The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more
The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more
3/20/2023
/ Amicus Briefs ,
BPCIA ,
Certiorari ,
Enablement Inquiries ,
Hatch-Waxman ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular
The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more
Minerva and Hologic, competitors selling devices used for ablating uterine endometrial tissue, are notable for their dispute last year that gave the Supreme Court an opportunity to reassess an established patent law doctrine,...more
In perhaps one of his most infelicitous lyrics* Bob Dylan inserted the adage that it is unwise to change horses in midstream. This lesson comes to mind with regard to the Federal Circuit's decision late last year regarding...more
It's always good to have a villain, a "Snidely Whiplash" or other cartoon caricature to support an argument, especially if the issue is complex and fails the cocktail party test...more
On December 14th*, the Patent Trial and Appeal Board rendered its decision on Preliminary Motions in Interference No. 106,133 between Senior Party Sigma-Aldrich and Junior Party The Broad Institute, Harvard University, and...more
As the dodo of patent practice, the number of interferences has been steadily dwindling since enactment of the Leahy-Smith America Invents Act in 2012 abolished the practice in favor of a "first inventor to file" regime and a...more
On December 14th, the Patent Trial and Appeal Board (PTAB) rendered its Decision on Motions in Interference No 106,132 between Senior Party Sigma-Aldrich ("Sigma") and Junior Party the University of California/Berkeley, the...more
Having heard oral argument at a hearing held on Monday, November 21st, the Patent Trial and Appeal Board on December 14th entered its decision on motions in Interference No 106,132 between Senior Party Sigma-Aldrich ("Sigma")...more
Idealism is a wonderful and at the same time frustrating character trait, because the world is not ideal as it is and is unlikely to ever be, but the motivation to achieve a more ideal world (or at least a more equitable one)...more
On November 18th, the U.S. Food and Drug Administration (FDA) announced its approval of Eli Lilly's Rezvoglar (insulin glargine-aglr) product as an interchangeable biosimilar to Sanofi's Lantus (insulin glargine). Both the...more
On November 15th, the Federal Circuit handed down its opinion affirming all aspects of the District Court's decision in Pharmacyclics LLC v. Alvogen, Inc. The case illustrates once more the importance of the substantial...more
Last week, IP Law360 published an erudite and provocative article by Joseph Matal and his colleagues regarding the Supreme Court's recent subject matter jurisprudence in the context of earlier decisions in the 19th and early...more
Biotechnology company Regeneron Pharmaceuticals, Inc. filed an amicus curiae brief at the Federal Circuit in support of the appeal by Junior Party the University of California/Berkeley, the University of Vienna, and...more
On October 24th, the Patent Trial and Appeal Board scheduled back-to-back oral hearings for interferences between Sigma-Aldrich (Senior Party) and Junior Party The Regents of the University of California, University of...more
Early last month, a group of scientists* filed an amici curiae brief in support of the appeal by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC")...more
High Court Will Tackle Proper Enablement Standard -
Constituting something of a surprise, the Supreme Court on Friday, November 3rd granted Amgen's petition for certiorari on the second of the Questions Presented in its...more
11/7/2022
/ Amgen ,
Biotechnology ,
Certiorari ,
Doctrine of Equivalents ,
Enablement Inquiries ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Sanofi ,
SCOTUS
The Patent Trial and Appeal Board (like its predecessor, the Board of Patent Appeals and Interferences or BPAI) occasionally renders an opinion having the tendency to raise an eyebrow or two, which on occasion has led the...more
On September 28, 2022, the Patent Trial and Appeal Board denied all preliminary motions by Junior Party the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") and Senior Party...more
On September 18, 2022, the Patent Trial and Appeal Board denied all preliminary motions by Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") and Senior Party ToolGen in Interference No....more
The Federal Circuit soon will have the opportunity to decide a question left open during a recent spate of opinions involving the judicially created doctrine of obviousness-type double patenting (OTDP): the effect patent...more
The PTAB held an Oral Hearing between Junior Party the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") and Senior Party ToolGen on September 12th, bringing to a close...more
President Biden announced his signing of an Executive Order launching a major effort to enhance U.S. capabilities in biotechnology and biomanufacturing last week (see "President Biden Signs Executive Order on Biotechnology...more
On Monday, September 12th, President Biden signed an Executive Order entitled "Advancing Biotechnology and Biomanufacturing Innovation for Sustainable, Safe and Secure American Bioeconomy."
The Executive Order (in Section...more