the treatment will not be as straightforward as copying a traditional chemical-based drug, because Lovenox is a large biological molecule that must be given by injection, Reuters notes.
But the decision clears the way for the FDA to make that decision, according to Deutsche Bank. Spokespeople for Teva and Amphastar declined to comment to Reuters. Last year, the FDA rejected a bid by Momenta Pharmaceuticals and Sandoz to sell a generic form of Lovenox.
At the time, Momenta said the FDA cited failure to fully address concerns about the drug's impact on the immune system. Late last month, the drugmaker said the FDA was still reviewing its application and that it would submit additional data to the agency in the third quarter, according to Reuters.
Hat tip to the Orange Book blog
6 Comments
Frivolous Capture of Profit
When a patented med is about to lose its patent, any other company can reverse engineer this particular product rightfully so, and its originator no longer profits off of this med in a very short period of time- usually within the first year of patent loss. Since we are talking about what could be a great loss of pharma profits, such companies initiate such tactics as bogus patent infringement lawsuits- especially when evergreening and other patent extension methods, such as obtaining a pediatric indication fail, perhaps. The industry does not like their profit stream to be inactive.
What exactly is patent infringement? Basically, in this case, the branded pharma company accuses another generic company of plagiarizing thier invention, which with pharma are chemical patents, such as in the case of a branded med, and therefore a generic company having possession of their former branded med are accused of trespassing without permission of the accuser, which again is the branded med. If another med is made, used, or sold without authorization, a patent is infringed, although it is allowed when the patent expires in the pharmaceutical industry. Patent attorneys get involved and file these largely pointless lawsuits which clearly lack merit not because there is an actual issue if the patent is in fact expired of the branded med, which is the case typically. But because by filing such a lawsuit, this wrongfully created case has a mandatory wait period of 2 ½ years with this type of lawsuit to be decided, which means that much more profits of the makers of the branded med for that period of time, which could mean billions for such a pharma company and their branded med. An analogy may be keeping the stock market open a bit longer to benefit a few, perhaps, but it is clearly dishonest.
This is allowed in our legal system and why this occurs, this system flaw, remains a mystery. Patients are coerced to continue to pay high prices of branded drugs due to the generic delays caused by these lawsuits filed by the branded pharma companies, so harm is caused by this tactic to the patients who take these meds. Is it not prevented, such lawsuits, because the lawmakers possibly have been bought by big pharma through lobbying? Is it because of the present administration’s affinity with the pharma industry? One can only speculate.
At one point, pharmaceutical companies’ culture and mission had what were called ethical medical standards. Why? Because it was the right thing to do, since medicine as a practice may be considered both sacred and complex. At times, drugs were created without patents with intent, believe it or not. Jonas Salk and the Polio vaccine is an example of this. Perhaps that was the last time such a noble event happened. Profit motive was not the entire focus, as it appears today with drug companies. No patent for Dr. Salk? Is that due to some mental illness of this creator? Absolutely not. The intent of Dr. Salk was to have greater availability of this vaccine for the benefit of public health. Dr. Salk believed that life was not a popularity contest. Today, such an act may be considered taboo or psychotic. I applaud his bravery and stance on his discovery, which, by the way, was funded by our government entirely.
Fast forward to today and such atrocious acts such as the lawsuit issue mentioned a moment ago. That once admired ethical industry somehow became possessed with a ‘greed is good’ mentality. Ethical Medical Standards are not visible and likely do not exist anymore, as far as I can observe. Deception, however, does. And the new pharma mentality is encouraged without regard to the optimal health for U.S. citizens. Yet what is stated by pharma (Billy Tauzin, et. al.) opposes what appears to be the case as illustrated by their actions such as what has been described. It’s my belief that U.S. citizens want a return of ethical medical standards, and they deserve this.
“Silence, indifference, and inaction were Hitler’s principal allies--- Lord Jacobovits
Dan Abshear
Spoken like a true American, Mr. Abshear. Why is health and medicine a god-given right?
Why should companies not be able to protect their intellectual properties? Even the very computer you use to communicate with has patents that can't be infringed upon. Why should they be given protection from another company, yet pharmaceuticals shouldn't?
If you want a healthier population, concentrate your efforts on making alcohol, tobacco, etc. illegal. Begin to educate children, and adults, on having a healthier lifestyle. Even in public schools today we hear about healthy lunches, but we don't hear that children are given the opportunity to buy "snacks" after the lunches are served, or that children can easily walk up to a vending machine and misuse their lunch money.
