Posts Tagged: "myriad"

Through the first half of June, a series of hearings on the state of patent eligibility in America held by the Senate Intellectual Property Subcommittee rendered a variety of interesting exchanges regarding current U.S. subject matter eligibility under Section 101 relating to various important sectors of the U.S. economy. During the second hearing, Senator Richard Blumenthal (D-CT) talked to panelists regarding his concerns about patent abuses in the pharmaceutical industry. During his period of questioning, Blumenthal grilled witnesses on the subject of whether the expansion of subject matter eligibility that would result from the proposed Section 101 draft text would exacerbate issues related to “patent thicketing,” a process by which drug companies attain large patent portfolios covering various aspects of a single drug formulation. Along with Senators Thom Tillis (R-NC) and Mazie Hirono (D-HI), Senator Blumenthal entered a series of questions for the record to be answered by panelists attending the recent patent eligibility hearings. Although the questions don’t overtly single out the pharmaceutical industry, panelist answers largely indicate that this sector was on most people’s mind while responding.

Coverage of the ongoing patent reform debate in the Senate Judiciary Committee by the popular press has been alarmist and largely incorrect. For example, even just yesterday—five days after the final hearing on patent eligibility reform concluded—the top story in Google’s patent alert results was “Corporations shouldn’t be able to patent your DNA,” which leads with the sentence, “The practice of patenting genes, once banned by the Supreme Court, may come back soon despite a measure of horror the very idea once inspired.” It would seem that those companies and entities that oppose reform to patent eligibility requirements are not going to meaningfully participate in the political process, and instead will wield their considerable PR machines in an effort to confuse, conflate and misdirect the public as part of their ongoing scheme to suppress innovation in America. Indeed, we know that the high-tech industry was invited to testify before the Senate Judiciary Committee, but refused, as Senator Thom Tillis (R-NC) explained at the second hearing. Why would the high-tech industry choose to ignore these Senate hearings, where many dozens of witnesses both for and against reform were invited to share their views?

After three hearings and 45 witnesses, there were few new fundamental arguments advanced for or against reforming patent eligibility law at today’s final Senate IP Subcommittee hearing on the topic, but several key—and some alarming—messages were underscored. A few takeaways off the bat: there are going to be considerable changes to the working draft. In particular, there were four issues that Senator Thom Tillis (R-NC) noted were raised repeatedly. First, both sides agreed the new proposed definition of “utility,” which requires “sufficient and practical utility in any field of technology through human intervention” needs to be further defined; those for reform felt that the language could be too narrowly interpreted, while those against feared it was not definite enough. “Clearly, those terms need better definition or more meat on the bones,” Tillis said. Secondly, everyone was concerned with Section 112(f). Tillis pointed to the practical argument made by inventor Paul Morinville about the impossibility of meeting that requirement in the context of software coding language, for example, while Tillis said the tech companies were afraid the language wasn’t strong enough to weed out overbroad software and business method claims that most agree should not be patent eligible.

The presently pending petition for en banc review in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC has been addressed by Sherry Knowles and Meredith Addy and is supported by a number of amicus briefs. The patent in issue has been described by the present author as a paradigm of patent eligibility, supporting the argument that en banc review is merited. Mayo has now filed its response brief, submitted on May 7, and argues that the panel’s decision invalidating the asserted claims as ineligible properly applied the two-step Alice framework in light of precedent, that the full Court need not re-examine it, and accordingly, that Appellants’ petition should be denied.

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.

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?

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 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.

Rather than the drastic measure of abolishing § 101, such as that proposed by previous USPTO Director Kappos, we think that a simple change to § 101 that removes the confusing notion of “inventiveness” from statutory interpretation would do the trick. Our proposal strikes a middle ground, in that, while removing “inventiveness” concepts from § 101 analysis, it retains the historical exceptions rooted in pre-emption that were reiterated in the Triad.

The waters surrounding Section 101 of the Patent Act are as muddied as they come. The statute sets forth only in broad strokes what inventions are patentable, leaving it to the courts to create an implied exception to patentability for laws of nature, natural phenomena, and abstract ideas. It has been difficult for lower courts to determine whether an invention falls within one of these excluded categories, and the U.S. Supreme Court has refused to provide a definition of what constitutes an “abstract idea.” Nonetheless, the Court in recent years has laid several foundation stones in Bilski, Mayo, Myriad and Alice for a bridge over these troubled waters. Trying to build upon these, the Federal Circuit issued two recent opinions dealing with Section 101: Enfish, LLC v. Microsoft Corporation and In re: TLI Communications LLC Patent Litigation. However, these decisions only create more confusion and cannot provide a safe means of passage over the turbulent waters of patent eligibility.

David Kappos, the director of the USPTO under President Obama from 2009 to 2013, recently called for congress to repeal section 101 of the patent act. According to Kappos, the current chaotic “I know it when I see it” 101 test that must be somehow consistently applied by thousands of USPTO examiners and hundreds of judges, means American inventors are better off seeking protection in China and Europe. While America “is providing less protection than other countries”, European countries are “putting their foot down in favor of innovation”.

The USPTO has released its ‘Report on Confirmatory Genetic Diagnostic Testing,’ which was prepared to fulfill the requirements of §27 of the Leahy-Smith America Invents Act. The USPTO did make an interesting observation that has been reflected in its patent examining guidelines. The USPTO Report concludes that ‘it is unlikely that exclusive provision of a diagnostic test, whether for an original diagnosis or to confirm the original result, will be possible based on patenting and licensing behavior.’ This statement reinforces the USPTO’s prior broad interpretations of the Court’s findings in Mayo and Myriad. Of note is that in the USPTO Report, the USPTO adopts the Supreme Court’s factually and scientifically unsupported distinction between genomic DNA and cDNA.