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U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.

The Food and Drug Administration said Thursday it cleared Perrigo’s once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won’t start shipping the pill until early next year, and there will be no age restrictions on sales.

Hormone-based pills have long been the most common form of birth control in the U.S., used by tens of millions of women since the 1960s. Until now, all of them required a prescription.

Medical societies and women’s health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the U.S. are unintended. Teens and girls, women of color and those with low incomes report greater hurdles in getting prescriptions and picking them up.

Some of the challenges can include paying for a doctor’s visit, getting time off from work and finding child care.

“This is really a transformation in access to contraceptive care,” said Kelly Blanchard, president of Ibis Reproductive Health, a non-profit group that supported the approval. “Hopefully this will help people overcome those barriers that exist now.”

Ireland-based Perrigo did not announce a price. Over-the-counter medicines are generally much cheaper than prescriptions, but they typically aren’t covered by insurance.

Forcing insurers to cover over-the-counter birth control would require a regulatory change by the federal government, which women’s advocates are urging the Biden administration to implement.

Many common medications have made the switch to non-prescription status in recent decades, including drugs for pain, heartburn and allergies. Birth control pills are available without a prescription across much of South America, Asia and Africa.


The U.S. Justice Department asked a federal appeals court to narrowly consider Major League Baseball’s antitrust exemption, a filing made in a case involving four eliminated minor league teams hoping to end the sport’s century-old legal protection.

MLB cut the minimum guaranteed minor league affiliation agreements from 160 to 120 in September 2020 and took over running the minors from the National Association of Professional Baseball Leagues, which had been in charge since 1901.

The parent companies of the Staten Island Yankees, Tri-City ValleyCats, Salem-Keizer Volcanoes and Norwich Sea Unicorns sued MLB in December 2021 in U.S. District Court in Manhattan, alleging a violation of the Sherman Antitrust Act caused by “a horizontal agreement between competitors that has artificially reduced and capped output in the market for MiLB teams affiliated with MLB clubs.”

The suit was dismissed in October by a judge who cited the antitrust exemption created by a 1922 U.S. Supreme Court decision involving the Federal League. The teams then asked the 2nd U.S. Circuit Court of Appeals to send the case onto the Supreme Court.

“The court need not resolve the exemption’s precise contours,” the Justice Department wrote in a brief to the 2nd Circuit filed Monday by Assistant Attorney General Jonathan S. Kanter and several other lawyers. “The United States therefore does not take a position on whether the exemption applies here. Instead, the United States files this brief to reaffirm, as the Supreme Court has said, that courts should ‘not extend’ the Federal Baseball exemption.”

After the case was filed, MLB moved to dismiss while citing the sport’s antritrust exemption, alleging lack of standing and claiming there was no antitrust violation.

U.S. District Judge Andrew L. Carter ruled on Oct. 26 that the minor league teams had standing and “had pleaded sufficient facts to show an actual adverse effect on competition in the identified market.” But he dismissed the suit because of the antitrust exemption.


The company that makes Jack Daniel’s is howling mad over a squeaking dog toy that parodies the whiskey’s signature bottle. Now, the liquor company is barking at the door of the Supreme Court.

Jack Daniel’s has asked the justices to hear its case against the manufacturer of the plastic Bad Spaniels toy. The high court could say as soon as Monday whether the justices will agree. A number of major companies from the makers of Campbell Soup to outdoor brand Patagonia and jeans maker Levi Strauss have urged the justices to take what they say is an important case for trademark law.

The toy that has Jack Daniel’s so doggone mad mimics the square shape of its whisky bottle as well as its black-and-white label and amber-colored liquor while adding what it calls “poop humor.” While the original bottle has the words “Old No. 7 brand” and “Tennessee Sour Mash Whiskey,” the parody proclaims: “The Old No. 2 on Your Tennessee Carpet.” Instead of the original’s note that it is 40% alcohol by volume, the parody says it’s “43% Poo by Vol.” and “100% Smelly.”

The toy retails for about $13 to $20 and the packaging notes in small font: “This product is not affiliated with Jack Daniel Distillery.”

The toy’s maker says Jack Daniel’s can’t take a joke. “It is ironic that America’s leading distiller of whiskey both lacks a sense of humor and does not recognize when it — and everyone else — has had enough,” lawyers for Arizona-based VIP Products wrote the high court. They told the justices that Jack Daniel’s has “waged war” against the company for “having the temerity to produce a pun-filled parody” of its bottle.

But Jack Daniel’s lead attorney, Lisa Blatt, made no bones about the company’s position in her filing.

“To be sure, everyone likes a good joke. But VIP’s profit-motivated ‘joke’ confuses consumers by taking advantage of Jack Daniel’s hard-earned goodwill,” she wrote for the Louisville, Kentucky-based Brown-Forman Corp., Jack Daniel’s parent company.

Blatt wrote that a lower court decision provides “near-blanket protection” to humorous trademark infringement. And she said it has “broad and dangerous consequences,” pointing to children who were hospitalized after eating marijuana-infused products that mimicked candy packaging.


