The life sciences are currently facing 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 science 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 the USPTO’s 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 at Aurora, leads a discussion, along with our all-star patent panel, delving deeply into these rejections, their backing case law, 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.
First Plague: Fewer Innovations are ‘Eligible’ for Patent Protection
Patent laws were written such that anything under the sun is protectable – machines, processes, manufactures, and compositions of matter. However, courts have long implicitly held that abstract ideas, natural phenomena, and laws of nature are excluded. This view came to the forefront in the Supreme Court’s seminal 2012 Mayo v. Prometheus, 566 U.S. 66 decision, which made certain life science innovations very difficult to protect.
This presents one of the biggest challenges inventors now face with life science patents – and that is the explicit requirement of having to show how natural phenomenon is practically applied or improved upon over prior known techniques. Just detecting something nature created with conventional techniques is not enough. And no matter how revolutionary the discovery may be, you’ll face 101 rejection if you can’t either build up your application in terms of how to apply the discovery or demonstrate that you’ve had to use unconventional methods.
Second Plague: Death of Broad Claims
Innovating in the life sciences is difficult, the results are unpredictable, and there will be more failure than success. Because of these drawbacks, the courts have held that even when an inventor is able to actually reduce the invention to practice and teach one of skill in the art how to practice the invention, the inventor may not be entitled to a broad or genus claim that covers multiple more narrow species or implementations of the invention. Based on multiple cases, the courts have indicated that they expect the inventor to actually reduce to practice every species they intend the genus claim to cover. Taken further, a specification that describes a screening process for the straightforward identification of working embodiments, if it does not describe each and every working embodiment, is considered to require undue experimentation in the eyes of the Federal Circuit (Idenix Pharma v. Gilead; Fed. Circ. 2019).
Many inventors understandably look for the broad umbrella, but only prove out a couple of cases. That used to work, but you now need to be able to reduce to practice most, if not all, of the variants to achieve the desired breadth in patent protection. This requires a lot more bench science on the part of the inventor and thoroughness on the part of the practitioner. Otherwise, you’ll have to be content with something more narrow.
The Other Part of Section 101
Eligible subject matter is presently the dominant topic under Section 101, but that’s a fairly recent development. For the most part, the focus on Section 101 has historically been about whether or not an invention is useful. This has also been generally viewed as a low bar, so it gets overlooked, but towards life sciences, the requirement is still there. Case law ends up generating three main aspects of utility – an invention’s utility must be:
- Well-defined, avoids “general” statements of possible uses.
- Provides a known and immediate “real world” benefit in its current form.
- Consistent with known scientific principles and the facts of the case.
And failing utility necessarily fails enablement. You can’t teach someone who’s skilled in the art to use something that is not useful.
As an inventor thinking through their 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 are you applying the natural phenomenon in a specific or unconventional way? What is the practical utility and use case for the natural phenomenon?
- Improvement over prior art methods. What does the prior art teach and how are you different? How does your technology improve upon prior detection methods, treatment methods, etc.?
- Overcome a particular technical challenge. Think through all the technical challenges that were faced and how they were all solved with technical solutions. Include these in the patent application and maybe even draft claims directed to the solutions.
- Different claim types. Include different claim types, for example method of treatment, method of diagnosis, and method of detection.
Ashley is also joined today by our always exceptional group of IP experts including:
- Kristen Hansen, Patent Strategist at Aurora
- Daniel Wright, Patent Strategist
- 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
Links to Discussed Materials
- The Death of the Genus Claim
- Final office action rejection frequency for life science patents
- Examiner statistics (not an endorsement)
Dr. Ashley Sloat is a USPTO-registered patent practitioner who specializes in the development and management of patent portfolios for startup ventures 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.