WASHINGTON (Reuters) - The U.S. government has reached a settlement with Teva Pharmaceuticals Industries Ltd over charges that its agreements with rivals impeded consumer access to lower-priced generic drugs.

FILE PHOTO: The logo of Teva Pharmaceutical Industries is seen during a news conference hold by its CEO, Kare Schultz, to discuss the company's 2019 outlooks in Tel Aviv, Israel February 19, 2019. REUTERS/Amir Cohen/File Photo

The Federal Trade Commission on Tuesday said it had settled three reverse payment fights with units of Teva, which will be prohibited from making similar agreements with competitors in the future.

The FTC has long fought against so-called “pay for delay” settlements, in which a brand-name drugmaker pays or otherwise compensates a generic rival to delay releasing a cheaper version of its product. The deal is often struck to resolve patent litigation.

“This broad settlement prevents the world’s largest manufacturer of generic drugs from entering into collusive agreements that prevent price competition by keeping generic drugs off the market,” FTC Chairman Joe Simons said in a statement.

“We are very pleased to put these litigations against the FTC behind us,” said Brendan O’Grady, a Teva executive vice president.

The FTC believes that paying rivals to stay off the market is a violation of antitrust law and fought one case to the Supreme Court, which agreed that it could be in some circumstances.

The agency has said that the deals cost consumers billions annually in higher drug costs.

In Congress, Senator Amy Klobuchar, a Democrat now running for president, and Senator Chuck Grassley, the Republican chair of the Judiciary Committee, introduced legislation in January to make such deals explicitly illegal.

The oldest of the three cases settled on Tuesday dates to 2009, when the FTC sued Solvay Pharmaceuticals for paying off Watson Pharmaceuticals, Par Pharmaceutical Co and Paddock Laboratories to delay bringing out a generic version of AndroGel, a testosterone cream. Watson is now owned by Teva.

The second case dates to 2014 and also involves AndroGel. In this instance, AbbVie Inc, which had acquired the drug, was accused of paying off Teva and another generic maker to again delay bringing out a cheaper version of the medicine.

In the third case, Endo Pharmaceuticals was accused of paying generic companies, including Watson, to refrain from bringing out a generic version of Lidoderm, which is used to relieve nerve pain. Endo settled with the FTC in 2017.

FTC litigation continues against Solvay and other of the brand name drug companies. The agency also said it would press on with a lawsuit accusing AbbVie and a partner for filing baseless patent litigation claims.</s>FILE PHOTO: The logo of Teva Pharmaceutical Industries is seen during a news conference hold by its CEO, Kare Schultz, to discuss the company's 2019 outlooks in Tel Aviv, Israel February 19, 2019. REUTERS/Amir Cohen/File Photo

WASHINGTON (Reuters) - The U.S. government has reached a settlement with Teva Pharmaceuticals Industries Ltd over charges that its agreements with rivals impeded consumer access to lower-priced generic drugs.

The Federal Trade Commission on Tuesday said it had settled three reverse payment fights with units of Teva, which will be prohibited from making any similar agreements with competitors in the future.

In a reverse payment scheme, a brand name drug company compensates a generic firm if it agrees to delay in bringing the cheaper version of the drug to market.

"This broad settlement prevents the world’s largest manufacturer of generic drugs from entering into collusive agreements that prevent price competition by keeping generic drugs off the market," FTC Chairman Joe Simons said in a statement.

The oldest of the three cases dates to 2009, when the FTC sued Solvay Pharmaceuticals for paying off Watson Pharmaceuticals, Par Pharmaceutical Co and Paddock Laboratories to delay in bringing out a generic version of AndroGel, a testosterone cream. Watson is now owned by Teva.

The second case dates to 2014 and also involves AndroGel. In this instance, AbbVie Inc, which had acquired the drug, was accused of paying off Teva and another generic maker to again delay bringing out a cheaper version of the medicine.

In the third case, Endo Pharmaceuticals was accused of paying generic companies, including Watson, to refrain from bringing out a generic version of Lidoderm, which is used to relieve nerve pain.</s>Teva Pharmaceutical Industries Ltd. and federal regulators have reached a tentative agreement to resolve a series of disputes over pacts to delay the sale of cheaper generic drugs.

The proposed settlement with the Federal Trade Commission, which would resolve three complaints, essentially extends and tightens restrictions under a 2015 settlement and resets the clock so that restrictions remain in place for 10 years from the date of the revised agreement.

Teva won't pay any additional money beyond the $1.2 billion in relief for overpayment as part of the 2015 settlement.

"This broad settlement prevents the world's largest manufacturer of generic drugs from entering into collusive agreements that prevent price competition by keeping generic drugs off the market," FTC Chairman Joe Simons said in a statement.

So-called "reverse-payment" or "pay-for-delay" settlements involve a branded drug company that pays or gives some kind of inducement to another company to delay sales of a generic. The FTC says such deals cost consumers and taxpayers some $3.5 billion a year.

Under the terms of the agreement, subject to court approval, the FTC would ask the court to dismiss Teva from two lawsuits over AndroGel, a popular testosterone replacement drug.

The FTC would also ask Teva be dismissed from another lawsuit involving Lidoderm lidocaine patch.

