The America Invents Act provides an expanded process for a third party to submit prior art to the examiner concerning any U.S. patent application. The new process is aimed to encourage the public to submit relevant art as a...more
9/14/2018
/ Administrative Procedure ,
America Invents Act ,
Design Patent ,
Foreign Patent Applications ,
Foreign Trademark ,
Inter Partes Review (IPR) Proceeding ,
International Litigation ,
Patent Infringement ,
Patent Trial and Appeal Board ,
Patents ,
Plant Patents ,
Prior Art ,
Third-Party ,
Trademark Infringement ,
Trademark Trial and Appeal Board ,
Utility Patents
Patent protection in Taiwan has increased in importance as the economic relationship between the US, Europe, and Taiwan has grown. According to the United States Trade Representative, Taiwan is currently our 10th largest...more
Please see full chart for Bolar Excemption rules in foreign countries regarding Clinical Trials, New Drugs, Biosimilars and Foreign Jurisdiction issues. ...more
12/22/2017
/ Biopharmaceutical ,
Biosimilars ,
Bolar Exemption ,
Clinical Trials ,
Foreign Jurisdictions ,
Generic Drugs ,
International Litigation ,
Patent Infringement ,
Patent Prosecution ,
Patents ,
Prescription Drugs ,
Safe Harbors
Bolar exemption in Europe -
The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or...more
Bolar Exemptions in the U.S.
Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use exemption with respect to regulated...more
12/20/2017
/ Biopharmaceutical ,
Bolar Exemption ,
Canada ,
FDA Approval ,
Generic Drugs ,
Hatch-Waxman ,
Mexico ,
Patent Infringement ,
Patent Prosecution ,
Patents ,
Prescription Drugs ,
Safe Harbors
Worldwide Bolar Exemptions -
Many countries have exemptions for patent infringement for a product and/or process that is not being used for direct commercialization and profit. For biopharmaceuticals, this exemption,...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
In borrowing a page from the '80s band "Men Without Hats," on June 12, 2017, the U.S. Supreme Court brought greater certainty for both biosimilar applicants and originator companies. In Sandoz Inc. v. Amgen Inc., the Supreme...more
7/19/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Relief ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Remedies ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims
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
As patent filing and grant numbers have skyrocketed in China, so has the attractiveness to settle patent infringement suits there. The opening of a series of specialized intellectual property courts, especially the courthouse...more
With the implementation of Revisions to the Chinese Patent Examination Guidelines on April 1, 2017, the April 2017 issue of Sterne Kessler's Global Patent Prosecution Newsletter includes information and practical tips for...more
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
On August 6, 2015, Amgen sued Apotex in the US District Court for the Southern District of Florida for patent infringement related to Apotex’s pegfilgrastim product, which is purported to be biosimilar to Neulasta®. What is...more
On April 14, 2015 the Biotechnology Industry Organization (BIO) filed an amicus curiae brief with the Court of Appeals for the Federal Circuit1 in support of remand or reversal of the Amgen v. Sandoz lower court’s ruling that...more
On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more
3/23/2015
/ Amgen ,
Biologics ,
BPCIA ,
Commercial Marketing ,
Conversion ,
Dismissals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition