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Bayer evaluating options in oral contraceptive patent case

Last Updated: Friday, April 19, 2013 - 16:49

New Delhi: German drug major Bayer AG Friday said it "disagrees" with a US court ruling that allowed Indian rival Lupin to sell generic version of its oral contraceptive (OC) tablet 'Yaz' in the American market and is "evaluating" options.

"We are disappointed by and disagree with the court's ruling and are evaluating our options," a Bayer spokesperson told PTI in an emailed response.

The spokesperson did not elaborate on what are the options the company is evaluating.

Earlier this week, Mumbai-based Lupin Ltd had announced that a US Court had ruled in its favour paving the way for the company to introduce a generic version of Bayer AG's Yaz tablets in the American market.

"The US Court of Appeals for the Federal Circuit has ruled in the company's favour regarding its appeal of a previous judgement by a lower court for Bayer AG's Yaz oral contraceptive product," Lupin had said in a statement.

On April 16, the United States Court of Appeals for the Federal Circuit ruled that United States Patent No RE 37,564 (the RE '564 Patent) was invalid thereby reversing the district court's decision of validity.

"We are pleased with the ruling which paves the path for entry of generic product which would immensely benefit customers," a Lupin spokesperson had said.

Lupin is currently seeking approval from the US Food and Drug Administration for generic Yaz and is working out its commercialisation plan.

The Mumbai-based firm's generic Drospirenone and Ethinyl Estradiol Tablets are indicated for various conditions including prevention of pregnancy and for treating symptoms of premenstrual dysphoric disorder (PMDD).

According IMS MAT December 2012 sales data, total sales for branded and generic versions of the product stood at USD 361 million.


First Published: Friday, April 19, 2013 - 16:49
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