It's the Law

The legal arm of the regulatory profession is fluid and changing. These articles attempt to explain some of the nuances of regulatory law and what should be considered when making decisions.

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23 July 2012

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

By Jane Wright-Mitchell, PharmD, JD

The US Supreme Court's recent Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S decision highlights the different viewpoints of the courts in the pharmaceutical arena, in particular drawing attention to the interaction of pharmaceutical patents to the US Food and Drug Administration (FDA)-generated Orange Book. [Read More...]

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Categories: It's the Law

1 December 2011

Considerations in View of the New US First-Inventor-to-File Patent System

By Shahnam Sharareh, PharmD, RAC, and Sarah Klosek, MS

The US patent system has a rendezvous with change. On 16 March 2013, it will officially change from a first-to-invent to a first-inventor-to-file system as authorized by the Leahy-Smith America Invents Act.

Under the current first-to-invent system, a patent is awarded to the inventive entity that invents first. In contrast, under a first-inventor-to-file system, a patent is awarded to the inventive entity that is the first one to file a patent application on its own invention.

[Read More...]

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2011

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America Invents Act

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Leahy-Smith America Invents Act

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Categories: It's the Law

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It's the Law

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

Considerations in View of the New US First-Inventor-to-File Patent System

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