Stop blaming a company that uses profits to create solutions to problems caused by society. Instead blame the individuals that have caused the problems.
Hi Dan, I do not know exactly whose side you are on?
Lilli
Dan,
The Government no longer funds research for new pharmaceuticals like they did for Dr. Salk. I'm sure Dr. Salk was taken care of pretty well. Fame, fortune, if I recall Dr. Salk rightfully so did not live below substandards? Perhaps you could give these companies the billions of dollars they need to research medicine in order to have a "chance" to make it through the FDA process.
Just a thought?
Who me? (kidding) ;-)
Or maybe these companies can take the billions they are spending on marketing and use it for research. A drug will stand fine on it's own if it is effective and has minimal side effects. They did for many years. Let the doctors decide instead of the patient walking in suggesting they need medication. Currently it seems like marketing departments are our primary physicians. We sure hear from them more.
Not taking a pill? Do you not own a TV?
If I were a doctor I'd be pissed that someone else is putting me into this precarious situation. Doctors get sued all the time. If they don't prescribe what their patients demand, they lose their clientele. Why? because the TV said I need it!
Well once again I really love the "Phrma develops medicines and they deserve to make money" crowd because while that is absolutely true, it does not mean that Phrma should be allowed to commit fraud on government agencies to get there. It is amazing and scary what kinds of things people are willing to accept and even defend if the end is on their political agenda.
What I think you see with a company like Sanofi is a dangerous and scary pattern. Just think about what is going on in the Ketek saga even as this new fraud story comes to light.
Recall that Ketek is a very serious antibiotic that is linked to serious liver problems with multiple deaths. And the facts have suggested serious fraud in one of he studies. As recent stories suggest, it appears that when the FDA audited Ketek study participants recruited by the drug’s maker Aventis (now Sanofi-Aventis) they found one family doctor in a small Alabama town had signed up 407 patients for the study. The doctor’s entire staff was enrolled in the trail, and it even appeared that some of the patient signatures on consent forms where forged. Eventually, I think that doctor was charged with fraud, and sentenced to prison. The FDA also visited several other sites with high numbers of participants, and found serious irregularities at every one.
That study prompted the FDA to issue Sanofi-Aventis a warning letter. The letter can be found at http://www.fda.gov/cder/warn/2007/07-HFD-45-1002.pdf
But the fraud did not keep Ketek off the market. Last year, FDA commissioner Von Eschenbach testified that the FDA did not use the flawed safety study to approve Ketek. Congress members have suggested that the statement may be untrue, and they have been seeking access to FDA briefing documents to make that determination.
Pharmalot has reported on this story. A February 12 post started with "An FDA criminal investigator told a Congressional committee that Sanofi-Aventis had evidence that a safety study of its Ketek antibiotic contained fake data, but submitted it to the agency anyway, the Associated Press writes. 'Catastrophic failure' was how Doug Loveland described the drugmaker’s handling of the study."
And a search of Ketek on any news blog like google or yahoo will yeld some reading that could make you sick.
So we have a very powerful drug that has caused serious liver damage, we have fraud in the clinical studies, we have questions about whether senior sanofi-aventis folks knew or should have known and we have an FDA which says that it didn't use those studies but apparently won't share documents necessary to confirm that. It's a mess. And it's very scary. Because no matter how you look at it your kid could have been prescribed that medicine.
Fraudulent clinical trial data, fraud on the patent office etc. It looks like a pattern.
Yes, Phrma companies bring the necessary capital to do major Phase III trials that are necessary to bring new therapies to patients. For taking those risks, Phrma deserves and indeed needs to make strong profits. It is a high risk play.
But all of that still depends on the integrity of the science. Companies don't DESERVE to make profits from fraud. Companies don't DESERVE to make profits from corrupt data. And patients don't deserve to be put at risk for the sake of profit.
Clearly it appears that the drive for profit has overtaken scientific integrity at companies like Sanofi-Aventis, Merck and Schering. It appears that the FDA is not prepared to step up and do it's job. So more and more we can only hope that the Courts and the people will force them too.
I work in Phrma and I love what I do. I absolutely think we deserve to make solid profit from innovative new therapies. But those medicines must be based on clinical data developed with scientific integrity. When you lose that, there's no foundation to stand on and people will be hurt.