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Hatch-Waxman goes to Taiwan

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

Patents and Patentability in Taiwan

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

Global Patent Prosecution Newsletter - April 2018

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

Worldwide Divisional Strategy Considerations

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

Obviousness-Type Double Patenting Dangers in the U.S.

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

Global Patent Prosecution Newsletter - January 2018

Double Patenting and Divisional Applications - Many countries allow an applicant to protect multiple inventions disclosed in a single application in one or more continuing applications. In most countries divisional...more

Worldwide Bolar-type Provisions*

Please see full chart for Bolar Excemption rules in foreign countries regarding Clinical Trials, New Drugs, Biosimilars and Foreign Jurisdiction issues. ...more

Bolar Exemption in Europe and Asia

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 North America

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

Global Patent Prosecution Newsletter - December 2017

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

Global Patent Prosecution Newsletter - November 2017

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

Compulsory Licensing of Biopharmaceutical Inventions

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 License in the United States

March-in rights in the US were created in 1980, as part of the Bayh-Dole Act. Simply stated, when the US government funds research that results in patents, it obtains rights to those patents. These rights are retained even...more

Global Patent Prosecution Newsletter - October 2017

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

A Seismic Shift in UK Patent Infringement Law - Actavis v. Eli Lilly

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

Global Patent Prosecution Newsletter - September 2017

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

Global Patent Term Extension/Supplementary Protection Certificate Provisions

Please see list of Countries and their rules regarding offering Patent Term Extensions and Supplementary Protection Certificates. ...more

Global Patent Prosecution Newsletter - August 2017

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

Biosimilar Uptake and Patent Litigation in Japan

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

Biosimilars in Europe

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more

You Can Dance If You Want To

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

Global Patent Prosecution Newsletter - July 2017

Biosimilars Around the World - Last month’s Supreme Court ruling in Sandoz v. Amgen brought greater certainty to both biosimilar applicants and originators in the United States. The July 2017 issue of Sterne Kessler’s...more

A Comparison of US and EPO Post Grant Practices

Challenging the validity of a patent through the courts of Europe and the United States can be a time-consuming and expensive process. Oppositions at the European Patent Office (EPO) and US post-grant cancellation...more

Global Patent Prosecution Newsletter - June 2017

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

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