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"Any Port in a Storm: The Hatch-Waxman’s (Ever Expanding) Safe Harbor Provision," IP & Technology Journal, July 2014

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Thomas Jefferson, Benjamin Franklin, and the multitude of men and women who helped establish the United States were visionaries in many ways. One of the most important of which was to provide Congress with the power “to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”1 While the drafters of the Constitution likely understood that this provision, a mere 27 words, would lead to many patents, they likely did not realize that their actions would help foster the incredible inventions and discoveries we have today. Additionally, while the drafters of the Constitution gave Congress the power to regulate this patent system as Congress saw fit, the Founding Fathers did not intend for certain patent holders to have their rights stifled by future legislative, regulatory, or judicial proceedings. However, in the wake of the Federal Circuit’s recent decisions in Classen Immunotherapies, Inc. v. Biogen IDEC2 and Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals,3 the right of patent owners, having patents directed to drugs, medical devices, and other products that require regulatory approval under a Federal law, to pursue infringers has been significantly limited. This could result in a diminished economic value of such patents.

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