Biosimilar Applicants Must Provide Notice of Commercial Launch:
What You Need To Know -
Case Background -
In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more
7/7/2016
/ Amgen ,
Apotex ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
In July of 2015, Sanofi filed petition for an inter partes review (IPR2015-01624) for 15 claims of U.S. Pat. No. 6,331,415 (“Cabilly II”). In the antibody field, the Cabilly family of patents is well known and is believed to...more
In a recent Inter Partes Review (“IPR”) institution decision, Apotex v Wyeth (IPR2015-00873, Paper No. 8), the USPTO’s Patent Trial and Appeal Board (the “Board”) found that some previously-asserted grounds of invalidity were...more
Recently, the Patent Trial and Appeal Board issued its first set of final written decisions in three inter partes reviews relating to molecules in the large molecule biopharma space (IPR2013-00534, IPR2013-00535 and...more
On February 5, the Federal Circuit issued its first decision on an appeal of a final written decision of an Inter Partes Review (“IPR”). The decision addressed two outstanding questions of interest to IPR proceedings. First,...more
In This Presentation:
- PATENT ELIGIBLE SUBJECT MATTER: LIFE IN SOFTWARE/IT AFTER ALICE CORPORATION V. CLS BANK (AND OTHER RECENT 101 DECISIONS)
- A Brief History with respect to Software and Biz...more
11/21/2014
/ Biotechnology ,
CLS Bank v Alice Corp ,
Direct Infringement ,
Indefiniteness ,
Induced Infringement ,
Limelight v Akamai ,
Mayo v. Prometheus ,
Myriad-Mayo ,
Nautilus Inc. v. Biosig Instruments ,
Patent-Eligible Subject Matter ,
Patents ,
Section 101 ,
Software ,
USPTO
FDA Publishes "Purple Book" to Catalog Biologics, Interchangeable and Biosimilar Products -
The US Food and Drug Administration (“FDA”) recently published its first “Lists of Licensed Biological Products with Reference...more
On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...more
For a Legal Perspective on today's much-anticipated U.S. Supreme Court "Myriad" decision that naturally occuring substances are not patentable, we turned to IP attorneys writing on JD Supra...more