Bayer AG’s (BAYN) patent on the birth control pill Yaz is invalid, a U.S. appeals court said in a decision ensuring that Actavis Inc. (ACT) and Novartis AG’s (NVS) Sandoz unit can sell copies of the contraceptive.
The U.S. Court of Appeals for the Federal Circuit in Washington, in siding with Actavis, Sandoz and Lupin Ltd. (LPC), overturned a trial judge’s upholding of the patent, which expires in June 2014. The opinion was posted yesterday on the court’s website.
“We do not agree with the decision of this court and are reviewing our legal options,” Astrid Kranz, a spokeswoman for Leverkusen, Germany-based Bayer, said by telephone.
Yaz has drospirenone, a synthetic version of the hormone progesterone. 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 ($1.57 billion) 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 wasn’t very different from traditional regimens involving 21 active pills and seven placebos.
In February, U.S. District Judge Kent Dawson in Las Vegas ordered that the effective approval date of the generic versions would be June 30, 2014. The Federal Circuit on March 13 put that order on hold pending its decision.
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).
Spain, Italy Lose EU Court Appeal Over Patent System Adoption
Spain and Italy lost a challenge at the European Union’s highest court against the EU’s decision to push ahead without them to create the bloc’s first common patent system.
The EU Court of Justice in Luxembourg ruled yesterday that given it was “impossible” for all of the EU’s 27 nations “to agree on a common system for the whole EU within a reasonable period,” it was lawful to move ahead without the two dissenting nations, who had objected to the plan largely over language concerns.
The remaining 25 EU nations agreed two years ago to move forward with a common patent system under a mechanism called enhanced cooperation whereby member states can work together as long as at least nine agree on the move.
The EU has 23 official languages and numerous compromises failed to satisfy political demands or risked increasing translation costs for companies.
The EU court yesterday said the decision didn’t damage the EU and “does not prejudice any competence, right or obligation” of Spain and Italy, who are free to join the agreed system.
EU ministers in February formally approved plans to set up the first patent court, paving the way for the common patent system after a decades-long deadlock on the plans.
The cases are C-274/11, Spain v. Council, C-295/11, Italy v. Council.
Mako to Acquire Stanmore Robotic Assets in Patent Settlement
Stanmore has agreed to withdraw from robotics, and Mako will drop patent-infringement litigation in federal courts in California and Massachusetts, and at the U.S. International Trade Commission in Washington, the two companies said in a joint statement yesterday. Financial terms weren’t disclosed
The dispute was over technology related to computerized surgical devices and software. In January, London-based Stanmore received U.S. Food and Drug Administration approval to market its Sculptor Robotic Guidance Arm, used for knee surgery.
The Stanmore product competed with Mako’s RIO Robotic Arm Interactive Orthopedic system, which accounted for $41.2 million in sales last year, or 40 percent of the Fort Lauderdale, Florida-based company’s revenue, according to data compiled by Bloomberg.
The Boston case is Mako Surgical Corp. v. Stanmore Implants Worldwide, 13-cv-10635, U.S. District Court, District of Massachusetts (Boston).
The California case is Mako Surgical Corp. v. Stanmore Implants Worldwide, 13-cv-01221, U.S. District Court, Northern District of California (San Francisco).
AbbVie Said to Fire Heart Drug Sales Force as Patents End
AbbVie Inc. (ABBV), the drugmaker split off from Abbott Laboratories this year, will fire its sales force for heart drugs as the medicines lose patent protection and face generic competition, according to a person familiar with the matter.
The firings total in the mid-hundreds and are a mix of AbbVie employees and contract workers, said the person, who, lacking authorization to speak about the issue, asked not to be identified.
AbbVie is shifting its focus from primary care, such as drugs that treat a patient’s cholesterol, stroke or diabetes, to so-called specialty medications in areas of unmet health needs, Chief Financial Officer William Chase said in January. With the cardiology drugs losing patent protection, the North Chicago, Illinois-based company no longer needs a large sales force to advertise them to doctors.
Chase in January called 2013 and 2014 “a time of transition for AbbVie, as our lipid franchise experiences the entry of generics.”
