• Regulatory NewsRegulatory News

    AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process

    Does a medical device cleared under the US Food and Drug Administration's 510(k) application mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer. In an amicus curiae brief filed with the nation's top court last week, AdvaMed takes issue with a decision from the US Court of Appeals for the Fourth Circuit, which upheld a $3.27 million j...
  • Regulatory NewsRegulatory News

    US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval

    The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars. The case, pitting biologics manufacturer Amgen against Novartis subsidiary and biosimilar manufacturer Sandoz, attempted to clarify what’s known as the biosimilars "patent dance," which is the process by which companies must exchange and figure out the pa...
  • Regulatory NewsRegulatory News

    US Supreme Court to Review Biosimilar ‘Patent Dance’

    The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. The decision will not only have an impact on how biosimilar developer Sandoz and biologics company Amgen move forward in their interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) but on the US biosimilar industry as a whole. T...
  • Regulatory NewsRegulatory News

    Sandoz Petitions Supreme Court to Rule on Biosimilars

    Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market. The petition for the Supreme Court’s review deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first bio...
  • Regulatory NewsRegulatory News

    Supreme Court Declines to Hear Case on Off-Label Prescribing Authority

    The US Supreme Court has refused to hear a challenge to an Arizona law that sought to limit the use of an abortion drug, avoiding a potential showdown over whether off-label prescribing is explicitly allowed under federal law, or simply tolerated. Background As Regulatory Focus has previously reported , the Supreme Court had been petitioned to hear an appeal of the federal court case  Planned Parenthood v. Humble —a case challenging a 2012 Arizona law which makes i...
  • Regulatory NewsRegulatory News

    Off-Label Use Case on Potential Path to Supreme Court, With Wide-Ranging Implications for FDA

    A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products. Background The matter in question concerns a federal court case, Planned Parenthood v. Humble , challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by FDA....
  • Supreme Court Again Rules in Favor of Generic Pharmaceutical Industry, Supports Federal Preemption

    The current term of the US Supreme Court has already been a momentous one for the life sciences industry, having declared patents on naturally-occurring DNA invalid and legal settlement agreements commonly known as "pay for delay" agreements potentially illegal under federal competition law. Now the court has released a third potentially landmark decision, Mutual Pharmaceutical Co. v. Bartlett , in which the justices have decided that when it comes to so-called "failur...
  • BREAKING: Supreme Court Rules Naturally Occurring DNA is Not Patentable

    In a landmark decision, the Supreme Court has decided in favor of the Association for Molecular Pathology in its case against Myriad Genetics, ruling that naturally occurring DNA is not patentable, while synthetic DNA is. Background The case, heard in April 2013, concerned patents held on two genes, BRCA 1 and BRCA2, which are closely linked to a woman's risk of breast and ovarian cancer. Myriad Genetics, a biotechnology company, owned the patent rights to the use of th...
  • FTC Seeks Supreme Court's Intervention in 'Pay-for-Delay' Cases

    The US Federal Trade Commission (FTC) is calling on the US Supreme Court to review a so-called "pay-for-delay" case concerning generic and branded versions of AndroGel , a topical testosterone treatment, a new escalation in the agency's long-standing efforts to curb the practice. Pay-for-delay cases involve the manufacturer of a patented, innovative medicine paying its potential competitors not to manufacture generic versions of that medicine. FTC has consistently attac...
  • Feature ArticlesFeature Articles

    Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

    The US court system has been busy recently with issues affecting the pharmaceutical industry, including a number of cases involving the Hatch-Waxman Act. On 17 April 2012, the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S marking the first Abbreviated New Drug Application (ANDA) case decided by the high court since the passage of the act in 1984. The Supreme Court has a long history of overturning Federal C...
  • Supreme Court Upholds Majority of Affordable Care Act in Historic Decision

    • 28 June 2012
    In a historic decision, the Supreme Court has upheld the vast majority of the Patient Protection and Affordable Care Act (PPACA), ruling in a tightly-contest 5-4 decision that the law-and its individual mandate-could stand with some minor alterations. Chief Justice John Roberts, appointed by President George W. Bush, joined with Justices Ginsberg, Sotomayor, Kagan and Breyer to decide in favor of the law. One of the law's most contested provisions, the individual mand...
  • How Will the Supreme Court's Ruling Affect Pharmaceutical and Medical Device Companies?

    • 27 June 2012
    On 28 June 2012, the Supreme Court of the United States (SCOTUS) is expected to pass down several judgments deciding the fate of the Patient Protection and Affordable Care Act (PPACA)- a sprawling piece of legislation that has inspired deep division among the American public. At issue before the court is a series of court cases all asking SCOTUS a similar question: Is PPACA constitutional? As indicated by the questions asked by the justices during the cases' respecti...