On October 6, the United States Patent and Trademark Office issued a Notice of Proposed Rulemaking regarding pre-issuance internal circulation and review of decisions of the Patent Trial and Appeal Board. The Office also...more
2022 was a milestone year for the Patent Trial and Appeal Board. In April, Kathi Vidal began her tenure as Director of the United States Patent and Trademark Office with an early focus on promoting increased efficiency at the...more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
1/23/2023
/ Antitrust Provisions ,
Biosimilars ,
BPCIA ,
Competition ,
FDA Approval ,
Food and Drug Administration (FDA) ,
New Legislation ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Post-Grant Review ,
Prescription Drugs ,
Regulatory Requirements
Earlier today, USPTO Director Kathi Vidal issued interim guidance regarding the application of the factors the PTAB considers in determining whether to institute an AIA post-grant proceeding where there is parallel district...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
1/12/2022
/ America Invents Act ,
Antitrust Provisions ,
Biden Administration ,
Biologics ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
Executive Orders ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
New Guidance ,
New Legislation ,
Orange Book ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Post-Grant Review ,
Prescription Drugs ,
Regulatory Requirements ,
USPTO
In a year of extraordinary change, the Patent Trial and Appeal Board (PTAB) rose to the challenge - Given the challenges of 2020 – a global pandemic, a deep economic recession, and a turbulent presidential election, among...more
3/8/2021
/ Appeals ,
Biologics ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
USPTO
On November 17, 2017, Genentech filed suit against Pfizer in the District of Delaware, alleging that Pfizer’s biosimilar of Herceptin® infringes forty Genentech patents covering Herceptin® and its methods of use and...more
11/24/2017
/ Biosimilars ,
BPCIA ,
Genentech ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On July 27th, the PTAB issued institution decisions in five IPRs brought by Hospira challenging four Genentech patents related to Herceptin® (trastuzumab). The patents are directed to various methods of treating cancer...more
Pfizer has shown its muscle in the biosimilars field, purchasing Hospira in 2015 and launching the second biosimilar on the U.S. market, Inflectra® (infliximab), a biosimilar of Johnson & Johnson’s Remicade®. Pfizer is now...more
Two patents related to methods of treating rheumatoid arthritis (RA) patients with rituximab have been brought before the PTAB for a third time – with mixed results.
The challenged patents are U.S. Patent Nos. 7,976,838...more
On Monday, the PTAB issued its ruling denying institution of three IPRs challenging Biogen’s patents claiming formulations and methods of treatment using natalizumab. Specifically, the PTAB denied institution of...more