USPTO Guidance On Patentable Subject Matter: Impediment to Biotech Innovation?

2014 ◽  
Vol 20 (3) ◽  
Author(s):  
Joanna T. Brougher ◽  
David A. Fazzolare
Keyword(s):  
Supreme Court ◽  
Subject Matter ◽  
Patent System ◽  
Court Cases ◽  
Gene Sequences ◽  
The Supreme Court ◽  
Patentable Subject Matter ◽  
The U.S

In June 2013, the U.S. Supreme Court issued a unanimous decision upending more than three decades worth of established patent practice when it ruled that isolated gene sequences are no longer patentable subject matter under 35 U.S.C. Section 101.While many practitioners in the field believed that the USPTO would interpret the decision narrowly, the USPTO actually expanded the scope of the decision when it issued its guidelines for determining whether an invention satisfies Section 101. The guidelines were met with intense backlash with many arguing that they unnecessarily expanded the scope of the Supreme Court cases in a way that could unduly restrict the scope of patentable subject matter, weaken the U.S. patent system, and create a disincentive to innovation. By undermining patentable subject matter in this way, the guidelines may end up harming not only the companies that patent medical innovations, but also the patients who need medical care.  This article examines the guidelines and their impact on various technologies.

Mayo “nays”: The Supreme Court says no to patenting laws of nature

2012 ◽  
Vol 18 (3) ◽  
Author(s):  
Jennifer A. Camacho
Keyword(s):  
Supreme Court ◽  
Subject Matter ◽  
Laws Of Nature ◽  
Supreme Court Decision ◽  
Patient Specific ◽  
Court Of Appeals ◽  
The Supreme Court ◽  
Patent Laws ◽  
Biotechnology Companies ◽  
The U.S

On March 20, 2012, the U.S. Supreme Court handed down its decision in Mayo Collaborative Services, et al v. Prometheus Laboratories, Inc (“Mayo”) and ended an eight-year legal battle over patents covering processes for determining patient-specific dosing for a thiopurine drug to treat autoimmune diseases.  In a unanimous decision, the Court held that the claimed processes are not patent-eligible subject matter under 35 U.S.C. §101 of the U.S. patent laws, and overturned the decision of the Court of Appeals for the Federal Circuit.The Supreme Court decision in Mayo established that the machine-or-transformation test is not the definitive test for determining the patent-eligibility of process claims, including process claims that embody laws of nature or natural phenomena.  In its analysis, the Court determined considered whether the claims were drawn to patent eligible subject matter as provided under 35 U.S.C. §101 of the U.S. patent laws, or patent ineligible subject matter excepted from §101.  The Court held that the process claims were essentially drawn to the laws of nature themselves and thus fell into the laws-of-nature exception to §101.  The process claims did not cover patent-eligible processes of applying certain laws of nature.  This decision has clear implications for the biotechnology industry that go beyond diagnostics and personalized medicine. As such, biotechnology companies should consider re-evaluating their patent position and adapting their patent strategies in view of Mayo.

scholarly journals Dolly and Alice

2016 ◽  
Author(s):  
Dan Burk
Keyword(s):  
United States ◽  
Supreme Court ◽  
Subject Matter ◽  
Somatic Cells ◽  
The United States ◽  
United States Supreme ◽  
Court Of Appeals ◽  
The Supreme Court ◽  
Patentable Subject Matter ◽  
Federal Circuit

The opinion of the United States Court of Appeals for the Federal Circuit, In re Roslin Institute, rejecting patent claims to mammals cloned from somatic cells, was rendered about a month before the United States Supreme Court's decision in Alice Corp. v. CLS Bank International. The Alice opinion explicitly sets out the standard for determining whether an invention falls within statutory patentable subject matter. Thus one is thus left to wonder what the Roslin opinion might have looked like had it been decided only a few weeks later, after the Alice decision was published, with the benefit of the Supreme Court's further direction on patentable subject matter. In this essay I explore whether in hindsight the Alice standard might have dictated a different outcome in Roslin, suggesting how the two-part test articulated by the Supreme Court in Alice might apply to a "products of nature" analysis for cloned mammals. Drawing on that analysis, I then use the Roslin case as a vehicle to highlight certain issues with the Supreme Court's current subject matter jurisprudence as applied to biotechnology. By juxtaposing Dolly with Alice, it becomes clear that the Supreme Court has revivified a number of dormant biotechnology patent problems in the guise of subject matter analysis.

