Biosimilars and federal preemption in the USA

2018 ◽  
Vol 15 (3) ◽  
pp. 138-144
Author(s):  
Jeffrey R Bousquet
Keyword(s):  
Supreme Court ◽  
Information Exchange ◽  
Price Competition ◽  
Exchange Process ◽  
State Law ◽  
License Application ◽  
The Supreme Court ◽  
Manufacturing Information ◽  
The Usa ◽  
Federal Circuit

Summary This article reports on the recent decision by the Court of Appeals for the Federal Circuit (“Federal Circuit”) in Amgen v. Sandoz on remand from the U.S. Supreme Court. The Supreme Court held that a biosimilar applicant cannot be compelled under federal law to provide a copy of its abbreviated biologics license application (“aBLA”) and manufacturing information to the reference product sponsor (“RPS”) as required by the Biologics Price Competition and Innovation Act (“BPCIA”). The Supreme Court remanded the case to the Federal Circuit to determine whether there was any remedy under California state law available to Amgen, and if so, whether such remedy is preempted by the BPCIA. The Federal Circuit held that the BPCIA preempts state law remedies for a biosimilar applicant’s failure to comply with the BPCIA. This article also briefly discusses three other recent cases involving situations where the biosimilar applicant initiates the BPCIA information exchange process but provides only partial or no manufacturing information to the RPS or fails to complete the process by opting out at some later stage of the process.

Wyeth v. Levine: Challenging Implied Pre-emption for drugs

2009 ◽  
Vol 37 (3) ◽  
pp. 527-530
Author(s):  
Pooja Nair
Keyword(s):  
Supreme Court ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
State Law ◽  
Drug Labeling ◽  
The Supreme Court ◽  
Premarket Approval ◽  
Tort Claims

In March 2009, the Supreme Court held in Wyeth v. Levine that federal drug labeling laws do not pre-empt state tort claims against drug manufacturers. The decision surprised many Court watchers, coming on the heels of a 2008 decision, Riegel v. Medtronic, in which the Court found that the Food, Drug, and Cosmetic Act (FDCA) does pre-empt state-law claims for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. Wyeth dealt an immediate and surprising blow to the pharmaceutical industry’s principal strategy for avoiding tort lawsuits, but failed to clarify the Court’s overall pre-emption jurisprudence.

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

2021 ◽  
Vol 17 (2) ◽  
pp. 77-83
Author(s):  
Keith A Zullow ◽  
Cindy Chang ◽  
Sean Anderson
Keyword(s):  
Case Report ◽  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Supreme Court ◽  
The Supreme Court ◽  
Federal Circuit ◽  
Written Description ◽  
Insufficient Number

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.

Sperry Corp. v. United States

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.

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 PENGAKUAN TERHADAP PIHAK NON-ADVOKAT DALAM PEMBERIAN BANTUAN HUKUM (Politik Hukum Bantuan Hukum Dalam Peraturan Perundang-Undangan Di Indonesia)

2017 ◽  
Vol 6 (3) ◽  
pp. 399
Author(s):  
Akmal Adicahya
Keyword(s):  
Supreme Court ◽  
Access To Justice ◽  
State Law ◽  
Legal Aid ◽  
Procedural Law ◽  
The Supreme Court ◽  
The Government ◽  
The Right ◽  
Law Student

Access to justice is everyone rights that have to be fulfilled by the government. The regulation number 16 year 2011 of legal aid is an instrument held by the government to guarantee the right. The regulation allowed the participation of non-advocates to provide the legal aid. Through this policy, government emphasizes that:1) Indonesia is a state law which legal aid is an obliged instrument; 2) the prohibition of non-advocate to participate in legal aid is not relevant due to inadequate amount of advocate and citizen seek for justice (justiciabelen), and the advocate is not widely extended throughout Indonesia; 3) Non-Advocates, especially lecturer and law student are widely spread; 4) there are no procedural law which prohibits non-advocate to provide a legal aid. Those conditions are enough argument for government to strengthen the participation of non-advocates in providing legal aid. Especially for The Supreme Court to revise The Book II of Guidance for Implementing Court’s Job and Administration.Keywords: legal aid, non-advocate, justice

Impeachment and Removal from Office

2020 ◽  
pp. 147-150
Author(s):  
Danny M. Adkison ◽  
Lisa McNair Palmer
Keyword(s):  
Supreme Court ◽  
Attorney General ◽  
Elected Officials ◽  
Grand Jury ◽  
State Law ◽  
Chief Justice ◽  
The Supreme Court

This chapter discusses Article VIII of the Oklahoma constitution, which concerns impeachment and removal from office. Section 1 states that “the Governor and other elective state officers, including the Justices of the Supreme Court, shall be liable and subject to impeachment for wilful neglect of duty, corruption in office, habitual drunkenness, incompetency, or any offense involving moral turpitude committed while in office.” Moreover, “all elected state officers, including Justices of the Supreme Court and Judges of the Court of Criminal Appeals, shall be automatically suspended from office upon their being declared guilty of a felony by a court of competent jurisdiction.” Two other methods for removing elected officials not mentioned in Section 1 are specified in state law pursuant to Section 2. The first provides for a grand jury to accuse an official and present its findings to a district judge. The second allows the governor to instruct the attorney general to investigate an official and, if official misconduct is found, to institute proceedings in court. Section 3 designates the chief justice of the Oklahoma Supreme Court as the presiding officer in an impeachment trial. Lastly, Section 4 requires senators to take an oath and specifies a two-thirds vote of those present in order to convict.

scholarly journals Advance Health Care Directives and “Public Guardian”: The Italian Supreme Court Requests the Status of Current and Not Future Inability

2014 ◽  
Vol 2014 ◽  
pp. 1-4 ◽  
Author(s):  
Francesco Paolo Busardò ◽  
Stefania Bello ◽  
Matteo Gulino ◽  
Simona Zaami ◽  
Paola Frati
Keyword(s):  
Health Care ◽  
Supreme Court ◽  
Advance Directives ◽  
Critical Issue ◽  
Health Care Decisions ◽  
The Public ◽  
The Supreme Court ◽  
The Status ◽  
The Usa ◽  
The Guardian

Advance health care decisions animate an intense debate in several European countries, which started more than 20 years ago in the USA and led to the adoption of different rules, based on the diverse legal, sociocultural and philosophical traditions of each society. In Italy, the controversial issue of advance directives and end of life’s rights, in the absence of a clear and comprehensive legislation, has been over time a subject of interest of the Supreme Court. Since 2004 a law introduced the “Public Guardian,” aiming to provide an instrument of assistance to the person lacking in autonomy because of an illness or incapacity. Recently, this critical issue has once again been brought to the interest of the Supreme Court, which passed a judgment trying to clarify the legislative application of the appointment of the Guardian in the field of advance directives.

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