FTC staff report attacks branded-generic patent settlements
WASHINGTON — The Federal Trade Commission released a report Tuesday finding that drug companies entered 28 deals that the FTC called anticompetitive and said would increase healthcare costs for consumers and the government.
The FTC, which under the leadership of chairman Jon Leibowitz, repeatedly has attacked what it calls "pay-for-delay" deals between branded and generic drug manufacturers and has been lobbying the Congressional Joint Select Committee on Deficit Reduction, also known as the super committee, to ban the deals.
Meanwhile, the generic drug industry said the deals, technically patent litigation settlements, help ensure early arrival of cheaper generic drugs in consumers’ medicine cabinets.
"While a lot of companies don’t engage in pay-for-delay settlements, the ones that do increase prescription drug costs for consumers and the government each year," Leibowitz said. "Fortunately, congress has the opportunity to fix this problem through the Joint Select Committee on Deficit Reduction and save the government and American taxpayers billions of dollars."
Under the Hatch-Waxman Act of 1984, a generic drug company that wishes to launch its version of a branded drug after the latter’s market exclusivity period has expired but before its loss of patent protection, may file a regulatory approval application containing a paragraph IV certification, which asserts that the patent is invalid, unenforceable or that the generic won’t infringe it.
In most circumstances, the branded manufacturer will sue the generic manufacturer for patent infringement. But usually, both companies will reach a settlement of some sort. In some cases, the settlement involves the generic drug company agreeing not to immediately launch a product in exchange for a payment, which sometimes includes cash but usually means that the branded drug manufacturer agrees not to launch a so-called authorized generic — essentially the branded drug marketed under its generic name at a reduced price — during the 180-day period in which the first company to win approval for the generic gets to compete exclusively with the brand manufacturer before the drug becomes commoditized, and any company can market a generic version.
It’s these settlements that have the FTC and Leibowitz, as well as members of Congress, including Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa, irked the most. The FRC said the deals cost consumers and taxpayers $3.5 billion per year because they result in delayed entry of cheaper generics into the market.
But the Generic Pharmaceutical Association said such deals usually result in generics becoming available months or even years ahead of a branded drug’s patent expiring, and delaying launch after a patent expired would be illegal anyway. According to a report by RBC Capital Markets, generic drug companies win 48% of patent litigation settlements that go to trial, but their success rate increases to 76% when settlements are included.
"The FTC continues to miss the fundamental point: Patent settlements speed up the availability of less costly generic drugs and safe money for everyone; banning settlements and forcing drug makers to continue lengthy litigation with uncertain outcomes will be costly," GPhA president and CEO Ralph Neas said.
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Kao Brands gets name change
CINCINNATI — The maker of such brands as John Frieda and Jergens is getting a name makeover.
Kao Brands said it will be called Kao USA, effective Jan. 1, 2012, to reflect its repositioning effort by parent company Kao Corp.
In line with the name change, Kao’s beauty care subsidiaries in North America and Europe will operate as unified organizations in the major countries in which they operate.
"The alignment with Kao’s beauty care business will provide us with an opportunity to better harness Kao’s global scale and resources for the benefit of consumers and customers in the North American and European markets," Kao Brands president and CEO Bill Gentner said. "It will also provide more career opportunities for people both locally and internationally."
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Sales, profits increase for Dr. Reddy’s in Q2
HYDERABAD, India — Dr. Reddy’s Labs reported sales of $462 million for second quarter 2012 and $866 million for the first half of the fiscal year, according to an earnings statement released Tuesday.
The Indian generic drug maker said the second-quarter sales represented a 21% increase over second quarter 2011. Sales from global generics were $329 million for the quarter, an 18% increase over second quarter 2011, driven mostly by growth in North America and Russia.
Profits for the quarter were $63 million, a 7% increase over second quarter 2011.
Other highlights during the quarter included 28 new generic product launches and 17 regulatory filings, as well as the Food and Drug Administration’s approval of its generic version of Eli Lilly’s schizophrenia and bipolar disorder drug Zyprexa (olanzapine).
Zyprexa issues continue PTSD treatment for Veterans found ineffective. Eli Lilly Zyprexa Olanzapine. The use of powerful antipsychotic drugs has increased in children as young as three years old. Weight gain, increases in triglyceride levels and associated risks for diabetes and cardiovascular disease. The average weight gain (adults) over the 12 week study period was the highest for Zyprexa—17 pounds. You’d be hard pressed to gain that kind of weight sport-eating your way through the holidays.One in 145 adults died in clinical trials of those taking the antipsychotic drug Zyprexa. This was Lilly's # 1 product over $ 4 billion per year sales,moreover Lilly also make billions on drugs that treat the diabetes often that has been caused by the zyprexa! --- Daniel Haszard Zyprexa victim activist and patient who got diabetes from it. http://www.zyprexa-victims.com