Sales for the branded drug were approximately US$40 million in the year ending June 2006. Chairman and CEO of Barr Pharmaceuticals, Bruce L. patent anyway. The BML-190 three parties eventually reached an agreement, which was subject to regulatory approval by the Federal BML-190 Trade Commission and the state attorney general, in which Apotex would delay marketing its generic in return for a minimum US$40-million payout from BMS and Sanofi-Aventis. However, after concerns were raised by the regulators about the deal, a revised settlement was proposed. BMS and Sanofi-Aventis agreed that if Apotex launched its generic and the ‘265 patent was subsequently held to be valid and enforceable, then the companies would waive the triple damages they are entitled to and instead would limit damages to 50% of Apotex’s net sales, or 40% if they were to launch their own authorized generic. The two companies also agreed to give Apotex 5 days working notice before filing for an injunction to stop drug shipments. The settlement effectively created a 5-day window for Apotex to sell its generic without legal restraint and with limited financial risk, during which time pharmacies could stock up on Cd24a the cheaper generic alternative and continue selling it until their supplies run out. But at the end of July 2006, when the state attorney general still refused to grant antitrust clearance for the deal, Apotex exercised its right not to pursue the settlement and announced its intention to ship its generic product immediately, seemingly confident that it will win the infringement case. At the time of going to press a decision on whether to grant the injunction had not been made, but BMS and Sanofi-Aventis hope to halt shipping of the drug and to recall drug that has already been shipped. Meanwhile they have already taken the measure of dropping the price of the branded drug. The case is the latest in a crackdown by regulators on attempts by pharmaceutical companies to use pay-off agreements to delay the launch of generic competitors. Pfizer struggle to protect Lipitor patents Pfizer’s attempts to keep generic versions of Lipitor (atorvastatin) at bay in the US markets were dealt a blow recently BML-190 when the US Court of Appeals ruled that one of its key patents for the drug is invalid because of a technical defect. Generic competition could now begin in 2010 2010, and potentially leave Pfizer out of pocket to the tune of several US$ billion in sales. The dispute centres on two Pfizer patents covering Lipitor that are the subject of a patent-infringement match against Ranbaxy Laboratories. In December 2005, a Delaware Area Court ruled that Ranbaxy failed to prove the patents US4,681,893 and US5,273,995 were invalid or unenforceable and found the generics firm guilty of infringement. However, on appeal, although the US Federal government Circuit agreed with the area court’s findings in the case of the ‘893 patent, which broadly covers atorvastatin, it found problem with the ‘995 patent, which relates to the calcium salt of atorvastatin. The key issue is definitely Pfizer’s failure to comply with the US patent law BML-190 specification for making a ‘dependent claim’, which essentially requires that such a claim must refer to a earlier claim and must also specify a further limitation of the claimed subject matter. Pfizer’s problem is definitely that claim 6 of the ‘995 patent covers the ‘hemicalcium salt of claim 2’ but claim 2 only recites ‘atorvastatin acid’ and crucially omits mention of ‘pharmaceutically suitable salts’ of atorvastatin acid, which are covered instead in claim 1. The appeals court argued that claim 6 could have been properly drafted either as dependent from claim 1 or in the form of an independent claim, but as written it failed to specify a further limitation of the subject matter because it fell completely outside the scope of claim 2. The ‘995 patent safeguarded Lipitor until June 2011. If Pfizer is unable to right the drafting defect at the US PTO and the appeals court decision stands, then Lipitor’s safety will run only until the expiry of the ‘893 patent in March 2010. The potential loss of 15 weeks of market exclusivity could demonstrate highly damaging to Pfizer, which recorded global sales exceeding US$12 billion for Lipitor in 2005. Barr and Shire settle on Adderall Barr Pharmaceuticals and Shire Laboratories have finally reached a settlement over Adderall, a drug for attention-deficitChyperactivity disorder (ADHD). The deal means that a common version of the drug will reach.The case is the latest inside a crackdown by regulators on attempts by pharmaceutical companies to use pay-off agreements to delay the