Idenix v. Gilead: The enablement and written description limits of a genus claim

In Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019), the Federal Circuit affirmed a judgment of invalidity of a patent claiming methods for treating Hepatitis C virus for, inter alia, lack of enablement. The Supreme Court denied Idenix’s petition for a writ of certiorari, meaning that the Federal Circuit decision stands, and genus claims covering thousands of compounds that were supported by an insufficient number of examples have failed the enablement test not once, but twice. See Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013). This case report presents the context surrounding the Federal Circuit’s Idenix decision and the Supreme Court’s decision not to hear the case.

Download Full-text

What is the "Invention"?

10.31228/osf.io/5y2r6 ◽

2018 ◽

Cited By ~ 2

Author(s):

Christopher A Cotropia

Keyword(s):

Supreme Court ◽

Patent Law ◽

Single Sentence ◽

Natural Reaction ◽

The Supreme Court ◽

Federal Circuit ◽

Written Description

Patent law is in flux, with recent disputes and changes in doctrine fueled by increased attention from the Supreme Court and en banc activity by the Federal Circuit. The natural reaction is to analyze each doctrinal area involved on its own. Upon a closer look, however, many patent cases concern a single, fundamental dispute. Conflicts in opinions on such issues as claim interpretation methodology and the written description requirement are really disagreements over which "invention" the courts should be considering. There are two concepts of invention currently in play in patent decisions. The first is an "external invention" definition, in which courts define the invention by the detailed technology discussion in the patent specification's descriptions and drawings. Other decisions invoke a "claim-centered invention" definition, which relies almost exclusively on the claim, a single sentence at the end of the patent. Judging these two definitions against common patent theories can help to determine which best fits the theories'narratives.T his Article concludes that the external invention is more favorable because it grounds exclusivity in what the inventor has actually done or plans to do and, accordingly, is more likely to comport with common patent theories.

Download Full-text

Do Federal Circuit Courts of Appeals Judges Fear Reversal from the Supreme Court?

SSRN Electronic Journal ◽

10.2139/ssrn.1120934 ◽

2008 ◽

Author(s):

Jennifer Barnes Bowie

Keyword(s):

Supreme Court ◽

Courts Of Appeals ◽

The Supreme Court ◽

Federal Circuit ◽

Circuit Courts

Download Full-text

Treatment of chronic hepatitis C virus infection with crushed ledipasvir/sofosbuvir administered through a percutaneous endoscopic gastrostomy tube in a patient with HIV coinfection

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxaa328 ◽

2020 ◽

Vol 78 (1) ◽

pp. 36-40

Author(s):

Vanessa Huffman ◽

Diana C Andrade ◽

Elizabeth Sherman ◽

Jianli Niu ◽

Paula A Eckardt

Keyword(s):

Case Report ◽

Hepatitis C Virus ◽

Hepatitis C ◽

Percutaneous Endoscopic Gastrostomy ◽

Fixed Dose ◽

Pharmacokinetic Data ◽

Percutaneous Endoscopic Gastrostomy Tube ◽

Endoscopic Gastrostomy ◽

Hiv Coinfection ◽

Peg Tube

Abstract Purpose Ledipasvir/sofosbuvir is an oral combination therapy containing fixed doses of direct-acting antiviral agents indicated for the treatment of hepatitis C virus (HCV) infection. Currently there are limited data on the clinical efficacy of crushed ledipasvir/sofosbuvir administered via feeding tube. Summary This case report discusses the successful treatment of chronic HCV genotype 1b infection with crushed ledipasvir/sofosbuvir administered through a percutaneous endoscopic gastrostomy (PEG) tube in a patient with human immunodeficiency virus (HIV) coinfection and high-grade sarcoma who had severe swallowing difficulties. The patient received crushed ledipasvir/sofosbuvir daily for a total of 12 weeks. At 12 weeks the patient had achieved a sustained virologic response. Conclusion Currently, ledipasvir/sofosbuvir is available only as a tablet, with limited pharmacokinetic data available to guide clinicians on use of the fixed-dose combination medication in crushed form. This case report highlights our experience treating a patient with HCV/HIV coinfection through administration of crushed ledipasvir/sofosbuvir via PEG tube, which we found to be a safe and effective therapeutic option.

Download Full-text

Sperry Corp. v. United States

The American Journal of International Law ◽

10.2307/2202794 ◽

1989 ◽

Vol 83 (1) ◽

pp. 86-90

Author(s):

Rose Cecile Chan

Keyword(s):

United States ◽

Supreme Court ◽

World Trade ◽

The United States ◽

United States Constitution ◽

Preliminary Ruling ◽

Fifth Amendment ◽

Court Of Appeals ◽

The Supreme Court ◽

Federal Circuit

Plaintiffs, Sperry Corp. and Sperry World Trade Inc. (Sperry), received an award from the Iran-United States Claims Tribunal (Tribunal). Upon payment of the award, the United States deducted 2 percent of the total amount pursuant to a directive license issued by the Secretary of the Treasury regarding recovered claims by U.S. nationals against Iran. When plaintiffs challenged the authority of the Treasury to make the deduction and the United States Claims Court announced a preliminary ruling that concurred with plaintiffs’ position, the Executive persuaded Congress to approve legislation authorizing specified percentages to be deducted by the United States from Tribunal awards to U.S. citizens. Responding to the plaintiffs’ challenge to the constitutionality of the newly enacted statute, the United States Claims Court dismissed the suit and, on appeal, the United States Court of Appeals for the Federal Circuit (per Meyer, J.) reversed and held: that the deduction constitutes a taking without compensation in violation of the Fifth Amendment to the United States Constitution. In September 1988, the United States filed notice of appeal with the Supreme Court.

Download Full-text

Life After Bilski

10.31235/osf.io/cr2zh ◽

2016 ◽

Cited By ~ 1

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.

Download Full-text