Once a final rejection has been entered in an application, there is no right to unrestricted further prosecution. However, to advance the goal of compact prosecution, the USPTO introduced a program in 2012 that outlined when...more
Time to grant is vitally important when generating a robust patent portfolio. While speed is critical for many start-ups, it often comes with a price. Track One examination requires payment of fees. And even the patent...more
Two Pilot Programs for Compact Prosecution – First Action Interview and After Final Consideration Pilot Programs -
Streamlining and accelerating patent prosecution are goals of both the USPTO and stakeholders. The USPTO has...more
Business factors typically drive many strategy decisions in terms of patent prosecution in foreign jurisdictions. Factors that influence these decisions might include the likelihood of foreign competition, the size of foreign...more
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
On December 19, 2019, the Hong Kong Intellectual Property Department (HKIPD) will launch a new patent system as the result of the Patents (Amendment) Ordinance 2016 and the Patents (General) (Amendment) Rules 2019. Under the...more
11/19/2019
/ CNIPA ,
Foreign Patent Applications ,
Global Patent Prosecution ,
Hong Kong ,
Hong Kong Intellectual Property Department (HKIPD) ,
Intellectual Property Protection ,
New Rules ,
Patent Prosecution ,
Patent Registration ,
Patents ,
Post-Grant Review
Use of Post-Filing Data to Support Patentability -
The use of post-filing data to support patentability can be a mechanism to alleviate time pressures related to first-to-file patent regimes. However, the admissibility of...more
9/26/2019
/ China ,
EU ,
Filing Requirements ,
Foreign Jurisdictions ,
Foreign Patent Applications ,
Global Patent Prosecution ,
Intellectual Property Protection ,
Japan ,
Patent Prosecution ,
Patents ,
Post-Filing Evidence ,
United States
Despite marijuana’s illegal status in most countries, the patent arms race for cannabis has already begun. Indeed, analysts have projected that in North America alone the cannabis industry will grow from $9.2 billion in 2017...more
At last count, there are 27 Global and IP5 Patent Prosecution Highway (PPH) participants with the U.S. Patent and Trademark Office (USPTO). Since the PPH provides a no fee way to speed up the examination process for...more
5/14/2019
/ Administrative Procedure ,
Claim Amendments ,
Expedited Actions Process ,
Global Patent Prosecution ,
Intellectual Property Protection ,
Patent Examinations ,
Patent Prosecution ,
Patent Prosecution Highway ,
Patents ,
Prior Art ,
USPTO
A Snapshot and Strategic Use of the Patent Prosecution Highway (PPH) -
The Patent Prosecution Highway (PPH) program accelerates examination among participating patent offices. As a no fee alternative for accelerated...more
Patent eligibility continues to be a hot topic in intellectual property law, and in our April issue of the Global Patent Prosecution newsletter, we look at three of the major forums impacting this area of IP. In our first...more
USPTO’s New Guidance on Subject Matter Eligibility -
Few areas of patent law are as unsettled as subject matter eligibility. To improve clarity, consistency, and predictability, the USPTO recently published new guidance on...more
Technology Spotlight- Protecting Agricultural Products -
The Green Revolution of the 20th century increased agricultural production worldwide primarily through high-yielding plant varieties. However, in order to...more
Technology Spotlight - Patenting Blockchain Technology -
Blockchain is a booming technology, causing a dramatic increase in patent filings at the U.S Patent and Trademark Office. The November 2018 issue of Sterne Kessler’s...more
A Survey on Subject Matter Eligibility
Few areas of patent law are as unsettled as subject matter eligibility. What is considered patentable varies greatly across jurisdictions and nuances in claim language can make...more
A Survey of Third Party Observation Systems -
Third party observations can be a cost-effective way of introducing prior art or arguments related to patentability of a published patent application. The September 2018 issue...more
9/13/2018
/ America Invents Act ,
China ,
EU ,
European Patent Office ,
Foreign Patent Applications ,
Japan ,
Japan Patent Office ,
Patent Cooperation Treaty ,
Patent Prosecution ,
Patentability Search ,
Patents ,
Prior Art ,
Third-Party
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
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
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
Please see full Doctrine of Equivalents Chart for Countries around the World. ...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
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