Barr 撤消对Ortho-Mcneil公司 Ortho-N
NEW YORK (Reuters Health) - Barr Laboratories said on Monday that it has agreed to drop patent litigation against Johnson & Johnson subsidiary Ortho-McNeil over the oral contraceptive Ortho-Novum 7/7/7 (norethindrone, ethinyl estradiol) in exchange for a non-exclusive license to the product that will become effective at the start of 2003.
Barr filed suit in June 2000 in an effort to invalidate Ortho-McNeil's patents on the drug. Nine months later, the US Food and Drug Administration gave tentative approval to Barr's generic version of the contraceptive.
The case was expected to reach trial this year, but Barr has now acknowledged that the patents are valid and enforceable. In exchange, the company has received a non-exclusive license to market its generic product beginning January 1, 2003--nine months before the patents on Ortho-Novum 7/7/7 officially expire.
Settlements in which an innovator company agrees to let a generic challenger launch a product before patent protection expires are relatively common. The Federal Trade Commission has launched a sweeping investigation of these arrangements--which often involve large payments to the generic firms--to determine whether they unfairly keep cheaper versions of drugs out of the hands of consumers.
Drugmakers argue that because the generic product launches before the branded drug's patent expires, such settlements actually promote generic competition. But consumer groups have argued that if generic firms pressed on with their challenges and won them, inexpensive drugs would reach the market even sooner.
An Ortho-McNeil spokesman said that no payment was made to Barr in connection with this settlement.
Pomona, New York-based Barr noted that the settlement does not affect its ongoing lawsuit seeking to invalidate patents on Ortho-McNeil's Ortho Tri-Cyclen (norgestimate/ethinyl estradiol), an oral contraceptive that is also indicated for the treatment of acne.
During mid-afternoon trading on the New York Stock Exchange, shares of Barr were up 1.32 at 77.32, while shares of New Brunswick, New Jersey-based Johnson & Johnson were up .42 at 59.09.
-New York Newsroom 212 273 1700, 百拇医药
Barr filed suit in June 2000 in an effort to invalidate Ortho-McNeil's patents on the drug. Nine months later, the US Food and Drug Administration gave tentative approval to Barr's generic version of the contraceptive.
The case was expected to reach trial this year, but Barr has now acknowledged that the patents are valid and enforceable. In exchange, the company has received a non-exclusive license to market its generic product beginning January 1, 2003--nine months before the patents on Ortho-Novum 7/7/7 officially expire.
Settlements in which an innovator company agrees to let a generic challenger launch a product before patent protection expires are relatively common. The Federal Trade Commission has launched a sweeping investigation of these arrangements--which often involve large payments to the generic firms--to determine whether they unfairly keep cheaper versions of drugs out of the hands of consumers.
Drugmakers argue that because the generic product launches before the branded drug's patent expires, such settlements actually promote generic competition. But consumer groups have argued that if generic firms pressed on with their challenges and won them, inexpensive drugs would reach the market even sooner.
An Ortho-McNeil spokesman said that no payment was made to Barr in connection with this settlement.
Pomona, New York-based Barr noted that the settlement does not affect its ongoing lawsuit seeking to invalidate patents on Ortho-McNeil's Ortho Tri-Cyclen (norgestimate/ethinyl estradiol), an oral contraceptive that is also indicated for the treatment of acne.
During mid-afternoon trading on the New York Stock Exchange, shares of Barr were up 1.32 at 77.32, while shares of New Brunswick, New Jersey-based Johnson & Johnson were up .42 at 59.09.
-New York Newsroom 212 273 1700, 百拇医药