Abbott Switched TriCor Patents, But Was It Legal?
8 CommentsBy Ed Silverman // June 2nd, 2008 // 12:28 pm
State and federal authorities are examining whether the drugmaker violated antitrust laws in its an effort to prevent Teva Pharmaceuticals from selling a generic version of its old standby TriCor cholesterol med, which racked up $1.2 billion in sales last year, The Wall Street Journal writes.
And the outcome could provide important guidance as drugmakers try to extend patents by using slight improvements, a practice also known as evergreening, which critics say abuse the patent system and hurt consumers and government health plans by denying access to legitimate and less expensive generics.
In a lawsuit filed in federal court in Delaware, 25 states and Washington, DC, allege that, in addition to filing new patents on questionable improvements to TriCor, Abbott engaged in a practice known as “product switching.” That involves retiring an existing drug and replacing it with a modified version that is marketed as “new and improved,” which prevents pharmacists from substituting a generic for the branded drug when they fill prescriptions for it. Here is the lawsuit.
Product switching isn’t against the law, but the lawsuit alleges that Abbott acted improperly by using this and other strategies solely to preserve its monopoly on TriCor. The Federal Trade Commission is investigating the same issue, the Journal adds. Abbott denies any wrongdoing.
The TriCor saga dates back to the 1960s, when the drug, known generically as fenofibrate, was discovered by France’s Laboratoires Fournier, which began selling the med Europe in 1975. More than two decades later, Abbott licensed the US rights and won FDA approval to sell it as TriCor. The underlying patent had expired, but Abbott patented a new way to make it.
In 1999, one year after TriCor hit the US market, a generic drugmaker called Novopharm, which was soon acquired by Teva, applied to the FDA to market a copycat version of the drug. Abbott struck back and sued Teva, alleging patent infringement. That triggered a 30-month waiting period, during which a generic can’t be launched while patent challenges are worked out, the paper explains.
During the waiting period, Abbott altered its product, lowering the dosage and changing it to a tablet from a capsule. After filing a patent on this modified form of TriCor, Abbott bought back the remaining supplies of the capsules from pharmacies and replaced them with the lower-dose tablets, the Journal writes.
By the time 30 months elapsed and Teva was ready to launch its generic, there was no longer a market for it. FDA rules say a pharmacist can substitute a cheaper generic for a branded drug only if they are strictly bioequivalent, the Journa explains, adding that not only does this mean the generic version must contain the same active ingredient, it also must also be in the same form and dosage.
Since Teva’s generic capsules were no longer technically bioequivalent to Abbott’s new TriCor tablets, pharmacists couldn’t automatically dispense them in place of the branded drug, the Journal writes.
In June 2002, Teva asked the FDA to let it sell a generic version of the TriCor tablets. Repeating the same pattern, Abbott sued Teva again for patent infringement, triggering another 30-month waiting period. Abbott then changed TriCor’s formulation and dosage a second time before Teva could bring its generic tablets to market, the Journal reports, noting that, fter courts repeatedly ruled against it in the patent lawsuits, Abbott dropped the patent litigation in 2005.
Teva has since filed a countersuit alleging that Abbott’s actions violated antitrust laws. If what Abbott did is allowed, drugmakers could switch from one formulation of a drug to another and protect their monopolies indefinitely, Teva says in its suit, which is scheduled for trial in November.
Abbott tells the Journal it has the right to protect its innovations and denies switching formulations for the sole purpose of warding off generic competition. The drugmaker also says the two switches brought improvements for patients. The first reformulation enabled the drug to raise patients’ good cholesterol and the second eliminated the requirement that it be taken with food.
“Any suggestion that new formulations did not offer patients benefit is false,” an Abbott spokeswoman tells the paper.
Yet the data on which Abbott bases the good-cholesterol claim is from clinical trials involving the original TriCor, not the subsequent versions of the drug, according to publicly available FDA documents. Teva argues the drug’s active ingredient stayed the same and that the supposed improvements were smoke screens.
In the past several months, more than two dozen state attorneys general have effectively sided with Teva. No hearing has been scheduled on the states’ lawsuit.
“Pharmaceutical companies should not be able to get away with protecting their patents purely on the basis of altering their products on dosage or small changes in order to keep their profits up,” Florida Attorney General Bill McCollum, who is spearheading the multistate suit, tells the Journal. “The public interest is for patents to eventually expire.”
Doc
If indeed Abbott made the so-called beneficial changes to the new formulations but continued to base their promotional claims on studies using the old formulation - they should be nailed to the wall. You can’t have it both ways.
Justice in Michigan
I am a little unclear why docs could not rx for fenofibrate in the original dosage and form - in other words, the version that is Teva’s generic. At that point, it would be “illegal” for a pharmacist to provide the “new” version, no?
Doc
Justice,
What you propose is possible, except there was/is no army of sales reps reinforcing the old dose to MDs every day. MDs are too busy to remember such details, especially when their sample closet is full of the Abbott drug.
Justice in Michigan
A version of this happened with Allergan’s iop drop, Alphagan. They brought out a new version with 25% less active ingredient and a different preservative as Alphagan was about to lose patent protection. They stopped selling Alphagan in the U.S. - in favor of the new “Alphagan P” - although continued to sell it in thirty other countries around the world.
Through a range of strategies, they were able to keep generic briminodine tartrate .2% (the original Alphagan) off the U.S. market for nearly three years.
Their final move was to suggest that Alph P was a safer med. (But, as lawyers pointed out, they then had to explain why they were still selling Alph classic around everywhere else in the world.)
While the clinical trials showed a 50% reduced risk of ocular allergy for P (relative risk number - actual difference quite small) the relative risk of P not having adequate efficacy was 400% over original Alphagan in clinical trials (also rel. risk number).
Needless to say, last bit was not in the presss releases.
Justice in Michigan
Thanks, Doc. But what still confuses me is why Teva would be kept from bringing out a generic of the original Tricor formulation, even if the original no longer exists (as original Alphgan no longer exists in the U.S.).
In the case of Alphagan and “P,” a number of opthies have gone to rx’ing the generic (even without reps) because of lack of efficacy and other problems with the “improved” version.
But it is true that a variety of legal shenanigans kept generic off market for nearly three years. (But, as reported, not in 30 other countries, including Canada, although the stuff was still made in California. Just not on sale there.)
Dan
What some people do involved in market that well exceeds 20 billion a year….
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
Doc
Dan,
Your comments are spot on. As a current industry insider with many decades of life in this business, I have never seen the crass pursuit of profit (I do recognize that profits are not evil and they are necessary for R&D)worse than it is now.
Yet I have never seen the industry spin in higher gear either, perhaps they necessarily go hand in hand, but it is sad to see science and patients steamrolled by marketing MBAs and CEOs that may be excellent managers but little regard for patients behind closed doors. There a few true leaders in the industry. My own compnay released a PR campaign about two years ago and at our meeting to introduce us to it, they made it very clear this was for PR purposes, to blunt negative news coming out about a settlement for company wrongdoing - oh and by the way, patients might eventually get helped too.
Jack
The Crazy thing about this whole lawsuit is that Tricor is not the only branded feofibrate in the market. Their is also Antara which made its dosing 130mg vs. Tricor 145. Their is also a brand new one on the market called fenoglide 120mg. I am a doctor and have always been a fan of fibrates. I did notice a difference when tricor was reformulated to be taken with or without food. With the older version it had to been taken with food and if it wasn’t, their were noticible efficacy issues. If the states argument is that the changes did not benefit the patients, I think that they will lose.