The 2015 settlement agreement over delayed competing versions of sleep-disorder drug Provigil marked the first time the U.S. agency obtained monetary remedies for drug purchasers in a "pay for delay" case.</s>Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced a settlement with the Federal Trade Commission (FTC) that will resolve all outstanding litigation between the parties. Under the terms of the settlement, which is subject to court approval, the FTC will dismiss its claims against Teva and its affiliates in three outstanding cases, and the parties will modify certain terms in their 2015 consent decree. Teva will not pay any additional money to the FTC as part of this settlement.

"We are very pleased to put these litigations against the FTC behind us," said Brendan O’Grady, EVP and Head of North America Commercial at Teva. "We also appreciate the FTC's willingness to modify our consent decree to eliminate certain administrative burdens that will make it easier for us to navigate the patent issues that are critical to our business."

Originally entered in 2015 in FTC v. Cephalon, Inc., the consent decree provides clear guidance on the types of patent litigation settlements that are appropriate from the FTC’s perspective. This clarity helps Teva manage the complex antitrust and other related issues inherent in the pharmaceutical business environment. The three outstanding cases that will be dismissed against Teva and its affiliates as a part of the settlement are FTC v. AbbVie Inc., Nos. 18-2621, 18-2748, 18-2758 (3d Cir.); FTC v. Actavis, Inc., Civ. Action No. 09-955 (N.D. Ga.); and FTC v. Allergan PLC, Civ. Action No. 17-00312 (N.D. Cal.).

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; and the effectiveness of our patents and other measures to protect our intellectual property rights;
• our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
• our business and operations in general, including: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
• compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into selling and marketing practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2018, including the sections thereof captioned "Risk Factors." Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.</s>Teva Pharmaceutical Industries Ltd. and federal regulators have reached a tentative agreement to resolve a series of disputes over pacts to delay sale of generic drugs.

The proposed settlement with the Federal Trade Commission, which would resolve three complaints, essentially extends and tightens restrictions under a 2015 settlement and resets the clock so that restrictions remain in place for 10 years from the date of the new agreement.

Teva won't pay any additional money beyond the $1.2 billion in relief for overpayment as part of the 2015 settlement.

So-called "reverse-payment" or "pay-for-delay" settlements involve a branded drug company that pays or gives some kind of inducement to another company to delay sales of a generic. The FTC says such deals cost consumers and taxpayers some $3.5 billion a year.</s>Dear Reader, As you can imagine, more people are reading The Jerusalem Post than ever before. Nevertheless, traditional business models are no longer sustainable and high-quality publications, like ours, are being forced to look for new ways to keep going. Unlike many other news organizations, we have not put up a paywall. We want to keep our journalism open and accessible and be able to keep providing you with news and analysis from the frontlines of Israel, the Middle East and the Jewish World.

WASHINGTON, Feb 19 - The U.S. government has reached a settlement with Teva Pharmaceuticals Industries Ltd over charges that its agreements with rivals impeded consumer access to lower-priced generic drugs.



The Federal Trade Commission on Tuesday said it had settled three reverse payment fights with units of Teva, which will be prohibited from making similar agreements with competitors in the future.

The FTC has long fought against so-called "pay for delay" settlements, in which a brand-name drugmaker pays or otherwise compensates a generic rival to delay releasing a cheaper version of its product. The deal is often struck to resolve patent litigation."This broad settlement prevents the world’s largest manufacturer of generic drugs from entering into collusive agreements that prevent price competition by keeping generic drugs off the market," FTC Chairman Joe Simons said in a statement."We are very pleased to put these litigations against the FTC behind us," said Brendan O’Grady, a Teva executive vice president.The FTC believes that paying rivals to stay off the market is a violation of antitrust law and fought one case to the Supreme Court, which agreed that it could be in some circumstances.The agency has said that the deals cost consumers billions annually in higher drug costs.In Congress, Senator Amy Klobuchar, a Democrat now running for president, and Senator Chuck Grassley, the Republican chair of the Judiciary Committee, introduced legislation in January to make such deals explicitly illegal.The oldest of the three cases settled on Tuesday dates to 2009, when the FTC sued Solvay Pharmaceuticals for paying off Watson Pharmaceuticals, Par Pharmaceutical Co and Paddock Laboratories to delay bringing out a generic version of AndroGel, a testosterone cream. Watson is now owned by Teva.The second case dates to 2014 and also involves AndroGel. In this instance, AbbVie Inc, which had acquired the drug, was accused of paying off Teva and another generic maker to again delay bringing out a cheaper version of the medicine.In the third case, Endo Pharmaceuticals was accused of paying generic companies, including Watson, to refrain from bringing out a generic version of Lidoderm, which is used to relieve nerve pain. Endo settled with the FTC in 2017.FTC litigation continues against Solvay and other of the brand name drug companies. The agency also said it would press on with a lawsuit accusing AbbVie and a partner for filing baseless patent litigation claims.

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Teva Pharmaceutical settles outstanding cases with the U.S. Federal Trade Commission involving payments from brand-name drugmakers to delay releasing a cheaper version of its product, so-called "pay-for-delay" agreements.