Clearly Strategic Podcast: Strengthening Patents in the Life Sciences

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The life sciences currently face at least two major scourges in our patent world. The first is that many innovations in the life sciences have been deemed ineligible in terms of patentable subject matter. In other words, the courts and the patent office believe that patent laws are not intended to protect these innovations. The second plague is that the courts find that many patents in the life sciences are not activated. In other words, they are not described in sufficient detail to enable those skilled in the art to make and use the invention.

These scourges of subject matter eligibility and entitlement manifest themselves in the dreaded rejections of Sections 101 and 112. The practical implications are staggering:

  • With respect to eligible subjects, over the past five years, more than 80% of abandoned applications in the field of life sciences received a final rejection from the USPTO stating that the innovation did not include patentable subject matter, based on the USPTO Subject Eligibility Criteria.
  • And as we’ll explore, rejections 101 and 112 can show up in any number of ways, but no idea is too big to fail. Case law today is littered with patents whose ideas of innovators have proven revolutionarybut whose patent claims were invalidated because they did not demonstrate in their applications how their observations could be applied in practice or did not prove that they deserved the breadth of coverage they sought .

Episode preview

In this month’s episode, Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora, leads a discussion, with our all-star patent panel, digging deeper into these rejections, their supporting case law. and in the interest of avoiding a podcast 101 rejection, provides some very practical application tips that will help you bolster your life science patent applications.

First scourge: fewer innovations are “eligible” for patent protection

Patent laws have been written so that everything under the sun is protectable – machines, processes, manufactures and compositions of matter. However, courts have long implicitly argued that abstract ideas, natural phenomena, and laws of nature are excluded. This view came to the fore in the Supreme Court’s seminal decision 2012 Mayo versus Prometheus566 US 66 decisionwhich has made some life science innovations very difficult to protect.

This presents one of the biggest challenges inventors now face with life science patents – and it’s the explicit requirement of having to show how the natural phenomenon is practically applied or improved over technical previously known. It is not enough to detect something that nature has created with conventional techniques. And no matter how groundbreaking the discovery may be, you’ll face a 101 rejection if you can’t either develop your application in terms of applying the discovery or demonstrate that you had to use unconventional methods.

Second scourge: the death of general demands

Innovating in the life sciences is difficult, the results are unpredictable, and there will be more failures than successes. Because of these disadvantages, courts have held that even where an inventor is able to reduce the invention to practice and teach a person skilled in the art how to practice the invention, the inventor may not be entitled to a general or generic claim that covers several species or narrower implementations of the invention. Based on several cases, the courts have indicated that they expect the inventor to actually reduce to practicing all the species he intends to cover by the genus claim. Additionally, a specification that describes a selection process for the direct identification of functional embodiments, if it does not describe every functional embodiment, is considered to require undue experimentation in the eyes of the federal circuit (Idenix Pharma vs. Gilead; Fed. Circ. 2019).

Many inventors naturally look for the wide umbrella, but only prove a few cases. It used to work, but now you need to be able to practice most, if not all, of the variants to get the desired extent of patent protection. This requires much more laboratory science on the part of the inventor and meticulousness on the part of the practitioner. Otherwise, you’ll have to settle for something narrower.

The other part of section 101

The eligible subject is currently the dominant subject under Section 101, but this is a fairly recent development. Much of the focus of Section 101 has always been on whether an invention is useful or not. This was also generally seen as a low bar so it gets overlooked, but when it comes to life sciences the requirement is still there. Case law ends up generating three main aspects of utility – the utility of an invention must be:

  • Well defined, avoids “general” statements of possible uses.
  • Provides a known and immediate “real” benefit in its present form.
  • In accordance with known scientific principles and the facts of the case.

And a faulty utility necessarily fails activation. You cannot teach someone who is skilled in the art to use something that is not useful.

Key points to remember

As an inventor reflecting on his innovation and as a practitioner working with an inventor, there are several lenses through which to view an innovation, a description of each should be included in the patent application.

  • Practical applications. How do you apply the natural phenomenon in a specific or unconventional way? What is the practical utility and use case of the natural phenomenon?
  • Improvement over prior art methods. What does the prior art teach and how are you different? How does your technology improve detection methods, treatment methods, etc. previous?
  • Overcome a particular technical challenge. Think about all the technical challenges encountered and how they were all solved with technical solutions. Include them in the patent application and perhaps even in the proposed solutions claims.
  • Different types of claims. Include different types of claims, for example treatment method, diagnostic method and detection method.

Discussion group

Ashley is also joined today by our always exceptional group of intellectual property experts, including:

  • Kristen Hansen, patent strategist at Aurora
  • Daniel Wright, Patent Strategist
  • David Jackrel, President of Jackrel Consulting
  • Shelley Couturier, Patent Strategist and Research Specialist
  • David Cohen, director at Cohen Sciences
  • Amy Fiene, Patent Attorney at Vancott and Adjunct Professor at BYU
  • Steve Stupp, Partner at Stupp Associates, LLC

Links to materials discussed

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Dr. Ashley Sloat is a USPTO Registered Patent Practitioner who specializes in developing and managing patent portfolios for start-ups and emerging growth companies. She takes a hands-on approach with each client, partnering with engineering and management teams to intimately understand each client’s business, competition and product vision. Armed with this knowledge, Ashley is able to increase the value of her clients’ patent portfolios while reducing overall legal costs.

Photo by Ashley Sloat

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