Appealing the Rejection of a Patent Application in the United States, Europe, and China -
In some circumstances, appealing the rejection of a patent application is the only practical recourse a patent applicant may have...more
7/1/2020
/ Appeals ,
Biopharmaceutical ,
CNIPA ,
European Patent Office ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
USPTO
Dividing a single patent application into multiple patents is often essential for deriving maximum economic benefit from the disclosed inventions. When an applicant wants to protect multiple inventions disclosed in a single...more
1/24/2018
/ Biopharmaceutical ,
Divisional Applications ,
Double Patent ,
Exclusive Licenses ,
Foreign Patent Applications ,
IP License ,
Parent Patents ,
Paris Convention ,
Patent Applications ,
Patent Filings ,
Patent Portfolios ,
Patents
The Federal Circuit’s decision in Gilead Sciences, Inc. v. Natco Pharma Ltd. introduced even more confusion in an already confusing area of the law – namely obviousness-type double patenting. Obviousness-type double patenting...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
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
March-in Rights and Compulsory Licensing of Biopharmaceutical Inventions -
Very few topics in international intellectual property have been as controversial as compulsory licensing. In the US, consumer groups have...more
Worldwide Patent Term Extension Provisions -
Mechanisms to recover patent term lost during regulatory approval are available in many countries throughout the world. The August 2017 issue of Sterne Kessler’s Global Patent...more