1. The Final Score: 2018 Drug & Biologic Patent Approvals

    Posted on 15.01.19 Brittany Knight, on Articles, Biologics/biosimilars, Patent Trends & Activity

    The past year was a big year for FDA approved new drugs and biologics – 59 in fact, compared to 46 in 2017 and a mere 22 in 2016. From the published list of approvals on the FDA website Novel Drug Approvals for 2018, we compiled data on the listed patents associated with these drugs. As a whole, the 59 drugs included 42 “conventional”, i.e. small molecule drugs, of which 35 were new chemical entities (NCEs approved via a New Drug Application or NDA), and 17 were biological molecules (approved via a Biological License Application or BLA). For background, “conventional” drugs are small (i.e. generally under 1000 molecular weight), synthetically manufactured chemical entities that are chemically and molecularly well-characterized. Currently, these drugs make up the majority of approved drugs. Information regarding patents and exclusivity for these “conventional” drugs is referenced in the Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the ‘Orange Book’.

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  2. Not Yet Evolved? Where is 35 USC §101 going?

    Posted on 12.12.18 Brittany Knight, on Articles, News and Events, Patent Trends & Activity

    Software is a generic term to refer to a collection of data or executing code used by a computer to implement arithmetic operations or logical operations. Back in 1936, Allen Turing, in his landmark paper On Computable Numbers proposed the capable use of instructions (i.e. software) to execute functions through his Turing Machine, an early precursor of the general purpose computer[1]. Today the modern computer is instrumental for complex computations, data analytics, high-powered graphing, simulations, and so on. Although, the development and use of software for these computer functions has become mainstream, determining the patent eligibility of software inventions under 35 USC §101 has been less intuitive.

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