Daily Dicta: You Guys Are Blowing It
In a new survey, more than 100 judges reported that they routinely find relevant case law that's not cited in an attorney's brief.
June 11, 2018 at 05:46 PM
8 minute read
Latham Wins One for Orphan Drug
Who doesn't root for orphan drug makers? That is, when pharmaceutical companies dump money into developing medications to treat rare diseases that afflict only a handful of people. It's like pro bono for Big Pharma. Or … not exactly. Because in return for these less-than-profitable endeavors, drugmakers can ask the Food & Drug Administration for seven years of market exclusivity as a reward. But how far does this benefit stretch? What if the drug in question isn't new, but instead is an improvement on an existing treatment? Does that count too? That was the question before U.S. District Judge Timothy Kelly in Washington, D.C. On Friday, he sided with Latham & Watkins client Eagle Pharmaceuticals, ruling that its drug Bendeka, which treats two rare lymphocytic cancers, is entitled to orphan drug exclusivity. Bendeka has the same active ingredient as another orphan drug, Treanda, owned and marketed by a subsidiary of Teva Pharmaceuticals. (Oh, and Teva is now marketing Bendeka for Eagle.) But Eagle and its lawyers from Latham—Philip Perry, Andrew Prins and John Manthei—stress that Bendeka is formulated differently than the original drug. Bendeka takes less time to administer; injecting it requires less fluid and sodium; it's more compatible with common medical devices, and it's got a longer shelf life. Eagle spent $30 million to develop and test it before bringing it to market. Nonetheless, the FDA denied Eagle seven-year orphan drug exclusivity, noting that Bendeka has not in fact been proven to be clinically superior to Treanda. “Eagle's drug, Bendeka, is the same as a previously approved drug that received its own exclusivity eight years ago. That exclusivity has since expired,” wrote Justice Department trial attorney Alexander V. Sverdlov in court papers. “FDA regulations logically give effect to the 'expiration' of exclusivity, by making exclusivity unavailable to a second-in-line drug—thus ensuring that exclusivity cannot be invoked in a way that would restrict approval of the same drug after the initial seven year period.” Sverdlov added, “[B]ecause Bendeka unquestionably has the same active moiety as Treanda, Eagle cannot obtain exclusivity unless it demonstrates that Bendeka is a clinically superior drug.” On June 8, Kelly sided with Eagle, and ordered the FDA to recognize orphan-drug exclusivity for Bendeka. His opinion is under seal until June 20, so we don't yet know his reasoning—but one thing is clear: This is a big win for Eagle and its team from Latham.Kirkland Scores for Honeywell in Benefits Case
An appellate team from Kirkland & Ellis led by K. Winn Allen notched a win for client Honeywell, convincing a U.S. Court of Appeals for the Sixth Circuit panel on Friday to reverse a lower court holding. The result: Retirees who worked at Honeywell's plant in Greenville, Ohio do not get lifetime health care benefits after all. It's not exactly the feel-good case of the year—Honeywell's business is booming , and presumably it would not have been ruinous for the company to pay health care benefits for about 500 retirees—but even Judge Eric Clay reluctantly concurred the result was what the law requires. At issue: a collective bargaining agreement where Honeywell specifically promised to continue health care coverage “for the spouse and dependent children for their lifetime” after a retiree's death—but didn't say anything about coverage for the actual retiree. “We acknowledge that the arrangement in the [collective bargaining agreement]—lifetime benefits for surviving spouses and dependents but not for retirees—is, as the district court put it, 'highly unusual,'” wrote Judge Julia Smith Gibbons for the panel. “The average person would find it very strange if her spouse and dependents were to receive lifetime healthcare benefits only after she has died, while prior to her death neither she nor her family is entitled to any benefits.” Gibbons continued, “But this strangeness cannot overcome the simple fact that the agreements expressly provide lifetime health care for surviving spouses and dependents but not for the retirees themselves.” In other words, if it's not in the contract, too bad. In his concurrence, Clay said he wished the court would have admitted extrinsic evidence to determine the intent of the parties when the agreement was drafted. “Nonetheless, our cases preclude us from doing so,” he acknowledged. Still, he reached for the (faint) silver lining. “Now, at least, the unions and the retirees that they represent are on notice as to what their agreements must say in order to vest retiree healthcare benefits. Although it seems less than fair to impose this new, heightened standard upon these retirees, that is what the cases require, and I therefore reluctantly concur in the majority opinion.”What I'm Reading
Appeals Panel Eying $1B Hip Implant Verdict Appears Dubious About Jurisdictional Arguments The panel seemed skeptical of J&J lawyer Paul Clement's argument that the Texas district court lacked personal jurisdiction to try the California cases. Wood Directs Cohen, Trump to File Privilege Objections Publicly The public has a right to know what categories of documents this court determines should remain privileged and why,” the Davis Wright team stated in its letter. End of Line for Appeal of $225 Million Exxon Settlement The Sierra Club and other environmental groups unsuccessfully argued that the claims were worth far more money, and that Exxon was given a sweetheart deal by the Christie administration. Harriet Miers' Nonprofit Client Hit With Discovery Abuse Sanctions The Locke Lord partner and former U.S. Supreme Court nominee represents a Christian charity based in Texas that's being sued for defrauding donors. 7th Circuit Strips Jones Day's $307K Legal-Fee Award in EEOC Case Yes, the EEOC lost, but the Seventh Circuit recognized that “the fee statute does not punish a civil rights litigant for pursuing a novel, even if ambitious, theory.” It Was a Tough Week for Bank General Counsel Around the Globe Australia. France. Switzerland. The United States. Boom. Pulse Nightclub Shooting Survivors Sue Orlando, Its Police “What if Orlando had better-trained police officers? Would my brother still be alive?” Meet the Justice Department Team That Won't Defend the Affordable Care Act In case you're wondering who to blame when you can't get coverage for pre-existing conditions anymore.This content has been archived. It is available through our partners, LexisNexis® and Bloomberg Law.
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