Tags: COPPA, FTC
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By: Faith Kasparian
On July 1, 2013, the amendments to the regulations that implement the Children’s Online Privacy Protection Act (COPPA) went into effect.
The COPPA Rule imposes requirements on operators of websites or online services (including apps) that are directed to children under the age of 13 or that have actual knowledge that they are collecting personal information online from a child under the age of 13. Among other COPPA Rule requirements, operators must provide notice to parents and obtain verifiable parental consent before collecting, using, or disclosing personal information from children under the age of 13. The amendments constitute the first major changes to the COPPA Rule since the Rule went into effect in 2000.
There are five important changes reflected in the COPPA amendments:
- Expanded Definitions
- Additional Methods for Obtaining Parental Consent
- Heightened Responsibilities on Operators
- Increased Oversight of Safe Harbor Programs
To learn more about these changes, please see the full article here.
Tags: FDA regulations, Hatch-Waxman Act, SCOTUS
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By: David Fazzolare
Uncertainty over the extent to which the Hatch-Waxman Act’s safe harbor applies to post-approval activities remains as the Supreme Court declined to grant certiorari in two prominent cases involving the safe harbor this year. In particular, the Court both denied Momenta’s petition for certiorari of the Federal Circuit’s decision in Momenta v. Amphastar Pharmaceutical’s and denied GlaxoSmithKline’s petition for certiorari of the Federal Circuit’s decision in Classen v. GlaxoSmithKine. Whereas the Federal Circuit panel sitting en banc in Classen held that the safe harbor applies only to pre-approval activities, a different panel of the Federal Circuit sitting en banc more recently held in Momenta that the safe harbor applies to certain post-approval activities, such as quality control batch testing to comply with FDA regulations. The safe harbor is codified in 35 U.S.C. 271(e) (1), which provides that “it shall not be an act of infringement to make, use, offer to sell or sell … a patented invention … solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use or sale of drugs or veterinary biological products.”
The Supreme Court’s refusal to grant certiorari in the Momenta case arguably means that the High Court is willing to accept that certain post-approval activities are protected under the safe harbor. The Court’s failure to opine on the issue, however, leaves interested stakeholders wondering exactly what types of post-approval activities are protected under the safe harbor. Given the divergence of opinions held by existing Federal Circuit justices, and the unresolved conflict between the Momenta and GlaxoSmithKline holdings, the Supreme Court will likely have another opportunity to clarify the types of post-approval activities that are protected under the safe harbor. In the meantime, industry stakeholders contemplating conducting post-approval activities that might infringe a patent would be well-advised to avoid extending the safe harbor beyond the facts of Momenta until the Supreme Court confirms that the safe harbor has indeed become a safe ocean.
To learn more about this topic, please contact David Fazzolare.
Developing an app? Make sure you own it! 02/20/2013Posted by Morse, Barnes-Brown Pendleton in Games & Interactive Entertainment, Intellectual Property, Licensing & Strategic Alliances.
Tags: app development, ownership rights, phone apps
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On February 11th, Adobe published an article “Developing an app? Make sure you own it!” written by MBBP Licensing, Technology and IP Attorney Michael Cavaretta. Mike advises readers on precautions app developers should take in order to ensure their ownership rights are protected.
To read the full article, please visit the Adobe Developer Connection.
For more information on developing an app, feel free to contact Mike.
Tags: Intellectual Property, IP Licensing, MCLE
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On June 16th, Massachusetts Continuing Legal Education (MCLE) is hosting the 14th Annual New England Intellectual Property Law Conference 2011, where attendees can get up-to-speed on trends and new developments that business lawyers and litigators need to know in the ever-changing field of intellectual property law. MBBP IP Licensing and Trademark Attorneys Howard Zaharoff and Faith Kasparian will be attending the conference as faculty members. Howard is a program Co-Chair, while Faith will present an overview and update to the FTC’s New Privacy Framework.
For more information and to register for the conference, please visit MCLE.