Posts Tagged: "mayo"

This morning, the American Civil Liberties Union (ACLU), which will be represented in Wednesday’s hearing on Section 101 reform by Senior Legislative Counsel Kate Ruane, announced an urgent phone briefing for members of Congress and staff to address the contention that the “Proposed Patent Bill Would Jeopardize Health Care and Harm Medical Research.” The phone briefing, which all interested stakeholders should join, takes place today at 2:30 pm EST and will be jointly held by representatives from the ACLU, the Association for Molecular Pathology, a breast cancer survivor and patient, My Gene Counsel, and Invitae. Anyone who would like to listen should dial in to the number provided here. Below, Sherry Knowles, a well-known patent attorney, policy expert and also a breast cancer survivor, rebuts the arguments made in both the ACLU’s briefing announcement and associated letter to Congress on this topic.

Senators and Representatives Coons, Tillis, Collins, Johnson, and Stivers recently announced in a press release a proposed framework to fix patent eligibility law in the United States. If written as proposed in the draft framework, section 101 may do harm to the patent system. The senators and representatives are now soliciting feedback on the draft framework. They are likely to take additional action on the framework as soon as early this week. Please send the following text with any of your edits to [email protected].

Recently, I’ve written several articles laying the blame for the patent eligibility crisis squarely on the Federal Circuit. Yes, we all know the Supreme Court is obviously to blame. They are the court with primary national jurisdiction, and there can be no doubt that the Mayo v. Prometheus decision is the root of the patent eligibility problem because it intentionally conflates novelty and obviousness with patent eligibility. In my recent writings, and in a variety or presentations and speeches I have been giving across the country—from Utah to Orlando to Charlotte—I’ve criticized the Federal Circuit for not distinguishing Mayo and Alice on the facts. If we listen to the Supreme Court at least, at issue in both Mayo and Alice were unusually simple “inventions” that are really not innovations at all. As I filed my latest article, Eileen said that she thought it was good because it would provoke discussion since I disagreed with Judge Michel’s view in the interview with him she had just published. There was a long pause in our conversation. “Am I really disagreeing with Judge Michel?” I asked. Whenever I disagree with Judge Michel, I pause. It isn’t that I am unwilling to disagree with him, but, over the years, I have come to learn that, when one is going to disagree with Judge Michel, prudence dictates reevaluating your position.

In one of its latest opinions attempting to parse precedent on the subject matter eligibility of software, method of use, and business method patents that arguably involve application of laws of nature or recitations of well-known, conventional methods and techniques, the U.S. Court of Appeals for the Federal Circuit found that a patent directed to a method for administering a naturally occurring beta amino acid to cause an increase in the concentration of a naturally occurring amino acid combination in muscle and brain tissues was subject matter eligible for patent protection (Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, No. 18-1295, 2019 U.S. App. LEXIS 7647 (Fed Cir. March 15, 2019). The panel’s 2-1 majority decision conceded that the claims at issue involved laws of nature and had similarities to claims the U.S. Supreme Court had found subject matter ineligible but found that the claims possessed sufficient inventiveness beyond natural phenomenon and conventional methods to make them subject matter eligible for patent protection. Since Alice, the Federal Circuit and the federal district courts have been striving to implement and apply the Alice test to methods of use, software, and business method inventions that arguably involve applications of laws of nature and conventional methods. The challenge for the court in these cases has been to determine whether the claims sufficiently go beyond applications of laws of nature and known conventions to qualify as subject matter eligible for patent protection under Section 101. The Federal Circuit has found an inventive concept in several such cases.

For almost ten years, U.S. patent law has experienced extraordinary confusion and uncertainty about what types of inventions and discoveries are patent eligible. The U.S. system changed from offering strong protection for novel and nonobvious inventions to questioning whether groundbreaking technologies are even the type the Founders thought would promote the progress of the “Useful Arts.” But recent developments, including the USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (Section 101 Guidance), suggest that winds of change may clear the fog and bring back some clarity to U.S. patent law.

What makes SCOTUS’s assertions in patent law jurisprudence that there are these “exceptions” or additional “requirements” particularly annoying to many of us in the patent bar is that patent law is essentially statutory.  In other words, there should be no “federal common law of patents” that allows SCOTUS (or any other court for that matter) to make “exceptions” to or make additional “requirements” for what is already expressly written in the patent statutes.  Indeed, in other areas of federal law, SCOTUS has made it abundantly clear that “federal common law” doesn’t exist.  The most famous example is Erie v. Tompkins where SCOTUS overturned its prior view of a “federal common law” applicable in cases involving diversity jurisdiction.  So we in the patent bar may rightly ask:  why does SCOTUS believe it can create what is, in essence, a “federal common law of patents” to supplant or modify the existing patent statutes?

