scholarly journals CODING FOR LIFE - SHOULD ANY ENTITY HAVE THE EXCLUSIVE RIGHT TO USE AND SELL ISOLATED DNA?

2012 ◽  
Vol 12 ◽  
pp. 85-152
Author(s):  
Douglas L. Rogers
Keyword(s):  
Supreme Court ◽  
Subject Matter ◽  
Cancer Susceptibility ◽  
Physical Phenomenon ◽  
District Court ◽  
Free Access ◽  
Cancer Susceptibility Genes ◽  
Patentable Subject Matter ◽  
Federal Circuit ◽  
Physical Phenomena

Myriad Genetics, Inc. ("Myriad") obtained patents in the 1990s on two "isolated" human breast and ovarian cancer susceptibility genes ("BRCA").  Myriad did not list all the isolated sequences it claims to have a right to monopolize, but instead claims a patent on the physical phenomena itself  -- all DNA segments that code for the BRCA1 polypeptide, even the sequences Myriad has not identified and even those someone else in the future creates or isolates the sequences of through a method or methods not contemplated by Myriad. An impressive array of non-profit medical societies, doctors and patients sued to have the Myriad patents declared invalid.  In 2010, the District Court for the Southern District of New York held in Association for Molecular Pathology v. United States Patent and Trademark Office that the claimed product patents for isolated DNA segments constituted unpatentable subject matter under 35 U.S.C. §101.  On July 29, 2011, a divided panel of the Federal Circuit reversed the District Court and held that the isolated DNA segments constituted patentable subject matter.  Of the three member panel, Judge Lourie concluded that the isolated DNA was markedly different than the native DNA, so constituted patentable subject matter.  Although Judge Moore agreed that certain DNA segments constituted patentable subject matter, she believed that the longer isolated DNA segments probably did not constitute patentable subject matter.  However, primarily in light of the fact that the US Patent and Trademark Office has been granting patents for isolated DNA  for years, Judge Moore concurred in the judgment of Judge Lourie.  Judge Bryson concurred on one of the product claims  (for synthetic cDNA) but dissented on claims pertaining to the isolated DNA segments on the grounds that isolated DNA did not differ markedly from the native DNA and that the function of the isolated DNA was identical to the function of the native DNA.The Supreme Court stated that "Congress may not authorize the issuance of patents whose effects are to remove existent knowledge from the  public domain, or to restrict free access to materials already available."  This article argues that the Federal Circuit - not Congress - has done just that and has given Myriad a wall to restrict free access to materials that have literally been in humans for centuries.  The isolated DNA segments of claim 1 do exactly the same coding as do the native segments--nothing more; nothing less.  The segments of claim 1 do not act as primers or probes, so they do not have markedly different characteristics or utility than native DNA, which the Supreme Court has ruled courts must consider.  Moreover, the functioning of the sequence of the nucleotide bases is a physical phenomenon that Myriad has not created but has captured in its claim.  Judges Lourie and Moore disregarded Supreme Court precedent and the fundamental principle that physical phenomena are not patentable subject matter.

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.

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 The Inventive Concept in Alice Corp. v. CLS Bank Int'l

2016 ◽  
Author(s):  
Dan Burk
Keyword(s):  
United States ◽  
Supreme Court ◽  
Subject Matter ◽  
United States Supreme Court ◽  
The United States ◽  
European Patent ◽  
United States Supreme ◽  
European Patent Convention ◽  
Patentable Subject Matter ◽  
Short Essay

In its recent patentable subject matter opinion in Alice Corp. v. CLS Bank Int'l, the United States Supreme Court articulated a two-step patent eligibility test that hinges on the presence of an "inventive concept" in the patent claims. This short essay considers the connection between the "inventive concept" requirement in the Alice Corp. test and the requirement of an "inventive step" or non-obviousness requirement for patentability, by relating the Supreme Court's holding to similar decisions considering patentable subject matter under the European Patent Convention.

scholarly journals It’s Not So Obvious

2014 ◽  
Vol 1 (3) ◽  
pp. 729-750
Author(s):  
Samuel Reger
Keyword(s):  
United States ◽  
Supreme Court ◽  
Subject Matter ◽  
United States Supreme Court ◽  
The United States ◽  
United States Supreme ◽  
Patent Claim ◽  
Specific Approach ◽  
Court Of Appeals ◽  
Federal Circuit

Currently, the United States Supreme Court requires a fact-specific approach to determine whether a patent claim is eligible subject matter under 35 U.S.C. § 101, even though, traditionally, this has been considered a question of law. However, recently, the United States Court of Appeals for the Federal Circuit introduced the “manifestly evident” standard. The court held that when it is not manifestly evident that a claim is directed to a patent-ineligible abstract idea, then that claim must be deemed patent-eligible subject matter. This Comment suggests that the manifestly evident standard, or one similar to it, will reduce litigation costs. This is because, under the current fact-specific requirements, it may become commonplace for courts to engage in formal claim construction, a costly pre-trial process, to decide whether these requirements are met. But under the manifestly evident standard, courts and litigants will be able to quickly move past the often confusing section 101 to the later sections of the Patent Act, which courts are better prepared to confront.

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.

ASAS TERBUKA UNTUK UMUM DAN KEHADIRAN FISIK PARA PIHAK DALAM SIDANG DI PENGADILAN NEGERI PASCA PERATURAN MAHKAMAH AGUNG NOMOR 1 TAHUN 2019

2020 ◽  
Vol 6 (1) ◽  
pp. 237-250
Author(s):  
Bernadette M Waluyo
Keyword(s):  
Supreme Court ◽  
Basic Principle ◽  
Civil Law ◽  
The Other ◽  
District Court ◽  
Procedural Law ◽  
Other Hand ◽  
Administration Of Justice ◽  
Law Courts ◽  
Court Proceedings

The Indonesian Supreme Court, in response to the information era, modernizes the civil procedural rules at the district court level.  This is done by issuing Supreme Court Regulation no. 1 of 2019 re. Administration of Justice at Civil Law Courts and Electronic-Court Proceedings. Undoubtedly, modernization of existing rules on the administration of justice is much needed.  On the other hand, these changes may violate a number of procedural civil law principles.  The author argues, from a civil procedural law perspective, that the above Supreme Court regulation violates the basic principle of transparency of court proceedings and physical attendance at court proceedings. 

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