The makers of "Fortnite" have asked a federal judge to throw out a lawsuit from a rapper who says the video game is illegally using a dance he created.

Epic Games filed the motion Monday to dismiss the lawsuit filed in December by 2 Milly, a Brooklyn-based rapper whose real name is Terrence Ferguson. He alleges that "Fortnite" uses the "Milly Rock," a dance he came up with in 2011 that became popular after a 2015 song and video.

Epic Games' attorneys argue in the motion that the dance known in the game as "Swipe It" is substantially different from the "Milly Rock," and that even if it weren't, courts have held that simple dances can't be copyrighted.

2 Milly's attorney David Hecht responded in an email to the Associated Press saying choreography does have copyright protection, and there is no doubt that Epic Games used and tried to profit off the "Milly Rock" dance.

The rapper was the first of several artists, including actor Alfonso Ribeiro and rapper BlocBoy JB, to sue "Fortnite" over dances used in its "emotes," short celebrations that users can buy for their characters to use to celebrate kills within the game.

A judge has scheduled arguments on the dismissal motion for March 4.


The Supreme Court on Wednesday sided with California-based Life Technologies Corp. in a patent infringement case that limits the international reach of U.S. patent laws.

The justices ruled unanimously that the company's shipment of a single part of a patented invention for assembly in another country did not violate patent laws.

Life Technologies supplied an enzyme used in DNA analysis kits to a plant in London and combined it with several other components to make kits sold worldwide. Wisconsin-based Promega Corp. sued, arguing that the kits infringed a U.S. patent.

A jury awarded $52 million in damages to Promega. A federal judge set aside the verdict and said the law did not cover export of a single component.

The federal appeals specializing in patent cases reversed and reinstated the verdict.

Patent laws are designed to prevent U.S. companies from mostly copying a competitor's invention and simply completing the final phase overseas to skirt the law. A violation occurs when "all or a substantial portion of the components of a patent invention" are supplied from the United States to a foreign location.

Writing for the high court, Justice Sonia Sotomayor said the law addresses only the quantity of components, not the quality. That means the law "does not cover the supply of a single component of a multicomponent invention," Sotomayor said.

Only seven justices took part in the ruling. Chief Justice John Roberts heard arguments in the case, but later withdrew after discovering he owned shares in the parent company of Life Technologies.




The Supreme Court unanimously sided with smartphone maker Samsung on Tuesday in its high-profile patent dispute with Apple over design of the iPhone.

The justices said Samsung may not be required to pay all the profits it earned from 11 phone models because the features it copied from the iPhone were only a part of Samsung's devices.

Cupertino, California-based Apple had won a $399 million judgment against South Korea-based Samsung for infringing parts of the iPhone's patented design, but the case now returns to a lower court to decide what Samsung must pay.

The case is part of a series of disputes between the technology rivals that began in 2011. Apple accused Samsung of duplicating a handful of distinctive iPhone features for which Apple holds patents: the flat screen, the rounded rectangular shape of the phone and the layout of icons on the screen.

At issue was how much Samsung is required to compensate Apple under an 1887 law that requires patent infringers to pay "total profit." Apple said that means all the profits from the phone sales, while Samsung argued it was limited to profits related to the specific components that were copied.

Justice Sonia Sotomayor wrote for the court that the law does not require damages to be based on the entire product, but can be limited to only a component of the product. The decision overturned a ruling from a federal appeals court in Washington, which said that Apple was entitled to all the profits.

But the high court declined to lay out a specific test for how such damage awards should be calculated. Sotomayor said doing so was not necessary and the justices left it up to lower courts to resolve.



Supreme Court Chief Justice John Roberts on Friday declined to temporarily block a lower court ruling that opens the world's best-selling multiple sclerosis drug to competition from generic rivals next month.

The decision is a victory for rivals challenging the patents of Israel-based Teva Pharmaceutical Industries Ltd., maker of the drug Copaxone.

Teva claims the U.S. Court of Appeals for the Federal Circuit wrongly overturned five of its patents for the drug. That ruling allows rivals Mylan Inc., Momenta Pharmaceuticals Inc. and Sandoz, Inc., to start selling cheaper generic versions in May instead of September 2015.

The Supreme Court has agreed to consider the case, but arguments won't take place until its new term begins in October and it could be next year before a decision is reached. Teva said it would suffer irreparable harm if the appeals court decision was not postponed. Copaxone brought the company $3.2 billion in U.S. sales last year.

In a one-page ruling, Roberts said he was not convinced Teva would suffer such harm. If Teva ultimately prevails in the case, Roberts said, the company would be able to recover damages from the generic rivals for past patent infringement. He acknowledged that Teva has "a fair prospect" of ultimately winning the case at the high court.

Roberts oversees emergency appeals from the U.S. Court of Appeals for the Federal Circuit, which hears appeals in patent cases.

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