FTC Files Amicus Brief Outlining Anticompetitive Harm Caused by Improper Orange Book Listings

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The Federal Trade Commission filed an amicus brief to address the anticompetitive harm that stems from improperly listed patents in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”

The Commission’s filing relates to an antitrust case brought by drug manufacturer Mylan Pharmaceuticals Inc. and several other affiliated entities alleging that Sanofi-Aventis U.S. LLC and other affiliated entities have engaged in anticompetitive conduct to monopolize the market for injectable insulin glargine, a drug used to treat diabetes. Mylan alleges Sanofi monopolized the injectable insulin glargine market in part by abusing the FDA’s Orange Book regulatory process. Specifically, Mylan alleges Sanofi delayed and blocked Mylan’s generic drug called Semglee from competing with Sanofi’s branded insulin glargine drug Lantus by improperly listing several drugs in the Orange Book.

In its amicus brief filed in Mylan Pharmaceuticals Inc., et al. v. Sanofi-Aventis U.S. LLC, et al., the FTC explains that improper Orange Book listings, such as those alleged in Mylan’s case, can cause significant harm to competition, including delaying consumer access to a lower-priced competing drug that would save patients money while also potentially offering better access and higher quality medications.

As detailed in the FTC’s amicus brief, when a brand pharmaceutical company lists a patent in the Orange Book it may lead to a statutory stay that blocks the introduction of competing drug products for up to 30 months, including lower-cost generic alternatives. When this stay is triggered by a patent that is improperly filed and does not meet the statutory listing criteria, the stay may improperly delay consumer access to a competing product that might reduce prices, improve quality and access, or both. Given the high cost of many drugs, even a short delay in competition can have enormous consequences for consumers in accessing cost-effective medications, the FTC stated in the brief.

In September, the FTC issued a policy statement which warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book. The Commission’s statement warned that improper listings in the Orange Book may harm competition from cheaper generic alternatives and keep brand prices artificially high. In November, the FTC sent letters to 10 drug manufacturers notifying them of more than 100 improperly listed Orange Book patents.

The FTC’s amicus brief was filed in the U.S. District Court for the Western District of Pennsylvania. The Commission vote approving the filing of the amicus brief was 3-0. The Commission takes no position on Mylan’s allegations.

The Federal Trade Commission works to promote competition, and protect and educate consumers. As part of the FTC’s policy work, the Commission submits amicus briefs in cases involving areas of law relevant to its competition and consumer protection missions to provide information that can help courts to make their decisions in ways that protect consumers or promote competition. You can learn more about how competition benefits consumers or file an antitrust complaint.  For the latest news and resources, follow the FTC on social mediasubscribe to press releases and read our blog.

Official news published at https://www.ftc.gov/news-events/news/press-releases/2023/11/ftc-files-amicus-brief-outlining-anticompetitive-harm-caused-improper-orange-book-listings

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VIP Minds CEO and Visionary Nora Abou Chakra Launches ‘Power Hearts,’ a Transformative Initiative Driving Social Change

CEOs revolutionizing philanthropy through inspiring charitable actions

Today marks the launch of "Power Hearts," an innovative initiative led by businesswoman and visionary Nora Abou Chakra. With each endeavor, Power Hearts embarks on a different mission, empowering CEOs to take direct action and make a tangible impact. Through immersive experiences and hands-on involvement, Power Hearts addresses pressing societal issues, fostering empathy and inspiring CEOs to become advocates for change within their organizations and communities.

Nora Abou Chakra, a respected entrepreneur known for her philanthropic endeavors, has once again demonstrated her commitment to driving social change with the launch of Power Hearts. Under this empowering initiative, CEOs from diverse industries come together to tackle pressing issues and create transformative solutions.

An example of these missions is hunger. Power Hearts combats hunger and alleviate the suffering of those affected by it. CEOs gather in a large-scale communal kitchen, where they actively participate in purchasing groceries and cooking meals for those in need.

The immersive experience provided by Power Hearts goes beyond the kitchen. CEOs physically hit the streets, personally distributing the freshly prepared meals to individuals experiencing hunger. This direct interaction with those in need further deepens their understanding of the issue, sparking a profound connection and a sense of shared humanity.

CEOs return to their organizations with a renewed perspective and a profound commitment to addressing the issue of hunger. They become ambassadors for change, leveraging their influence and resources to advocate for hunger relief initiatives within their respective communities and among their staff members.

Nora Abou Chakra, the driving force behind Power Hearts, expressed her enthusiasm for the initiative, stating, "Power Hearts aims to create a ripple effect of compassion and advocacy. By immersing CEOs in the realities of pressing social issues, we ignite a powerful drive for change that reverberates throughout their personal and professional spheres. Together, we can make a significant difference and create a more compassionate and equitable world."

Power Hearts represents Nora Abou Chakra's unwavering commitment to leveraging the influence and resources of business leaders for the greater good. By providing CEOs with transformative experiences, Power Hearts empowers them to become catalysts for change and advocates for social causes that resonate with their hearts.

For more information about Power Hearts and its upcoming initiatives, please visit powerhearts.com or follow us on @power.hearts

Contact Information:
Stephanie Khalil
Executive Assistant to CEO

Original Source: VIP Minds CEO and Visionary Nora Abou Chakra Launches 'Power Hearts,' a Transformative Initiative Driving Social Change

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