Teva filed lawsuit against USFDA on Risperidone exclusivity
Teva Pharma announced (as reported earlier by this blog) today that its U.S. subsidiary has filed a lawsuit against the USFDA seeking an order requiring the FDA to relist in the Orange Book US5158952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal (Risperidone) Tablets.Teva argues that the FDA's denial of Teva's Citizen's Petition, seeking the relisting of US5158952 and restoration of Teva's 180-day exclusivity for its pending abbreviated new drug application for risperidone tablets, was unlawful, as Teva disputes that the agency provided legal notice that the patent had been delisted prior to Teva's submission of a Paragraph IV certification to that patent.
Solvay Filed lawsuit against Teva on Fenofibrate patent infringemnet
Solvay SA said its pharmaceutical business' units Laboratoires Fournier SA and Fournier Laboratories Ireland Ltd have filed a patent lawsuit against Teva Pharmaceutical Industries over fenofibrate drug TriCor.Fenofibrate is a drug of the fibrate class. The development of Fenofibrate was discovered by Groupe Fournier SA, before it was acquired by Solvay Pharmaceutical in 2005. It is mainly used to reduce cholesterol levels in patients at risk of cardiovascular disease. Like other fibrates, it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density liporotein (HDL) levels and reducing tryglycerides level. It also appears to have a beneficial effect on the insulin resistance featured by the metabolic syndrome. It is used alone or in conjunction with statins in the treatment of hypercholesterolemia and hypertriglyceridemia. Fenofibrate is sold under the brand name Tricor by Abbott Labs and Lipanthyl by Solvay Pharmaceutical.
Teva filed an abbreviated new drug application at the end of January seeking approval for a generic version of the fenofibrate 145 mg form tablets in the US.'Solvay Pharmaceuticals is fully committed to its fenofibrate franchise and will vigorously protect the intellectual property for this product against any infringement,' the group said in a statement.
US Court Splits Evenly In Warner-Lambert Troglitazone Suit
The U.S. Supreme Court Monday deadlocked in a Michigan lawsuit against Pfizer Warner-Lambert unit, an outcome that allows a product liability case over Troglitazone (Rezulin) to proceed. The high court heard oral arguments in the appeal just last week where the justices appeared sharply-divided on whether earlier Supreme Court precedent restricts state product liability lawsuits alleging fraud in the Food and Drug Administration drug-review process.
Troglitazone (Rezulin, Resulin or Romozin) is an anti-diabetic and antiinflammatory drug, and a member of the drug class of the thiazolidinediones. It was introduced in the late 1990s but turned out to be associated with an idiosyncratic reaction leading to drug-induced hepatitis. It was withdrawn from the USA market on 21 March 2000, and from other markets soon afterwards
The court was split 4-4, it announced in a brief order. Chief Justice John Roberts Jr. was recused from the case, presumably because he owns less than $15, 000 in Pfizer stock, his most recent financial disclosure shows.
The outcome provides no new legal precedent, but it is a blow for Warner- Lambert because a lower-court ruling that revived the lawsuit now stands.
Pfizer, which acquired Warner-Lambert in 2000, has already announced a fourth- quarter charge against earnings in 2003 to cover all the costs associated with Rezulin litigation.
The case was over injuries from Troglitazone (Rezulin), a diabetes drug that was removed from the market in 2000 after less than four years on the market. The lawsuit is proceeding under a unique Michigan state drug products liability law that favors pharmaceutical companies by generally barring lawsuits over drugs approved for sale by the FDA. But the law has an exemption that allows injured patients to sue if they allege a drug company committed fraud during the FDA drug-review process.
The issue of federal preemption of state lawsuits over drugs is one the Supreme Court is scheduled to hear in a separate case next fall when it takes up Wyeth's challenge to a $6.8 million judgment awarded to a Vermont woman over complications from an anti-nausea drug.The Michigan claims were thrown out by a federal trial judge in 2005 prior to the Second Circuit ruling that revived the claims on appeal.
