By: Robert R. Sachs

The Supreme Court’s actions to invalidate the patents at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012) and Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., 569 U.S. ___ (2013), unequivocally demonstrate that the USPTO has failed to properly prevent patents on laws of nature from issuing. Similarly, the Food and Drug Administration does not appear to understand the significance of its role as potential steward of biological laws of nature in approving new therapeutics, many based on what we now know to be patented laws of nature. In view of this melancholy state of affairs, I have a very modest proposal.

Continue Reading A Modest Proposal for Protecting the Laws of Nature from Being Burdened by Patents, and Making them Free to All Men and Reserved Exclusively to None

By: Robert R. Sachs

As mentioned in my September 13 post, Fenwick sponsored UC Davis’ fifth annual Lecture Series in Technology, Entrepreneurship, Science and Law (TESLaw) on September 27, 2013. A video recording of the event is available at the following link: On the Frontier of the Future: Innovation and the Evolution of Patentable Subject Matter.   

This year’s program featured spirited discussion among scholars and practitioners in the patentable subject matter debate, with a particular focus on the software and life sciences spaces. The panelists addressed problems in the Supreme Court’s approach to laws of nature and abstract ideas, and discussed different ways that the courts could address the issue. At the end of the life sciences panel, I questioned panelists Kevin Emerson Collins and Rebecca Eisenberg as to why they felt it necessary to reinterpret Prometheus as talking about per se categories, rather than taking it at face value for being about laws of nature, in which event the Court should be cognizant of what scientists and philosophers of science think about laws of nature. See the discussion starting at 01:20:40. I moderated the afternoon panel on abstract ideas, which panelist Pam Samuelson called a “feisty debate.” 

It has truly been an honor for my Fenwick partners and I to co-host this symposium with UC Davis over the past five years, and we look forward to collaborating with the university in the future.

By: Robert R. Sachs, Jennifer R. Bush

In our previous post, we explored the philosophical aspects of what is a law of nature. We can now apply that analysis and consider whether Prometheus’ claim recites a law of nature under the variously described criteria. Here is the claim 1 of the ‘623 patent:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated
gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to
a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said
subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about
230 pmol per 8×108 red blood cells indicates a need to increase the
amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than
about 400 pmol per 8×108 red blood cells indicates a need to
decrease the amount of said drug subsequently administered to said subject. 

Continue Reading <i>Prometheus</i> Unbound II: Does Prometheus’ Claim Recite a Law of Nature?

By: Robert R. Sachs, Jennifer R. Bush

In March 2012, the Supreme Court ruled, in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012), that a patent claim on a method of determining whether a given dose of a particular type of medication was safe and effective was a “law of nature” and thus invalid. In the following two-part series, we will show that the Court’s characterization of Prometheus' patent as nothing more than a law of nature does not withstand critical analysis. 

Prometheus Labs is the exclusive licensee of U.S. patents 6,355,623 and 6,680,302. The patents deal with a protocol to determine the safe and effective dosage for thiopurines, which are medications that treat autoimmune diseases such as Crohn’s disease and ulcerative colitis. These medications metabolize in the patient’s body into 6-thioguanine (“6-TG”). The different rates at which the medications metabolize make it difficult for physicians to determine whether a given dose is too high (and thus toxic) or too low (and thus ineffective). The Prometheus patents’ claims identify the range for safe and effective dosages as those which result in a concentration of 6-TG between about 230 pmol and about 400 pmol per 8×108 RBC red blood cells (“RBC”). The patents claim no underlying biological process that accounts for the differences in metabolization.

The Supreme Court ruled that Prometheus’ claims were not eligible for patent protection, holding that Prometheus did nothing more than identify a law of nature. However, The Court’s analysis of the claim as a law of nature is based on a superficial understanding of the scientific status of laws of nature.

