Innovator Eli Lilly got a favorable decision from Court of Appeal for federal Circuit (CAFC) on Feb 24, 2008 w.r.t Raloxifene Hydrochloride 60 mg Tablets. CAFC has delayed Teva’s ANDA approval by 6 months. The Chief Judge Rader and Michel affirmed a district court order (by 2-1, with dissent from fellow Judge Prost)) extending the thirty-month stay of FDA approval of Teva's ANDA.
Teva filed its Para IV certification against Following Orange Book listed patents:
US5393763 (Expiry: Jul 28, 2012); which covers a method of inhibiting bone loss
US6906086 (Expiry: Jul 28, 2012); which covers a method of inhibiting post-menopausal bone loss in a post-menopausal woman in need of treatment to prevent or treat post-menopausal osteoporosis comprising administering a single daily oral dose to said woman of an effective amount of 6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl-4-[2-(piperidin-1-yl)ethox yphenyl]methanone hydrochloride.
USRE38968 (Expiry: Jul 28, 2012); which covers method of use in a post-menopausal woman in need of treatment to prevent or treat post-menopausal osteoporosis by use of Raloxifen
USRE39049 (Expiry: Jul 28, 2012); which covers method of use in a post-menopausal woman in need of treatment to prevent or treat post-menopausal osteoporosis by use of Raloxifen
USRE39050 (Expiry:Mar 2, 2014); which covers a method of inhibiting bone loss or resorption, or lowering serum cholesterol, comprising administering to a human in need thereof Raloxifen
US5478847 (Expiry:Mar 2, 2014); which covers a method of inhibiting bone loss or bone resorption comprising administering to a human in need thereof a Raloxifen, in an amount of about 50 to 150 mg/day.
US5457117 (Expiry: Jul 28, 2012); which covers a method of inhibiting bone loss comprising administering to a human in need thereof an effective amount of 6-hydroxy-2-(4-hydroxyphenyl)-benzo[B]thien-3-yl-4-[2-(piperidin-1-yl)etho xyphenyl]methanone hydrochloride.
US5393763 (Expiry: Jul 28, 2012); which covers a method of inhibiting bone loss or resorption, or lowering serum cholesterol, comprising administering to a human in need thereof Raloxifen
US5811120 (Expiry:Mar 2, 2014); which covers a solid administerable pharmaceutical formulation comprising raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein: the surfactant is a sorbitan fatty acid ester or a polyoxvethylene sorbitan fatty acid ester; and the water soluble diluent is a polyol or sugar.
US5972383 (Expiry:Mar 2, 2014); which covers a method of treating mammary tumors, prostatic tumors, or osteoporosis, comprising administering to a human in need thereof a solid orally administerable pharmaceutical formulation comprising raloxifene hydrochloride in combination with a surfactant, polyvinylpyrrolidone, and a water soluble diluent, wherein: the surfactant is a sorbitan fatty acid ester or a polyoxyethylene sorbitan fatty acid ester; and the water soluble diluent is a polyol or sugar.
US6894064 (Expiry:Mar 10, 2017); which covers a pharmaceutical composition comprising: a) 60 mg of 6-hydroxy-2-(4-hydroxy-phenyl)-3-[4-(2-piperidinoethoxy)benzoyl]benzo[b]th iophene hydrochloride, characterized in that the benzo[b]thiophene compound is in particulate form, said particles having a mean particle size of less than about 25 microns, at least about 90% of said particles have a size of less than about 50 microns; b) a surfactant; and c) a water-soluble diluent.
US6458811 (Expiry:Mar 10, 2017); which covers Raloxifen in particulate form, said particles having a mean particle size of less than about 25 microns, at least about 90% of said particles have a size of less than about 50 microns.
US6797719 (Expiry:Mar 10, 2017): which covers Raloxifen in particulate form, said particles having a mean particle size of less than about 25 microns, at least about 90% of said particles have a size of less than about 50 microns; b) a surfactant; and c) a water-soluble diluent.
