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Searching Content by Jennifer Chheda ordered by Published Date Descending.
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Secret Sales Are Still Prior Art: U.S. Supreme Court Affirms Helsinn Healthcare
The Supreme Court unanimously finds that the AIA's "on sale" statutory language did not alter the pre-AIA "on-sale" bar.
United States
31 Jan 2019
2
Post-Priority Document Usable As Evidence Of POSITA Motivation
The Federal Circuit recently affirmed the Patent Trial and Appeal Board's ("PTAB") final written decisions finding the claims of Yeda Research and Development Co., Ltd.'s.
United States
31 Oct 2018
3
Petition For Writ Of Mandamus Not An End Run Around Cuozzo
The Federal Circuit recently denied Power Integrations, Inc.'s attempt to obtain a writ of mandamus to circumvent the bar in 35 U.S.C. § 314(d) to appeal the PTAB's decisions denying the institution of four inter partes review petitions.
United States
9 Sep 2018
4
Federal Circuit Grants Motion Remanding For Consideration Of All Grounds
Following the logic set forth in SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, the Federal Circuit granted Petitioner Adidas AG's motion to remand IPR2016-00921 and IPR2016-00922 to the PTAB for consideration...
United States
16 Jul 2018
5
Patent Prosecutors Beware: Earlier Publication Anticipates Broad Claims Of Continuing Application
A recent written decision by the PTAB in connection with an inter partes review (IPR) proceeding is a reminder to patent prosecutors to carefully consider the possible construction of claim terms in a continuation or...
United States
14 Feb 2018
6
Federal Circuit Clarifies Probative Value Of Patent Dance Statements
The United States Court of Appeals for the Federal Circuit ("Federal Circuit") considered the Biologics Price Competition and Innovation Act ("BPCAI") once again on November 13, 2017.
United States
24 Nov 2017
7
Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval
Intended to provide a faster route to approval for generic biologics, the Biologics Price Competition and Innovation Act, was the basis for a decision rendered by the U.S. Supreme Court in Sandoz Inc. v. Amgen Inc.
United States
26 Jun 2017
8
Supreme Court Hears Oral Arguments In Sandoz Inc. v. Amgen
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting...
United States
12 May 2017
9
Meet The New Boss, Same As The Old Boss: Federal Circuit Interprets AIA's On-Sale Bar
The Federal Circuit addressed the scope of the on-sale bar provision in the America Invents Act amendments to the Patent Act.
United States
11 May 2017
10
Meet The New Boss, Same As The Old Boss: Federal Circuit Interprets AIA's On-Sale Bar
For more than 60 years, Section 102(b) of the Patent Act precluded patentability when the invention was "in public use or on sale in this country [for] more than one year" before the filing...
United States
10 May 2017
11
PTAB Denies Institution of IPR Proceedings Against Bayer's Patent Covering STIVARGA®
On February 8, 2017, the PTAB denied Fustibal LLC's ("Fustibal") petition to institute inter partes review of U.S. Patent 8,637,553 B2 ("the '553 patent") owned by Bayer HealthCare LLC ("Bayer") (IPR2016-01490).
United States
14 Mar 2017
12
Regulatory Developments Life Sciences Companies Should Expect In The New Presidential Administration
Essential to implementation of the incoming President's agenda is the appointment of senior leaders in the executive departments and administrative agencies responsible for implementing the agenda.
United States
24 Jan 2017
14
NIH Publishes New Clinical Disclosure Rules: Changing Scope Of "Publicly Accessible" Information
These rule changes increase the amount and type of information that will be made accessible to the public.
United States
6 Dec 2016
15
180-Day Notice Of Commercial Marketing Mandatory Even When Biosimilar Applicants Do The "Patent Dance"
On July 5, 2016, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act of 2009 ("BPCIA").
United States
15 Jul 2016
16
Changes Being Effected To Drug Labeling Regime: FDA Releases Proposed Pathway For Generic Safety Updates
On November 13, the U.S. Food and Drug Administration ("FDA") published a proposed rule concerning "procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information prior to FDA's review of the change" that would, specifically, allow abbreviated new drug application ("ANDA") holders to update product labeling for their "generic" drug products in advance of its reference listed drug ("RLD"; i.e., the
United States
13 Dec 2013
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