For at least a decade, Congress has been concerned (not to say obsessed) with drug costs (understandably so, no matter how ineffective; see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived...more
One of the wonderful (as in, it makes one wonder) and frustrating (which needs no explanation) aspects of patent law is that just when you think a question is settled it either isn't or the conventional interpretation is...more
The decision by the Patent Trial and Appeal Board (PTAB) in favor of Senior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") and against Junior Party the University of California/Berkeley, the...more
It is not surprising that the Federal Circuit has taken the opportunity to apply the Supreme Court's recent precedent in Amgen v. Sanofi regarding the sufficiency of disclosure needed to satisfy the statutory enablement...more
In addition to his efforts regarding patent subject matter eligibility law (see "Senate Bill Proposed to Provide Subject Matter Eligibility Solution", co-sponsored with Senator Tillis), Senator Coons, joined by Senators...more
The Federal Circuit provided a reminder last week that merely identifying an unappreciated consequence of a prior art method cannot confer non-obviousness on practice of methods that did not acknowledge that consequence, in...more
Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting to provide a legislative solution. They chaired a series of Congressional hearings in...more
Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting to provide a legislative solution. They chaired a series of Congressional hearings...more
Responsive to the letter from Judge Pauline Newman's counsel sent June 15th (see "Judge Newman Matter Continues"), the Special Committee directing the Federal Circuit's inquiry regarding Judge Newman's fitness for continued...more
The Federal Circuit's Special Committee released two documents relevant to their continuing assessment of Judge Pauline Newman's fitness for the bench today, neither of which can be considered comforting to the patent...more
In its recent review of a district court decision the Federal Circuit characterized as "a thorough opinion," the Federal Circuit affirmed invalidation for obviousness of four claims from four different Orange Book-listed...more
Einstein's aphorism that doing the same thing over and over again and expecting a different outcome is a hallmark of madness (or at least an inability to learn from the past) inevitably comes to mind when perusing the recent...more
On April 26th, Ambassador Katherine Tai, U.S. Trade Representative (USTR), issued the 2023 Special 301 Report. In a press release, the USTR stated that "[i]nnovation and creativity are at the heart of American...more
The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more
5/19/2023
/ Amgen ,
Biotechnology ,
Enablement Inquiries ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Sanofi ,
SCOTUS
The Supreme Court handed down its decision in Amgen v. Sanofi today. In Justice Gorsuch’s unanimous opinion, the Court held that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies....more
The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v....more
The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v....more
5/12/2023
/ Amicus Briefs ,
Clear and Convincing Evidence ,
Enablement Inquiries ,
Intellectual Property Protection ,
Life Sciences ,
Patent Litigation ,
Patents ,
Reduction to Practice ,
Standard of Proof ,
Trade Secrets ,
USPTO
The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v. Sanofi. ...more
The Solicitor General, responding to a call from the Supreme Court for the government’s views, in April filed a brief directed to the proper legal standard for the “abstract idea” exception to patent eligibility under 35...more
"Hope springs eternal [in the human breast]" (Alexander Pope) and "Insanity is doing the same thing over and over and expecting different results" (the latter attributed variably to Albert Einstein and Werner Erhart) are two...more
An appellant's burden on appeal is never easy but it is particularly difficult when the questions at issue are based on factual evidence. The appellate judiciary is loathe (generally) to second guess a district court judge...more
"This application claims priority to [properly identified earlier-filed application, the disclosure of which is expressly incorporated herein in its entirety" is a phrase commonly found in patents and patent applications as...more
The Supreme Court heard oral argument in Amgen v. Sanofi last week in an extended session with argument from the parties and the U.S. government. Petitioner was represented by Jeffrey Lamken, Respondents by Paul Clement, and...more
During oral argument before the Supreme Court on Monday in Amgen v. Sanofi, all three advocates (Jeff Lamken for Amgen, Paul Clement for Sanofi, and Colleen Sindzak for the United States) had reason to reference and discuss...more
The Supreme Court heard oral arguments in Amgen v. Sanofi yesterday in an extended session with arguments from the parties and the U.S. government. The Justices showed a great deal of interest, albeit with some difficulty,...more