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​​Patently Strategic Musings

Fortifying Life Science Patents

7/13/2022

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By: Josh Sloat
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Fortifying Life Science Patents

Eligibility and Enablement – Sections 101 and 112
​

The life sciences are currently faced by at least two major plagues in our patent world. The first is that many life science innovations have been deemed ineligible in terms of patentable subject matter. In other words, the courts and the patent office believe that the patent laws are not meant to protect these innovations. The second plague is that the courts believe that many life sciences patents are not enabled. In other words, they are not described in sufficient detail to enable one of skill in the art to make and use the invention.

These subject matter eligibility and enablement plagues manifest in dreaded Section 101 and 112 rejections. The practical implications are staggering:

  • When it comes to eligible subject matter, in the last five years, over 80% of abandoned life science applications had a final rejection from the USPTO stating that the innovation did not include patentable subject matter, based on subject matter eligibility criteria.
  • And as we’ll explore, 101 and 112 rejections can surface in a myriad of ways, but no idea is too big to fail. Case law is now littered with patents whose innovator’s ideas proved to be revolutionary, but whose patent claims ended up invalidated because they failed to demonstrate in their applications how their observations could be practically applied or failed to prove that they deserved the breadth of coverage they sought.

In this month’s episode, Dr. Ashley Sloat, President and Director of Patent Strategy here at Aurora, leads a discussion, along with our all star patent panel, delving deeply into these rejections. And in the interest of avoiding a podcast 101 rejection, provides some very practical application tips that will help to fortify your life science patent applications. 


Ashley is joined today by our always exceptional group of IP experts including:
  • Kristen Hansen, Patent Strategist at Aurora
  • Daniel Wright, Patent Strategist here at Aurora
  • David Jackrel, President of Jackrel Consulting 
  • Shelley Couturier, Patent Strategist and Search Specialist
  • David Cohen, Principal at Cohen Sciences
  • Amy Fiene, Patent attorney at Vancott and adjunct professor at BYU
  • Steve Stupp, Partner at Stupp Associates, LLC. 

Availability

​Patently Strategic is available on all major podcasting directories, including Apple Podcasts, Spotify, and Google Podcasts. We're also available on 12 other directories including Stitcher, iHeart Radio, and TuneIn, so you should be able to find us wherever you listen to podcasts.
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Topic and guest participant requests

If you’re an agent or attorney and would like to be part of the discussion or an inventor with a topic you’d like to hear discussed, please reach out.​

Resources

  • Related content. This podcast is part of a multi-part series covering life science patents. The two prior blog installments explore How to Read Drug and Chemical Patents and 
    Drug patents and the FDA: Timelines, Exclusivity, and Extensions.
  • ​Transcripts. We're also providing computer-generated transcripts for improved accessibility and additional reference opportunities. 
  • Slides. For the visual learners out there, we also like to make our presenter slides available for your reference. 
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