Innovator sued Teva (within 45 days of Para IV notice from Teva) in Indiana Southern District Court in June, 2006 for infringement of method of use patents (Innovator not sued Teva on ‘064, '819 ,‘719 ), accordingly, Teva 's ANDA approval was delayed by 30 months. Additionally, innovator also sued Teva for following patents not listed in Orange Book:
US5747510 (Expiry:Mar 2, 2014); A pharmaceutical formulation in daily dosage unit form comprising, per daily dosage unit, an amount within the range of about 55 to about 150 mg of Raloxifen or a pharmaceutically acceptable salt or solvate thereof, said formulation in dosage unit form being adapted for oral administration in the form of a capsule or tablet.
US5641790 (Expiry:Jun 24, 2014); A pharmacuetical formulation in dosage unit form comprising per dosage unit, an amount within the range of about 55 to about 150 mg of a Raloxifen or a pharmaceutically acceptable salt or solvate thereof.
Innovator in it's amended complaint in 2007, asserted that Teva infringed patents covering particle size and formulation (‘064, '819 ,‘719 patents) of Raloxifen, after that Teva incorporated technical changes in its specification to design around against Orange Book patents on Particle size.
Innovator Eli Lilly, filed its Motion for Extension of Statutory Stay on September 17, 2008, pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), to extend the thirty-month statutory stay of the US FDA approval of Teva Pharma’s ANDA No. 78-193 for Raloxifene Hydrochloride 60 mg Tablets. The statutory stay was set to expire on November 16, 2008, and Teva has informed Lilly that it will launch its generic Raloxifene hydrochloride upon expiration of the statutory stay, if USFDA final approval is obtained by that date. Trial of this case was scheduled for March 9, 2009. Lilly requests a six-month extension of the thirty-month statutory stay based on Teva's failure to "reasonably cooperate in expediting the action," pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), as evidenced by Teva's last-minute change in its proposed drug product and its "multiple delays in producing critical discovery w.r.t particle size patents ‘064, 819 and ‘719 patents, which have adversely affected Lilly's infringement case and trial preparation." Lilly contends that, on July 10, 2008, it learned that, more than two years after filing ANDA No. 78-193, Teva altered its proposed drug product by changing:
(1) The particle size manufacturing specification of its Raloxifene hydrochloride API
(2) The method of measuring particle size (removing a five-second sonification step).
According to Lilly, these changes directly affect the underlying infringement action and, as a result of Teva's "eleventh hour" change to the proposed generic product and Teva's discovery tactics and delay in producing related documents and the altered Raloxifene samples, Lilly has been prejudiced in preparing for trial and developing its infringement case and the stay should be granted.Teva rejoins that the amendment it made to its Raloxifene ANDA, filed with the USFDA on July 8, 2008, is nothing more than a minor alteration of the product, and further, that it has reasonably cooperated in advancing this litigation by timely notifying Lilly on July 10, 2008, of the amendment and, within sixty days of filing the amendment, producing approximately 27,000 documents related to Teva's various Raloxifene lots and three industrial batch samples of the altered product that Lilly requested. Thus, Teva contends that an extension of the thirty-month stay would be inappropriate because Lilly is unable to demonstrate that Teva has failed to reasonably cooperate in advancing this litigation.
According to Teva, because ANDA amendments occur "with some frequency without regard for the status of the parallel patent litigation, absent some legislative history to the contrary, the thirty-month statutory stay should be viewed as already having accounted for the possibility of such amendments." Teva asserts that, rather than focusing on the substantive patent issues that this litigation is intended to address, Lilly is instead dedicating all of its efforts to raising regulatory issues that should be left to the USFDA.
Court in its decision concluded that the composition of the generic drug product for which USFDA approval is being sought and which innovator Lilly alleges to be the infringing product should be Verified. In light of the fact that Teva has recast its product more than eighteen months after it provided the original sample to Lilly and only eight months before trial is set to commence, we find that, in preparation for trial, Lilly is entitled to have a sufficient opportunity to identify the nature and composition of the Raloxifene product as Teva intends for it to be sold. A similar extension is warranted here in order to provide Lilly with a reasonable amount of time to allow its expert to test and report on the altered Raloxifene samples provided by Teva and for Lilly to assess and utilize that information and analysis in preparation for trial, which is set to commence on March 9, 2009. For the foregoing reasons, the Court hereby Extends until March 9, 2009, in this action the period under 21 U.S.C. § 355(j)(5)(B)(iii) during which the FDA is barred from approving ANDA No. 78-193.
Court Opinion Here
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