Lupin Ltd. announced that U.S Court of Appeals for the federal Circuit has ruled in its favor regarding its appeal of a previous judgment by a lower court for Bayer AG's Yaz oral contraceptive product.
On April 16, 2013 the United States Court of Appeals for the Federal Circuit has ruled that United States Patent No. RE 37,564 (the RE'564 Patent) is invalid, thereby reversing the district court's decision of validity.
Lupin's Generic Drospirenone and Ethinyl Estradiol tablets (3 mg +0.02 mg) of Bayer AG's Yaz tablets are indicated for preventing of pregnancy, to treat the symptoms of premenstrual dysphoric disorder (PMDD) for women and to treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control.
The total sale for Branded and generic sales for the product stood at $361 million, as per IMS MAT December 2012 data.
Confirming the same, Lupin Spokesperson commented, "We are pleased with the ruling which paves the path for entry of generic product which would immensely benefit customers.
Lupin is currently seeking approval from the US FDA for its generic and is working out its commercialization plan.
At the BSE, Lupin closed Wednesday's trading at a new high of Rs.673.25, up 2.34 percent from the previous close.
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