release of generic competitors. Pfizer struggle to protect Lipitor patents Pfizer’s efforts to keep common versions of Lipitor (atorvastatin) at bay in the US markets were dealt a blow recently when the US Court of Appeals ruled that one of its key patents for the drug is invalid because of a complex defect. it is anticipated by a prior patent (US 4,529,596, right now expired) claiming both enantiomers of clopidrogel bisulphate. Moreover, because the ‘265 patent only covers the (+) enantiomer, Apotex maintains that its product does not infringe the patent anyhow. The three parties eventually reached an agreement, which was subject to regulatory approval from the Federal government Trade Commission and the state attorney general, in which Apotex would delay marketing its common in return BML-190 for a minimum US$40-million payout from BMS and Sanofi-Aventis. However, after concerns were raised from the regulators about the deal, a revised arrangement was proposed. BMS and Sanofi-Aventis agreed that if Apotex launched its common and the ‘265 patent was consequently held to be valid and enforceable, then the companies would waive the triple damages they are entitled to and instead would limit damages to 50% of Apotex’s online sales, or 40% if they were to release their own authorized common. The two companies also agreed to give Apotex 5 days working notice before filing for an injunction to stop drug shipments. The arrangement effectively produced a 5-day time windowpane for Apotex to sell its common without legal restraint and with limited monetary risk, during which time pharmacies could stock up within the cheaper common alternate and continue selling it until their materials run out. But at the end of July 2006, when the state attorney general still refused to grant antitrust clearance for the deal, Apotex exercised its right not to pursue the arrangement and announced its intention to ship its common product immediately, seemingly confident that it will win the infringement case. At the time of going to press a decision on whether to give the injunction had not been made, but BMS and Sanofi-Aventis hope to halt shipping of the drug and to recall drug that has already been shipped. Meanwhile they have already taken the measure of dropping the price of the branded drug. The case is the latest inside a crackdown by regulators on attempts by pharmaceutical companies to use pay-off agreements to delay the release of common competitors. Pfizer struggle to guard Lipitor patents Pfizer’s efforts to keep common versions of Lipitor (atorvastatin) at bay in the US markets were dealt a blow recently when the US Court of Appeals ruled that one of its important patents for the drug is invalid because of a technical defect. Common competition could right now begin in 2010 2010, and potentially leave Pfizer out of pocket to the tune of several US$ billion in sales. The dispute centres on two Pfizer patents covering Lipitor that are the subject of a patent-infringement match against Ranbaxy Laboratories. In December 2005, a Delaware Area Court ruled that Ranbaxy failed to prove the patents US4,681,893 and US5,273,995 were invalid or unenforceable and found the generics firm guilty of infringement. However, on appeal, although the US Federal government Circuit agreed with the area court’s findings in the case of the ‘893 patent, which broadly covers atorvastatin, it found fault with the ‘995 patent, which relates to the calcium salt of atorvastatin. The key issue is definitely Pfizer’s failure to comply with the US patent law specification for making a ‘dependent claim’, which essentially requires that such a claim must refer to a earlier claim and must also specify a further limitation of the claimed subject matter. Pfizer’s problem is definitely that claim 6 of the ‘995 patent covers the ‘hemicalcium salt of claim 2’ but claim 2 only recites ‘atorvastatin acid’ and crucially omits mention of ‘pharmaceutically acceptable salts’ of atorvastatin acid, which are covered instead in claim 1. The appeals court argued that claim 6 could have been properly drafted either as dependent from claim 1 or in the form of an independent claim, but as written it failed to specify a further limitation of the subject matter because it fell completely outside the scope of claim 2. The ‘995 patent guarded Lipitor until June 2011. If Pfizer is unable to correct the drafting defect at the US PTO and the appeals court decision stands, then Lipitor’s protection will run only until the expiry of the ‘893 patent in March 2010. The potential loss of 15 months of market exclusivity could show highly damaging to Pfizer, which recorded global sales exceeding.