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  1. Jan 1, 2010 · One of the requirements for obtaining a patent is that the claimed subject matter in the patent not be obvious in view of prior art (previously disclosed patents and publications). Obviousness [16] and prior art [17] are legally codified in Title 35 of the United States Code.

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      The resulting negative effect on support for new drug and...

    • Volume 45

      Chapter 27 - Patents in Drug Discovery: Case Studies,...

  2. Obviousness: To be patentable, an invention must be unobvious: section 28.3 of the Patent Act. Relevant date: The claimed subject-matter must not have been obvious on the claim date: section 28.3 of the Patent Act. Four-step approach: The approach for assessing obviousness has four steps (Sanofi):

  3. Sep 4, 2019 · Here I develop an alternative framework for the opinion-free and evidence-based determination of obviousness (EBDO) that is based on the actual patenting practices and actions of a peer group of...

    • Graham S. Timmins
    • gtimmins@salud.unm.edu
    • 2019
  4. Pharmaceutical research often entails making small modifications to candidate drug molecules—modifications that might be deemed “obvious to try”—and then studying the largely unpredictable, yet critical, resulting biological effects.

  5. Sep 15, 2017 · In 2007, the Supreme Court rejected the Federal Circuit’s rigid application of the so-called “TSM test”—that there must be an explicit teaching, suggestion, or motivation in the prior art—in order to find a claimed invention is obvious.

  6. Apr 21, 2020 · In addition, so called “obvious to try” cases of obviousness can be established even if the variable being manipulated (i.e., ‘tried’) is not the “first variable.”. The ‘025 patent claims a methylnaltrexone pharmaceutical formulation that is stable when the pH of the solution is adjusted to between 3.0 and 3.5.

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  8. Why does a particular drug product only have patents? Only have exclusivity? Have neither? What information related to pediatric exclusivity is listed in the Orange Book? Where can I find...

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