EXPRESSIVE MEANING, RACE, AND THE LAW:

Legal Theory ◽  
1999 ◽  
Vol 5 (1) ◽  
pp. 75-99
Author(s):  
Andrew Altman
Keyword(s):  
Supreme Court ◽  
Legal Reasoning ◽  
Court Cases ◽  
The Supreme Court ◽  
Expressive Meaning ◽  
The Law

Recently, legal and social thinkers have turned to the idea that actions possess a nonlinguistic meaning, called “expressive meaning.” In this article I examine the idea of expressive meaning and its role in legal reasoning. My focus is on a series of U.S. Supreme Court cases involving constitutional challenges to election districts drawn on the basis of race. The Supreme Court used the idea of expressive meaning in striking down the districts. After explicating the idea of expressive meaning, I explain and criticize the Court’s reasoning. I distinguish the approach of Justices Thomas and Scalia, who hold that all uses of race in districting do constitutional harm, from that of Justice O’Connor, who distinguishes uses of race that do constitutional harm from those that do not. I contend that Justice O’Connor is right to make the distinction but she draws the line using a questionable standard. A more defensible standard would be more accommodating to the districts that the Court invalidated.

scholarly journals Life After Bilski

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
Supreme Court ◽  
Real World ◽  
Subject Matter ◽  
Case Law ◽  
Patent Law ◽  
District Courts ◽  
The Supreme Court ◽  
Federal Circuit ◽  
Abstract Ideas ◽  
New Applications

In Bilski v. Kappos, the Supreme Court declined calls to categoricallyexclude business methods - or any technology - from the patent law. It alsorejected as the sole test of subject matter eligibility the FederalCircuit’s deeply-flawed "machine or transformation" test, under which noprocess is patentable unless it is tied to a particular machine ortransforms an article to another state or thing. Subsequent developmentsthreaten to undo that holding, however. Relying on the Court’s descriptionof the Federal Circuit test as a "useful and important clue', the U.S.Patent and Trademark Office, patent litigants, and district courts have allcontinued to rely on the machine-or-transformation test in the wake ofBilski: no longer as the sole rule, but as a presumptive starting pointthat threatens to effectively become mandatory. In this Article, we suggesta new way to understand the exclusion of abstract ideas from patentablesubject matter. No class of invention is inherently too abstract forpatenting. Rather, the rule against patenting abstract ideas is an effortto prevent inventors from claiming their ideas too broadly. By requiringthat patent claims be limited to a specific set of practical applicationsof an idea, the abstract ideas doctrine both makes the scope of theresulting patent clearer and leaves room for subsequent inventors toimprove upon - and patent new applications of - the same basic principle.Recasting the abstract ideas doctrine as an overclaiming test eliminatesthe constraints of the artificial machine-or-transformation test, as wellas the pointless effort to fit inventions into permissible or impermissiblecategories. It also helps understand some otherwise-inexplicabledistinctions in the case law. Testing for overclaiming allows courts tofocus on what really matters: whether the scope of the patentee's claimsare commensurate with the invention’s practical, real-world contribution.This inquiry, we suggest, is the touchstone of the abstract ideas analysis,and the way out of the post-Bilski confusion.

scholarly journals In Search for the Scope of Main Subject Matter within Article 4(2) of Directive 93/13 after Andriciuc. Practical Consequences of the General CJEU Pronouncements

2020 ◽  
Vol 9 (2) ◽  
pp. 127-146
Author(s):  
Piotr Sitnik
Keyword(s):  
Supreme Court ◽  
Subject Matter ◽  
Focal Point ◽  
Recent Case ◽  
Swiss Franc ◽  
Main Subject ◽  
Control Practice ◽  
The Supreme Court ◽  
Unfair Terms ◽  
The Eu

The paper delves into the intricacies surrounding the ‘main subject matter’ requirement with a view to delineating its scope by reference to CJEU jurisprudence. Specifically, regard is had to the recent case of Andriciuc, its dictum and potential ramifications it may have for the judicial purview in the field of unfair terms control. Practice in recent years has brought to the fore the issue of indexation clauses as the focal point for doctrinal disputes. Comprehensive analyses of the main subject matter have also been carried out by Polish courts at all instances, including that in the Supreme Court, within the context of claims brought by consumers who entered into loans denominated in the Swiss Franc following the events of the so-called ‘Black Thursday’. The paper strives to decode the practical ramifications of the CJEU’s general doctrinal interpretations, offeringsuccinct corollaries pertaining to the compatibility with the EU standard, of the judicial interpretations of Poland’s courts with regard to the concept.

scholarly journals Patterson v. McLean: A Confirmation of the New Right at the U.S. Supreme Court

2005 ◽  
Vol 30 (4) ◽  
pp. 987-1009
Author(s):  
George M. Sullivan
Keyword(s):  
Civil Rights ◽  
Supreme Court ◽  
Reagan Administration ◽  
Ronald Reagan ◽  
The United States ◽  
National Elections ◽  
Presidential Appointments ◽  
The Supreme Court ◽  
The Impact ◽  
The U.S