Teva Pharma announced (as reported earlier by this blog) today that its U.S. subsidiary has filed a lawsuit against the USFDA seeking an order requiring the FDA to relist in the Orange Book US5158952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal (Risperidone) Tablets.Teva argues that the FDA's denial of Teva's Citizen's Petition, seeking the relisting of US5158952 and restoration of Teva's 180-day exclusivity for its pending abbreviated new drug application for risperidone tablets, was unlawful, as Teva disputes that the agency provided legal notice that the patent had been delisted prior to Teva's submission of a Paragraph IV certification to that patent.
Solvay Filed lawsuit against Teva on Fenofibrate patent infringemnet
Solvay SA said its pharmaceutical business' units Laboratoires Fournier SA and Fournier Laboratories Ireland Ltd have filed a patent lawsuit against Teva Pharmaceutical Industries over fenofibrate drug TriCor.Fenofibrate is a drug of the fibrate class. The development of Fenofibrate was discovered by Groupe Fournier SA, before it was acquired by Solvay Pharmaceutical in 2005. It is mainly used to reduce cholesterol levels in patients at risk of cardiovascular disease. Like other fibrates, it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density liporotein (HDL) levels and reducing tryglycerides level. It also appears to have a beneficial effect on the insulin resistance featured by the metabolic syndrome. It is used alone or in conjunction with statins in the treatment of hypercholesterolemia and hypertriglyceridemia. Fenofibrate is sold under the brand name Tricor by Abbott Labs and Lipanthyl by Solvay Pharmaceutical.
Teva filed an abbreviated new drug application at the end of January seeking approval for a generic version of the fenofibrate 145 mg form tablets in the US.'Solvay Pharmaceuticals is fully committed to its fenofibrate franchise and will vigorously protect the intellectual property for this product against any infringement,' the group said in a statement.
US Court Splits Evenly In Warner-Lambert Troglitazone Suit
The U.S. Supreme Court Monday deadlocked in a Michigan lawsuit against Pfizer Warner-Lambert unit, an outcome that allows a product liability case over Troglitazone (Rezulin) to proceed. The high court heard oral arguments in the appeal just last week where the justices appeared sharply-divided on whether earlier Supreme Court precedent restricts state product liability lawsuits alleging fraud in the Food and Drug Administration drug-review process.
Troglitazone (Rezulin, Resulin or Romozin) is an anti-diabetic and antiinflammatory drug, and a member of the drug class of the thiazolidinediones. It was introduced in the late 1990s but turned out to be associated with an idiosyncratic reaction leading to drug-induced hepatitis. It was withdrawn from the USA market on 21 March 2000, and from other markets soon afterwards
The court was split 4-4, it announced in a brief order. Chief Justice John Roberts Jr. was recused from the case, presumably because he owns less than $15, 000 in Pfizer stock, his most recent financial disclosure shows.
The outcome provides no new legal precedent, but it is a blow for Warner- Lambert because a lower-court ruling that revived the lawsuit now stands.
Pfizer, which acquired Warner-Lambert in 2000, has already announced a fourth- quarter charge against earnings in 2003 to cover all the costs associated with Rezulin litigation.
The case was over injuries from Troglitazone (Rezulin), a diabetes drug that was removed from the market in 2000 after less than four years on the market. The lawsuit is proceeding under a unique Michigan state drug products liability law that favors pharmaceutical companies by generally barring lawsuits over drugs approved for sale by the FDA. But the law has an exemption that allows injured patients to sue if they allege a drug company committed fraud during the FDA drug-review process.
The issue of federal preemption of state lawsuits over drugs is one the Supreme Court is scheduled to hear in a separate case next fall when it takes up Wyeth's challenge to a $6.8 million judgment awarded to a Vermont woman over complications from an anti-nausea drug.The Michigan claims were thrown out by a federal trial judge in 2005 prior to the Second Circuit ruling that revived the claims on appeal.