Adelle Infante, an AbbVie spokeswoman, declined to comment on the firings.
“TriCor began facing generic competition in late 2012 and several other products in our cardiovascular franchise will lose patent exclusivity in 2013,” she said April 15 in an e-mail.
Biogen Idec Loses Appeal in Arzerra Patent Case Against Glaxo
Biogen Idec Inc. (BIIB) and Roche Holding AG (ROG)’s Genentech unit lost an appeals court ruling yesterday over a patent-infringement case it filed against GlaxoSmithKline Plc (GSK)regarding the cancer drug Arzerra.
A U.S. judge was correct in his interpretation of the Biogen Idec patent, the U.S. Court of Appeals for the Federal Circuit in Washington yesterday said in an opinion posted on the court’s website. Biogen Idec had conceded that, based on the judge’s definition of the patent, Glaxo didn’t infringe it.
The case is Biogen Idec Inc. v. Glaxosmithkline LLC, 3:10- cv-00608, U.S. District Court, Southern District of California (San Diego).
Google-EU Deal Wouldn’t Target Global Solution, Almunia Says
Google Inc. (GOOG)’s competitors, clamoring for the European Union to press the search company to make global changes, face disappointment after the bloc’s antitrust chief said any settlement would focus on Europe.
While confined to Google’s competition abuses there, any accord to end the EU’s antitrust probe that started in 2010 must stand the test of time and be impossible to circumvent, Joaquin Almunia said. Google this month submitted an offer to the Brussels-based European Commission that would create more distinction in Internet searches between its own services and those of its competitors, according to a person familiar with the talks.
“The U.S. and the EU have different systems and, on top of that, Google has a very different market position in the U.S., where its competitors have a market share of around 30 percent,” Almunia said in response to written questions. “In Europe, Google’s market share is more than 90 percent.”
Rivals, such as Microsoft Corp. (MSFT), want the EU to extract changes after the U.S. closed a 20-month investigation into whether Mountain View, California-based Google unfairly promoted its own services in search results. The Federal Trade Commission in January concluded that Google was motivated more by wanting to improve its search results than by a desire to stifle competition.
Although the EU commission’s jurisdiction doesn’t go beyond the European Economic Area, it can order remedies that reach beyond Europe if the disputed conduct has an anti-competitive effect within the region, Thomas Vinje, a Brussels lawyer for the FairSearch Coalition, a group of technology companies including Microsoft, Expedia Inc. (EXPE) and Nokia Oyj (NOK1V), said in an e- mail. The EEA encompasses the 27-nation EU plus Iceland, Norway and Liechtenstein.
Almunia said he hopes a settlement will be possible to allow for “quick solutions to the competition problems we have identified.”
“On the other hand, as I have always said, if such an outcome is not possible I will decide to go back to the normal antitrust procedure,” he said.
Ex-Aeropostale CEO Says He Fired Finazzo Over Vendor Deal
Aeropostale Inc. (ARO)’s ex-chief executive officer testified in the conspiracy trial of Christopher Finazzo that he fired the former merchandise executive in 2006 because of a secret deal with a vendor.
Julian Geiger, now CEO of Crumbs Bake Shop Inc. (CRMBU), told jurors yesterday in federal court in Brooklyn, New York, that Finazzo appeared to have a close relationship with South Bay Apparel Inc., a T-shirt supplier.
Finazzo is accused by the government of conspiring to overcharge Aeropostale, a New York-based retailer, and split the profits, netting him as much as $25 million from about 1996 to late 2006.
In discussions about finding lower-priced vendors for the shirts, Finazzo reacted harshly to criticism of South Bay, Geiger said on the stand.
Geiger’s testimony came in the second week of a trial before U.S. District Judge Roslynn R. Mauskopf. Finazzo is facing 16 counts, including conspiracy, mail fraud and wire fraud charges. He could be sentenced to as long as 20 years in prison if convicted of a fraud charge.
The case is U.S. v. Finazzo, 10cr00457, U.S. District Court, Eastern District of New York (Brooklyn).