If the claim is directed to an abstract idea, then abstractness is an essential property of the claimed subject matter as a whole. As such, a claim directed to an abstract idea cannot be transformed to possess non-abstractness by whether or not it embodies an inventive concept, since whether the inventive concept is inventive or not depends upon when the concept was conceived, which is an accidental property rather than an essential property of the claimed subject matter… Mayo may make sense for natural laws and physical phenomena but given the very different nature of abstract ideas the test logically falls apart when one thinks they can turn something that is by its fundamental nature abstract into something that is not abstract.

This article examines Supreme Court and Federal Circuit analyses of patent eligibility under 35 U.S.C. § 101 where the patent claims at issue were directed to Life Sciences-related technologies. I first examine this topic in the context of composition of matter patent claims and then in the context of method claims. As reflected in the below discussion, while the § 101 case law is fairly straightforward with respect to composition claims, the case law is murkier when it comes to method claims.

In Vanda, Chief Judge Prost, one of the judges on the CellzDirect panel, dissented from the majority’s decision that found claims patent eligible for not being directed to a judicial exception in step one of the Mayo/Alice test. What differences between the claims in Vanda and those in CellzDirect led Judge Prost to dissent? Can these differences shed further light on the characteristics necessary for a claim to be found not directed to a patent-ineligible concept in step one?

In Exergen Corporation v. Kaz USA, No. 16-2315 (March 8, 2018), the Federal Circuit, in a split non-precedential opinion, affirmed a holding that Exergen’s claims directed to methods and apparatuses for detecting core body temperature were directed to patentable subject matter under 35 U.S.C. § 101… The majority held that the district court did not clearly err in finding that it was unconventional to use temperature scanning technology to measure arterial temperature beneath the skin… Judge Hughes dissented, arguing that the majority erred by relying on the natural law in determining inventiveness at step two… Judge Hughes seems to suggest that the correct step-two inquiry should be whether, assuming the natural phenomenon were known, it would have been conventional to combine that phenomenon with existing technology to practice the asserted claims.

Many district courts have interpreted Alice as authorizing invalidation of issued patents as “abstract” based solely on the pleadings. They have done so even where the invalidation rests on resolution of a disputed issue of fact or of claim construction or scope. In short, since Alice, the Federal Circuit has done nothing to clear up the district courts’ confusion, but instead has affirmed pleading invalidations more than 90 percent of the time. Nothing in Alice, or Mayo for that matter, authorized these “pleadings invalidations.” Whether you agree with the decisions or not, both Alice and Mayo, were decided on summary judgment.

A memorandum signed by Judge Sleet shows that Mallinckrodt’s patents were invalidated under the Section 101 patentability standard set by the U.S. Supreme Court in 2012’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., a standard affirmed by SCOTUS’ 2014 decision in Alice Corporation v. CLS Bank International. Applying the two-step test for Section 101 patentability, the Delaware court found that the Mallinckrodt patents covered natural phenomenon which did not include an inventive step. The court found that patent claim limitations directed at echocardiography or severe adverse reactions did not satisfy the inventive concept step. “It does not matter what the severe adverse reaction is,” Judge Sleet’s memo reads. “Any reaction to treatment with iNO will be a natural phenomenon, dictated by the patient’s physiological response to the drug.”

“In our time together today we are going to try and take stock of the health of the American patent system,” Michel began. “It is important to remember that the patent system was founded in the Constitution… and although the world ‘right’ appears many times in the Bill of Rights, in the original Constitution the only ‘right’ mentioned is the patent right.”… Investment is being disincentivized by uncertainty created by the aforementioned three waves of changes to the system. We should be looking at the impact on the flow of money, Michel explained.

The § 101 rejection rate for patent applications in the e-commerce work groups approaches 100%, then drops precipitously for the remaining seven of the top ten work groups with the greatest percentage of § 101 rejections. Before Bilski, the § 101 rejection rate in the e-commerce work groups hovered around around the 30% mark, but has now tripled. The remaining work groups have also seen their § 101 rejection rates rise by 200-300%, although they make up a significantly smaller proportion of total rejections than in the e-commerce art units. While it did not surprise us that these work groups were at the very top of the list for § 101 rejections, we also wanted to know what other technologies are particularly prone to § 101 rejections.