Tag: court
UPDATE: Second Circuit Rejects Government’s Off-Label Enforcement Approach
UPDATE TO EARLIER POST:
On Wednesday, January 23, Food and Drug Administration officials said the government will not appeal the decision in the United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012). The FDA decided against asking the court to rehear the case, and will not appeal to the Supreme Court. The FDA stated that it “does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug & Cosmetic Act.”
Read Jesse Witten’s recent post on this case here.
Patent War Between St. Jude Medical and Volcano Has Mixed Results
St. Jude Medical and Volcano have been embroiled in a legal battle over patents held by both companies, related to pressure wire technology that is used for heart patients. The battle began over two years ago when St. Jude Medical sued Volcano, in Delaware district court, for infringement of 5 of its patents for pressure guide wire products. The patents in suit were U. S. Patent No. 5,938,624, U.S. Patent No. 6,196,980, U.S. Patent No. 6,112,598, U.S. Patent No. 6,167,763 and U.S. Patent No. 6,248,083. St. Jude requested an injunction and damages for infringement of the five asserted patents.
Volcano replied by counterclaiming, alleging that St. Jude Medical had infringed four of its own patents, but later dropped one of those patents from the suit. The three remaining patents asserted by Volcano against St. Jude were U.S. Patent No. 6,976,965, U.S. … Read More »
The Federal Circuit’s Recent “Safe Harbor” Ruling Could Impact Biosimilars Drug Development
A recent Federal Circuit case, Momenta v. Amphastar, involves the Hatch-Waxman 271(e)(1) safe harbor, and is rousing the biologics and biosimilars industry. In particular, the court held in Momenta, that section 271(e)(1) does apply to certain post-approval activities.
As background, Momenta Pharmaceuticals, Inc. and Sandoz Inc. filed for a preliminary injunction against Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. in the U.S. District Court for the District of Massachusetts alleging infringement of U.S. Patent No. 7,575,886. The ‘886 patent generally claims processes for analyzing heterogeneous populations of sulfated polysaccharides. Momenta alleged that Amphastar infringed the claimed processes when developing and manufacturing of batches of generic Lovenox (enoxaparin), a low-molecular-weight complex polysaccharide, for commercial sale. (Momenta used the claimed processes to gain approval of its own generic enoxaparin one year earlier.) The district court granted Momenta a preliminary injunction, concluding that Amphastar’s testing … Read More »
Pharmaceutical Industry Executives Face Enforcement Risks Under The Responsible Corporate Officer Doctrine
The recent decision of the D.C. Circuit in Friedman v. Sebelius, No. 11-5028 (D.C. Cir. July 27, 2012), demonstrates the enforcement risk to pharmaceutical and medical device industry executives under the “responsible corporate officer” (RCO) doctrine. Under the RCO doctrine, officers, managers and in-house counsel employed by life sciences companies could face misdemeanor criminal liability and exclusion from Medicare and other federal health programs, even if they were not personally involved in wrongdoing. Indeed, an executive can be liable under the RCO doctrine even if they did not know that their organization had engaged in wrongdoing, so long as the executive should have known of the organization misconduct by virtue of the executive’s position within the organization.
The RCO doctrine originated in United States v. Dotterweich, 320 U.S. 277 (1943), in which the Supreme Court upheld the misdemeanor conviction of the president of a … Read More »
Drinker Biddle’s Health Government Relations Team Hosting: Health Care Reform & Supreme Court Review Webinar
From Capitol Health Record: By the end of June, it is expected the Supreme Court will rule on the constitutionality of the Patient Protection and Affordable Care Act. Join us to gain a better understanding of the four questions before the Court and the political, legislative and regulatory implications of the Court’s pending decisions. Our panel also will discuss the different possible outcomes of the Court’s deliberations and their respective political and policy ramifications. Regardless of where you work or who you represent, this presentation will provide important insight and analysis to help inform your business, association, legislative and/or regulatory planning.
Register now to participate in this webinar, featuring the DBR Health Government Relations team!
7th Circuit Finds Pharma Sales Reps are Exempt Employees on Eve of Anticipated Ruling from Supreme Court
In a significant opinion for the pharmaceutical industry, the U.S. Court of Appeals for the Seventh Circuit found this week that pharmaceutical sales representatives at Eli Lilly and Abbott Laboratories are exempt from overtime under the administrative employee exemption in the Fair Labor Standards Act (“FLSA”). That exemption applies to employees who 1) primarily perform nonmanual work directly related to the business of the employer, and 2) exercise discretion and independent judgment with respect to matters of significance to the business of the employer.
The Seventh Circuit, rejecting the position of the Department of Labor as amicus curiae, found that the administrative exemption applied because the substantial work of the sales representatives is to prepare for, make, and document their sales calls to physicians to persuade them to prescribe the companies’ products, and that they exercise “significant discretion in the manner and mode of delivery of … Read More »
Abbott Off-Label Settlement Facts and Figures
The government has made available materials relating to Abbott’s $1.5 billion settlement. (See link below). Here are some quick observations.
Abbott pled guilty to a misdemeanor for “misbranding” its drug Depakote as a result of off-label promotion. Between January 1998 and December 2006, Abbott promoted Depakote to treat behaviors associated with dementia, but FDA had approved the drug only to treat certain types of epileptic seizures and biopolar mania, and to prevent the onset of migraines. (That’s all according to the Plea Agreement and Agreed Statement of Facts filed in court). Abbott has agreed to pay a criminal penalty of $500 million and an additional forfeiture of $198.5 million.
The documents filed in court as part of the plea indicate that the value of the misbranded drugs was $198.5 million (that’s why the forfeiture was for that amount) and that Abbott … Read More »