The enactment of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010 established for the first time ever in the US an abbreviated pathway for obtaining FDA approval of a new biological product that is deemed...more
7/14/2020
/ Biosimilars ,
BPCIA ,
Corporate Branding ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Protection ,
Litigation Strategies ,
Patent Prosecution ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions
In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms. The amended Act is expected to come into effect in late 2018 or early 2019....more
4/16/2018
/ Biobased Chemicals ,
Biologics ,
Food and Drug Administration (FDA) ,
Foreign Patent Applications ,
Generic Drugs ,
Hatch-Waxman ,
Marketing Exclusivity Periods ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Taiwan
Patents and a New Patent Linkage System in Taiwan -
Patent protection in Taiwan is becoming of everincreasing importance as the country’s economic influence grows worldwide. The April 2018 issue of Sterne Kessler’s Global...more
An Update on Brazilian Patent Law – Emergency Backlog/Fast-Track Options and Enforcement Issues -
We are delighted to have as contributors to the November Global Patent Prosecution newsletter, Ricardo Nunes and Andre...more
Very few topics in international intellectual property have been as controversial as compulsory licenses. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for...more
Please see full Doctrine of Equivalents Chart for Countries around the World. ...more
In a decision that appears to have introduced a doctrine of equivalents for the first time, the UK Supreme Court has shifted the laws on patent infringement in Actavis v. Eli Lilly UK [2017] UKSC 48. While this case...more
Worldwide Doctrine of Equivalents and Prosecution History Estoppel -
The doctrine of equivalents (DOE) arises in the context of a patent infringement action where the accused product or process does not literally infringe...more
9/19/2017
/ Biotechnology ,
Doctrine of Equivalents ,
Estoppel ,
Global Standards ,
International Litigation ,
Patent Infringement ,
Patent Prosecution ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
UK ,
UK Supreme Court
Biosimilar uptake in Japan has been a bit mixed, but according to experts the volume shares of biosimilars suggests it could be a key market in years to come. The Pharmaceuticals and Medical Devices Agency (PMDA), which is...more
Revocation Proceedings Around the World -
Mechanisms to challenge the validity of granted patents are available in many countries throughout the world. The June 2017 issue of Sterne Kessler’s Global Patent Prosecution...more
In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more
6/13/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
China is in the midst of a tremendous patent boom. Worldwide, total patent application filings were up 7.8% in 2015, with China accounting for 84% of the total growth[1]. In 2015, the State Intellectual Property Office of the...more
5/17/2017
/ Animal Patents ,
China ,
Diagnostic Method ,
Filing Requirements ,
Life Sciences ,
Patent Applications ,
Patent Cooperation Treaty ,
Patent Fees ,
Patent Prosecution ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Request for Examination ,
SIPO ,
Stem cells
The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more
7/8/2016
/ Amgen ,
Apotex ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
Since August 2015, Amgen and Apotex have been locked in litigation in the US District Court for the Southern District of Florida related to Apotex’s pegfilgrastim product, which is purported to be biosimilar to Amgen’s...more
On July 2, 2015, the Court of Appeals for the Federal Circuit held that a patent owner’s use of a contract manufacturer (CMO) to prepare validation batches of a drug formulation for submission to FDA created an invalidating...more
On Friday, December 5, the U.S. Court of Appeals for the Federal Circuit rendered its decision in Sandoz v. Amgen, No. 2014-1693, a case with major implications for the emerging U.S. biosimilars industry. The decision...more