Tag Archives: Innovation Act

225th Anniversary of First U.S. Patent

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225 years ago last Friday the first U.S. patent was issued to Samuel Hopkins for an improved process for creating potash, America’s first industrial chemical compound. America’s Founding Fathers recognized Intellectual property as a fundamental right, so much so they enshrined it into our Constitution. The systems for issuing patents have changed over the years, but Congress retains the authority to regulate and change matters of patent law. Unfortunately, not all changes to patent law Read More >

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Updated Legal and Regulatory Frameworks Needed for Biosimilars

Jim Greenwood

Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks. We call on the FDA to release final guidance on processes and scientific criteria for the approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining a biosimilar to be interchangeable with its reference biological. There has been positive momentum recently, however, we believe the appropriate way to develop policy on such Read More >

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Patent Reform Legislation Off The Table For Now

Williams

If the mainstream media is to be believed, the patent system is broken.  This notion is frequently blamed on the perceived increase in so-called patent assertion entities (“PAEs”), referred to derogatorily as “patent trolls.”  More often than not, these media reports cite to a limited number of examples illustrating the perceived abuses, and reach the conclusion that patents are stifling innovation.  And, even though there has been serious disagreement about the extent of the problem, Read More >

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Universities Express Concerns About Recently Passed House “Innovation Act”

Earlier this month, the House passed the Innovation Act (H.R. 3309), which seeks to address abuses of the U.S. patent litigation system. While the goal is commendable, the bill is overly broad in important respects and if enacted into law would produce unintended and unknowable consequences for innovators who rely on the patent system to fund and protect their inventions. The U.S. Senate is now developing similar legislation, the Patent Transparency and Improvement Act of Read More >

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Emerging Company Policy Deconstructed: Fostering Innovation Act (H.R. 2629)

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In a nutshell: Representative Michael Fitzpatrick (R-PA) introduced H.R. 2629, the Fostering Innovation Act, to update SEC filing status classifications for public companies and help ease regulatory burdens on emerging companies and reduce the bureaucratic hurdles and red tape that lengthen the time to bring cures from discovery to patient. Why you should care: SEC Rule 12b-2 establishes three classifications for public companies to determine their filing status, which include large accelerated filers (companies with Read More >

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