Judge Lourie Suggests Jepson Claims For Patent Eligibility

08 December 2015 PharmaPatents Blog

As reported previously, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc. I wrote about Judge ‘Dyk’s opinion concurring in the denial but offering alternative views on patent eligibility in this article. Here, I look at the other concurring opinion, which was authored by Judge Lourie and joined by Judge Moore. 

Judge Lourie’s Tutorial On Patent Eligibility

Judge Lourie’s opinion starts where you might expect a scientist to start, with a tutorial on laws of nature. (Judge Lourie received a Master’s degree in organic chemistry from the University of Wisconsin and a Ph.D. in chemistry from the University of Pennsylvania.) In particular, Judge Lourie emphasizes that “Laws of nature are exact statements of physical relationships, deduced from scientific observations of natural phenomena,” and gives examples such as E=mc², F=ma, “and many more.”

With that in mind, Judge Lourie states that while laws of nature “are not and should not be patent-eligible subject matter,” the same rule does not (should not?) apply to “methods that utilize laws of nature.” Judge Lourie reminds us that “nothing in the physical universe would be patent-eligible” since “all physical steps of human ingenuity utilize natural laws or involve natural phenomena.”

Judge Lourie also explains “abstract” steps:

Abstract steps are, axiomatically, the opposite of tangible steps; that which is not tangible is abstract. But steps that involve machines, which are tangible, steps that involve transformation of tangible subject matter, or tangible implementations of ideas or abstractions should not be considered to be abstract ideas. ….

But the fact that steps are well-known, although relevant to other statutory sections of the patent law, does not necessarily make them abstract.

Is this a critique of University of Utah Research Foundation v. Ambry Genetics Corp.?

Judge Lourie’s Concerns With The Sequenom Claims

Turning to the claims at issue, Judge Lourie raises questions about their breadth, but not their eligibility:

The claims in this case perhaps should be in jeopardy, not because they recite natural laws or abstract ideas, but because they may be indefinite or too broad. But they should not be patent-ineligible on the ground that they set forth natural laws or are abstractions.

*****

[N]either of the representative claims here merely recites a law of nature, a natural phenomenon, or an abstract idea. The claims rely on or operate by, but do not recite, a natural phenomenon or law. The claimed invention involves taking maternal serum, separating it, amplifying the genetic material to detect cffDNA, and running tests to identify certain genes or genetic defects; these are all physical, and not insignificant, steps requiring human intervention. The claims might be indefinite or too broad …. But the finer filter of § 112 might be better suited to treating these as questions of patentability, rather than reviewing them under the less-defined eligibility rules.

Is this a veiled reference to Mayo v. Prometheus, where Justice Breyer’s “decline[d] the Government’s invitation to substitute §§102, 103, and 112 inquiries for the better established inquiry under §101“?

Can The Supreme Court Undo The Damage Of Mayo?

While Judge Dyk’s concurrence offers a way to refine the Mayo test for patent eligibility, Judge Lourie seems to find it to be more fundamentally flawed:

[T]he claims here are directed to an actual use of the natural material of cffDNA. They recite innovative and practical uses for it, particularly for diagnostic testing: blood typing, sex typing, and screening for genetic abnormalities. And it is undisputed that before this invention, the amplification and detection of cffDNA from maternal blood, and use of these methods for prenatal diagnoses, were not routine and conventional. But applying Mayo, we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process.

Judge Lourie’s conclusion is even more direct:

[I]t is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts. But I agree that the panel did not err in its conclusion that under Supreme Court precedent it had no option other than to affirm the district court.

Judge Lourie’s Work-Around

Perhaps wanting to avert the “crisis of patent law and medical innovation [that] may be upon us,” Judge Lourie suggests that presenting diagnostic method claims in Jepson format might avoid patent eligibility issues. He even goes so far as to provide sample language for Sequenom’s claims:

In a method of performing a prenatal diagnosis using techniques of fractionation and amplification, the improvement consisting of using the non-cellular fraction of a maternal blood sample.

Has anyone pursued claims like this?

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Insights

California Statute Offers Dramatic Change to Independent Contractor, Franchise-Franchisee Relationships
20 September 2019
Legal News: Distribution & Franchise
AI Ouch! AI Job Interview Law Starting in 2020!
20 September 2019
Internet, IT & e-Discovery Blog
RCE PTA Carve-Out Resumes After Interference
18 September 2019
PharmaPatents
The Ninth Circuit Expected to Rule that Doctors Can Be Wrong in the Winter v. Gardens False Claims Act Case
18 September 2019
Legal News: Government Enforcement Defense & Investigations
Lacktman, Ferrante Cited in mHealth Intelligence About Ryan Haight Act
19 September 2019
mHealth Intelligence
Vernaglia Comments on AHA v Azar Decision
18 September 2019
MedPage Today
Tinnen Discusses How Viewpoint Diversity Helps Businesses Thrive
18 September 2019
InsideTrack
Lach Comments on Launch of New Group
16 September 2019
BizTimes Milwaukee
MedTech Impact Expo & Conference
13-15 December 2019
Las Vegas, NV
Review of 2020 Medicare Changes for Telehealth
11 December 2019
Member Call
BRG Healthcare Leadership Conference
06 December 2019
Washington, D.C.
CTeL Telehealth Fall Summit 2019
04-06 December 2019
Washington, D.C.