Alaska initiated an investigation of the merger between two companies providing barge-delivered petroleum products to western Alaska. A consent decree was reached between the parties that requires significant divestiture of vessels, storage facilities, and property to a qualified buyer approved by the state. The consent decreed was filed for approval in the Alaska Superior Court, and was approved in September, 2005 after a hearing to consider strong opposition from fuel customers in western Alaska.
FTC and Plaintiff States v. Mallilnckrodt Ard Inc. (formerly Questcor), No. 1:17-cv-00120 (D.D.C. Jan. 18, 2017)
Four states and the FTC reached a $100 million settlement with Mallinckrodt plc and its US subsidiary, formerly known as Questcor Pharmaceuticals, Inc. resolving a lawsuit accusing Questcor of monopolizing the market for Achthar, the only adrenocorticotropic hormone (ACTH) based therapeutic drug sold in the United States. ACTH is used as a last resort to treat infantile spasms and multiple sclerosis. Questcor allegedly blocked competition for Acthar by disrupting the bidding process and acquiring the U.S. rights for Synacthen Depot, the only other ACTH based drug sold in the world. In 2001, Questcor bought the rights to Acthar and increased the price of it by 85,000 percent, charging over $34,000 for a vial of the drug that used to cost $40 per vial. In 2012, Novartis Pharma A.G sold the U.S. rights of Synacthen, Achthar’s only competitor. The complaint alleges that three other companies had all conducted due diligence and submitted formal offers for Synacthen with plans to develop and launch Synacthen in the United States in direct competition with Questcor. However, perceiving the threat to its U.S. monopoly if a rival drug company purchased the assets, Questcor stepped in to outbid the three other companies, offering Novartis $135 million in guaranteed payments with only vague plans for Synacthen and after very limited due diligence. Through the acquisition, Questcor sought to extinguish the most likely challenges to its Acthar monopoly. According to the complaint, this allowed Questcor to continue charging over $34,000 per vial for H.P. Acthar Gel. In addition to paying $100 million in disgorgement, Under the settlement, Mallinckrodt will pay $100 million. The company will also be required to license a competitor to the rights it acquired from Novartis to commercialize and develop Synacthen in the United States, including the Synacthen trademark, along with clinical trial data and certain intellectual property related to manufacturing and formulation. Mallinckrodt is also prohibited from taking actions that would interfere with clinical trials or clinical plans for Synacthen.
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.
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.
Tesoro agreed with Flint Hills Resources (FHR) last year to purchase most of FHR’s Alaska fuel storage assets, including FHR’s storage facility at the Port of Anchorage. Tesoro also owns two storage facilities at the Port of Anchorage. After an investigation, the state determined that Tesoro’s acquisition of FHR’s tank farm would limit the ability of competitors to import fuel through the Port of Anchorage and impair competition in markets for some fuel products, including gasoline. The state entered into a consent agreement with Tesoro Alaska Company that requires Tesoro to sell a petroleum fuel terminal at the Port of Anchorage in order to preserve competition in Alaska fuel markets. Tesoro has agreed to sell its Terminal 1 to a qualified buyer. Tesoro will have one year from the approval of the Consent Decree to sell the terminal. If it cannot find a buyer, it must lease the terminal.
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.
State challenged the acquisition by Lynden, which operates Alaska Marine Lines, of Northland. The companies are the only two competitors in the market for marine cargo delivery to Southeast Alaska. The parties reached a settlement under which Northland will operate as an independent company under Lynden. Sitka-based Samson Tug and Barge will lease space and equipment that previously belonged to Northland, effectively replacing Northland as Lynden’s competitor in Southeast Alaska. The Attorney General’s office will monitor shipping in Southeast to make sure the market remains competitive.
Hilcorp Alaska LLC’s proposed to acquire Marathon Oil Company’s Cook Inlet, Alaska natural gas production, storage and pipeline assets for $375 million. Both the FTC and the state of Alaska expressed concerns about the acquisition because Marathon and Hilcorp are two of the three primary competitors for sales of natural gas in south-central Alaska, and account for over 90 percent of the natural gas produced in Cook Inlet and the acquisition would harm competition by diminishing the negotiating strength of the area’s primary purchasers, local utilities and industrial users. On the other hand, the acquisition could also alleviate concerns regarding local energy supply shortages. Existing fields in Cook Inlet are declining in production, and local utility demand is expected to exceed annual production within a few years. Because of this, the state has been actively working to encourage new investment in exploration and production in the Cook Inlet. The Alaska Attorney General entered into a consent decree with Hilcorp, which included (1) price caps on natural gas sold to local utilities and industrial users for the next five years; (2) a prohibition on selling Cook Inlet natural gas for liquefied natural gas export for five years; and (3) it will not knowingly sell Cook Inlet natural gas to other companies who intend to resell the gas for LNG export. The FTC decided to end its investigation as a result of the Alaska Attorney General’s action, in light of the concerns about energy scarcity in the future and the fact that only consumers in Alaska would be affected.
33 states investigated “pay for delay” allegations relating to DDAVP, a drug used to alleviate bed-wetting. States alleged that Aventis, holder of the patent for the medication, engaged in a scheme to delay the regulatory approval and sale of a generic version of DDAVP, in violation of state and federal antitrust law. States and defendants entered into a settlement under which states received $3.45 million, not as a civil penalty and defendants did not admit guilt.
34 states filed suit alleging that Warner Chilcott entered into an illegal agreement with Barr Pharmaceuticals to raise the prices of Ovcon, an oral contraceptive. The lawsuit alleged that after Barr Pharmaceuticals publicly announced that it planned to have a generic version of Ovcon on the market by the end of the year, Warner Chilcott paid Barr Pharmaceuticals $1 million for an agreement designed to prevent Barr’s generic product from coming to market. Under the terms of the alleged agreement, once Barr received FDA approval to market generic Ovcon, Warner Chilcott had 90 days to pay Barr $19 million, after which Barr would refuse to bring the cheaper generic version to the market. The lawsuit alleged that as a result of the agreement, Warner Chilcott paid Barr a total of $20 million to keep it from marketing its generic version of Ovcon. In additon to a payment of $5.5 million, the settlement prohibits Warner Chilcott, for ten years, from entering into any agreement that would have the effect of limiting the research, development, manufacture, or sale of a generic alternative to one of its drugs. Furthermore, Warner Chilcott must provide the states notice of certain agreements it has entered into with generic manufacturers, and must continue to make its records available to the states for inspection to determine whether the company is complying with the terms of the agreement.