Generic player Teva Pharma announced (in a press release Here ) that Teva has entered into a licensing agreement with innovator Ortho-McNeil-Janssen to settle the patent infringement lawsuit in the U.S. District Court for the District of New Jersey related to Teva's generic version of the oral contraceptive formulation Norgestimate+Ethinyl Estradiol (Ortho Tri-Cyclen) 0.18 + 0.025 mg, 0.215 +0.025 mg and 0.25 + 0.025 mg Tablets
Under the terms of the settlement, Teva will obtain a release for past sales of its generic product, in exchange for an undisclosed royalty payment. Teva also will obtain a license to re-enter the market on December 31, 2015, or earlier in certain circumstances.
The settlement will not become effective until the court enters a proposed consent judgment upholding the validity and enforceability of Ortho's patent.
Background
The generic player Barr (Now, a subsidiary of Teva Pharma) has earlier challenged innovator’s Orange Book listed key patent for Norgestimate+Ethinyl Estradiol (Ortho Tri-Cyclen) 0.18 + 0.025 mg, 0.215 +0.025 mg and 0.25 + 0.025 mg Tablets in October, 2003, accordingly, innovator sued Barr in New Jersey District Court for the infringement of following Orange Book listed patent:
US6214815 (Assignee: Ortho-McNeil Pharmaceuticals; Date of grant: April 10, 2001; Expiry: Dec 9, 2019): The independent claims 1 and 4 were at issue in this trial, the disputed claims covers:
1. A method of contraception which comprises administering for 21 successive days to a female of childbearing age a combination of 17.alpha.-ethinylestradiol and norgestimate for the first 7 days in a daily dosage corresponding to 25 .mu.g of 17.alpha.-ethinylestradiol and 0.180 mg of norgestimate, for the succeeding 7 days a daily dosage equal to 25 .mu.g of 17.alpha.-ethinylestradiol aid 0.215 mg of norgestimate; and for the next 7 days a daily dosage equal to 25 .mu.g of 17.alpha.-ethinylestradiol and 0.250 mg of norgestimate; followed by 7 days without estrogen and progestogen administration.
4. A triphasic oral contraceptive unit having 21 separate dosage units, adapted for successive daily oral administration comprising: 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, 25 .mu.g of 17.alpha.-ethinylestradiol and 0.180 mg of norgestimate, 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, 25 .mu.g of 17.alpha.-ethinylestradiol and 0.215 mg of norgestimate; and 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, 25 .mu.g of 17.alpha.-ethinylestradiol and 0.250 mg of norgestimate; and optionally containing 7 additional dosage units free of estrogen and progestogen.
Generic player Barr challenged ‘815 patent on obviousness and anticipation grounds, based on prior art disclosure in US4616006 and US4628051. Also, some of the terms used in claim language like “method of contraception” and “oral contraceptive unit” were contentious issue, for which Marksman hearing held in 2005. Further, as per Marksman hearing held in 2005, court construed the claim language based on intrinsic evidences. In Oct 2006, court denied summary judgment to both parties.
Under the terms of the settlement, Teva will obtain a release for past sales of its generic product, in exchange for an undisclosed royalty payment. Teva also will obtain a license to re-enter the market on December 31, 2015, or earlier in certain circumstances.
The settlement will not become effective until the court enters a proposed consent judgment upholding the validity and enforceability of Ortho's patent.
Background
The generic player Barr (Now, a subsidiary of Teva Pharma) has earlier challenged innovator’s Orange Book listed key patent for Norgestimate+Ethinyl Estradiol (Ortho Tri-Cyclen) 0.18 + 0.025 mg, 0.215 +0.025 mg and 0.25 + 0.025 mg Tablets in October, 2003, accordingly, innovator sued Barr in New Jersey District Court for the infringement of following Orange Book listed patent:
US6214815 (Assignee: Ortho-McNeil Pharmaceuticals; Date of grant: April 10, 2001; Expiry: Dec 9, 2019): The independent claims 1 and 4 were at issue in this trial, the disputed claims covers:
1. A method of contraception which comprises administering for 21 successive days to a female of childbearing age a combination of 17.alpha.-ethinylestradiol and norgestimate for the first 7 days in a daily dosage corresponding to 25 .mu.g of 17.alpha.-ethinylestradiol and 0.180 mg of norgestimate, for the succeeding 7 days a daily dosage equal to 25 .mu.g of 17.alpha.-ethinylestradiol aid 0.215 mg of norgestimate; and for the next 7 days a daily dosage equal to 25 .mu.g of 17.alpha.-ethinylestradiol and 0.250 mg of norgestimate; followed by 7 days without estrogen and progestogen administration.
4. A triphasic oral contraceptive unit having 21 separate dosage units, adapted for successive daily oral administration comprising: 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, 25 .mu.g of 17.alpha.-ethinylestradiol and 0.180 mg of norgestimate, 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, 25 .mu.g of 17.alpha.-ethinylestradiol and 0.215 mg of norgestimate; and 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, 25 .mu.g of 17.alpha.-ethinylestradiol and 0.250 mg of norgestimate; and optionally containing 7 additional dosage units free of estrogen and progestogen.
Generic player Barr challenged ‘815 patent on obviousness and anticipation grounds, based on prior art disclosure in US4616006 and US4628051. Also, some of the terms used in claim language like “method of contraception” and “oral contraceptive unit” were contentious issue, for which Marksman hearing held in 2005. Further, as per Marksman hearing held in 2005, court construed the claim language based on intrinsic evidences. In Oct 2006, court denied summary judgment to both parties.
On July 1, 2009, Teva who announced "at risk" launch (in press release here) agreed to suspend generic launch till preliminary Injunction opinion (as per Teva press release Here and Here). The PI proceedings were ongoing when both the parties announced settlement.
Probably, patent litigation settlement is beneficial to both the parties. Innovator for the time being is able to delay generic challenge till 2015. For Teva, they will have certainty in product launch without the threat of litigation (they were in litigation with innovator for the last 6 years). For American public, they will get cheaper generic version from 2015 onwards (or earlier), otherwise, they would have to wait till 2019.
Probably, patent litigation settlement is beneficial to both the parties. Innovator for the time being is able to delay generic challenge till 2015. For Teva, they will have certainty in product launch without the threat of litigation (they were in litigation with innovator for the last 6 years). For American public, they will get cheaper generic version from 2015 onwards (or earlier), otherwise, they would have to wait till 2019.
Earlier, innovator got approval to market this product on Aug 22, 2002.
Also, as per complaints filed by innovator in New Jersey District Court, innovator has sued generic players like Sandoz and Watson for this product.
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