In two consecutive national elections a conservative, Ronald Reagan, was elected President of the United States. When Justice Lewis Powell announced his retirement during the late months of the Reagan administration, it was apparent that the President's last appointment could shift the ideology of the Court to conservatism for the first time since the presidency of Dwight Eisenhower. President Reagan's prior appointments, Sandra Day O'Connor and Antonin Scalia, had joined William Rehnquist, an appointee of President Nixon and Bryon White, an appointee of President Kennedy to comprise a vociferous minority of four in many instances, especially cases involving civil rights. The unexpected opportunity for the appointment of a conservative jurist caused great anxiety in the media and in the U.S. Senate, the later having confirmation power over presidential appointments to the Supreme Court. This article examines the consequences of the Senate's confirmation of Justice Anthony Kennedy to the Supreme Court. The impact, which was immediate and dramatic, indicates that conservative ideology will predominate on major civil rights issues for the remainder of this century.

scholarly journals Le contrôle des prix et des revenus au Canada

2009 ◽  
Vol 52 (3) ◽  
pp. 271-310
Author(s):  
Richard G. Lipsey
Keyword(s):  
Supreme Court ◽  
Economic Crisis ◽  
Supreme Court Of Canada ◽  
Traditional Methods ◽  
The Supreme Court ◽  
The U.S

Abstract This paper is a summary of the Legal Factum submitted by the Canadian Labor Congress to the Supreme Court of Canada. It intends to demonstrate the irrelevance of the Anti-Inflationnary Act of October 1975. Three main questions are dealt with. First, was there an economic crisis in October 1975? Analysing various sets of data, the paper concludes that, by no stretch of imagination, could October 1975 be called an economic crisis. Second, was there a policy crisis in the sense that traditional methods had been tried and failed? It establishes here that no serious attempt had been made to contain inflation by traditional fiscal and monetary tools by October 1975. Third, what results can be expected from income policies? This part gives a summary of the voluminous evidence for the U.K. and the U.S., and concludes that the evidence of other incomes policies is that their effects on slowing the rate of inflation are small and often transitory.

The Company They Keep

2020 ◽  
Author(s):  
Lawrence Baum ◽  
Neal Devins
Keyword(s):  
Political Parties ◽  
Supreme Court ◽  
Political Party ◽  
Political Polarization ◽  
Dominant Ideology ◽  
Partisan Polarization ◽  
The People ◽  
The Supreme Court ◽  
New Perspective ◽  
The U.S

Today’s ideological division on the U.S. Supreme Court is also a partisan division: all the Court’s liberals were appointed by Democratic presidents, all its conservatives by Republican presidents. That pattern never existed in the Court until 2010, and this book focuses on how it came about and why it’s likely to continue. Its explanation lies in the growing level of political polarization over the last several decades. One effect of polarization is that potential nominees will reflect the dominant ideology of the president’s political party. Correspondingly, the sharpened ideological division between the two political parties has given presidents stronger incentives to give high priority to ideological considerations. In addition to these well-known effects of polarization, The Company They Keep explores what social psychologists have taught us about people’s motivations. Justices take cues primarily from the people who are closest to them and whose approval they care most about: political, social, and professional elites. In an era of strong partisan polarization, elite social networks are largely bifurcated by partisan and ideological elites, and justices such as Clarence Thomas and Ruth Bader Ginsburg live in milieus populated by like-minded elites that reinforce their liberalism or conservatism during their tenure on the Supreme Court. By highlighting and documenting this development, the book provides a new perspective on the Court and its justices.

The Appearance of Corruption

2021 ◽  
Author(s):  
Daron R. Shaw ◽  
Brian E. Roberts ◽  
Mijeong Baek
Keyword(s):  
Supreme Court ◽  
Campaign Finance ◽  
Behavioral Model ◽  
Political Speech ◽  
The Supreme Court ◽  
Original Survey ◽  
And Behavior ◽  
Political Opinions ◽  
Modern Era ◽  
The U.S

The sanctity of political speech is a key element of the U.S. Constitution and a cornerstone of the American republic. When the Supreme Court linked political speech to campaign finance in its landmark Buckley v. Valeo (1976) decision, the modern era of campaign finance regulation was born. In practical terms, this decision meant that in order to pass constitutional muster, any laws limiting money in politics must be narrowly tailored and serve a compelling state interest. The lone state interest the Court was willing to entertain was the mitigation of corruption. In order to reach this argument the Court advanced a sophisticated behavioral model, one with key assumptions about how laws will affect voters’ opinions and behavior. These assumptions have received surprisingly little attention in the literature. This book takes up the task of identifying and analyzing empirically the Court’s presumed links between campaign finance regulations and political opinions and behavior. In so doing, we rely on original survey data and experiments from 2009–2016 to openly confront the question of what happens when the Supreme Court is wrong, and when the foundation of over forty years of jurisprudence is simply not true.

Sign in / Sign up

Export Citation Format

Share Document