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A Win for Skinny Labels; Insights for Enforcing Use Patents

Most drugs are covered by multiple patents, with initial patents directed broadly to the compound and later patents directed to increasingly narrower uses of the compound. This provides opportunities for the compound to be approved as a generic drug before expiration of all of the patents, based on a “skinny” label – i.e., a label … Continue Reading

National Advertising Division’s 2022 Annual Report: An Advertising Compliance Roadmap for the Year Ahead

“[N]o legacy is so rich as honesty”1 might fairly summarize the Federal Trade Commission (FTC)’s theme to the advertising industry for 2023, as gleaned from the National Advertising Division (NAD) 2022 Annual Report. “FTC leadership,” the NAD Report elaborates, “sent a consistent, strong message that national advertisers should take a hard look at their own … Continue Reading

Guidance for UK Life Sciences Offered During End of Brexit Transition

With the Brexit transition period ending on December 31st, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is issuing guidance for the UK Life Science industry – including guidance on clinical trials, market authorizations, and manufacture and supply, among other areas. The guidance will apply from the start of 2021. Squire Patton Boggs’ Triage … Continue Reading

HHS Announces $400,000 HIPAA Settlement with Community Health Center

The Department of Health and Human Services Office of Civil Rights (HHS OCR) recently settled with a notable covered entity – a nonprofit Federally Qualified Community Health Center (FQHC) – over alleged Health Information Portability and Accountability Act (HIPAA) Privacy and Security Rule violations. FQHC’s generally serve underserved populations, and qualify for enhanced reimbursement from … Continue Reading

The Department of Health and Human Services Issues Guidance on HIPAA & Cloud Computing

On October 7, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published guidance (“Guidance”) on how cloud services providers (“CSPs”) and covered entities using cloud computing solutions can comply with the privacy, security, and breach notification rules of the Health Insurance Portability and Accountability Act (“HIPAA”). Over the last … Continue Reading

The Federal Circuit Declines to Revisit its Decision that the Biosimilars Patent Dance is Optional – Next Stop, Supreme Court?

This past summer, a divided Federal Circuit panel found, in the case of Amgen v. Sandoz, that the so-called “patent dance” under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is optional.  This past Friday, the Federal Circuit declined to rehear that decision.  Its decision provides biosimilar developers with continued choice while opening … Continue Reading

The Single Party Rule for Direct Patent Infringement: Guidance from the Federal Circuit’s latest Akamai vs. Limelight decision

In its fourth decision in the ten-year litigation between Akamai and Limelight, the Federal Circuit again addresses the issue of so-called divided infringement, this time providing guidance on the requirement that only a “single party” can directly infringe. This case had its most momentous turning point last summer, in June 2014, when the Supreme Court … Continue Reading
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