NAAG Endorses Stopping Overdoses of Fentanyl Analogues (SOFA) Act
States and localities are on the front line of this crisis and are a large part of winning the battle from both a law enforcement and public health perspective.
State of Wisconsin et al. v. Indivior, No. 16-5073 (E.D. Pa. Sept. 22,2016)
Plaintiff states alleged that the makers of Suboxone, a drug used to treat opioid addiction, engaged in a scheme to block generic competitors and raise prices. Specifically, they are conspiring to wtich Suboxone from a tablet version to a flim in order to prevent or delay generic entry. The states allege that the manufacturers engaged in “product hopping” in which a company makes slight changes to its product to extend patent protections and prvent generic alternatives. The complaint was filed under seal.
New York et al. v. Cephalon, No. 2:16-cv-04234 (E.D. Pa. Aug. 4, 2016)
In May 2015, the FTC settled a “pay-for-delay” suit against Cephalon for injunctive relief and $1.2 billion, which was paid into an escrow account. The FTC settlement allowed for those escrow funds to be distributed for settlement of certain related cases and government investigations. In August 2016, forty-eight states filed suit in the Eastern District of Pennsylvania against Cephalon alleging anticompetitive conduct by Cephalon to protect the profits it earned from having a patent-protected monopoly on the sale of its landmark drug, Provigil. According to the complaint, Cephalon’s conduct delayed generic versions of Provigil from entering the market for several years. The complaint alleged that as patent and regulatory barriers that prevented generic competition to Provigil neared expiration, Cephalon intentionally defrauded the Patent and Trademark Office to secure an additional patent, which a court subsequently deemed invalid and unenforceable. Before it was declared invalid, Cephalon was able to use the patent to delay generic competition for nearly six additional years by filing patent infringement lawsuits. Cephalon settled those lawsuits by paying competitors to delay sale of their generic versions of Provigil until at least April 2012. Consumers, states, and others paid millions more for Provigil than they would have had generic versions of the drug launched by early 2006, as expected. A settlement was filed with the complaint, which includes $35 million for distribution to consumers who bought Provigil.
United States et al. v. Aetna et. al., No. 1:16-cv-01494 (D.D.C. July 21, 2016)
U.S. DOJ and plaintiff states sued to block the merger of two of the country’s largest health insurers. According to the complaint, alleges that their merger would substantially reduce Medicare Advantage competition in more than 350 counties in 21 states, affecting more than 1.5 million Medicare Advantage customers in those counties. Before seeking to acquire Humana, Aetna had pursued aggressive expansion in Medicare Advantage. Aetna, the nation’s fourth-largest Medicare Advantage insurer by membership, has nearly doubled its Medicare Advantage footprint over the past four years. Humana is the nation’s second-largest Medicare Advantage insurer by membership. The lawsuit also alleges that Aetna’s purchase of Humana would substantially reduce competition to sell commercial health insurance to individuals and families on the public exchanges in 17 counties in Florida, Georgia and Missouri, affecting more than 700,000 people in those counties. The lawsuit alleges that by buying Humana, Aetna would eliminate one of its strongest and most capable competitors in these markets. The district court granted the injunction, rejecting the parties arguments that the Medicare Advantage and Medicare programs were competing products that constrained one another’s prices, and noting that Aetna’s exit from several markets, allegedly because of the Affordable Care Act, appeared to be designed to eliminate a problem with the merger, rather than being an unrelated business decision.
United States et al. v. Anthem et al., No. 1:16-cv-01493 (D.D.C., July 21, 2016)
The US and plaintiff states sued to block the merger of two of the country’s largest health insurers. The complaint alleges that their merger would substantially reduce competition for millions of consumers who receive commercial health insurance coverage from national employers throughout the United States; from large-group employers in at least 35 metropolitan areas, including New York, Los Angeles, San Francisco, Denver and Indianapolis; and from public exchanges created by the Affordable Care Act in St. Louis and Denver. The complaint also alleges that the elimination of Cigna threatens competition among commercial insurers for the purchase of healthcare services from hospitals, physicians and other healthcare providers. According to the complaint, the merger would eliminate substantial head-to-head competition in all these markets, and it would remove the independent competitive force of Cigna, which has been a leader in the industry’s transition to value-based care. the court granted the injunction. Anthem appealed to the DC Circuit, which affirmed the district court.
Maryland et al. v. Perrigo Company, No. 1:04CV01398 (D.D.C. Aug. 17, 2004)
The FTC and states alleged that the companies had entered into a “pay-for-delay” arrangement, whereby Perrigo paid Alpharma to withdraw its generic version from the market for Children’t ibuprofen.According to the complaint, in June 1998, Perrigo and Alpharma signed an agreement allocating to Perrigo the sale of OTC children’s liquid ibuprofen for seven years. In exchange for agreeing not to compete, Alpharma received an up-front payment and a royalty on Perrigo’s sales of children’s liquid ibuprofen. The FTC received $6.25 million to compensate injured consumers. The states received $1.5 million in lieu of civil penalties. the parties were enjoined from future agreements.
Federal Trade Commission and State of Georgia v. Phoebe Putney Health System, Inc.,No. 1:11-cv-00058-WLS (M.D. Ga. Apr. 20, 2011)
Georgia Attorney General’s Office filed a joint complaint with the FTC seeking to enjoin any transaction involving Phoebe Putney, the Hospital Authority of Albany-Dougherty County or Palmyra Park Hospital under which Phoebe Putney would acquire control of Palmyra Park Hospital’s operations, until the conclusion of the FTC’s administrative proceeding and any subsequent appeals.
The complaint alleges that the transaction as proposed would violate federal law by eliminating the vigorous competition that currently exists between Phoebe Putney and Palmyra Park Hospital in Albany and the surrounding six-county area. The complaint also alleges that Phoebe Putney has used the Hospital Authority to cloak private, anticompetitive activity in governmental guise in the hopes that it would exempt the acquisition from federal antitrust law. Court granted TRO, case filed under seal.
Texas et al. v. Organon (Remeron), No. 04-5126 (D.N.J. 2004)
Plaintiff states settled with drug maker Organon USA, Inc. and its parent company, Akzo Nobel N.V., resolving antitrust claims involving the antidepressant drug Remeron between June 2001 and October 2004. The states’ complaint alleged that Organon unlawfully extended its monopoly by improperly listing a new “combination therapy” patent with the U.S. Federal Drug Administration. In addition, the complaint alleged that Organon delayed listing the patent with the FDA in another effort to delay the availability of lower-cost generic substitutes. The $26 million settlement resolved claims brought by state attorneys general, as well as a private class action brought on behalf of a class of end payors. Organon also agreed to make timely listings of patents and to submit accurate and truthful information to the FDA.
In the Matter of GlaxoSmithKline, PLC (Augmentin)
States alleged that GlaxoSmithKline fraudulently obtained patent protection for Augmentin and then delayed generic entry through sham patent litigation. Through this conduct, GlaxoSmithKline unlawfully maintained its monopoly over Augmentin. A $3.5 million multistate settlement for state proprietary claims was entered into by the participating states and GlaxoSmithKline.
In Re Relafen Antitrust Litigation
States sued manufacturer of antidepressant Relafen, alleging patent misuse and sham litigation designed to prevent generic entry. Parties settled the state proprietary claims for $10 million.