Continue Reading <i>Prometheus</i> Unbound I: The Untethering of Laws of Nature and Patent Eligibility from Scientific Reality

By: Robert R. Sachs

In my posting on the differences between abstract ideas and abstractions, I stated that “The problem is not abstraction: the problem is inclination of the academy and the judiciary to throw up their hands in defeat when dealing with these issues. See Mark A. Lemley et al., Life After Bilski, 63 STAN. L. REV. 1315, 1316 (2011) (“Put simply, the problem is that no one understands what makes an idea ‘abstract’ . . . .”).

Michael Risch, one of the co-authors of Life After Bilski (LAB), correctly pointed out that I read this statement too broadly, that they were referring to “observers,” rather than themselves, and that they did propose various tests for abstract ideas. Michael is, of course, correct. I should have been more careful in my phrasing.

However, having now re-read LAB, I remain of the view that the approach therein does not tackle the question of What is an abstract idea? itself, independent of any reliance on patent law requirements and policy considerations. Instead, LAB proposes a functional approach to the question of patent eligibility by employing various legal, policy and value considerations of claim scope, preemption, contribution to innovation and so forth, as factors. In short, I would argue that LAB elides the question entirely and instead attempts to answer the ultimate question: What claims are patent ineligible? 

Continue Reading Is There Life After <i>Bilski</i>? Yes, but It’s Not as We Know It: A Response to Michael Risch

By: Robert R. Sachs

There are three 19th century cases that form part of the canon of Supreme Court caselaw on patent eligibility: Le Roy v. Tatham, 55 U.S. 156 (1852), O'Reilly v. Morse, 15 How. 62 (1853) and Tilghman v. Proctor, 102 U.S. 707 (1880). 

Le Roy v. Tatham

I'll begin our historical tour with Le Roy v. Tatham, which is cited and quoted in just about every recent Supreme Court and Federal Circuit decision for nothing more than this singular statement: "A principle, in the abstract, is a fundamental truth; an original cause; a motive; and these cannot be patented, as no one can claim in either of them an exclusive right." Given the ubiquity with which Le Roy is cited, one can be forgiven for believing that this case was indeed about whether a 'principle,' etc. was patent-eligible. It is not.

Continue Reading Patent Eligibility: The Historical Cases

By: Robert R. Sachs

In July 2012, two panels of Federal Circuit issued decisions regarding patentable subject matter for computer implemented business methods, CLS Bank Int’l v. Alice Corp. No. 2011-1301 (Fed. Cir. July 9, 2012), and Bancorp Services v. Sun Life Assurance Co. of Canada, No. 2011-1467 (Fed. Cir. July 26, 2012). The decisions demonstrated conflicting approaches various members of the court apply to this question. On what appears to be similar business methods patents, the two panels came to opposite decisions—the CLS panel finding the claims patent-eligible, and the Bancorp panel holding not.

In October 2012, the Federal Circuit vacated the CLS panel decision, granted CLS’s motion for en banc review. The en banc order posed two questions for the parties to address:

a. Whether a computer-implemented invention is a patent ineligible “abstract idea”; and when, if ever, does the presence of a computer in a claim lend patent eligibility to an otherwise patent-ineligible idea?

b. In assessing patent eligibility under 35 U.S.C. § 101 of a computer-implemented invention, should it matter whether the invention is claimed as a method, system, or storage medium; and should such claims at times be considered equivalent for §101 purposes?

On February 8, 2013, the court heard oral arguments from CLS, Alice, and the Solicitor General. Most surprisingly, no one attempted to actually answer the underlying questions here: What is an abstract idea? How do you know when a claim recites one? Instead, what was offered up as a “test” by both parties was whether the claim recites “significantly more” than just having a computer apply a (still undefined) abstract idea. This is just another ‘I know it when I see it test,’—just like Potter Stewart’s test for obscenity in Jacobellis v. Ohio. “Significantly more” provides no objective, analytical method to identify what is patent eligible. In this series of posts, we will explore some of the issues and problems raised by these questions, and offer the outlines of an objective answer and methodology.

Continue Reading The Confusion between Abstractions and Abstract Intellectual Ideas