Bayer Patent on Yaz Birth Control Pill Ruled Invalid

Bayer AG’s patent on the birth control pill Yaz is invalid, a U.S. appeals court said in a decision that ensures Actavis Inc. and Novartis AG’s Sandoz unit can sell copies of the contraceptive.

Actavis, Sandoz and Lupin Ltd. won a ruling that the patent is invalid because it’s an obvious variation of earlier know-how, the U.S. Court of Appeals for the Federal Circuit in Washington said in an opinion posted today on its website. The court overturned a trial judge’s decision to uphold the patent, which expires in June 2014.

U.S. sales of branded and generic Yaz were about $347 million in the 12 months ended Feb. 28, according to Actavis, which said in a statement today it began sales of its own version because of the court ruling. Yaz and related contraceptives account for about 2.7 percent of Leverkusen, Germany-based Bayer’s revenue, according to data compiled by Bloomberg.

“We do not agree with the decision of this court and are reviewing our legal options,” Astrid Kranz, a Bayer spokeswoman, said by telephone today.

Global sales of Yaz and Yasmin have already dropped because of low-cost competition. Sales in the fourth quarter fell 6.9 percent to 270 million euros ($365 million) due mainly to sales of generic versions in Europe, the company said in February.

Legal Conflict

Yaz has drospirenone, a synthetic version of the hormone progesterone, and has been dogged by legal conflict over safety concerns as well as patents. Regulators have been demanding stronger safety warnings on birth-control pills with drospirenone. Bayer has faced a wave of litigation in the U.S. related to allegations linking Yaz and Yasmin to blood-clot injuries. Settlements and legal expenses cost the German drugmaker 1.19 billion euros last year.

The patent covers dosing regimens for oral contraceptives. Yaz, which has been on the market since 2006, contains 24 active pills and four placebos. The Federal Circuit said that’s little different than traditional regimens involving 21 active pills and seven placebos.

Sandoz began selling its version of Yaz, which it called Loryna, after receiving U.S. Food and Drug Administration approval in May 2011. Actavis, then called Watson Pharmaceuticals, began selling its version, called Vestura, in January 2012. It removed the product from the market in March 2012.

Approval Date

In February, U.S. District Judge Kent Dawson in Las Vegas ordered that the effective approval date of both versions would be June 30, 2014. The Federal Circuit on March 13 granted Sandoz’s request to put that order on hold pending its decision.

Bayer could have sought compensation from Basel, Switzerland-based Novartis and Morristown, New Jersey-based Actavis for any sales or profits it lost, had it won the case. That portion of the case was held in abeyance pending the validity appeal.

The case is Bayer Healthcare Pharma v. Sandoz Inc., 13-1207, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Bayer Healthcare Pharmaceuticals Inc. v. Watson Pharmaceuticals Inc., 07cv1472, U.S. District Court for the District of Nevada (Las Vegas).

Before it's here, it's on the Bloomberg Terminal.